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0086

IMMUNOASSAY PREMIUM - LEVEL 1


(IA PREMIUM 1)
CAT. NO. IA2638 GTIN: 05055273203844 SIZE: 12 x 5 ml
CAT. NO. IA2633 GTIN: 05055273203837 SIZE: 4 x 5 ml
LOT NO. 1816EC EXPIRY: 2021-05-28
INTENDED USE
This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of
analytes listed in the package insert.

This device is for prescription use only.

SAFETY PRECAUTIONS AND WARNINGS


For in vitro diagnostic use only. Do not pipette by mouth. Exercise the normal precautions required for handling laboratory reagents.

Human source material, from which this product has been derived, has been tested at donor level for the Human Immunodeficiency
Virus (HIV 1, HIV 2) antibody, Hepatitis B Surface Antigen (HbsAg), and Hepatitis C Virus (HCV) antibody and found to be NON-
REACTIVE. FDA approved methods have been used to conduct these tests.
However, since no method can offer complete assurance as to the absence of infectious agents, this material and all patient samples
should be handled as though capable of transmitting infectious diseases and disposed of accordingly.

Health and Safety Data Sheets are available on request.

STORAGE AND STABILITY


OPENED: Store refrigerated (+2ºC to +8ºC). Reconstituted serum is stable for 7 days at +2°C to +8°C, if kept capped in original
container and free from contamination, or 4 weeks frozen once at –20°C. C-Peptide is stable for 1 day at +2°C to +8°C.
Thyroglobulin should be tested within 4 hours of reconstitution when stored at +2°C to +8°C, or within 2 weeks when stored at
–20°C. ACTH should be tested immediately after the 30-minute reconstitution period. No frozen stability claim is made for ACTH,
Aldosterone and C-Peptide. Only the required amount of product should be removed. After use, any residual product should NOT BE
RETURNED to the original vial.

UNOPENED: Store refrigerated (+2°C to +8°C). Stable to expiration date printed on individual vials.

Bacterial contamination of the reconstituted serum will cause reductions in the stability of many components. If bacterial
contamination is suspected, the vial should be discarded and a fresh vial reconstituted.

PREPARATION
Immunoassay Premium is supplied lyophilised.
1. Carefully reconstitute each vial of lyophilised serum with exactly 5 ml of distilled water at +15°C to +25°C. Close the bottle and
allow to stand for 30 minutes before use. Ensure contents are completely dissolved by swirling gently. Avoid formation of
foam. Do not shake.
2. Refer to the Control section of the individual analyser application.
3. Refrigerate any unused material. Prior to reuse, mix contents thoroughly.

MATERIALS PROVIDED
Immunoassay Premium - Level 1: 12 x 5 ml Tri-Level: 4 x 5 ml

MATERIAL REQUIRED BUT NOT PROVIDED


Volumetric pipette

VALUE ASSIGNMENT
Each batch of Immunoassay Premium is submitted to a number of external laboratories. Values are assigned from a consensus of
results obtained by these laboratories, using a unique statistical analysis. Average values should normally fall within the listed ranges for
analytes in the instruments specified in this product insert. However, variations may be caused by instrument reagents and laboratory
technique. Therefore, the range produced herein should only be considered as a reference and it is recommended that each laboratory
establish its own mean and acceptable ranges. Aldosterone is present in control levels 2 and level 3 only. Parathyroid Hormone (PTH)
is present in the control, but no claim is made for the expected value or stability of this analyte.

If a method is unavailable, contact Randox Laboratories - Technical Services, Northern Ireland, tel: +44 (0) 28 9445 1070 or email
Technical.Services@randox.com.

06 Dec ’18 ne

PAGE 1 OF 22
A
IMMUNOASSAY PREMIUM - LEVEL 1 (IA PREMIUM 1)
Cat. No. IA2638 / IA2633 Lot No. 1816EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
17-OH-Progesterone nmol/l 2.64 1.98 3.30 Immunotech RIA
ng/ml 0.874 0.655 1.09
nmol/l 3.46 2.60 4.33 DRG ELISA
ng/ml 1.15 0.861 1.44
nmol/l 4.43 3.32 5.54 DIAsource RIA
ng/ml 1.47 1.10 1.84
nmol/l 3.67 2.75 4.59 SNIBE Maglumi Analysers
ng/ml 1.21 0.910 1.51
25-OH Vitamin D nmol/l 31.7 23.8 39.6 Diasorin Liaison
nmol/l 16.2 12.2 20.3 Roche Vitamin D Total
nmol/l 15.0 11.3 18.8 Abbott Architect
nmol/l 63.7 47.8 79.6 SNIBE Maglumi Analysers
nmol/l 57.5 43.1 71.9 Vitros ECi
nmol/l 24.7 18.5 30.9 Tosoh Series
nmol/l 21.4 16.1 26.8 BioMerieux Vidas
nmol/l 34.7 26.0 43.4 Beckman DxI 600/800
nmol/l 11.4 8.55 14.3 Fujirebio Lumipulse G Series
nmol/l 33.4 25.1 41.8 Beckman Access 25 OH Vitamin D Total
ACTH pmol/l 1.13 0.848 1.41 Siemens Immulite 2000/2500
pg/ml 5.14 3.85 6.43
pmol/l 2.13 1.60 2.66 Roche Cobas E411
pg/ml 9.68 7.27 12.1
pmol/l 2.02 1.52 2.53 Roche Cobas 6000/8000
pg/ml 9.18 6.91 11.5
Alpha-fetoprotein KIU/l = lU/ml 8.71 6.97 10.5 Abbott Architect
ng/ml 10.5 8.43 12.6
KIU/l = lU/ml 8.07 6.46 9.68 BioMerieux Vidas
ng/ml 9.76 7.82 11.7
KIU/l = lU/ml 9.90 7.82 12.0 Siemens Centaur XP/XPT/Classic
ng/ml 12.0 9.48 14.5
KIU/l = lU/ml 8.33 6.66 10.0 Siemens Immulite 2000/2500
ng/ml 10.1 8.06 12.1
KIU/l = lU/ml 8.43 6.74 10.1 Siemens Immulite 1000
ng/ml 10.2 8.16 12.2
KIU/l = lU/ml 9.46 7.57 11.4 Beckman DxI800
ng/ml 11.4 9.16 13.6
KIU/l = lU/ml 9.60 7.68 11.5 Roche Elecsys
ng/ml 11.6 9.29 13.9
KIU/l = lU/ml 11.0 8.80 13.2 Diasorin Liaison
ng/ml 13.3 10.6 16.0
KIU/l = lU/ml 9.81 7.85 11.8 Roche Modular E170
ng/ml 11.9 9.50 14.3

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 2 OF 22
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 1 (IA PREMIUM 1)
Cat. No. IA2638 / IA2633 Lot No. 1816EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Alpha-fetoprotein KIU/l = lU/ml 9.63 7.70 11.6 Beckman Access
ng/ml 11.7 9.32 14.1
KIU/l = lU/ml 9.87 7.90 11.8 Tosoh Series
ng/ml 11.9 9.56 14.2
KIU/l = lU/ml 10.2 8.16 12.2 Vitros ECi
ng/ml 12.3 9.87 14.7
KIU/l = lU/ml 9.82 7.86 11.8 Roche Cobas 6000/8000
ng/ml 11.9 9.51 14.3
KIU/l = lU/ml 15.3 12.2 18.4 CIS IRMA
ng/ml 18.5 14.8 22.2
KIU/l = lU/ml 9.70 7.76 11.6 Roche Cobas E411
ng/ml 11.7 9.39 14.0
KIU/l = lU/ml 10.2 8.16 12.2 SNIBE Maglumi Analysers
ng/ml 12.3 9.87 14.7
KIU/l = lU/ml 9.37 7.50 11.2 Fujirebio Lumipulse G Series
ng/ml 11.3 9.08 13.5
KIU/l = lU/ml 10.4 8.32 12.5 Siemens Dimension
ng/ml 12.6 10.1 15.1
KIU/l = lU/ml 9.61 7.59 11.6 Siemens Centaur CP
ng/ml 11.6 9.16 14.0
Amikacin µmol/l 6.49 5.19 7.79 Roche Integra
µg/ml 3.80 3.04 4.56
µmol/l 6.45 5.16 7.74 Roche Cobas 6000/8000
µg/ml 3.78 3.02 4.54
µmol/l 6.40 5.12 7.68 Gravimetric
µg/ml 3.75 3.00 4.50
Androstenedione nmol/l 4.34 3.26 5.43 Siemens Immulite 2000
ng/ml 1.25 0.936 1.56
Beta-2-microglobulin µg/ml = mg/l 1.04 0.832 1.25 Abbott Architect
µg/ml = mg/l 1.13 0.904 1.36 BioMerieux Vidas
µg/ml = mg/l 1.02 0.816 1.22 Behring Nephelometer
µg/ml = mg/l 1.07 0.856 1.28 Siemens Immulite 2000/2500
µg/ml = mg/l 1.11 0.888 1.33 Siemens Immulite 1000
µg/ml = mg/l 0.856 0.685 1.03 Diasorin Liaison
µg/ml = mg/l 1.22 0.976 1.46 Tosoh Series
µg/ml = mg/l 1.09 0.872 1.31 Roche Cobas E411
µg/ml = mg/l 1.17 0.936 1.40 Roche Cobas 6000/8000
µg/ml = mg/l 1.06 0.848 1.27 Siemens Dimension
µg/ml = mg/l 0.698 0.558 0.838 SNIBE Maglumi Analysers
µg/ml = mg/l 0.976 0.781 1.17 Fujirebio Lumipulse G Series
C-Peptide nmol/l 0.275 0.206 0.344 Siemens Immulite 2000/2500
ng/ml 0.830 0.622 1.04
nmol/l 0.433 0.325 0.541 Roche Elecsys
ng/ml 1.31 0.981 1.64
nmol/l 0.434 0.326 0.543 Roche Cobas 6000/8000
ng/ml 1.31 0.984 1.64

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 3 OF 22
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 1 (IA PREMIUM 1)
Cat. No. IA2638 / IA2633 Lot No. 1816EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
C-Peptide nmol/l 0.250 0.188 0.313 Siemens Immulite 1000
ng/ml 0.755 0.568 0.942
nmol/l 0.405 0.304 0.506 Diasorin Liaison
ng/ml 1.22 0.918 1.52
nmol/l 0.431 0.323 0.539 Roche Cobas E411
ng/ml 1.30 0.975 1.63
nmol/l 0.332 0.249 0.415 Abbott Architect
ng/ml 1.00 0.752 1.25
nmol/l 0.262 0.183 0.341 Siemens Centaur XP/XPT/Classic
ng/ml 0.791 0.554 1.03
nmol/l 0.577 0.433 0.721 SNIBE Maglumi Analysers
ng/ml 1.74 1.31 2.17
Carbamazepine µmol/l 15.8 12.6 19.0 Abbott Architect
µg/ml 3.74 2.98 4.50
µmol/l 16.9 12.2 21.6 Siemens Centaur XP/XPT/Classic
µg/ml 4.00 2.88 5.12
µmol/l 14.3 11.4 17.2 Siemens Dimension
µg/ml 3.38 2.69 4.07
µmol/l 12.5 10.0 15.0 Siemens Immulite 2000/2500
µg/ml 2.96 2.36 3.56
µmol/l 11.9 9.52 14.3 Siemens Immulite 1000
µg/ml 2.81 2.25 3.37
µmol/l 15.4 12.3 18.5 Roche Integra
µg/ml 3.64 2.91 4.37
µmol/l 12.7 10.2 15.2 Vitros
µg/ml 3.00 2.41 3.59
µmol/l 14.7 11.8 17.6 Roche Cobas E411
µg/ml 3.48 2.79 4.17
µmol/l 14.0 11.2 16.8 Roche Cobas 6000/8000
µg/ml 3.31 2.65 3.97
µmol/l 13.9 11.1 16.7 Beckman DxC
µg/ml 3.29 2.62 3.96
µmol/l 16.6 13.3 19.9 Beckman AU400/600/640/2700/5400
µg/ml 3.92 3.14 4.70
µmol/l 15.6 12.5 18.7 Siemens ADVIA 1200/1650/1800/2400
µg/ml 3.69 2.96 4.42
µmol/l 15.4 12.3 18.5 Gravimetric
µg/ml 3.64 2.91 4.37
Carcinoembryonic ng/ml = µg/l 2.74 2.19 3.29 BioMerieux Vidas
Antigen (CEA)
ng/ml = µg/l 2.89 2.31 3.47 Roche Cobas 6000/8000
ng/ml = µg/l 3.06 2.45 3.67 Roche Cobas E411
Cortisol nmol/l 177 133 221 Abbott Architect
µg/dl 6.37 4.79 7.95
nmol/l 103 77.3 129 BioMerieux Vidas
µg/dl 3.71 2.78 4.64
nmol/l 163 108 218 Siemens Centaur XP/XPT/Classic
µg/dl 5.87 3.87 7.87

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 4 OF 22
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 1 (IA PREMIUM 1)
Cat. No. IA2638 / IA2633 Lot No. 1816EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Cortisol nmol/l 135 101 169 CIS RIA
µg/dl 4.86 3.64 6.08
nmol/l 175 131 219 Siemens Immulite 2000/2500
µg/dl 6.30 4.72 7.88
nmol/l 165 124 206 Siemens Immulite 1000
µg/dl 5.94 4.46 7.42
nmol/l 170 128 213 Beckman DxI800
µg/dl 6.12 4.61 7.63
nmol/l 157 118 196 Roche Elecsys
µg/dl 5.65 4.25 7.05
nmol/l 195 146 244 Diasorin Liaison
µg/dl 7.02 5.26 8.78
nmol/l 152 114 190 Roche Modular E170
µg/dl 5.47 4.10 6.84
nmol/l 176 132 220 Beckman Access
µg/dl 6.34 4.75 7.93
nmol/l 159 119 199 Tosoh Series
µg/dl 5.72 4.28 7.16
nmol/l 130 97.5 163 Vitros ECi
µg/dl 4.68 3.51 5.85
nmol/l 153 115 191 Roche Cobas 6000/8000
µg/dl 5.51 4.14 6.88
nmol/l 162 122 203 Roche Cobas E411
µg/dl 5.83 4.39 7.27
nmol/l 238 179 298 SNIBE Maglumi Analysers
µg/dl 8.57 6.44 10.7
nmol/l 183 121 245 Siemens Centaur CP
µg/dl 6.59 4.35 8.83
nmol/l 157 118 196 Roche Modular E170 Gen II
µg/dl 5.65 4.25 7.05
nmol/l 162 122 203 Roche Cobas 4000/e411 Gen II
µg/dl 5.83 4.39 7.27
nmol/l 152 114 190 Roche Cobas 6000/8000 Gen II
µg/dl 5.47 4.10 6.84
nmol/l 168 126 210 Roche Elecsys Gen II
µg/dl 6.05 4.54 7.56
DHEA-S µmol/l 2.21 1.77 2.65 Abbott Architect
µmol/l 1.72 1.38 2.06 Siemens Immulite 2000/2500
µmol/l 1.73 1.38 2.08 Siemens Immulite 1000
µmol/l 2.12 1.70 2.54 Beckman DxI800
µmol/l 2.91 2.33 3.49 Roche Elecsys
µmol/l 2.91 2.33 3.49 Roche Modular E170
µmol/l 2.44 1.95 2.93 Beckman Access
µmol/l 1.57 1.26 1.88 Diasorin Liaison
µmol/l 1.51 0.982 2.04 Siemens Centaur XP/XPT/Classic

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 5 OF 22
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 1 (IA PREMIUM 1)
Cat. No. IA2638 / IA2633 Lot No. 1816EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
DHEA-S µmol/l 2.78 2.22 3.34 Roche Cobas E411
µmol/l 2.79 2.23 3.35 Roche Cobas 6000/8000
µmol/l 2.23 1.78 2.68 SNIBE Maglumi Analysers
Digoxin nmol/l 0.680 0.544 0.816 Abbott Architect
ng/ml 0.531 0.425 0.637
nmol/l 0.718 0.574 0.862 BioMerieux Vidas
ng/ml 0.561 0.448 0.674
nmol/l 1.07 0.803 1.34 Siemens Centaur XP/XPT/Classic
ng/ml 0.836 0.627 1.05
nmol/l 0.758 0.606 0.910 Siemens Dimension
ng/ml 0.592 0.473 0.711
nmol/l 0.796 0.637 0.955 Siemens Immulite 2000/2500
ng/ml 0.622 0.497 0.747
nmol/l 0.868 0.694 1.04 Beckman DxI800
ng/ml 0.678 0.542 0.814
nmol/l 0.891 0.713 1.07 Roche Integra
ng/ml 0.696 0.557 0.835
nmol/l 0.938 0.750 1.13 Roche Cobas 6000/8000
ng/ml 0.733 0.586 0.880
nmol/l 0.808 0.646 0.970 Beckman DxC
ng/ml 0.631 0.505 0.757
nmol/l 1.00 0.800 1.20 Beckman AU400/600/640/2700/5400
ng/ml 0.781 0.625 0.937
nmol/l 0.730 0.584 0.876 Siemens ADVIA 1200/1650/1800/2400
ng/ml 0.570 0.456 0.684
nmol/l 0.560 0.448 0.672 SNIBE Maglumi Analysers
ng/ml 0.437 0.350 0.524
nmol/l 0.969 0.775 1.16 Roche Cobas 4000/E411
ng/ml 0.757 0.605 0.909
nmol/l 0.896 0.720 1.08 Gravimetric
ng/ml 0.700 0.560 0.840
Ethosuximide µmol/l 226 181 271 Gravimetric
µg/ml 32.0 25.7 38.4
Ferritin ng/ml = µg/l 14.1 11.3 16.9 Abbott Architect
ng/ml = µg/l 10.7 8.56 12.8 BioMerieux Vidas
ng/ml = µg/l 12.3 9.23 15.4 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 12.2 9.76 14.6 Siemens Immulite 2000/2500
ng/ml = µg/l 12.6 10.1 15.1 Siemens Immulite 1000
ng/ml = µg/l 9.26 7.41 11.1 Beckman DxI800
ng/ml = µg/l 14.2 11.4 17.0 Roche Elecsys
ng/ml = µg/l 11.8 9.44 14.2 Diasorin Liaison
ng/ml = µg/l 14.1 11.3 16.9 Roche Modular E170
ng/ml = µg/l 8.94 7.15 10.7 Beckman Access
ng/ml = µg/l 8.48 6.78 10.2 Tosoh Series
ng/ml = µg/l 10.5 8.40 12.6 Vitros ECi
ng/ml = µg/l 13.2 10.6 15.8 Immunotech IRMA

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 6 OF 22
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 1 (IA PREMIUM 1)
Cat. No. IA2638 / IA2633 Lot No. 1816EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Ferritin ng/ml = µg/l 14.3 11.4 17.2 Roche Cobas E411
ng/ml = µg/l 8.63 6.90 10.4 SNIBE Maglumi Analysers
ng/ml = µg/l 6.40 5.12 7.68 Fujirebio Lumipulse G Series
ng/ml = µg/l 10.5 7.88 13.1 Siemens Centaur CP
Folate nmol/l 4.25 3.23 5.27 Abbott Architect
ng/ml 1.87 1.42 2.32
nmol/l 9.11 5.01 13.2 Siemens Centaur XP/XPT/Classic (enhanced kit)
ng/ml 4.02 2.21 5.83
nmol/l 3.17 2.41 3.93 Siemens Immulite 2000
ng/ml 1.40 1.06 1.74
nmol/l 3.80 2.89 4.71 Beckman DxI800
ng/ml 1.68 1.27 2.09
nmol/l 4.14 3.15 5.13 Beckman Access
ng/ml 1.83 1.39 2.27
nmol/l 7.03 5.34 8.72 Tosoh Series
ng/ml 3.10 2.35 3.85
nmol/l 4.55 3.46 5.64 Vitros ECi
ng/ml 2.01 1.53 2.49
nmol/l 2.51 1.91 3.11 MP Biomedicals RIA
ng/ml 1.11 0.842 1.38
nmol/l 3.61 2.74 4.48 Roche Cobas 6000/8000
ng/ml 1.59 1.21 1.97
nmol/l 2.81 2.14 3.48 SNIBE Maglumi Analysers
ng/ml 1.24 0.944 1.54
nmol/l 9.82 5.40 14.2 Siemens Centaur CP (enhanced kit)
ng/ml 4.33 2.38 6.28
nmol/l 3.58 2.72 4.44 Roche Cobas 6000/8000 Folate III
ng/ml 1.58 1.20 1.96
Free T3 pmol/l 2.45 1.84 3.06 Abbott Architect
ng/dl 0.159 0.120 0.198
pg/ml 1.59 1.20 1.98
pmol/l 2.28 1.71 2.85 BioMerieux Vidas
ng/dl 0.148 0.111 0.185
pg/ml 1.48 1.11 1.85
pmol/l 2.80 1.68 3.92 Siemens Centaur XP/XPT/Classic
ng/dl 0.182 0.109 0.255
pg/ml 1.82 1.09 2.55
pmol/l 2.64 1.98 3.30 Siemens Immulite 2000/2500
ng/dl 0.172 0.129 0.215
pg/ml 1.72 1.29 2.15
pmol/l 2.69 2.02 3.36 Siemens Immulite 1000
ng/dl 0.175 0.131 0.219
pg/ml 1.75 1.32 2.18
pmol/l 3.07 2.30 3.84 Beckman DxI800
ng/dl 0.200 0.150 0.250
pg/ml 2.00 1.50 2.50

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 7 OF 22
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 1 (IA PREMIUM 1)
Cat. No. IA2638 / IA2633 Lot No. 1816EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Free T3 pmol/l 3.43 2.57 4.29 Roche Elecsys
ng/dl 0.223 0.167 0.279
pg/ml 2.23 1.67 2.79
pmol/l 2.29 1.72 2.86 Diasorin Liaison
ng/dl 0.149 0.112 0.186
pg/ml 1.49 1.12 1.86
pmol/l 3.28 2.46 4.10 Roche Modular E170
ng/dl 0.213 0.160 0.266
pg/ml 2.14 1.60 2.68
pmol/l 3.13 2.35 3.91 Beckman Access
ng/dl 0.203 0.153 0.253
pg/ml 2.04 1.53 2.55
pmol/l 2.92 2.19 3.65 Tosoh Series
ng/dl 0.190 0.142 0.238
pg/ml 1.90 1.43 2.37
pmol/l 6.21 4.66 7.76 Vitros ECi
ng/dl 0.404 0.303 0.505
pg/ml 4.04 3.03 5.05
pmol/l 3.53 2.65 4.41 Roche Cobas E411
ng/dl 0.229 0.172 0.286
pg/ml 2.30 1.73 2.87
pmol/l 3.33 2.50 4.16 Roche Cobas 6000/8000
ng/dl 0.216 0.163 0.269
pg/ml 2.17 1.63 2.71
pmol/l 1.78 1.34 2.23 SNIBE Maglumi Analysers
ng/dl 0.116 0.087 0.145
pg/ml 1.16 0.872 1.45
pmol/l 3.02 1.81 4.23 Siemens Centaur CP
ng/dl 0.196 0.118 0.274
pg/ml 1.97 1.18 2.76
Free T4 pmol/l 9.69 7.27 12.1 Abbott Architect
ng/dl 0.756 0.567 0.945
pg/ml 7.56 5.67 9.45
pmol/l 8.04 6.03 10.1 Siemens Centaur XP/XPT/Classic
ng/dl 0.627 0.470 0.784
pg/ml 6.27 4.70 7.84
pmol/l 10.7 8.03 13.4 CIS RIA Coated tube
ng/dl 0.835 0.626 1.04
pg/ml 8.35 6.26 10.4
pmol/l 11.6 8.70 14.5 Siemens Dimension
ng/dl 0.905 0.679 1.13
pg/ml 9.05 6.79 11.3
pmol/l 13.0 9.75 16.3 Siemens Immulite 2000/2500
ng/dl 1.01 0.761 1.26
pg/ml 10.1 7.61 12.6
pmol/l 12.8 9.60 16.0 Siemens Immulite 1000
ng/dl 0.998 0.749 1.25
pg/ml 9.98 7.49 12.5

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 8 OF 22
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 1 (IA PREMIUM 1)
Cat. No. IA2638 / IA2633 Lot No. 1816EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Free T4 pmol/l 10.1 7.58 12.6 Beckman DxI800
ng/dl 0.788 0.591 0.985
pg/ml 7.88 5.91 9.85
pmol/l 13.6 10.2 17.0 Roche Elecsys
ng/dl 1.06 0.796 1.32
pg/ml 10.6 7.96 13.2
pmol/l 13.1 9.83 16.4 Diasorin Liaison
ng/dl 1.02 0.767 1.27
pg/ml 10.2 7.67 12.7
pmol/l 12.5 9.38 15.6 Roche Modular E170
ng/dl 0.975 0.732 1.22
pg/ml 9.75 7.32 12.2
pmol/l 10.6 7.95 13.3 Beckman Access
ng/dl 0.827 0.620 1.03
pg/ml 8.27 6.20 10.3
pmol/l 10.1 7.58 12.6 Tosoh Series
ng/dl 0.788 0.591 0.985
pg/ml 7.88 5.91 9.85
pmol/l 23.5 17.6 29.4 Vitros ECi
ng/dl 1.83 1.37 2.29
pg/ml 18.3 13.7 22.9
pmol/l 13.1 9.83 16.4 Roche Cobas 6000/8000
ng/dl 1.02 0.767 1.27
pg/ml 10.2 7.67 12.7
pmol/l 12.5 9.38 15.6 Immunotech IRMA
ng/dl 0.975 0.732 1.22
pg/ml 9.75 7.32 12.2
pmol/l 13.9 10.4 17.4 Roche Cobas E411
ng/dl 1.08 0.811 1.35
pg/ml 10.8 8.11 13.5
pmol/l 11.3 8.48 14.1 Siemens Dimension Vista LOCI
ng/dl 0.881 0.661 1.10
pg/ml 8.81 6.61 11.0
pmol/l 13.2 9.90 16.5 SNIBE Maglumi Analysers
ng/dl 1.03 0.772 1.29
pg/ml 10.3 7.72 12.9
pmol/l 10.4 7.80 13.0 Biomerieux Vidas FT4N Kit
ng/dl 0.811 0.608 1.01
pg/ml 8.11 6.08 10.1
pmol/l 8.82 6.62 11.0 Siemens Centaur CP
ng/dl 0.688 0.516 0.860
pg/ml 6.88 5.16 8.60
FSH mU/ml 8.06 6.45 9.67 Abbott Architect
mU/ml 9.30 7.44 11.2 BioMerieux Vidas

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 9 OF 22
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 1 (IA PREMIUM 1)
Cat. No. IA2638 / IA2633 Lot No. 1816EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
FSH mU/ml 11.1 7.77 14.4 Siemens Centaur XP/XPT/Classic
mU/ml 8.96 7.17 10.8 Siemens Immulite 2000/2500
mU/ml 9.39 7.51 11.3 Siemens Immulite 1000
mU/ml 9.70 7.76 11.6 Beckman DxI800
mU/ml 9.07 7.26 10.9 Roche/BM Elecsys
mU/ml 10.8 8.64 13.0 Diasorin Liaison
mU/ml 8.16 6.53 9.79 Roche Modular E170
mU/ml 9.51 7.61 11.4 Beckman Access
mU/ml 11.1 8.88 13.3 Tosoh Series
mU/ml 7.12 5.70 8.54 Vitros ECi
mU/ml 9.00 7.20 10.8 Roche Cobas E411
mU/ml 8.53 6.82 10.2 Roche Cobas 6000/8000
mU/ml 10.1 8.08 12.1 SNIBE Maglumi Analysers
mU/ml 7.41 5.93 8.89 Fujirebio Lumipulse G Series
mU/ml 8.13 5.69 10.6 Siemens Centaur CP
Gentamicin µmol/l 4.17 3.34 5.00 Roche Integra
µg/ml 1.99 1.60 2.38
µmol/l 4.95 3.56 6.34 Siemens Centaur XP/XPT/Classic
µg/ml 2.37 1.71 3.03
µmol/l 4.38 3.50 5.26 Siemens Dimension Vista
µg/ml 2.09 1.67 2.51
µmol/l 3.32 2.66 3.98 Roche Cobas 6000/8000
µg/ml 1.59 1.27 1.91
µmol/l 4.77 3.82 5.72 Beckman DxC
µg/ml 2.28 1.83 2.73
µmol/l 4.85 3.88 5.82 Gravimetric
µg/ml 2.32 1.85 2.78
Growth Hormone (GH) µU/ml 4.36 3.49 5.23 Siemens Immulite 2000/2500
ng/ml 1.45 1.16 1.74
µU/ml 4.03 3.22 4.84 Siemens Immulite 1000
ng/ml 1.34 1.07 1.61
µU/ml 3.01 2.41 3.61 Beckman DxI800
ng/ml 1.00 0.803 1.20
µU/ml 3.09 2.47 3.71 Beckman Access
ng/ml 1.03 0.823 1.24
µU/ml 4.07 3.26 4.88 Tosoh Series
ng/ml 1.36 1.09 1.63
µU/ml 3.45 2.76 4.14 Diasorin Liaison
ng/ml 1.15 0.919 1.38
µU/ml 4.54 3.63 5.45 Roche Cobas E411
ng/ml 1.51 1.21 1.81
µU/ml 6.39 5.11 7.67 SNIBE Maglumi Analysers
ng/ml 2.13 1.70 2.56
µU/ml 4.45 3.56 5.34 Roche Cobas 6000/8000
ng/ml 1.48 1.19 1.77
µU/ml 3.41 2.73 4.09 IDS iSYS
ng/ml 1.14 0.909 1.37

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 10 OF 22
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 1 (IA PREMIUM 1)
Cat. No. IA2638 / IA2633 Lot No. 1816EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Immunoglobulin E KIU/l = IU/ml 272 218 326 Abbott Architect
KIU/l = IU/ml 207 166 248 BioMerieux Vidas
KIU/l = IU/ml 225 135 315 Siemens Centaur XP/XPT/Classic
KIU/l = IU/ml 247 198 296 Siemens Immulite 2000/2500
KIU/l = IU/ml 256 205 307 Siemens Immulite 1000
KIU/l = IU/ml 271 217 325 Beckman DxI800
KIU/l = IU/ml 231 185 277 Roche Elecsys
KIU/l = IU/ml 220 176 264 Pharmacia Unicap
KIU/l = IU/ml 233 186 280 Roche Modular E170
KIU/l = IU/ml 236 189 283 Tosoh Series
KIU/l = IU/ml 240 192 288 Roche Cobas E411
KIU/l = IU/ml 237 190 284 Roche Cobas 6000/8000
KIU/l = IU/ml 196 157 235 SNIBE Maglumi Analysers
KIU/l = IU/ml 201 161 241 Fujirebio Lumipulse G Series
KIU/l = IU/ml 211 127 295 Siemens Centaur CP
Insulin mU/l 1.94 1.46 2.42 Siemens Centaur XP/XPT/Classic
mU/l 2.29 1.72 2.86 Roche Modular E170
mU/l 2.59 1.94 3.24 Siemens Immulite 2000
mU/l 2.19 1.64 2.74 Roche Elecsys
mU/l 1.26 0.945 1.58 Beckman Access
mU/l 1.60 1.20 2.00 Abbott Architect
mU/l 2.36 1.77 2.95 Tosoh Series
mU/l 2.13 1.60 2.66 Roche Cobas E411
mU/l 1.25 0.938 1.56 Beckman DxI 600/800
mU/l 1.46 1.10 1.83 Diasorin Liaison
mU/l 2.21 1.66 2.76 Roche Cobas 6000/8000
mU/l 5.27 3.95 6.59 SNIBE Maglumi Analysers
mU/l 1.70 1.28 2.13 Fujirebio Lumipulse G Series
mU/l 1.79 1.34 2.24 Siemens Centaur CP
Luteinising Hormone mU/ml 1.79 1.43 2.15 Abbott Architect
(LH)
mU/ml 2.55 2.04 3.06 BioMerieux Vidas
mU/ml 2.38 1.79 2.97 Siemens Centaur XP/XPT/Classic
mU/ml 5.86 4.69 7.03 Siemens Immulite 2000
mU/ml 6.27 5.02 7.52 Siemens Immulite 1000
mU/ml 1.65 1.32 1.98 Beckman DxI800
mU/ml 3.14 2.51 3.77 Roche Elecsys
mU/ml 2.84 2.27 3.41 Diasorin Liaison
mU/ml 3.08 2.46 3.70 Roche Modular E170
mU/ml 1.69 1.35 2.03 Beckman Access
mU/ml 2.14 1.71 2.57 Tosoh Series
mU/ml 4.40 3.52 5.28 Vitros ECi
mU/ml 3.08 2.46 3.70 Roche Cobas E411
mU/ml 3.11 2.49 3.73 Roche Cobas 6000/8000
mU/ml 3.35 2.68 4.02 SNIBE Maglumi Analysers
mU/ml 2.42 1.94 2.90 Fujirebio Lumipulse G Series

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 11 OF 22
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 1 (IA PREMIUM 1)
Cat. No. IA2638 / IA2633 Lot No. 1816EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Luteinising Hormone mU/ml 2.19 1.64 2.74 Siemens Centaur CP
Oestradiol pmol/l 244 195 293 Abbott Architect
pg/ml 66.4 53.0 79.8
pmol/l 232 186 278 BioMerieux Vidas
pg/ml 63.1 50.6 75.6
pmol/l 223 134 312 Siemens Centaur XP/XPT/Classic
pg/ml 60.7 36.4 85.0
pmol/l 168 134 202 Siemens Immulite 2000/2500
pg/ml 45.7 36.4 55.0
pmol/l 163 130 196 Siemens Immulite 1000
pg/ml 44.3 35.4 53.2
pmol/l 185 148 222 Roche Elecsys (Estradiol II)
pg/ml 50.3 40.3 60.3
pmol/l 140 112 168 Vitros ECi
pg/ml 38.1 30.5 45.7
pmol/l 203 162 244 Roche Cobas 6000/8000 (Estradiol II)
pg/ml 55.2 44.1 66.3
pmol/l 192 154 230 Roche Cobas 4000/E411 (Estradiol II)
pg/ml 52.2 41.9 62.5
pmol/l 226 136 316 Siemens Centaur XP/XPT/Classic Enhanced (eE2)
pg/ml 61.5 36.9 86.1
pmol/l 210 126 294 Siemens Centaur XP/XPT/Classic E26 III
pg/ml 57.1 34.3 79.9
pmol/l 185 148 222 SNIBE Maglumi Analysers
pg/ml 50.3 40.3 60.3
pmol/l 254 152 356 Siemens Centaur CP
pg/ml 69.1 41.5 96.7
pmol/l 223 134 312 Siemens Centaur CP Enhanced (eE2)
pg/ml 60.7 36.4 85.0
pmol/l 226 181 271 Fujirebio Lumipulse G Series
pg/ml 61.5 49.2 73.8
pmol/l 203 162 244 Roche Cobas 6000/8000 (Estradiol III)
pg/ml 55.2 44.1 66.3
pmol/l 187 150 224 Roche Elecsys (Estradiol III)
pg/ml 50.9 40.8 61.0
pmol/l 185 148 222 Roche Cobas 4000/E411 (Estradiol III)
pg/ml 50.3 40.3 60.3
pmol/l 211 169 253 Roche Modular E170 (Estradiol III)
pg/ml 57.4 46.0 68.8
Paracetamol mmol/l 0.150 0.120 0.180 Roche Integra
mg/l 22.7 18.2 27.2
mmol/l 0.161 0.129 0.193 Abbott Architect
mg/l 24.4 19.5 29.3
mmol/l 0.132 0.106 0.158 Roche Cobas 6000/8000
mg/l 20.0 16.0 24.0
mmol/l 0.166 0.130 0.200 Gravimetric
mg/l 25.1 19.7 30.3

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 12 OF 22
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 1 (IA PREMIUM 1)
Cat. No. IA2638 / IA2633 Lot No. 1816EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Phenobarbital µmol/l 35.6 28.5 42.7 Abbott Architect
µg/ml 8.26 6.61 9.91
µmol/l 32.9 26.3 39.5 Roche Cobas 6000/8000
µg/ml 7.63 6.10 9.16
µmol/l 36.3 29.0 43.6 Siemens Immulite 2000/2500
µg/ml 8.42 6.73 10.1
µmol/l 32.9 26.3 39.5 Beckman AU400/600/640/2700/5400
µg/ml 7.63 6.10 9.16
µmol/l 42.5 29.8 55.2 Siemens Centaur XP/XPT/Classic
µg/ml 9.86 6.90 12.8
µmol/l 34.2 27.4 41.0 Roche Integra
µg/ml 7.93 6.36 9.50
µmol/l 37.3 29.8 44.8 Siemens Immulite 1000
µg/ml 8.65 6.91 10.4
µmol/l 28.4 22.7 34.1 Roche Cobas E411
µg/ml 6.59 5.27 7.91
µmol/l 32.1 25.7 38.5 Beckman DxC
µg/ml 7.45 5.96 8.94
µmol/l 34.5 27.6 41.4 Gravimetric
µg/ml 8.00 6.40 9.60
Phenytoin µmol/l 19.3 15.4 23.2 Abbott Architect
µg/ml 4.87 3.89 5.85
µmol/l 18.4 13.8 23.0 Siemens Centaur XP/XPT/Classic
µg/ml 4.65 3.49 5.81
µmol/l 17.8 14.2 21.4 Siemens Dimension
µg/ml 4.49 3.59 5.39
µmol/l 18.7 15.0 22.4 Siemens Immulite 2000/2500
µg/ml 4.72 3.79 5.65
µmol/l 19.2 15.4 23.0 Siemens Immulite 1000
µg/ml 4.85 3.89 5.81
µmol/l 18.8 15.0 22.6 Roche Integra
µg/ml 4.75 3.79 5.71
µmol/l 15.4 12.3 18.5 Vitros
µg/ml 3.89 3.11 4.67
µmol/l 18.6 14.9 22.3 Roche Cobas E411
µg/ml 4.70 3.76 5.64
µmol/l 18.5 14.8 22.2 Roche Cobas 6000/8000
µg/ml 4.67 3.74 5.60
µmol/l 19.0 15.2 22.8 Beckman DxC
µg/ml 4.80 3.84 5.76
µmol/l 20.2 16.2 24.2 Gravimetric
µg/ml 5.10 4.09 6.11
Primidone µmol/l 12.3 9.84 14.8 Gravimetric
µg/ml 2.69 2.15 3.23
Progesterone nmol/l 3.28 2.62 3.94 Abbott Architect
ng/ml 1.03 0.820 1.24

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 13 OF 22
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 1 (IA PREMIUM 1)
Cat. No. IA2638 / IA2633 Lot No. 1816EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Progesterone nmol/l 4.60 3.68 5.52 BioMerieux Vidas
ng/ml 1.44 1.15 1.73
nmol/l 2.47 1.36 3.58 Siemens Centaur XP/XPT/Classic
ng/ml 0.773 0.425 1.12
nmol/l 3.60 2.88 4.32 Siemens Immulite 2000/2500
ng/ml 1.13 0.901 1.36
nmol/l 3.61 2.89 4.33 Siemens Immulite 1000
ng/ml 1.13 0.905 1.36
nmol/l 3.49 2.79 4.19 Beckman DxI Prog Cal 33555
ng/ml 1.09 0.873 1.31
nmol/l 3.39 2.71 4.07 Roche Elecsys (Prog. II)
ng/ml 1.06 0.848 1.27
nmol/l 3.50 2.80 4.20 Beckman Access Prog Cal 33555
ng/ml 1.10 0.876 1.32
nmol/l 2.64 2.11 3.17 Tosoh Series
ng/ml 0.826 0.660 0.992
nmol/l 3.09 2.47 3.71 Vitros ECi
ng/ml 0.967 0.773 1.16
nmol/l 3.42 2.74 4.10 Roche Cobas 4000/e411 (Prog. II)
ng/ml 1.07 0.858 1.28
nmol/l 3.62 2.90 4.34 Roche Cobas 6000/8000 (Prog. II)
ng/ml 1.13 0.908 1.35
nmol/l 2.88 2.30 3.46 Diasorin Liaison
ng/ml 0.901 0.720 1.08
nmol/l 1.92 1.54 2.30 SNIBE Maglumi Analysers
ng/ml 0.601 0.482 0.720
nmol/l 3.26 2.61 3.91 Beckman DxI Prog DE Cal A80773
ng/ml 1.02 0.817 1.22
nmol/l 2.79 1.53 4.05 Siemens Centaur CP
ng/ml 0.873 0.480 1.27
nmol/l 3.55 2.84 4.26 Roche Cobas 6000/8000 (Prog. III)
ng/ml 1.11 0.889 1.33
nmol/l 3.22 2.58 3.86 Roche Elecsys (Prog. III)
ng/ml 1.01 0.808 1.21
nmol/l 3.47 2.78 4.16 Roche Cobas 4000/e411 (Prog. III)
ng/ml 1.09 0.870 1.31
nmol/l 3.69 2.95 4.43 Roche Modular E170 (Prog. III)
ng/ml 1.15 0.923 1.38
Prolactin µU/ml 162 130 194 Abbott Architect
µU/ml 161 129 193 BioMerieux Vidas
µU/ml 150 105 195 Siemens Centaur XP/XPT/Classic
µU/ml 145 116 174 Siemens Immulite 2000/2500
µU/ml 163 130 196 Siemens Immulite 1000
µU/ml 145 116 174 Beckman DxI800
µU/ml 162 130 194 Roche Elecsys

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 14 OF 22
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 1 (IA PREMIUM 1)
Cat. No. IA2638 / IA2633 Lot No. 1816EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Prolactin µU/ml 172 138 206 Diasorin Liaison
µU/ml 153 122 184 Roche Modular E170
µU/ml 148 118 178 Beckman Access
µU/ml 177 142 212 Tosoh Series
µU/ml 184 147 221 Vitros ECi
µU/ml 155 124 186 Roche Elecsys/E170/Cobas 6000/8000 PRLII
µU/ml 175 140 210 Immunotech IRMA
µU/ml 160 128 192 Roche Cobas E411
µU/ml 155 124 186 Roche Cobas 6000/8000
µU/ml 179 143 215 SNIBE Maglumi Analysers
µU/ml 187 150 224 Fujirebio Lumipulse G Series
µU/ml 160 128 192 Abbott Architect restandardised
µU/ml 141 98.7 183 Siemens Centaur CP
PSA Free ng/ml = µg/l 1.40 1.05 1.75 Abbott Architect
ng/ml = µg/l 1.82 1.37 2.28 BioMerieux Vidas
ng/ml = µg/l 1.72 1.29 2.15 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 1.12 0.840 1.40 Siemens Dimension
ng/ml = µg/l 1.44 1.08 1.80 Siemens Immulite 2000/2500
ng/ml = µg/l 1.27 0.953 1.59 Siemens Immulite 1000
ng/ml = µg/l 2.00 1.50 2.50 Beckman DXI standardised to Hybritech
ng/ml = µg/l 1.50 1.13 1.88 Roche Elecsys
ng/ml = µg/l 0.409 0.307 0.511 Diasorin Liaison
ng/ml = µg/l 1.51 1.13 1.89 Roche Modular E170
ng/ml = µg/l 2.09 1.57 2.61 Beckman Access standardised to Hybritech
ng/ml = µg/l 1.42 1.07 1.78 Tosoh Series
ng/ml = µg/l 1.53 1.15 1.91 Roche Cobas E411
ng/ml = µg/l 1.50 1.13 1.88 Roche Cobas 6000/8000
ng/ml = µg/l 1.64 1.23 2.05 Beckman DxI800 standardised to WHO IRP96/670
ng/ml = µg/l 1.19 0.893 1.49 SNIBE Maglumi Analysers
ng/ml = µg/l 1.34 1.01 1.68 Ortho Vitros 3600/5600/ECi PSA II
ng/ml = µg/l 1.12 0.840 1.40 Fujirebio Lumipulse G Series
PSA Total ng/ml = µg/l 1.62 1.22 2.03 Abbott Architect
ng/ml = µg/l 1.89 1.42 2.36 BioMerieux Vidas
ng/ml = µg/l 1.96 1.47 2.45 bioMerieux VIDAS TPSA
ng/ml = µg/l 1.65 1.24 2.06 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 1.57 1.18 1.96 Siemens Immulite 2000/2500 1st generation
ng/ml = µg/l 1.66 1.25 2.08 Siemens Immulite 2000/2500 3rd generation
ng/ml = µg/l 1.55 1.16 1.94 Siemens Immulite 1000 1st generation
ng/ml = µg/l 1.67 1.25 2.09 Beckman DxI standardisd to Hybritech
ng/ml = µg/l 1.48 1.11 1.85 Beckman DxI800 standardised to WHO IRP96/670
ng/ml = µg/l 1.88 1.41 2.35 Roche Elecsys
ng/ml = µg/l 0.441 0.331 0.551 Diasorin Liaison
ng/ml = µg/l 1.95 1.46 2.44 Roche Modular E170
ng/ml = µg/l 1.72 1.29 2.15 Beckman Access standardised to Hybritech
ng/ml = µg/l 1.61 1.21 2.01 Beckman Access standardised to WHO IRP96/670
ng/ml = µg/l 1.09 0.818 1.36 Tosoh Series

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 15 OF 22
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 1 (IA PREMIUM 1)
Cat. No. IA2638 / IA2633 Lot No. 1816EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
PSA Total ng/ml = µg/l 1.87 1.40 2.34 Vitros ECi
ng/ml = µg/l 1.96 1.47 2.45 CIS RIA Coated tube
ng/ml = µg/l 1.95 1.46 2.44 Roche Cobas E411
ng/ml = µg/l 2.01 1.51 2.51 Roche Cobas 6000/8000
ng/ml = µg/l 2.31 1.73 2.89 SNIBE Maglumi Analysers
ng/ml = µg/l 1.37 1.03 1.71 Fujirebio Lumipulse G Series
ng/ml = µg/l 1.90 1.43 2.38 Ortho Vitros 3600/5600/ECi PSA II
ng/ml = µg/l 1.57 1.18 1.96 Siemens Centaur CP
Salicylic Acid mmol/l 0.362 0.290 0.434 Abbott Architect
mg/dl 5.00 4.01 5.99
mmol/l 0.286 0.230 0.340 Gravimetric
mg/dl 3.95 3.18 4.70
SHBG nmol/l 12.0 9.60 14.4 Siemens Centaur XP/XPT/Classic
nmol/l 11.0 8.80 13.2 Siemens Immulite 1000
nmol/l 11.1 8.88 13.3 Siemens Immulite 2000/2500
nmol/l 12.4 9.92 14.9 Roche Elecsys
nmol/l 11.9 9.52 14.3 Roche Modular E170
nmol/l 10.7 8.56 12.8 Abbott Architect
nmol/l 12.0 9.60 14.4 Roche Cobas E411
nmol/l 11.9 9.52 14.3 Roche Cobas 6000/8000
nmol/l 11.2 8.96 13.4 Beckman DxI800
nmol/l 11.9 9.52 14.3 SNIBE Maglumi Analysers
T Uptake %U 33.4 27.4 39.4 Siemens Immulite 2000
Testosterone nmol/l 1.74 1.39 2.09 Abbott Architect
ng/ml 0.501 0.400 0.602
ng/dl 50.1 40.0 60.2
nmol/l 1.03 0.824 1.24 BioMerieux Vidas
ng/ml 0.297 0.237 0.357
ng/dl 29.7 23.7 35.7
nmol/l 1.53 1.22 1.84 CIS RIA Coated tube
ng/ml 0.441 0.351 0.531
ng/dl 44.1 35.1 53.1
nmol/l 1.20 0.960 1.44 Siemens Immulite 2000/2500
ng/ml 0.346 0.276 0.416
ng/dl 34.6 27.6 41.6
nmol/l 1.37 1.10 1.64 Siemens Immulite 1000
ng/ml 0.395 0.317 0.473
ng/dl 39.5 31.7 47.3
nmol/l 1.61 1.29 1.93 Beckman DxI800
ng/ml 0.464 0.372 0.556
ng/dl 46.4 37.2 55.6
nmol/l 1.68 1.34 2.02 Beckman Access
ng/ml 0.484 0.386 0.582
ng/dl 48.4 38.6 58.2
nmol/l 1.12 0.896 1.34 Vitros ECi
ng/ml 0.323 0.258 0.388
ng/dl 32.3 25.8 38.8

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 16 OF 22
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 1 (IA PREMIUM 1)
Cat. No. IA2638 / IA2633 Lot No. 1816EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Testosterone nmol/l 1.77 1.42 2.12 Roche Cobas 6000 Test 2
ng/ml 0.510 0.409 0.611
ng/dl 51.0 40.9 61.1
nmol/l 1.73 1.38 2.08 Roche Elecsys Test II
ng/ml 0.498 0.397 0.599
ng/dl 49.8 39.7 59.9
nmol/l 1.80 1.44 2.16 Roche Modular E170 Test II
ng/ml 0.518 0.415 0.621
ng/dl 51.8 41.5 62.1
nmol/l 1.81 1.45 2.17 Roche Cobas 4000/e411 Test II
ng/ml 0.521 0.418 0.624
ng/dl 52.1 41.8 62.4
nmol/l 1.81 1.45 2.17 Abbott Architect 2nd Generation
ng/ml 0.521 0.418 0.624
ng/dl 52.1 41.8 62.4
nmol/l 1.92 1.25 2.59 Siemens Centaur CP
ng/ml 0.553 0.359 0.747
ng/dl 55.3 35.9 74.7
nmol/l 1.07 0.856 1.28 BioMerieux Vidas Testosterone II
ng/ml 0.308 0.247 0.369
ng/dl 30.8 24.7 36.9
nmol/l 1.54 1.00 2.08 Siemens Centaur TST II
ng/ml 0.444 0.289 0.599
ng/dl 44.4 28.9 59.9
Theophylline µmol/l 33.2 23.2 43.2 Siemens Centaur XP/XPT/Classic
µg/ml 5.98 4.19 7.77
µmol/l 24.2 19.4 29.0 Siemens Dimension
µg/ml 4.36 3.50 5.22
µmol/l 28.3 22.6 34.0 Roche Integra
µg/ml 5.10 4.07 6.13
µmol/l 25.2 20.2 30.2 Abbott Architect
µg/ml 4.54 3.64 5.44
µmol/l 26.6 21.3 31.9 Roche Cobas 6000/8000
µg/ml 4.79 3.84 5.74
µmol/l 23.3 18.6 28.0 Beckman DxC
µg/ml 4.20 3.35 5.05
µmol/l 22.1 17.7 26.5 Beckman AU400/600/640/2700/5400
µg/ml 3.98 3.19 4.77
µmol/l 28.3 22.6 34.0 Gravimetric
µg/ml 5.10 4.07 6.13
Thyroglobulin ng/ml 2.93 2.20 3.66 Roche Elecsys
ng/ml 2.12 1.59 2.65 Beckman DxI800
ng/ml 3.07 2.30 3.84 Roche Cobas E411
ng/ml 2.98 2.24 3.73 Roche Cobas 6000/8000
ng/ml 2.21 1.66 2.76 Beckman Access

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 17 OF 22
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 1 (IA PREMIUM 1)
Cat. No. IA2638 / IA2633 Lot No. 1816EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Thyroglobulin ng/ml 1.32 0.990 1.65 SNIBE Maglumi Analysers
ng/ml 3.24 2.43 4.05 Tosoh Series
ng/ml 2.92 2.19 3.65 Roche Cobas 6000 TGII
ng/ml 2.95 2.21 3.69 Roche Elecsys TGII
ng/ml 2.99 2.24 3.74 Roche Cobas 4000/E411 TGII
ng/ml 2.91 2.18 3.64 Roche Modular E170 TGII
Thyroid Stimulating µU/ml = mlU/l 0.126 0.101 0.151 Abbott Architect
Hormone
µU/ml = mlU/l 0.097 0.078 0.116 bioMerieux VIDAS TSH
µU/ml = mlU/l 0.093 0.074 0.112 bioMerieux VIDAS TSH3 Ultrasensitive
µU/ml = mlU/l 0.127 0.086 0.168 Siemens Centaur XP/XPT/Classic
µU/ml = mlU/l 0.122 0.083 0.161 Siemens Centaur XP/XPT/Classic 3rd Generation
µU/ml = mlU/l 0.133 0.106 0.160 Siemens Immulite 2000/2500
µU/ml = mlU/l 0.145 0.116 0.174 Siemens Immulite 1000
µU/ml = mlU/l 0.115 0.092 0.138 Beckman DxI800 Fast TSH
µU/ml = mlU/l 0.110 0.088 0.132 Beckman DxI800
µU/ml = mlU/l 0.167 0.134 0.200 Roche Elecsys
µU/ml = mlU/l 0.168 0.134 0.202 Diasorin Liaison
µU/ml = mlU/l 0.170 0.136 0.204 Roche Modular E170
µU/ml = mlU/l 0.112 0.090 0.134 Beckman Access Fast TSH
µU/ml = mlU/l 0.115 0.092 0.138 Beckman Access hyperTSH 3rd Generation
µU/ml = mlU/l 0.186 0.149 0.223 Tosoh Series
µU/ml = mlU/l 0.248 0.198 0.298 Vitros ECi
µU/ml = mlU/l 0.165 0.132 0.198 Roche Cobas E411
µU/ml = mlU/l 0.167 0.134 0.200 Roche Cobas 6000/8000
µU/ml = mlU/l 0.113 0.090 0.136 Beckman DxI800 Hyper TSH
µU/ml = mlU/l 0.121 0.097 0.145 Siemens Dimension Vista LOCI
µU/ml = mlU/l 0.182 0.146 0.218 SNIBE Maglumi Analysers
µU/ml = mlU/l 0.128 0.087 0.169 Siemens Centaur XP/XPT/Classic TSH3-Ultra
µU/ml = mlU/l 0.130 0.088 0.172 Siemens Centaur CP
µU/ml = mlU/l 0.127 0.086 0.168 Siemens Centaur CP TSH3-Ultra
µU/ml = mlU/l 0.111 0.089 0.133 Beckman DxI 600/800 Access (3rd IS)
Tobramycin µmol/l 4.17 3.34 5.00 Gravimetric
µg/ml 1.95 1.56 2.34
Total Beta hCG mU/ml=IU/l 5.29 4.23 6.35 Abbott Architect
IU/ml 0.005 0.004 0.006
mU/ml=IU/l 9.81 7.85 11.8 BioMerieux Vidas
IU/ml 0.010 0.008 0.012
mU/ml=IU/l 10.0 6.00 14.0 Siemens Centaur XP/XPT/Classic
IU/ml 0.010 0.006 0.014
mU/ml=IU/l 9.94 7.95 11.9 Siemens Dimension
IU/ml 0.010 0.008 0.012
mU/ml=IU/l 12.8 10.2 15.4 Siemens Immulite 2000
IU/ml 0.013 0.010 0.016
mU/ml=IU/l 12.8 10.2 15.4 Siemens Immulite 1000
IU/ml 0.013 0.010 0.016
mU/ml=IU/l 5.94 4.75 7.13 Beckman DxI800
IU/ml 0.006 0.005 0.007

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 18 OF 22
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 1 (IA PREMIUM 1)
Cat. No. IA2638 / IA2633 Lot No. 1816EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Total Beta hCG mU/ml=IU/l 4.38 3.50 5.26 Diasorin Liaison
IU/ml 0.004 0.004 0.004
mU/ml=IU/l 5.55 4.44 6.66 Roche Cobas Core EIA
IU/ml 0.006 0.004 0.008
mU/ml=IU/l 5.85 4.68 7.02 Beckman Access
IU/ml 0.006 0.005 0.007
mU/ml=IU/l 9.95 7.96 11.9 Tosoh Series
IU/ml 0.010 0.008 0.012
mU/ml=IU/l 11.3 9.04 13.6 Vitros ECi
IU/ml 0.011 0.009 0.013
mU/ml=IU/l 7.14 5.71 8.57 Roche STAT (Intact)
IU/ml 0.007 0.006 0.008
mU/ml=IU/l 5.68 4.54 6.82 Roche hCG+Beta
IU/ml 0.006 0.005 0.007
mU/ml=IU/l 6.62 5.30 7.94 SNIBE Maglumi Analysers
IU/ml 0.007 0.005 0.009
mU/ml=IU/l 4.34 3.47 5.21 Fujirebio Lumipulse G Series
IU/ml 0.004 0.003 0.005
mU/ml=IU/l 5.93 4.74 7.12 Beckman Access Total BhCG (5th IS)
IU/ml 0.006 0.005 0.007
mU/ml=IU/l 5.92 4.74 7.10 Beckman DxI Total BhCG (5th IS)
IU/ml 0.006 0.005 0.007
mU/ml=IU/l 7.46 4.48 10.4 Siemens Centaur CP
IU/ml 0.007 0.004 0.010
Total T3 nmol/l 0.655 0.491 0.819 Abbott Architect
ng/ml 0.426 0.320 0.532
ng/dl 42.6 32.0 53.2
nmol/l 0.617 0.463 0.771 Siemens Immulite 2000/2500
ng/ml 0.402 0.301 0.503
ng/dl 40.2 30.1 50.3
nmol/l 0.616 0.462 0.770 Siemens Immulite 1000
ng/ml 0.401 0.301 0.501
ng/dl 40.1 30.1 50.1
nmol/l 0.711 0.533 0.889 Beckman DxI800
ng/ml 0.463 0.347 0.579
ng/dl 46.3 34.7 57.9
nmol/l 1.18 0.885 1.48 Roche Elecsys
ng/ml 0.768 0.576 0.960
ng/dl 76.8 57.6 96.0
nmol/l 0.731 0.548 0.914 Diasorin Liaison
ng/ml 0.476 0.357 0.595
ng/dl 47.6 35.7 59.5
nmol/l 0.788 0.591 0.985 Beckman Access
ng/ml 0.513 0.385 0.641
ng/dl 51.3 38.5 64.1

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 19 OF 22
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 1 (IA PREMIUM 1)
Cat. No. IA2638 / IA2633 Lot No. 1816EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Total T3 nmol/l 0.422 0.317 0.528 Tosoh Series
ng/ml 0.275 0.206 0.344
ng/dl 27.5 20.6 34.4
nmol/l 0.737 0.553 0.921 Vitros ECi
ng/ml 0.480 0.360 0.600
ng/dl 48.0 36.0 60.0
nmol/l 0.496 0.372 0.620 CIS RIA Coated tube
ng/ml 0.323 0.242 0.404
ng/dl 32.3 24.2 40.4
nmol/l 1.22 0.915 1.53 Roche Cobas E411
ng/ml 0.794 0.596 0.992
ng/dl 79.4 59.6 99.2
nmol/l 1.08 0.810 1.35 Roche Cobas 6000/8000
ng/ml 0.703 0.527 0.879
ng/dl 70.3 52.7 87.9
nmol/l 0.390 0.293 0.488 SNIBE Maglumi Analysers
ng/ml 0.254 0.191 0.317
ng/dl 25.4 19.1 31.7
nmol/l 0.521 0.391 0.651 Siemens Centaur CP
ng/ml 0.339 0.254 0.424
ng/dl 33.9 25.4 42.4
Total T4 nmol/l 34.8 26.1 43.5 Abbott Architect
µg/dl 2.71 2.04 3.38
ng/ml 27.1 20.4 33.8
nmol/l 32.5 24.4 40.6 BioMerieux Vidas
µg/dl 2.54 1.90 3.18
ng/ml 25.4 19.0 31.8
nmol/l 23.2 16.2 30.2 Siemens Centaur XP/XPT/Classic
µg/dl 1.81 1.27 2.35
ng/ml 18.1 12.7 23.5
nmol/l 22.7 17.0 28.4 Siemens Immulite 2000/2500
µg/dl 1.77 1.33 2.21
ng/ml 17.7 13.3 22.1
nmol/l 25.0 18.8 31.3 Siemens Immulite 1000
µg/dl 1.95 1.47 2.43
ng/ml 19.5 14.7 24.3
nmol/l 36.2 27.2 45.3 Roche Elecsys
µg/dl 2.82 2.12 3.52
ng/ml 28.2 21.2 35.2
nmol/l 28.3 21.2 35.4 Diasorin Liaison
µg/dl 2.21 1.65 2.77
ng/ml 22.1 16.5 27.7
nmol/l 23.3 17.5 29.1 Beckman Access
µg/dl 1.82 1.37 2.27
ng/ml 18.2 13.7 22.7
nmol/l 24.4 18.3 30.5 Tosoh Series
µg/dl 1.90 1.43 2.37
ng/ml 19.0 14.3 23.7

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 20 OF 22
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 1 (IA PREMIUM 1)
Cat. No. IA2638 / IA2633 Lot No. 1816EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Total T4 nmol/l 27.8 20.9 34.8 Vitros ECi
µg/dl 2.17 1.63 2.71
ng/ml 21.7 16.3 27.1
nmol/l 29.0 21.8 36.3 CIS RIA Coated tube
µg/dl 2.26 1.70 2.82
ng/ml 22.6 17.0 28.2
nmol/l 36.0 27.0 45.0 Roche Cobas E411
µg/dl 2.81 2.11 3.51
ng/ml 28.1 21.1 35.1
nmol/l 34.1 25.6 42.6 Roche Cobas 6000/8000
µg/dl 2.66 2.00 3.32
ng/ml 26.6 20.0 33.2
nmol/l 29.2 21.9 36.5 Immunotech IRMA
µg/dl 2.28 1.71 2.85
ng/ml 22.8 17.1 28.5
nmol/l 32.9 24.7 41.1 SNIBE Maglumi Analysers
µg/dl 2.57 1.93 3.21
ng/ml 25.7 19.3 32.1
Valproic Acid µmol/l 222 178 266 Abbott Architect
µg/ml 32.0 25.7 38.3
µmol/l 235 165 305 Siemens Centaur XP/XPT/Classic
µg/ml 33.9 23.7 44.1
µmol/l 207 166 248 Siemens Dimension
µg/ml 29.9 24.0 35.8
µmol/l 186 149 223 Siemens Immulite 2000/2500
µg/ml 26.8 21.5 32.1
µmol/l 195 156 234 Siemens Immulite 1000
µg/ml 28.1 22.5 33.7
µmol/l 197 158 236 Roche Integra
µg/ml 28.4 22.8 34.0
µmol/l 169 135 203 Vitros
µg/ml 24.4 19.5 29.3
µmol/l 205 164 246 Roche Cobas E411
µg/ml 29.6 23.7 35.5
µmol/l 198 158 238 Roche Cobas 6000/8000
µg/ml 28.6 22.8 34.4
µmol/l 151 121 181 Beckman DxC
µg/ml 21.8 17.5 26.1
µmol/l 208 166 250 Beckman AU400/600/640/2700/5400
µg/ml 30.0 24.0 36.0
µmol/l 215 172 258 Siemens ADVIA 1200/1650/1800/2400
µg/ml 31.0 24.8 37.2
µmol/l 243 194 292 Gravimetric
µg/ml 35.1 28.0 42.1

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 21 OF 22
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 1 (IA PREMIUM 1)
Cat. No. IA2638 / IA2633 Lot No. 1816EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Vancomycin µmol/l 3.94 3.15 4.73 Roche Integra
µg/ml 5.85 4.68 7.02
µmol/l 3.20 2.56 3.84 Abbott Architect
µg/ml 4.75 3.80 5.70
µmol/l 2.35 1.76 2.94 Siemens Centaur XP/XPT/Classic
µg/ml 3.49 2.62 4.36
µmol/l 2.85 2.28 3.42 Siemens Dimension
µg/ml 4.23 3.39 5.07
µmol/l 3.35 2.68 4.02 Roche Cobas 6000/8000
µg/ml 4.98 3.98 5.98
µmol/l 3.43 2.74 4.12 Gravimetric
µg/ml 5.10 4.07 6.12
Vitamin B12 pmol/l 138 110 166 Abbott Architect
pg/ml 187 149 225
pmol/l 124 86.8 161 Siemens Centaur XP/XPT/Classic
pg/ml 168 118 218
pmol/l 87.5 70.0 105 Beckman DxI800
pg/ml 119 94.9 143
pmol/l 138 110 166 Roche Modular E170
pg/ml 187 149 225
pmol/l 92.3 73.8 111 Beckman Access
pg/ml 125 100 150
pmol/l 134 107 161 Tosoh Series
pg/ml 182 145 219
pmol/l 144 115 173 Vitros ECi
pg/ml 195 156 234
pmol/l 121 96.8 145 MP Biomedicals RIA
pg/ml 164 131 197
pmol/l 167 134 200 Roche Cobas E411
pg/ml 226 182 270
pmol/l 132 106 158 Roche Cobas 6000/8000
pg/ml 179 144 214
pmol/l 114 91.2 137 Siemens Dimension
pg/ml 154 124 184
pmol/l 158 126 190 SNIBE Maglumi Analysers
pg/ml 214 171 257
pmol/l 117 81.9 152 Siemens Centaur CP
pg/ml 159 111 207

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 22 OF 22
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
0086

IMMUNOASSAY PREMIUM - LEVEL 2


(IA PREMIUM 2)
CAT. NO. IA2639 GTIN: 05055273203851 SIZE: 12 x 5 ml
CAT. NO. IA2633 GTIN: 05055273203837 SIZE: 4 x 5 ml
LOT NO. 1817EC EXPIRY: 2021-05-28
INTENDED USE
This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of
analytes listed in the package insert.

This device is for prescription use only.

SAFETY PRECAUTIONS AND WARNINGS


For in vitro diagnostic use only. Do not pipette by mouth. Exercise the normal precautions required for handling laboratory reagents.

Human source material, from which this product has been derived, has been tested at donor level for the Human Immunodeficiency
Virus (HIV 1, HIV 2) antibody, Hepatitis B Surface Antigen (HbsAg), and Hepatitis C Virus (HCV) antibody and found to be NON-
REACTIVE. FDA approved methods have been used to conduct these tests.
However, since no method can offer complete assurance as to the absence of infectious agents, this material and all patient samples
should be handled as though capable of transmitting infectious diseases and disposed of accordingly.

Health and Safety Data Sheets are available on request.

STORAGE AND STABILITY


OPENED: Store refrigerated (+2ºC to +8ºC). Reconstituted serum is stable for 7 days at +2°C to +8°C, if kept capped in original
container and free from contamination, or 4 weeks frozen once at –20°C. C-Peptide is stable for 1 day at +2°C to +8°C.
Thyroglobulin should be tested within 4 hours of reconstitution when stored at +2°C to +8°C, or within 2 weeks when stored at
–20°C. ACTH should be tested immediately after the 30-minute reconstitution period. No frozen stability claim is made for ACTH,
Aldosterone and C-Peptide. Only the required amount of product should be removed. After use, any residual product should NOT BE
RETURNED to the original vial.

UNOPENED: Store refrigerated (+2°C to +8°C). Stable to expiration date printed on individual vials.

Bacterial contamination of the reconstituted serum will cause reductions in the stability of many components. If bacterial
contamination is suspected, the vial should be discarded and a fresh vial reconstituted.

PREPARATION
Immunoassay Premium is supplied lyophilised.
1. Carefully reconstitute each vial of lyophilised serum with exactly 5 ml of distilled water at +15°C to +25°C. Close the bottle and
allow to stand for 30 minutes before use. Ensure contents are completely dissolved by swirling gently. Avoid formation of
foam. Do not shake.
2. Refer to the Control section of the individual analyser application.
3. Refrigerate any unused material. Prior to reuse, mix contents thoroughly.

MATERIALS PROVIDED
Immunoassay Premium - Level 2: 12 x 5 ml Tri-Level: 4 x 5 ml

MATERIAL REQUIRED BUT NOT PROVIDED


Volumetric pipette

VALUE ASSIGNMENT
Each batch of Immunoassay Premium is submitted to a number of external laboratories. Values are assigned from a consensus of
results obtained by these laboratories, using a unique statistical analysis. Average values should normally fall within the listed ranges for
analytes in the instruments specified in this product insert. However, variations may be caused by instrument reagents and laboratory
technique. Therefore, the range produced herein should only be considered as a reference and it is recommended that each laboratory
establish its own mean and acceptable ranges. Aldosterone is present in control levels 2 and level 3 only. Parathyroid Hormone (PTH)
is present in the control, but no claim is made for the expected value or stability of this analyte.

If a method is unavailable, contact Randox Laboratories - Technical Services, Northern Ireland, tel: +44 (0) 28 9445 1070 or email
Technical.Services@randox.com.

06 Dec ’18 ne

PAGE 1 OF 25
A
IMMUNOASSAY PREMIUM - LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1817EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
17-OH-Progesterone nmol/l 9.97 7.48 12.5 Immunotech RIA
ng/ml 3.30 2.48 4.12
nmol/l 14.1 10.6 17.6 DRG ELISA
ng/ml 4.67 3.51 5.83
nmol/l 14.5 10.9 18.1 DIAsource RIA
ng/ml 4.80 3.61 5.99
nmol/l 14.6 11.0 18.3 DiaMetra ELISA
ng/ml 4.83 3.64 6.02
nmol/l 11.8 8.85 14.8 SNIBE Maglumi Analysers
ng/ml 3.91 2.93 4.89
25-OH Vitamin D nmol/l 71.9 53.9 89.9 Diasorin Liaison
nmol/l 84.1 63.1 105 Siemens Centaur XP/XPT/Classic
nmol/l 56.1 42.1 70.1 Roche Vitamin D Total
nmol/l 67.8 50.9 84.8 HPLC
nmol/l 57.7 43.3 72.1 Abbott Architect
nmol/l 62.0 46.5 77.5 IDS iSYS
nmol/l 71.6 53.7 89.5 SNIBE Maglumi Analysers
nmol/l 77.0 57.8 96.3 Vitros ECi
nmol/l 64.6 48.5 80.8 Tosoh Series
nmol/l 73.9 55.4 92.4 BioMerieux Vidas
nmol/l 55.2 41.4 69.0 Beckman DxI 600/800
nmol/l 57.1 42.8 71.4 Fujirebio Lumipulse G Series
nmol/l 58.0 43.5 72.5 Beckman Access 25 OH Vitamin D Total
nmol/l 59.5 44.6 74.4 Roche Vitamin D Total II
ACTH pmol/l 9.35 7.01 11.7 Siemens Immulite 2000/2500
pg/ml 42.5 31.9 53.1
pmol/l 4.46 3.35 5.58 Roche Cobas 6000/8000
pg/ml 20.3 15.2 25.4
pmol/l 15.3 11.5 19.1 CIS IRMA
pg/ml 69.5 52.3 86.7
pmol/l 9.29 6.97 11.6 Siemens Immulite 1000
pg/ml 42.2 31.7 52.7
pmol/l 11.6 8.70 14.5 SNIBE Maglumi Analysers
pg/ml 52.7 39.5 65.9
Aldosterone pmol/l 93.8 70.4 117 CIS RIA
pg/ml 33.8 25.4 42.2
pmol/l 347 260 434 ELISA
pg/ml 125 93.8 156
pmol/l 351 263 439 SNIBE Maglumi Analysers
pg/ml 127 94.9 159
pmol/l 298 224 373 IDS iSYS
pg/ml 108 80.8 135

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 2 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1817EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Aldosterone pmol/l 290 218 363 Diasorin Liaison
pg/ml 105 78.7 131
Alpha-fetoprotein KIU/l = lU/ml 45.6 36.5 54.7 Abbott Architect
ng/ml 55.2 44.2 66.2
KIU/l = lU/ml 41.9 33.5 50.3 BioMerieux Vidas
ng/ml 50.7 40.5 60.9
KIU/l = lU/ml 54.1 42.7 65.5 Siemens Centaur XP/XPT/Classic
ng/ml 65.5 51.7 79.3
KIU/l = lU/ml 42.7 34.2 51.2 Siemens Immulite 2000/2500
ng/ml 51.7 41.4 62.0
KIU/l = lU/ml 44.7 35.8 53.6 Siemens Immulite 1000
ng/ml 54.1 43.3 64.9
KIU/l = lU/ml 46.2 37.0 55.4 Beckman DxI800
ng/ml 55.9 44.8 67.0
KIU/l = lU/ml 48.5 38.8 58.2 Roche Elecsys
ng/ml 58.7 46.9 70.5
KIU/l = lU/ml 49.2 39.4 59.0 Diasorin Liaison
ng/ml 59.5 47.7 71.3
KIU/l = lU/ml 49.6 39.7 59.5 Roche Modular E170
ng/ml 60.0 48.0 72.0
KIU/l = lU/ml 48.6 38.9 58.3 Beckman Access
ng/ml 58.8 47.1 70.5
KIU/l = lU/ml 44.6 35.7 53.5 Tosoh Series
ng/ml 54.0 43.2 64.8
KIU/l = lU/ml 49.5 39.6 59.4 Vitros ECi
ng/ml 59.9 47.9 71.9
KIU/l = lU/ml 49.7 39.8 59.6 Roche Cobas 6000/8000
ng/ml 60.1 48.2 72.0
KIU/l = lU/ml 66.4 53.1 79.7 CIS IRMA
ng/ml 80.3 64.3 96.3
KIU/l = lU/ml 49.9 39.9 59.9 Roche Cobas E411
ng/ml 60.4 48.3 72.5
KIU/l = lU/ml 44.3 35.4 53.2 SNIBE Maglumi Analysers
ng/ml 53.6 42.8 64.4
KIU/l = lU/ml 46.8 37.4 56.2 Fujirebio Lumipulse G Series
ng/ml 56.6 45.3 67.9
KIU/l = lU/ml 52.0 41.6 62.4 Siemens Dimension
ng/ml 62.9 50.3 75.5
KIU/l = lU/ml 52.5 41.5 63.5 Siemens Centaur CP
ng/ml 63.5 50.2 76.8
Amikacin µmol/l 13.9 11.1 16.7 Roche Cobas 6000/8000
µg/ml 8.14 6.50 9.78
µmol/l 15.2 12.2 18.2 Gravimetric
µg/ml 8.90 7.14 10.7
Androstenedione nmol/l 13.3 9.98 16.6 Siemens Immulite 2000
ng/ml 3.82 2.86 4.78

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 3 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1817EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Beta-2-microglobulin µg/ml = mg/l 3.44 2.75 4.13 Abbott Architect
µg/ml = mg/l 3.58 2.86 4.30 BioMerieux Vidas
µg/ml = mg/l 3.46 2.77 4.15 Behring Nephelometer
µg/ml = mg/l 3.12 2.50 3.74 Siemens Immulite 2000/2500
µg/ml = mg/l 3.85 3.08 4.62 Siemens Immulite 1000
µg/ml = mg/l 3.00 2.40 3.60 Diasorin Liaison
µg/ml = mg/l 3.36 2.69 4.03 Tosoh Series
µg/ml = mg/l 3.47 2.78 4.16 Roche Cobas 6000/8000
µg/ml = mg/l 3.42 2.74 4.10 Siemens Dimension
µg/ml = mg/l 2.79 2.23 3.35 SNIBE Maglumi Analysers
µg/ml = mg/l 2.96 2.37 3.55 Fujirebio Lumipulse G Series
C-Peptide nmol/l 1.670 1.250 2.090 Siemens Immulite 2000/2500
ng/ml 5.04 3.77 6.31
nmol/l 1.730 1.300 2.160 Roche Elecsys
ng/ml 5.22 3.92 6.52
nmol/l 1.720 1.290 2.150 Roche Cobas 6000/8000
ng/ml 5.19 3.89 6.49
nmol/l 1.590 1.190 1.990 Siemens Immulite 1000
ng/ml 4.80 3.59 6.01
nmol/l 1.980 1.490 2.480 Diasorin Liaison
ng/ml 5.98 4.50 7.46
nmol/l 1.740 1.310 2.180 Roche Cobas E411
ng/ml 5.25 3.95 6.55
nmol/l 1.580 1.190 1.980 Abbott Architect
ng/ml 4.77 3.59 5.95
nmol/l 1.240 0.930 1.550 Siemens Centaur XP/XPT/Classic
ng/ml 3.74 2.81 4.67
nmol/l 1.530 1.150 1.910 Tosoh Series
ng/ml 4.62 3.47 5.77
nmol/l 1.500 1.130 1.880 ELISA
ng/ml 4.53 3.41 5.65
nmol/l 1.770 1.330 2.210 SNIBE Maglumi Analysers
ng/ml 5.34 4.02 6.66
Carbamazepine µmol/l 37.0 29.6 44.4 Abbott Architect
µg/ml 8.75 7.00 10.5
µmol/l 40.8 28.6 53.0 Siemens Centaur XP/XPT/Classic
µg/ml 9.65 6.76 12.5
µmol/l 35.2 28.2 42.2 Siemens Dimension
µg/ml 8.32 6.67 9.97
µmol/l 31.7 25.4 38.0 Siemens Immulite 2000/2500
µg/ml 7.49 6.00 8.98
µmol/l 34.1 27.3 40.9 Siemens Immulite 1000
µg/ml 8.06 6.45 9.67
µmol/l 37.4 29.9 44.9 Roche Integra
µg/ml 8.84 7.07 10.6
µmol/l 34.8 27.8 41.8 Vitros
µg/ml 8.23 6.57 9.89

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 4 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1817EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Carbamazepine µmol/l 35.7 28.6 42.8 Roche Cobas E411
µg/ml 8.44 6.76 10.1
µmol/l 37.1 29.7 44.5 Roche Cobas 6000/8000
µg/ml 8.77 7.02 10.5
µmol/l 33.5 26.8 40.2 Beckman DxC
µg/ml 7.92 6.34 9.50
µmol/l 40.4 32.3 48.5 Beckman AU400/600/640/2700/5400
µg/ml 9.55 7.64 11.5
µmol/l 37.0 29.6 44.4 Siemens ADVIA 1200/1650/1800/2400
µg/ml 8.75 7.00 10.5
µmol/l 38.5 30.8 46.2 Gravimetric
µg/ml 9.10 7.28 10.9
Carcinoembryonic ng/ml = µg/l 26.1 20.9 31.3 Abbott Architect
Antigen (CEA)
ng/ml = µg/l 23.6 18.9 28.3 BioMerieux Vidas
ng/ml = µg/l 25.9 17.6 34.2 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 17.5 14.0 21.0 CIS RIA Coated tube
ng/ml = µg/l 33.2 26.6 39.8 Siemens Immulite 2000/2500
ng/ml = µg/l 33.4 26.7 40.1 Siemens Immulite 1000
ng/ml = µg/l 21.7 17.4 26.0 Beckman DxI800
ng/ml = µg/l 21.3 17.0 25.6 Roche Elecsys
ng/ml = µg/l 21.5 17.2 25.8 Diasorin Liaison
ng/ml = µg/l 21.8 17.4 26.2 Roche Modular E170
ng/ml = µg/l 22.9 18.3 27.5 Beckman Access
ng/ml = µg/l 33.0 26.4 39.6 Tosoh Series
ng/ml = µg/l 27.6 22.1 33.1 Vitros ECi
ng/ml = µg/l 21.5 17.2 25.8 Roche Cobas 6000/8000
ng/ml = µg/l 21.7 17.4 26.0 Roche Cobas E411
ng/ml = µg/l 22.5 18.0 27.0 SNIBE Maglumi Analysers
ng/ml = µg/l 32.4 25.9 38.9 Fujirebio Lumipulse G Series
ng/ml = µg/l 26.6 18.1 35.1 Siemens Centaur CP
Cortisol nmol/l 555 416 694 Abbott Architect
µg/dl 20.0 15.0 25.0
nmol/l 536 402 670 BioMerieux Vidas
µg/dl 19.3 14.5 24.1
nmol/l 716 494 938 Siemens Centaur XP/XPT/Classic
µg/dl 25.8 17.8 33.8
nmol/l 533 400 666 CIS RIA
µg/dl 19.2 14.4 24.0
nmol/l 647 485 809 Siemens Immulite 2000/2500
µg/dl 23.3 17.5 29.1
nmol/l 666 500 833 Siemens Immulite 1000
µg/dl 24.0 18.0 30.0
nmol/l 603 452 754 Beckman DxI800
µg/dl 21.7 16.3 27.1
nmol/l 613 460 766 Roche Elecsys
µg/dl 22.1 16.6 27.6

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 5 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1817EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Cortisol nmol/l 655 491 819 Diasorin Liaison
µg/dl 23.6 17.7 29.5
nmol/l 621 466 776 Roche Modular E170
µg/dl 22.4 16.8 28.0
nmol/l 667 500 834 Beckman Access
µg/dl 24.0 18.0 30.0
nmol/l 675 506 844 Tosoh Series
µg/dl 24.3 18.2 30.4
nmol/l 588 441 735 Vitros ECi
µg/dl 21.2 15.9 26.5
nmol/l 617 463 771 Roche Cobas 6000/8000
µg/dl 22.2 16.7 27.7
nmol/l 644 483 805 Roche Cobas E411
µg/dl 23.2 17.4 29.0
nmol/l 679 509 849 SNIBE Maglumi Analysers
µg/dl 24.4 18.3 30.5
nmol/l 761 525 997 Siemens Centaur CP
µg/dl 27.4 18.9 35.9
nmol/l 608 456 760 Roche Modular E170 Gen II
µg/dl 21.9 16.4 27.4
nmol/l 658 494 823 Roche Cobas 4000/e411 Gen II
µg/dl 23.7 17.8 29.6
nmol/l 610 458 763 Roche Cobas 6000/8000 Gen II
µg/dl 22.0 16.5 27.5
nmol/l 641 481 801 Roche Elecsys Gen II
µg/dl 23.1 17.3 28.9
DHEA-S µmol/l 13.6 10.9 16.3 Abbott Architect
µmol/l 11.7 9.36 14.0 Siemens Immulite 2000/2500
µmol/l 12.1 9.68 14.5 Siemens Immulite 1000
µmol/l 11.2 8.96 13.4 Beckman DxI800
µmol/l 16.1 12.9 19.3 Roche Elecsys
µmol/l 16.4 13.1 19.7 Roche Modular E170
µmol/l 12.5 10.0 15.0 Beckman Access
µmol/l 11.3 9.04 13.6 Diasorin Liaison
µmol/l 11.5 7.48 15.5 Siemens Centaur XP/XPT/Classic
µmol/l 15.9 12.7 19.1 Roche Cobas E411
µmol/l 16.3 13.0 19.6 Roche Cobas 6000/8000
µmol/l 13.5 10.8 16.2 SNIBE Maglumi Analysers
Digoxin nmol/l 2.60 2.08 3.12 Abbott Architect
ng/ml 2.03 1.62 2.44
nmol/l 2.81 2.25 3.37 BioMerieux Vidas
ng/ml 2.19 1.76 2.62
nmol/l 3.37 2.59 4.15 Siemens Centaur XP/XPT/Classic
ng/ml 2.63 2.03 3.23
nmol/l 2.98 2.38 3.58 Siemens Dimension
ng/ml 2.33 1.86 2.80

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 6 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1817EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Digoxin nmol/l 3.57 2.86 4.28 Siemens Immulite 2000/2500
ng/ml 2.79 2.23 3.35
nmol/l 3.12 2.50 3.74 Beckman DxI800
ng/ml 2.44 1.95 2.93
nmol/l 3.32 2.66 3.98 Roche Elecsys
ng/ml 2.59 2.08 3.10
nmol/l 2.94 2.35 3.53 Roche Integra
ng/ml 2.30 1.84 2.76
nmol/l 3.17 2.54 3.80 Beckman Access
ng/ml 2.48 1.98 2.98
nmol/l 3.11 2.49 3.73 Vitros
ng/ml 2.43 1.94 2.92
nmol/l 3.11 2.49 3.73 Roche Cobas 6000/8000
ng/ml 2.43 1.94 2.92
nmol/l 2.60 2.08 3.12 Beckman DxC
ng/ml 2.03 1.62 2.44
nmol/l 3.20 2.56 3.84 Beckman AU400/600/640/2700/5400
ng/ml 2.50 2.00 3.00
nmol/l 3.02 2.42 3.62 Siemens ADVIA 1200/1650/1800/2400
ng/ml 2.36 1.89 2.83
nmol/l 3.51 2.81 4.21 SNIBE Maglumi Analysers
ng/ml 2.74 2.19 3.29
nmol/l 3.19 2.55 3.83 Roche Cobas 4000/E411
ng/ml 2.49 1.99 2.99
nmol/l 3.07 2.46 3.68 Gravimetric
ng/ml 2.40 1.92 2.87
Ethosuximide µmol/l 360 288 432 Gravimetric
µg/ml 51.0 40.8 61.3
Ferritin ng/ml = µg/l 118 94.4 142 Abbott Architect
ng/ml = µg/l 91.2 73.0 109 BioMerieux Vidas
ng/ml = µg/l 101 75.8 126 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 100 80.0 120 Siemens Dimension
ng/ml = µg/l 102 81.6 122 Siemens Immulite 2000/2500
ng/ml = µg/l 95.7 76.6 115 Siemens Immulite 1000
ng/ml = µg/l 77.9 62.3 93.5 Beckman DxI800
ng/ml = µg/l 120 96.0 144 Roche Elecsys
ng/ml = µg/l 101 80.8 121 Diasorin Liaison
ng/ml = µg/l 118 94.4 142 Roche Modular E170
ng/ml = µg/l 80.7 64.6 96.8 Beckman Access
ng/ml = µg/l 78.8 63.0 94.6 Tosoh Series
ng/ml = µg/l 73.1 58.5 87.7 Vitros ECi
ng/ml = µg/l 108 86.4 130 Immunotech IRMA
ng/ml = µg/l 116 92.8 139 Roche Cobas E411
ng/ml = µg/l 94.2 75.4 113 Beckman AU400/600/640/2700/5400
ng/ml = µg/l 89.0 71.2 107 SNIBE Maglumi Analysers

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 7 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1817EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Ferritin ng/ml = µg/l 63.7 51.0 76.4 Fujirebio Lumipulse G Series
ng/ml = µg/l 95.9 71.9 120 Siemens Centaur CP
Folate nmol/l 11.8 8.97 14.6 Abbott Architect
ng/ml 5.20 3.96 6.44
nmol/l 27.5 17.9 37.1 Siemens Centaur XP/XPT/Classic (enhanced kit)
ng/ml 12.1 7.87 16.3
nmol/l 10.2 7.75 12.6 Siemens Immulite 2000
ng/ml 4.50 3.42 5.58
nmol/l 13.9 10.6 17.2 Beckman DxI800
ng/ml 6.13 4.67 7.59
nmol/l 11.4 8.66 14.1 Roche Elecsys
ng/ml 5.03 3.82 6.24
nmol/l 14.1 10.7 17.5 Beckman Access
ng/ml 6.22 4.72 7.72
nmol/l 20.9 15.9 25.9 Tosoh Series
ng/ml 9.22 7.01 11.4
nmol/l 8.96 6.81 11.1 Vitros ECi
ng/ml 3.95 3.00 4.90
nmol/l 10.6 8.06 13.1 MP Biomedicals RIA
ng/ml 4.67 3.55 5.79
nmol/l 12.2 9.27 15.1 Roche Cobas E411
ng/ml 5.38 4.09 6.67
nmol/l 12.3 9.35 15.3 Roche Cobas 6000/8000
ng/ml 5.42 4.12 6.72
nmol/l 8.43 6.41 10.5 Siemens Dimension
ng/ml 3.72 2.83 4.61
nmol/l 30.8 20.0 41.6 Siemens Centaur CP (enhanced kit)
ng/ml 13.6 8.84 18.4
nmol/l 12.3 9.35 15.3 Roche Cobas 6000/8000 Folate III
ng/ml 5.42 4.12 6.72
nmol/l 11.4 8.66 14.1 Roche Cobas 4000/e411 Folate III
ng/ml 5.03 3.82 6.24
Free T3 pmol/l 12.1 9.08 15.1 Abbott Architect
ng/dl 0.787 0.590 0.984
pg/ml 7.88 5.91 9.85
pmol/l 13.9 10.4 17.4 BioMerieux Vidas
ng/dl 0.904 0.676 1.13
pg/ml 9.05 6.77 11.3
pmol/l 13.6 8.16 19.0 Siemens Centaur XP/XPT/Classic
ng/dl 0.884 0.530 1.24
pg/ml 8.85 5.31 12.4
pmol/l 9.53 7.15 11.9 Siemens Immulite 2000/2500
ng/dl 0.619 0.465 0.773
pg/ml 6.20 4.65 7.75
pmol/l 9.49 7.12 11.9 Siemens Immulite 1000
ng/dl 0.617 0.463 0.771
pg/ml 6.18 4.64 7.72

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 8 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1817EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Free T3 pmol/l 10.0 7.50 12.5 Beckman DxI800
ng/dl 0.650 0.488 0.812
pg/ml 6.51 4.88 8.14
pmol/l 15.8 11.9 19.8 Roche Elecsys
ng/dl 1.03 0.774 1.29
pg/ml 10.3 7.75 12.9
pmol/l 18.0 13.5 22.5 Diasorin Liaison
ng/dl 1.17 0.878 1.46
pg/ml 11.7 8.79 14.6
pmol/l 15.6 11.7 19.5 Roche Modular E170
ng/dl 1.01 0.761 1.26
pg/ml 10.2 7.62 12.8
pmol/l 11.2 8.40 14.0 Beckman Access
ng/dl 0.728 0.546 0.910
pg/ml 7.29 5.47 9.11
pmol/l 17.2 12.9 21.5 Tosoh Series
ng/dl 1.12 0.839 1.40
pg/ml 11.2 8.40 14.0
pmol/l 31.6 23.7 39.5 Vitros ECi
ng/dl 2.05 1.54 2.56
pg/ml 20.6 15.4 25.8
pmol/l 15.8 11.9 19.8 Roche Cobas E411
ng/dl 1.03 0.774 1.29
pg/ml 10.3 7.75 12.9
pmol/l 15.9 11.9 19.9 Roche Cobas 6000/8000
ng/dl 1.03 0.774 1.29
pg/ml 10.4 7.75 13.1
pmol/l 16.4 12.3 20.5 Siemens Dimension
ng/dl 1.07 0.800 1.34
pg/ml 10.7 8.01 13.4
pmol/l 16.2 12.2 20.3 Siemens Dimension Vista LOCI
ng/dl 1.05 0.793 1.31
pg/ml 10.5 7.94 13.1
pmol/l 13.0 9.75 16.3 SNIBE Maglumi Analysers
ng/dl 0.845 0.634 1.06
pg/ml 8.46 6.35 10.6
pmol/l 12.8 7.68 17.9 Siemens Centaur CP
ng/dl 0.832 0.499 1.17
pg/ml 8.33 5.00 11.7
Free T4 pmol/l 29.9 22.4 37.4 Abbott Architect
ng/dl 2.33 1.75 2.91
pg/ml 23.3 17.5 29.1
pmol/l 32.2 24.2 40.2 Siemens Centaur XP/XPT/Classic
ng/dl 2.51 1.88 3.14
pg/ml 25.1 18.8 31.4

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 9 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1817EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Free T4 pmol/l 44.6 33.5 55.8 CIS RIA Coated tube
ng/dl 3.48 2.61 4.35
pg/ml 34.8 26.1 43.5
pmol/l 35.7 26.8 44.6 Siemens Dimension
ng/dl 2.78 2.09 3.47
pg/ml 27.8 20.9 34.7
pmol/l 43.8 32.9 54.8 Siemens Immulite 2000/2500
ng/dl 3.42 2.57 4.27
pg/ml 34.2 25.7 42.7
pmol/l 45.5 34.1 56.9 Siemens Immulite 1000
ng/dl 3.55 2.66 4.44
pg/ml 35.5 26.6 44.4
pmol/l 35.1 26.3 43.9 Beckman DxI800
ng/dl 2.74 2.05 3.43
pg/ml 27.4 20.5 34.3
pmol/l 42.9 32.2 53.6 Roche Elecsys
ng/dl 3.35 2.51 4.19
pg/ml 33.5 25.1 41.9
pmol/l 53.6 40.2 67.0 Diasorin Liaison
ng/dl 4.18 3.14 5.22
pg/ml 41.8 31.4 52.2
pmol/l 39.4 29.6 49.3 Roche Modular E170
ng/dl 3.07 2.31 3.83
pg/ml 30.7 23.1 38.3
pmol/l 34.8 26.1 43.5 Beckman Access
ng/dl 2.71 2.04 3.38
pg/ml 27.1 20.4 33.8
pmol/l 43.1 32.3 53.9 Tosoh Series
ng/dl 3.36 2.52 4.20
pg/ml 33.6 25.2 42.0
pmol/l 79.3 59.5 99.0 Vitros ECi
ng/dl 6.19 4.64 7.74
pg/ml 61.9 46.4 77.4
pmol/l 41.5 31.1 51.9 Roche Cobas 6000/8000
ng/dl 3.24 2.43 4.05
pg/ml 32.4 24.3 40.5
pmol/l 37.2 27.9 46.5 Immunotech IRMA
ng/dl 2.90 2.18 3.62
pg/ml 29.0 21.8 36.2
pmol/l 42.6 32.0 53.3 Roche Cobas E411
ng/dl 3.32 2.50 4.14
pg/ml 33.2 25.0 41.4
pmol/l 30.0 22.5 37.5 ELISA
ng/dl 2.34 1.76 2.92
pg/ml 23.4 17.6 29.2
pmol/l 36.4 27.3 45.5 Siemens Dimension Vista LOCI
ng/dl 2.84 2.13 3.55
pg/ml 28.4 21.3 35.5

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 10 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1817EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Free T4 pmol/l 45.0 33.8 56.3 SNIBE Maglumi Analysers
ng/dl 3.51 2.64 4.38
pg/ml 35.1 26.4 43.8
pmol/l 47.2 35.4 59.0 Biomerieux Vidas FT4N Kit
ng/dl 3.68 2.76 4.60
pg/ml 36.8 27.6 46.0
pmol/l 34.1 25.6 42.6 Siemens Centaur CP
ng/dl 2.66 2.00 3.32
pg/ml 26.6 20.0 33.2
FSH mU/ml 21.8 17.4 26.2 Abbott Architect
mU/ml 30.7 24.6 36.8 BioMerieux Vidas
mU/ml 33.0 24.8 41.2 Siemens Centaur XP/XPT/Classic
mU/ml 27.0 21.6 32.4 Siemens Immulite 2000/2500
mU/ml 25.7 20.6 30.8 Siemens Immulite 1000
mU/ml 26.8 21.4 32.2 Beckman DxI800
mU/ml 24.8 19.8 29.8 Roche/BM Elecsys
mU/ml 29.9 23.9 35.9 Diasorin Liaison
mU/ml 23.9 19.1 28.7 Roche Modular E170
mU/ml 26.9 21.5 32.3 Beckman Access
mU/ml 24.9 19.9 29.9 Tosoh Series
mU/ml 20.0 16.0 24.0 Vitros ECi
mU/ml 25.0 20.0 30.0 Roche Cobas E411
mU/ml 23.9 19.1 28.7 Roche Cobas 6000/8000
mU/ml 29.0 23.2 34.8 SNIBE Maglumi Analysers
mU/ml 21.0 16.8 25.2 Fujirebio Lumipulse G Series
mU/ml 28.8 21.6 36.0 Siemens Centaur CP
Gentamicin µmol/l 7.04 5.63 8.45 Roche Integra
µg/ml 3.37 2.69 4.05
µmol/l 8.70 6.18 11.2 Siemens Centaur XP/XPT/Classic
µg/ml 4.16 2.95 5.37
µmol/l 7.21 5.77 8.65 Siemens Dimension Vista
µg/ml 3.45 2.76 4.14
µmol/l 5.54 4.43 6.65 Roche Cobas 6000/8000
µg/ml 2.65 2.12 3.18
µmol/l 8.65 6.92 10.4 Beckman DxC
µg/ml 4.13 3.31 4.95
µmol/l 8.16 6.53 9.79 Gravimetric
µg/ml 3.90 3.12 4.68
Growth Hormone (GH) µU/ml 17.5 14.0 21.0 Siemens Immulite 2000/2500
ng/ml 5.83 4.66 7.00
µU/ml 15.7 12.6 18.8 Siemens Immulite 1000
ng/ml 5.23 4.20 6.26
µU/ml 13.3 10.6 16.0 Beckman DxI800
ng/ml 4.43 3.53 5.33

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 11 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1817EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Growth Hormone (GH) µU/ml 13.7 11.0 16.4 Beckman Access
ng/ml 4.56 3.66 5.46
µU/ml 16.3 13.0 19.6 Tosoh Series
ng/ml 5.43 4.33 6.53
µU/ml 15.0 12.0 18.0 Diasorin Liaison
ng/ml 5.00 4.00 6.00
µU/ml 17.5 14.0 21.0 Roche Cobas E411
ng/ml 5.83 4.66 7.00
µU/ml 21.8 17.4 26.2 SNIBE Maglumi Analysers
ng/ml 7.26 5.79 8.73
µU/ml 17.6 14.1 21.1 Roche Cobas 6000/8000
ng/ml 5.86 4.70 7.02
µU/ml 14.7 11.8 17.6 IDS iSYS
ng/ml 4.90 3.93 5.87
Immunoglobulin E KIU/l = IU/ml 106 84.8 127 Abbott Architect
KIU/l = IU/ml 96.4 77.1 116 BioMerieux Vidas
KIU/l = IU/ml 113 67.8 158 Siemens Centaur XP/XPT/Classic
KIU/l = IU/ml 119 95.2 143 Siemens Immulite 2000/2500
KIU/l = IU/ml 123 98.4 148 Siemens Immulite 1000
KIU/l = IU/ml 106 84.8 127 Beckman DxI800
KIU/l = IU/ml 133 106 160 Roche Elecsys
KIU/l = IU/ml 116 92.8 139 Pharmacia Unicap
KIU/l = IU/ml 125 100 150 Roche Modular E170
KIU/l = IU/ml 116 92.8 139 Tosoh Series
KIU/l = IU/ml 128 102 154 Roche Cobas E411
KIU/l = IU/ml 128 102 154 Roche Cobas 6000/8000
KIU/l = IU/ml 106 84.8 127 SNIBE Maglumi Analysers
KIU/l = IU/ml 107 85.6 128 Fujirebio Lumipulse G Series
KIU/l = IU/ml 112 67.2 157 Siemens Centaur CP
Insulin mU/l 21.1 15.8 26.4 Siemens Centaur XP/XPT/Classic
µU/ml 21.1 15.8 26.4
mU/l 6.86 5.15 8.58 Siemens Immulite 1000
µU/ml 6.86 5.15 8.57
mU/l 22.3 16.7 27.9 Roche Modular E170
µU/ml 22.3 16.7 27.9
mU/l 8.36 6.27 10.5 Siemens Immulite 2000
µU/ml 8.36 6.27 10.5
mU/l 21.6 16.2 27.0 Roche Elecsys
µU/ml 21.6 16.2 27.0
mU/l 16.4 12.3 20.5 Beckman Access
µU/ml 16.4 12.3 20.5
mU/l 18.6 14.0 23.3 Abbott Architect
µU/ml 18.6 14.0 23.2
mU/l 21.6 16.2 27.0 Tosoh Series
µU/ml 21.6 16.2 27.0
mU/l 22.0 16.5 27.5 Roche Cobas E411
µU/ml 22.0 16.5 27.5

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 12 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1817EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Insulin mU/l 16.5 12.4 20.6 Beckman DxI 600/800
µU/ml 16.5 12.4 20.6
mU/l 25.5 19.1 31.9 Diasorin Liaison
µU/ml 25.5 19.1 31.9
mU/l 22.2 16.7 27.8 Roche Cobas 6000/8000
µU/ml 22.2 16.7 27.7
mU/l 19.3 14.5 24.1 SNIBE Maglumi Analysers
µU/ml 19.3 14.5 24.1
mU/l 21.8 16.4 27.3 Fujirebio Lumipulse G Series
µU/ml 21.8 16.4 27.2
mU/l 22.0 16.5 27.5 Siemens Centaur CP
µU/ml 22.0 16.5 27.5
Luteinising Hormone mU/ml 20.0 16.0 24.0 Abbott Architect
(LH)
mU/ml 22.6 18.1 27.1 BioMerieux Vidas
mU/ml 24.4 18.8 30.0 Siemens Centaur XP/XPT/Classic
mU/ml 35.7 28.6 42.8 Siemens Immulite 2000
mU/ml 37.8 30.2 45.4 Siemens Immulite 1000
mU/ml 17.2 13.8 20.6 Beckman DxI800
mU/ml 26.1 20.9 31.3 Roche Elecsys
mU/ml 28.1 22.5 33.7 Diasorin Liaison
mU/ml 26.0 20.8 31.2 Roche Modular E170
mU/ml 17.6 14.1 21.1 Beckman Access
mU/ml 22.4 17.9 26.9 Tosoh Series
mU/ml 34.5 27.6 41.4 Vitros ECi
mU/ml 25.8 20.6 31.0 Roche Cobas E411
mU/ml 25.9 20.7 31.1 Roche Cobas 6000/8000
mU/ml 24.2 19.4 29.0 SNIBE Maglumi Analysers
mU/ml 22.2 17.8 26.6 Fujirebio Lumipulse G Series
mU/ml 26.2 20.2 32.2 Siemens Centaur CP
Oestradiol pmol/l 746 597 895 Abbott Architect
pg/ml 203 162 244
pmol/l 1130 904 1356 BioMerieux Vidas
pg/ml 307 246 368
pmol/l 1013 608 1418 Siemens Centaur XP/XPT/Classic
pg/ml 276 166 386
pmol/l 997 798 1196 Siemens Immulite 2000/2500
pg/ml 271 217 325
pmol/l 1091 873 1309 Siemens Immulite 1000
pg/ml 297 237 357
pmol/l 1061 849 1273 Beckman DxI800
pg/ml 289 231 347
pmol/l 774 619 929 Roche Elecsys (Estradiol II)
pg/ml 211 168 254
pmol/l 1124 899 1349 Beckman Access
pg/ml 306 245 367

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 13 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1817EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Oestradiol pmol/l 856 685 1027 Tosoh (E2)
pg/ml 233 186 280
pmol/l 960 768 1152 Vitros ECi
pg/ml 261 209 313
pmol/l 793 634 952 Roche Cobas 6000/8000 (Estradiol II)
pg/ml 216 172 260
pmol/l 772 618 926 Roche Cobas 4000/E411 (Estradiol II)
pg/ml 210 168 252
pmol/l 1026 616 1436 Siemens Centaur XP/XPT/Classic Enhanced (eE2)
pg/ml 279 167 391
pmol/l 986 592 1380 Siemens Centaur XP/XPT/Classic E26 III
pg/ml 268 161 375
pmol/l 1323 1058 1588 SNIBE Maglumi Analysers
pg/ml 360 288 432
pmol/l 789 631 947 Tosoh (iE2-hsE2)
pg/ml 215 172 258
pmol/l 1055 633 1477 Siemens Centaur CP
pg/ml 287 172 402
pmol/l 1088 653 1523 Siemens Centaur CP Enhanced (eE2)
pg/ml 296 178 414
pmol/l 900 720 1080 Fujirebio Lumipulse G Series
pg/ml 245 196 294
pmol/l 798 638 958 Roche Cobas 6000/8000 (Estradiol III)
pg/ml 217 174 260
pmol/l 753 602 904 Roche Elecsys (Estradiol III)
pg/ml 205 164 246
pmol/l 783 626 940 Roche Cobas 4000/E411 (Estradiol III)
pg/ml 213 170 256
pmol/l 787 630 944 Roche Modular E170 (Estradiol III)
pg/ml 214 171 257
Paracetamol mmol/l 0.325 0.260 0.390 Abbott Architect
mg/l 49.2 39.3 59.1
mmol/l 0.301 0.241 0.361 Roche Cobas 6000/8000
mg/l 45.5 36.5 54.5
mmol/l 0.348 0.280 0.420 Gravimetric
mg/l 52.7 42.4 63.5
Phenobarbital µmol/l 80.7 64.6 96.8 Abbott Architect
µg/ml 18.7 15.0 22.4
µmol/l 76.6 61.3 91.9 Siemens ADVIA 1200/1650/1800/2400
µg/ml 17.8 14.2 21.4
µmol/l 74.2 59.4 89.0 Roche Cobas 6000/8000
µg/ml 17.2 13.8 20.6
µmol/l 76.6 61.3 91.9 Siemens Immulite 2000/2500
µg/ml 17.8 14.2 21.4
µmol/l 78.9 63.1 94.7 Beckman AU400/600/640/2700/5400
µg/ml 18.3 14.6 22.0

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 14 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1817EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Phenobarbital µmol/l 95.9 69.0 123 Siemens Centaur XP/XPT/Classic
µg/ml 22.2 16.0 28.4
µmol/l 73.2 58.6 87.8 Roche Integra
µg/ml 17.0 13.6 20.4
µmol/l 78.0 62.4 93.6 Siemens Immulite 1000
µg/ml 18.1 14.5 21.7
µmol/l 81.6 65.3 97.9 Beckman DxC
µg/ml 18.9 15.1 22.7
µmol/l 77.6 62.1 93.1 Gravimetric
µg/ml 18.0 14.4 21.6
Phenytoin µmol/l 65.5 52.4 78.6 Abbott Architect
µg/ml 16.5 13.2 19.8
µmol/l 82.2 64.1 100 Siemens Centaur XP/XPT/Classic
µg/ml 20.8 16.2 25.4
µmol/l 71.5 57.2 85.8 Siemens Dimension
µg/ml 18.1 14.4 21.8
µmol/l 57.9 46.3 69.5 Siemens Immulite 2000/2500
µg/ml 14.6 11.7 17.5
µmol/l 64.9 51.9 77.9 Siemens Immulite 1000
µg/ml 16.4 13.1 19.7
µmol/l 64.6 51.7 77.5 Roche Integra
µg/ml 16.3 13.1 19.5
µmol/l 69.5 55.6 83.4 Vitros
µg/ml 17.5 14.0 21.0
µmol/l 60.9 48.7 73.1 Roche Cobas E411
µg/ml 15.4 12.3 18.5
µmol/l 64.7 51.8 77.6 Roche Cobas 6000/8000
µg/ml 16.3 13.1 19.5
µmol/l 67.0 53.6 80.4 Beckman DxC
µg/ml 16.9 13.5 20.3
µmol/l 71.3 57.0 85.6 Gravimetric
µg/ml 18.0 14.4 21.6
Primidone µmol/l 22.5 18.0 27.0 Gravimetric
µg/ml 4.91 3.93 5.89
Progesterone nmol/l 28.3 22.6 34.0 Abbott Architect
ng/ml 8.86 7.07 10.7
nmol/l 42.8 34.2 51.4 BioMerieux Vidas
ng/ml 13.4 10.7 16.1
nmol/l 24.0 16.8 31.2 Siemens Centaur XP/XPT/Classic
ng/ml 7.51 5.26 9.76
nmol/l 25.9 20.7 31.1 Siemens Immulite 2000/2500
ng/ml 8.11 6.48 9.74
nmol/l 29.3 23.4 35.2 Siemens Immulite 1000
ng/ml 9.17 7.32 11.0
nmol/l 33.3 26.6 40.0 Beckman DxI Prog Cal 33555
ng/ml 10.4 8.33 12.5

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 15 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1817EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Progesterone nmol/l 32.8 26.2 39.4 Roche Elecsys (Prog. II)
ng/ml 10.3 8.20 12.4
nmol/l 34.2 27.4 41.0 Beckman Access Prog Cal 33555
ng/ml 10.7 8.58 12.8
nmol/l 39.1 31.3 46.9 Tosoh Series
ng/ml 12.2 9.80 14.6
nmol/l 39.7 31.8 47.6 Vitros ECi
ng/ml 12.4 9.95 14.9
nmol/l 33.6 26.9 40.3 Roche Cobas 4000/e411 (Prog. II)
ng/ml 10.5 8.42 12.6
nmol/l 34.6 27.7 41.5 Roche Cobas 6000/8000 (Prog. II)
ng/ml 10.8 8.67 12.9
nmol/l 27.7 22.2 33.2 Diasorin Liaison
ng/ml 8.67 6.95 10.4
nmol/l 35.3 28.2 42.4 SNIBE Maglumi Analysers
ng/ml 11.0 8.83 13.2
nmol/l 29.7 23.8 35.6 Beckman DxI Prog DE Cal A80773
ng/ml 9.30 7.45 11.2
nmol/l 25.8 18.1 33.5 Siemens Centaur CP
ng/ml 8.08 5.66 10.5
nmol/l 34.0 27.2 40.8 Roche Cobas 6000/8000 (Prog. III)
ng/ml 10.6 8.51 12.7
nmol/l 33.6 26.9 40.3 Roche Elecsys (Prog. III)
ng/ml 10.5 8.42 12.6
nmol/l 33.8 27.0 40.6 Roche Cobas 4000/e411 (Prog. III)
ng/ml 10.6 8.45 12.8
nmol/l 33.6 26.9 40.3 Roche Modular E170 (Prog. III)
ng/ml 10.5 8.42 12.6
Prolactin µU/ml 723 578 868 Abbott Architect
µU/ml 828 662 994 BioMerieux Vidas
µU/ml 643 502 784 Siemens Centaur XP/XPT/Classic
µU/ml 647 518 776 Siemens Immulite 2000/2500
µU/ml 681 545 817 Siemens Immulite 1000
µU/ml 627 502 752 Beckman DxI800
µU/ml 809 647 971 Roche Elecsys
µU/ml 803 642 964 Diasorin Liaison
µU/ml 769 615 923 Roche Modular E170
µU/ml 644 515 773 Beckman Access
µU/ml 782 626 938 Tosoh Series
µU/ml 656 525 787 Vitros ECi
µU/ml 778 622 934 Roche Elecsys/E170/Cobas 6000/8000 PRLII
µU/ml 743 594 892 Immunotech IRMA
µU/ml 808 646 970 Roche Cobas E411
µU/ml 782 626 938 Roche Cobas 6000/8000
µU/ml 762 610 914 SNIBE Maglumi Analysers
µU/ml 872 698 1046 Fujirebio Lumipulse G Series

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 16 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1817EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Prolactin µU/ml 707 566 848 Abbott Architect restandardised
µU/ml 646 504 788 Siemens Centaur CP
PSA Free ng/ml = µg/l 11.0 8.25 13.8 Abbott Architect
ng/ml = µg/l 13.1 9.83 16.4 BioMerieux Vidas
ng/ml = µg/l 12.5 9.38 15.6 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 8.46 6.35 10.6 Siemens Dimension
ng/ml = µg/l 10.3 7.73 12.9 Siemens Immulite 2000/2500
ng/ml = µg/l 9.46 7.10 11.8 Siemens Immulite 1000
ng/ml = µg/l 14.2 10.7 17.8 Beckman DXI standardised to Hybritech
ng/ml = µg/l 11.6 8.70 14.5 Roche Elecsys
ng/ml = µg/l 3.27 2.45 4.09 Diasorin Liaison
ng/ml = µg/l 11.6 8.70 14.5 Roche Modular E170
ng/ml = µg/l 14.4 10.8 18.0 Beckman Access standardised to Hybritech
ng/ml = µg/l 10.3 7.73 12.9 Tosoh Series
ng/ml = µg/l 11.7 8.78 14.6 Roche Cobas E411
ng/ml = µg/l 11.2 8.40 14.0 Roche Cobas 6000/8000
ng/ml = µg/l 11.6 8.70 14.5 Beckman DxI800 standardised to WHO IRP96/670
ng/ml = µg/l 9.79 7.34 12.2 SNIBE Maglumi Analysers
ng/ml = µg/l 10.5 7.88 13.1 Ortho Vitros 3600/5600/ECi PSA II
ng/ml = µg/l 8.39 6.29 10.5 Fujirebio Lumipulse G Series
PSA Total ng/ml = µg/l 12.7 9.53 15.9 Abbott Architect
ng/ml = µg/l 13.1 9.83 16.4 BioMerieux Vidas
ng/ml = µg/l 13.4 10.1 16.8 bioMerieux VIDAS TPSA
ng/ml = µg/l 12.4 9.30 15.5 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 12.5 9.38 15.6 Siemens Immulite 2000/2500 1st generation
ng/ml = µg/l 11.3 8.48 14.1 Siemens Immulite 1000 1st generation
ng/ml = µg/l 13.1 9.83 16.4 Beckman DxI standardisd to Hybritech
ng/ml = µg/l 11.5 8.63 14.4 Beckman DxI800 standardised to WHO IRP96/670
ng/ml = µg/l 15.0 11.3 18.8 Roche Elecsys
ng/ml = µg/l 4.25 3.19 5.31 Diasorin Liaison
ng/ml = µg/l 15.0 11.3 18.8 Roche Modular E170
ng/ml = µg/l 13.4 10.1 16.8 Beckman Access standardised to Hybritech
ng/ml = µg/l 12.9 9.68 16.1 Beckman Access standardised to WHO IRP96/670
ng/ml = µg/l 8.45 6.34 10.6 Tosoh Series
ng/ml = µg/l 14.6 11.0 18.3 Vitros ECi
ng/ml = µg/l 12.2 9.15 15.3 CIS RIA Coated tube
ng/ml = µg/l 15.4 11.6 19.3 Roche Cobas E411
ng/ml = µg/l 15.2 11.4 19.0 Roche Cobas 6000/8000
ng/ml = µg/l 16.3 12.2 20.4 SNIBE Maglumi Analysers
ng/ml = µg/l 11.1 8.33 13.9 Fujirebio Lumipulse G Series
ng/ml = µg/l 15.2 11.4 19.0 Ortho Vitros 3600/5600/ECi PSA II
ng/ml = µg/l 12.3 9.23 15.4 Siemens Centaur CP
Salicylic Acid mmol/l 1.13 0.904 1.36 Roche Integra
mg/dl 15.6 12.5 18.7
mmol/l 1.19 0.952 1.43 Abbott Architect
mg/dl 16.4 13.1 19.7

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 17 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1817EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Salicylic Acid mmol/l 1.23 0.984 1.48 Beckman DxC
mg/dl 17.0 13.6 20.4
mmol/l 1.22 0.980 1.46 Gravimetric
mg/dl 16.9 13.5 20.2
SHBG nmol/l 20.8 16.6 25.0 Siemens Immulite 1000
nmol/l 24.3 19.4 29.2 Siemens Immulite 2000/2500
nmol/l 25.4 20.3 30.5 Roche Modular E170
nmol/l 23.7 19.0 28.4 Abbott Architect
nmol/l 26.8 21.4 32.2 Roche Cobas E411
nmol/l 26.1 20.9 31.3 Roche Cobas 6000/8000
nmol/l 22.9 18.3 27.5 Beckman DxI800
nmol/l 21.9 17.5 26.3 SNIBE Maglumi Analysers
T Uptake %U 34.4 28.2 40.6 Siemens Immulite 2000
Testosterone nmol/l 19.4 15.5 23.3 Abbott Architect
ng/ml 5.59 4.46 6.72
ng/dl 559 446 672
nmol/l 15.9 12.7 19.1 BioMerieux Vidas
ng/ml 4.58 3.66 5.50
ng/dl 458 366 550
nmol/l 17.6 12.3 22.9 Siemens Centaur XP/XPT/Classic
ng/ml 5.07 3.55 6.59
ng/dl 507 355 659
nmol/l 19.7 15.8 23.6 CIS RIA Coated tube
ng/ml 5.67 4.55 6.79
ng/dl 567 455 679
nmol/l 23.2 18.6 27.8 Siemens Immulite 2000/2500
ng/ml 6.68 5.36 8.00
ng/dl 668 536 800
nmol/l 26.7 21.4 32.0 Siemens Immulite 1000
ng/ml 7.69 6.16 9.22
ng/dl 769 616 922
nmol/l 17.7 14.2 21.2 Beckman DxI800
ng/ml 5.10 4.09 6.11
ng/dl 510 409 611
nmol/l 19.0 15.2 22.8 Beckman Access
ng/ml 5.47 4.38 6.56
ng/dl 547 438 656
nmol/l 27.6 22.1 33.1 Tosoh Series
ng/ml 7.95 6.36 9.54
ng/dl 795 636 954
nmol/l 25.0 20.0 30.0 Vitros ECi
ng/ml 7.20 5.76 8.64
ng/dl 720 576 864
nmol/l 20.7 16.6 24.8 Roche Cobas 6000 Test 2
ng/ml 5.96 4.78 7.14
ng/dl 596 478 714

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 18 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1817EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Testosterone nmol/l 19.7 15.8 23.6 Roche Elecsys Test II
ng/ml 5.67 4.55 6.79
ng/dl 567 455 679
nmol/l 20.7 16.6 24.8 Roche Modular E170 Test II
ng/ml 5.96 4.78 7.14
ng/dl 596 478 714
nmol/l 20.3 16.2 24.4 Roche Cobas 4000/e411 Test II
ng/ml 5.85 4.67 7.03
ng/dl 585 467 703
nmol/l 21.9 17.5 26.3 SNIBE Maglumi Analysers
ng/ml 6.31 5.04 7.58
ng/dl 631 504 758
nmol/l 19.8 15.8 23.8 Abbott Architect 2nd Generation
ng/ml 5.70 4.55 6.85
ng/dl 570 455 685
nmol/l 17.3 12.1 22.5 Siemens Centaur CP
ng/ml 4.98 3.49 6.47
ng/dl 498 349 647
nmol/l 15.9 12.7 19.1 BioMerieux Vidas Testosterone II
ng/ml 4.58 3.66 5.50
ng/dl 458 366 550
nmol/l 19.0 13.3 24.7 Siemens Centaur TST II
ng/ml 5.47 3.83 7.11
ng/dl 547 383 711
Theophylline µmol/l 75.0 60.0 90.0 Siemens Centaur XP/XPT/Classic
µg/ml 13.5 10.8 16.2
µmol/l 81.8 65.4 98.2 Siemens Dimension
µg/ml 14.7 11.8 17.6
µmol/l 81.5 65.2 97.8 Roche Integra
µg/ml 14.7 11.7 17.7
µmol/l 73.4 58.7 88.1 Abbott Architect
µg/ml 13.2 10.6 15.8
µmol/l 77.7 62.2 93.2 Roche Cobas 6000/8000
µg/ml 14.0 11.2 16.8
µmol/l 76.0 60.8 91.2 Beckman DxC
µg/ml 13.7 11.0 16.4
µmol/l 72.7 58.2 87.2 Beckman AU400/600/640/2700/5400
µg/ml 13.1 10.5 15.7
µmol/l 83.8 67.0 101 Gravimetric
µg/ml 15.1 12.1 18.2
Thyroglobulin ng/ml 20.3 15.2 25.4 Siemens Immulite 1000
ng/ml 19.1 14.3 23.9 Siemens Immulite 2000
ng/ml 33.4 25.1 41.8 Roche Elecsys
ng/ml 29.9 22.4 37.4 Beckman DxI800
ng/ml 33.3 25.0 41.6 Roche Cobas E411
ng/ml 11.0 8.25 13.8 Diesse Chorus

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 19 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1817EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Thyroglobulin ng/ml 32.2 24.2 40.3 Roche Cobas 6000/8000
ng/ml 31.5 23.6 39.4 Beckman Access
ng/ml 15.8 11.9 19.8 SNIBE Maglumi Analysers
ng/ml 34.6 26.0 43.3 Tosoh Series
ng/ml 32.2 24.2 40.3 Roche Cobas 6000 TGII
ng/ml 32.7 24.5 40.9 Roche Elecsys TGII
ng/ml 32.3 24.2 40.4 Roche Cobas 4000/E411 TGII
ng/ml 32.3 24.2 40.4 Roche Modular E170 TGII
Thyroid Stimulating µU/ml = mlU/l 1.99 1.59 2.39 Abbott Architect
Hormone
µU/ml = mlU/l 2.43 1.94 2.92 bioMerieux VIDAS TSH
µU/ml = mlU/l 2.33 1.86 2.80 bioMerieux VIDAS TSH3 Ultrasensitive
µU/ml = mlU/l 2.37 1.61 3.13 Siemens Centaur XP/XPT/Classic
µU/ml = mlU/l 2.88 2.30 3.46 CIS IRMA
µU/ml = mlU/l 2.62 1.78 3.46 Siemens Centaur XP/XPT/Classic 3rd Generation
µU/ml = mlU/l 2.35 1.88 2.82 Siemens Immulite 2000/2500
µU/ml = mlU/l 2.25 1.80 2.70 Siemens Immulite 1000
µU/ml = mlU/l 2.07 1.66 2.48 Beckman DxI800 Fast TSH
µU/ml = mlU/l 2.04 1.63 2.45 Beckman DxI800
µU/ml = mlU/l 2.51 2.01 3.01 Roche Elecsys
µU/ml = mlU/l 2.77 2.22 3.32 Diasorin Liaison
µU/ml = mlU/l 2.46 1.97 2.95 Roche Modular E170
µU/ml = mlU/l 2.04 1.63 2.45 Beckman Access Fast TSH
µU/ml = mlU/l 2.14 1.71 2.57 Beckman Access hyperTSH 3rd Generation
µU/ml = mlU/l 2.43 1.94 2.92 Tosoh Series
µU/ml = mlU/l 2.73 2.18 3.28 Vitros ECi
µU/ml = mlU/l 2.47 1.98 2.96 Roche Cobas E411
µU/ml = mlU/l 2.51 2.01 3.01 Roche Cobas 6000/8000
µU/ml = mlU/l 2.11 1.69 2.53 Beckman DxI800 Hyper TSH
µU/ml = mlU/l 2.04 1.63 2.45 Siemens Dimension Vista LOCI
µU/ml = mlU/l 2.52 2.02 3.02 SNIBE Maglumi Analysers
µU/ml = mlU/l 2.28 1.55 3.01 Siemens Centaur XP/XPT/Classic TSH3-Ultra
µU/ml = mlU/l 2.37 1.61 3.13 Siemens Centaur CP
µU/ml = mlU/l 2.29 1.56 3.02 Siemens Centaur CP TSH3-Ultra
µU/ml = mlU/l 2.08 1.66 2.50 Beckman DxI 600/800 Access (3rd IS)
Tobramycin µmol/l 7.16 5.73 8.59 Gravimetric
µg/ml 3.35 2.68 4.02
Total Beta hCG mU/ml=IU/l 11.6 9.28 13.9 Abbott Architect
IU/ml 0.012 0.009 0.015
mU/ml=IU/l 27.5 22.0 33.0 BioMerieux Vidas
IU/ml 0.028 0.022 0.034
mU/ml=IU/l 14.0 8.40 19.6 Siemens Centaur XP/XPT/Classic
IU/ml 0.014 0.008 0.020
mU/ml=IU/l 26.4 21.1 31.7 Siemens Dimension
IU/ml 0.026 0.021 0.031
mU/ml=IU/l 34.2 27.4 41.0 Siemens Immulite 2000
IU/ml 0.034 0.027 0.041

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 20 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1817EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Total Beta hCG mU/ml=IU/l 32.9 26.3 39.5 Siemens Immulite 1000
IU/ml 0.033 0.026 0.040
mU/ml=IU/l 12.9 10.3 15.5 Beckman DxI800
IU/ml 0.013 0.010 0.016
mU/ml=IU/l 11.6 9.28 13.9 Diasorin Liaison
IU/ml 0.012 0.009 0.015
mU/ml=IU/l 14.8 11.8 17.8 Roche Cobas Core EIA
IU/ml 0.015 0.012 0.018
mU/ml=IU/l 13.0 10.4 15.6 Beckman Access
IU/ml 0.013 0.010 0.016
mU/ml=IU/l 26.7 21.4 32.0 Tosoh Series
IU/ml 0.027 0.021 0.033
mU/ml=IU/l 30.4 24.3 36.5 Vitros ECi
IU/ml 0.030 0.024 0.036
mU/ml=IU/l 17.8 14.2 21.4 Roche STAT (Intact)
IU/ml 0.018 0.014 0.022
mU/ml=IU/l 15.0 12.0 18.0 Roche hCG+Beta
IU/ml 0.015 0.012 0.018
mU/ml=IU/l 20.5 16.4 24.6 SNIBE Maglumi Analysers
IU/ml 0.021 0.016 0.026
mU/ml=IU/l 9.94 7.95 11.9 Fujirebio Lumipulse G Series
IU/ml 0.010 0.008 0.012
mU/ml=IU/l 12.9 10.3 15.5 Beckman Access Total BhCG (5th IS)
IU/ml 0.013 0.010 0.016
mU/ml=IU/l 13.1 10.5 15.7 Beckman DxI Total BhCG (5th IS)
IU/ml 0.013 0.011 0.015
mU/ml=IU/l 14.4 8.64 20.2 Siemens Centaur CP
IU/ml 0.014 0.008 0.020
Total T3 nmol/l 3.31 2.48 4.14 Abbott Architect
ng/ml 2.15 1.61 2.69
ng/dl 215 161 269
nmol/l 4.18 3.14 5.23 BioMerieux Vidas
ng/ml 2.72 2.04 3.40
ng/dl 272 204 340
nmol/l 4.17 3.13 5.21 Siemens Centaur XP/XPT/Classic
ng/ml 2.71 2.03 3.39
ng/dl 271 203 339
nmol/l 3.47 2.60 4.34 Siemens Immulite 2000/2500
ng/ml 2.26 1.69 2.83
ng/dl 226 169 283
nmol/l 3.67 2.75 4.59 Siemens Immulite 1000
ng/ml 2.39 1.79 2.99
ng/dl 239 179 299
nmol/l 3.42 2.57 4.28 Beckman DxI800
ng/ml 2.23 1.67 2.79
ng/dl 223 167 279

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 21 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1817EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Total T3 nmol/l 3.82 2.87 4.78 Roche Elecsys
ng/ml 2.49 1.87 3.11
ng/dl 249 187 311
nmol/l 3.58 2.69 4.48 Diasorin Liaison
ng/ml 2.33 1.75 2.91
ng/dl 233 175 291
nmol/l 3.99 2.99 4.99 Roche Modular E170
ng/ml 2.60 1.95 3.25
ng/dl 260 195 325
nmol/l 3.39 2.54 4.24 Beckman Access
ng/ml 2.21 1.65 2.77
ng/dl 221 165 277
nmol/l 3.64 2.73 4.55 Tosoh Series
ng/ml 2.37 1.78 2.96
ng/dl 237 178 296
nmol/l 4.23 3.17 5.29 Vitros ECi
ng/ml 2.75 2.06 3.44
ng/dl 275 206 344
nmol/l 2.89 2.17 3.61 CIS RIA Coated tube
ng/ml 1.88 1.41 2.35
ng/dl 188 141 235
nmol/l 4.08 3.06 5.10 Roche Cobas E411
ng/ml 2.66 1.99 3.33
ng/dl 266 199 333
nmol/l 3.98 2.99 4.98 Roche Cobas 6000/8000
ng/ml 2.59 1.95 3.23
ng/dl 259 195 323
nmol/l 4.15 3.11 5.19 SNIBE Maglumi Analysers
ng/ml 2.70 2.02 3.38
ng/dl 270 202 338
nmol/l 4.20 3.15 5.25 Siemens Centaur CP
ng/ml 2.73 2.05 3.41
ng/dl 273 205 341
Total T4 nmol/l 134 101 168 Abbott Architect
µg/dl 10.5 7.88 13.1
ng/ml 105 78.8 131
nmol/l 154 116 193 BioMerieux Vidas
µg/dl 12.0 9.05 15.0
ng/ml 120 90.5 150
nmol/l 140 91.0 189 Siemens Centaur XP/XPT/Classic
µg/dl 10.9 7.09 14.7
ng/ml 109 70.9 147
nmol/l 138 104 173 Siemens Immulite 2000/2500
µg/dl 10.8 8.11 13.5
ng/ml 108 81.1 135
nmol/l 141 106 176 Siemens Immulite 1000
µg/dl 11.0 8.27 13.7
ng/ml 110 82.7 137

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 22 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1817EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Total T4 nmol/l 142 107 178 Beckman DxI800
µg/dl 11.1 8.35 13.9
ng/ml 111 83.5 139
nmol/l 130 97.5 163 Roche Elecsys
µg/dl 10.1 7.61 12.6
ng/ml 101 76.1 126
nmol/l 127 95.3 159 Roche Modular E170
µg/dl 9.91 7.43 12.4
ng/ml 99.1 74.3 124
nmol/l 147 110 184 Beckman Access
µg/dl 11.5 8.58 14.4
ng/ml 115 85.8 144
nmol/l 126 94.5 158 Tosoh Series
µg/dl 9.83 7.37 12.3
ng/ml 98.3 73.7 123
nmol/l 139 104 174 Vitros ECi
µg/dl 10.8 8.11 13.5
ng/ml 108 81.1 135
nmol/l 137 103 171 CIS RIA Coated tube
µg/dl 10.7 8.03 13.4
ng/ml 107 80.3 134
nmol/l 134 101 168 Roche Cobas E411
µg/dl 10.5 7.88 13.1
ng/ml 105 78.8 131
nmol/l 129 96.8 161 Roche Cobas 6000/8000
µg/dl 10.1 7.55 12.7
ng/ml 101 75.5 127
nmol/l 109 81.8 136 Immunotech IRMA
µg/dl 8.50 6.38 10.6
ng/ml 85.0 63.8 106
nmol/l 141 106 176 SNIBE Maglumi Analysers
µg/dl 11.0 8.27 13.7
ng/ml 110 82.7 137
nmol/l 151 98.2 204 Siemens Centaur CP
µg/dl 11.8 7.67 15.9
ng/ml 118 76.7 159
Valproic Acid µmol/l 495 396 594 Abbott Architect
µg/ml 71.4 57.1 85.7
µmol/l 545 436 654 Siemens Centaur XP/XPT/Classic
µg/ml 78.6 62.9 94.3
µmol/l 523 418 628 Siemens Dimension
µg/ml 75.5 60.3 90.7
µmol/l 523 418 628 Siemens Immulite 2000/2500
µg/ml 75.5 60.3 90.7

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 23 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1817EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Valproic Acid µmol/l 534 427 641 Siemens Immulite 1000
µg/ml 77.1 61.6 92.6
µmol/l 514 411 617 Roche Integra
µg/ml 74.2 59.3 89.1
µmol/l 539 431 647 Vitros
µg/ml 77.8 62.2 93.4
µmol/l 531 425 637 Roche Cobas 6000/8000
µg/ml 76.6 61.3 91.9
µmol/l 514 411 617 Beckman DxC
µg/ml 74.2 59.3 89.1
µmol/l 572 458 686 Beckman AU400/600/640/2700/5400
µg/ml 82.5 66.1 98.9
µmol/l 553 442 664 Siemens ADVIA 1200/1650/1800/2400
µg/ml 79.8 63.8 95.8
µmol/l 638 510 766 Gravimetric
µg/ml 92.1 73.6 111
Vancomycin µmol/l 7.77 6.22 9.32 Roche Integra
µg/ml 11.5 9.24 13.8
µmol/l 7.10 5.68 8.52 Abbott Architect
µg/ml 10.5 8.44 12.6
µmol/l 5.57 4.34 6.80 Siemens Centaur XP/XPT/Classic
µg/ml 8.28 6.46 10.1
µmol/l 6.62 5.30 7.94 Siemens Dimension
µg/ml 9.84 7.87 11.8
µmol/l 6.74 5.39 8.09 Roche Cobas 6000/8000
µg/ml 10.0 8.01 12.0
µmol/l 7.16 5.73 8.59 Beckman DxC
µg/ml 10.6 8.51 12.7
µmol/l 7.10 5.68 8.52 Gravimetric
µg/ml 10.5 8.44 12.7
Vitamin B12 pmol/l 465 372 558 Abbott Architect
pg/ml 630 504 756
pmol/l 519 389 649 Siemens Centaur XP/XPT/Classic
pg/ml 703 527 879
pmol/l 463 370 556 Siemens Immulite 2000
pg/ml 627 501 753
pmol/l 426 341 511 Beckman DxI800
pg/ml 577 462 692
pmol/l 516 413 619 Roche Elecsys
pg/ml 699 560 838
pmol/l 509 407 611 Roche Modular E170
pg/ml 690 551 829
pmol/l 437 350 524 Beckman Access
pg/ml 592 474 710
pmol/l 618 494 742 Tosoh Series
pg/ml 837 669 1005

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 24 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1817EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Vitamin B12 pmol/l 504 403 605 Vitros ECi
pg/ml 683 546 820
pmol/l 501 401 601 MP Biomedicals RIA
pg/ml 679 543 815
pmol/l 495 396 594 Roche Cobas E411
pg/ml 671 537 805
pmol/l 513 410 616 Roche Cobas 6000/8000
pg/ml 695 556 834
pmol/l 443 354 532 Siemens Dimension
pg/ml 600 480 720
pmol/l 425 340 510 SNIBE Maglumi Analysers
pg/ml 576 461 691
pmol/l 521 391 651 Siemens Centaur CP
pg/ml 706 530 882

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 25 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
0086

IMMUNOASSAY PREMIUM - LEVEL 3


(IA PREMIUM 3)
CAT. NO. IA2640 GTIN: 05055273203868 SIZE: 12 x 5 ml
CAT. NO. IA2633 GTIN: 05055273203837 SIZE: 4 x 5 ml
LOT NO. 1818EC EXPIRY: 2021-05-28
INTENDED USE
This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of
analytes listed in the package insert.

This device is for prescription use only.

SAFETY PRECAUTIONS AND WARNINGS


For in vitro diagnostic use only. Do not pipette by mouth. Exercise the normal precautions required for handling laboratory reagents.

Human source material, from which this product has been derived, has been tested at donor level for the Human Immunodeficiency
Virus (HIV 1, HIV 2) antibody, Hepatitis B Surface Antigen (HbsAg), and Hepatitis C Virus (HCV) antibody and found to be NON-
REACTIVE. FDA approved methods have been used to conduct these tests.
However, since no method can offer complete assurance as to the absence of infectious agents, this material and all patient samples
should be handled as though capable of transmitting infectious diseases and disposed of accordingly.

Health and Safety Data Sheets are available on request.

STORAGE AND STABILITY


OPENED: Store refrigerated (+2ºC to +8ºC). Reconstituted serum is stable for 7 days at +2°C to +8°C, if kept capped in original
container and free from contamination, or 4 weeks frozen once at –20°C. C-Peptide is stable for 1 day at +2°C to +8°C.
Thyroglobulin should be tested within 4 hours of reconstitution when stored at +2°C to +8°C, or within 2 weeks when stored at
–20°C. ACTH should be tested immediately after the 30-minute reconstitution period. No frozen stability claim is made for ACTH,
Aldosterone and C-Peptide. Only the required amount of product should be removed. After use, any residual product should NOT BE
RETURNED to the original vial.

UNOPENED: Store refrigerated (+2°C to +8°C). Stable to expiration date printed on individual vials.

Bacterial contamination of the reconstituted serum will cause reductions in the stability of many components. If bacterial
contamination is suspected, the vial should be discarded and a fresh vial reconstituted.

PREPARATION
Immunoassay Premium is supplied lyophilised.
1. Carefully reconstitute each vial of lyophilised serum with exactly 5 ml of distilled water at +15°C to +25°C. Close the bottle and
allow to stand for 30 minutes before use. Ensure contents are completely dissolved by swirling gently. Avoid formation of
foam. Do not shake.
2. Refer to the Control section of the individual analyser application.
3. Refrigerate any unused material. Prior to reuse, mix contents thoroughly.

MATERIALS PROVIDED
Immunoassay Premium - Level 3: 12 x 5 ml Tri-Level: 4 x 5 ml

MATERIAL REQUIRED BUT NOT PROVIDED


Volumetric pipette

VALUE ASSIGNMENT
Each batch of Immunoassay Premium is submitted to a number of external laboratories. Values are assigned from a consensus of
results obtained by these laboratories, using a unique statistical analysis. Average values should normally fall within the listed ranges for
analytes in the instruments specified in this product insert. However, variations may be caused by instrument reagents and laboratory
technique. Therefore, the range produced herein should only be considered as a reference and it is recommended that each laboratory
establish its own mean and acceptable ranges. Aldosterone is present in control levels 2 and level 3 only. Parathyroid Hormone (PTH)
is present in the control, but no claim is made for the expected value or stability of this analyte.

If a method is unavailable, contact Randox Laboratories - Technical Services, Northern Ireland, tel: +44 (0) 28 9445 1070 or email
Technical.Services@randox.com.

06 Dec ’18 ne

PAGE 1 OF 25
A
IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1818EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
17-OH-Progesterone nmol/l 31.3 23.5 39.1 Immunotech RIA
ng/ml 10.4 7.78 13.0
nmol/l 35.7 26.8 44.6 DIAsource RIA
ng/ml 11.8 8.87 14.7
nmol/l 35.9 26.9 44.9 DiaMetra ELISA
ng/ml 11.9 8.90 14.9
nmol/l 40.9 30.7 51.1 IBL ELISA
ng/ml 13.5 10.2 16.8
nmol/l 40.6 30.5 50.8 SNIBE Maglumi Analysers
ng/ml 13.4 10.1 16.7
25-OH Vitamin D nmol/l 98.5 73.9 123 Diasorin Liaison
nmol/l 118 88.5 148 Siemens Centaur XP/XPT/Classic
nmol/l 80.7 60.5 101 Roche Vitamin D Total
nmol/l 93.5 70.1 117 HPLC
nmol/l 85.8 64.4 107 Abbott Architect
nmol/l 98.0 73.5 123 IDS iSYS
nmol/l 89.0 66.8 111 SNIBE Maglumi Analysers
nmol/l 105 78.8 131 Vitros ECi
nmol/l 79.4 59.6 99.0 Tosoh Series
nmol/l 86.9 65.2 109 BioMerieux Vidas
nmol/l 81.8 61.4 102 Beckman DxI 600/800
nmol/l 90.1 67.6 113 Fujirebio Lumipulse G Series
nmol/l 82.7 62.0 103 Beckman Access 25 OH Vitamin D Total
nmol/l 94.4 70.8 118 Roche Vitamin D Total II
ACTH pmol/l 40.4 30.3 50.5 Siemens Immulite 2000/2500
pg/ml 184 138 230
pmol/l 27.3 20.5 34.1 Roche Cobas 6000/8000
pg/ml 124 93.2 155
pmol/l 76.0 57.0 95.0 CIS IRMA
pg/ml 345 259 431
pmol/l 42.3 31.7 52.9 Siemens Immulite 1000
pg/ml 192 144 240
pmol/l 37.1 27.8 46.4 SNIBE Maglumi Analysers
pg/ml 169 126 212
Aldosterone pmol/l 741 556 926 DRG ELISA
pg/ml 267 201 333
pmol/l 227 170 284 CIS RIA
pg/ml 81.9 61.3 103
pmol/l 1067 800 1334 Immunotech RIA
pg/ml 385 289 481
pmol/l 839 629 1049 ELISA
pg/ml 303 227 379

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 2 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1818EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Aldosterone pmol/l 610 458 763 SNIBE Maglumi Analysers
pg/ml 220 165 275
pmol/l 713 535 891 IDS iSYS
pg/ml 257 193 321
pmol/l 596 447 745 Diasorin Liaison
pg/ml 215 161 269
Alpha-fetoprotein KIU/l = lU/ml 153 122 184 Abbott Architect
ng/ml 185 148 222
KIU/l = lU/ml 162 130 194 BioMerieux Vidas
ng/ml 196 157 235
KIU/l = lU/ml 180 142 218 Siemens Centaur XP/XPT/Classic
ng/ml 218 172 264
KIU/l = lU/ml 144 115 173 Siemens Immulite 2000/2500
ng/ml 174 139 209
KIU/l = lU/ml 148 118 178 Siemens Immulite 1000
ng/ml 179 143 215
KIU/l = lU/ml 156 125 187 Beckman DxI800
ng/ml 189 151 227
KIU/l = lU/ml 168 134 202 Roche Elecsys
ng/ml 203 162 244
KIU/l = lU/ml 187 150 224 Diasorin Liaison
ng/ml 226 182 270
KIU/l = lU/ml 166 133 199 Roche Modular E170
ng/ml 201 161 241
KIU/l = lU/ml 159 127 191 Beckman Access
ng/ml 192 154 230
KIU/l = lU/ml 145 116 174 Tosoh Series
ng/ml 175 140 210
KIU/l = lU/ml 172 138 206 Vitros ECi
ng/ml 179 143 215
KIU/l = lU/ml 173 138 208 Roche Cobas 6000/8000
ng/ml 209 167 251
KIU/l = lU/ml 199 159 239 CIS IRMA
ng/ml 241 192 290
KIU/l = lU/ml 174 139 209 Roche Cobas E411
ng/ml 211 168 254
KIU/l = lU/ml 161 129 193 SNIBE Maglumi Analysers
ng/ml 195 156 234
KIU/l = lU/ml 158 126 190 Fujirebio Lumipulse G Series
ng/ml 191 152 230
KIU/l = lU/ml 184 147 221 Siemens Dimension
ng/ml 223 178 268
KIU/l = lU/ml 182 144 220 Siemens Centaur CP
ng/ml 220 174 266
Amikacin µmol/l 23.2 18.6 27.8 Roche Integra
µg/ml 13.6 10.9 16.3

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 3 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1818EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Amikacin µmol/l 23.3 18.6 28.0 Roche Cobas 6000/8000
µg/ml 13.6 10.9 16.3
µmol/l 24.1 19.3 28.9 Gravimetric
µg/ml 14.1 11.3 16.9
Androstenedione nmol/l 31.7 23.8 39.6 Siemens Immulite 2000
ng/ml 9.10 6.83 11.4
Beta-2-microglobulin µg/ml = mg/l 7.37 5.90 8.84 Abbott Architect
µg/ml = mg/l 7.14 5.71 8.57 BioMerieux Vidas
µg/ml = mg/l 7.54 6.03 9.05 Behring Nephelometer
µg/ml = mg/l 6.24 4.99 7.49 Siemens Immulite 2000/2500
µg/ml = mg/l 7.03 5.62 8.44 Siemens Immulite 1000
µg/ml = mg/l 6.51 5.21 7.81 Diasorin Liaison
µg/ml = mg/l 7.76 6.21 9.31 Tosoh Series
µg/ml = mg/l 7.11 5.69 8.53 Roche Cobas 6000/8000
µg/ml = mg/l 6.56 5.25 7.87 SNIBE Maglumi Analysers
µg/ml = mg/l 6.01 4.81 7.21 Fujirebio Lumipulse G Series
µg/ml = mg/l 7.60 6.08 9.12 Siemens ADVIA 1200/1650/1800/2400
C-Peptide nmol/l 2.830 2.120 3.540 Siemens Immulite 2000/2500
ng/ml 8.54 6.40 10.7
nmol/l 2.690 2.020 3.360 Roche Elecsys
ng/ml 8.12 6.10 10.1
nmol/l 2.750 2.060 3.440 Roche Cobas 6000/8000
ng/ml 8.30 6.22 10.4
nmol/l 2.790 2.090 3.490 Siemens Immulite 1000
ng/ml 8.42 6.31 10.5
nmol/l 3.070 2.300 3.840 Diasorin Liaison
ng/ml 9.27 6.94 11.6
nmol/l 2.790 2.090 3.490 Roche Cobas E411
ng/ml 8.42 6.31 10.5
nmol/l 2.530 1.900 3.160 Abbott Architect
ng/ml 7.64 5.74 9.54
nmol/l 2.140 1.610 2.670 Siemens Centaur XP/XPT/Classic
ng/ml 6.46 4.85 8.07
nmol/l 2.570 1.930 3.210 Tosoh Series
ng/ml 7.76 5.83 9.69
nmol/l 3.000 2.250 3.750 SNIBE Maglumi Analysers
ng/ml 9.06 6.79 11.3
Carbamazepine µmol/l 68.1 54.5 81.7 Abbott Architect
µg/ml 16.1 12.9 19.3
µmol/l 71.0 44.0 98.0 Siemens Centaur XP/XPT/Classic
µg/ml 16.8 10.4 23.2
µmol/l 67.5 54.0 81.0 Siemens Dimension
µg/ml 16.0 12.8 19.2
µmol/l 61.7 49.4 74.0 Siemens Immulite 2000/2500
µg/ml 14.6 11.7 17.5
µmol/l 61.8 49.4 74.2 Siemens Immulite 1000
µg/ml 14.6 11.7 17.5

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 4 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1818EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Carbamazepine µmol/l 72.3 57.8 86.8 Roche Integra
µg/ml 17.1 13.7 20.5
µmol/l 63.8 51.0 76.6 Vitros
µg/ml 15.1 12.1 18.1
µmol/l 67.3 53.8 80.8 Roche Cobas E411
µg/ml 15.9 12.7 19.1
µmol/l 67.1 53.7 80.5 Roche Cobas 6000/8000
µg/ml 15.9 12.7 19.1
µmol/l 68.2 54.6 81.8 Beckman DxC
µg/ml 16.1 12.9 19.3
µmol/l 72.6 58.1 87.1 Beckman AU400/600/640/2700/5400
µg/ml 17.2 13.7 20.7
µmol/l 71.8 57.4 86.2 Siemens ADVIA 1200/1650/1800/2400
µg/ml 17.0 13.6 20.4
µmol/l 72.2 57.8 86.6 Gravimetric
µg/ml 17.1 13.7 20.5
Carcinoembryonic ng/ml = µg/l 63.5 50.8 76.2 Abbott Architect
Antigen (CEA)
ng/ml = µg/l 58.5 46.8 70.2 BioMerieux Vidas
ng/ml = µg/l 58.3 40.2 76.4 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 46.3 37.0 55.6 CIS RIA Coated tube
ng/ml = µg/l 77.9 62.3 93.5 Siemens Immulite 2000/2500
ng/ml = µg/l 79.4 63.5 95.3 Siemens Immulite 1000
ng/ml = µg/l 52.2 41.8 62.6 Beckman DxI800
ng/ml = µg/l 48.0 38.4 57.6 Roche Elecsys
ng/ml = µg/l 53.6 42.9 64.3 Diasorin Liaison
ng/ml = µg/l 48.0 38.4 57.6 Roche Modular E170
ng/ml = µg/l 54.3 43.4 65.2 Beckman Access
ng/ml = µg/l 75.0 60.0 90.0 Tosoh Series
ng/ml = µg/l 62.5 50.0 75.0 Vitros ECi
ng/ml = µg/l 48.2 38.6 57.8 Roche Cobas 6000/8000
ng/ml = µg/l 48.6 38.9 58.3 Roche Cobas E411
ng/ml = µg/l 48.0 38.4 57.6 SNIBE Maglumi Analysers
ng/ml = µg/l 78.5 62.8 94.2 Fujirebio Lumipulse G Series
ng/ml = µg/l 60.4 41.7 79.1 Siemens Centaur CP
Cortisol nmol/l 875 656 1094 Abbott Architect
µg/dl 31.5 23.6 39.4
nmol/l 947 710 1184 BioMerieux Vidas
µg/dl 34.1 25.6 42.6
nmol/l 1138 785 1491 Siemens Centaur XP/XPT/Classic
µg/dl 41.0 28.3 53.7
nmol/l 844 633 1055 CIS RIA
µg/dl 30.4 22.8 38.0
nmol/l 965 724 1206 Siemens Immulite 2000/2500
µg/dl 34.7 26.1 43.3
nmol/l 1014 761 1268 Siemens Immulite 1000
µg/dl 36.5 27.4 45.6

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 5 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1818EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Cortisol nmol/l 972 729 1215 Beckman DxI800
µg/dl 35.0 26.2 43.8
nmol/l 1047 785 1309 Roche Elecsys
µg/dl 37.7 28.3 47.1
nmol/l 1014 761 1268 Diasorin Liaison
µg/dl 36.5 27.4 45.6
nmol/l 1076 807 1345 Beckman Access
µg/dl 38.7 29.1 48.3
nmol/l 1033 775 1291 Tosoh Series
µg/dl 37.2 27.9 46.5
nmol/l 935 701 1169 Vitros ECi
µg/dl 33.7 25.2 42.2
nmol/l 1006 755 1258 Roche Cobas 6000/8000
µg/dl 36.2 27.2 45.2
nmol/l 1053 790 1316 Roche Cobas E411
µg/dl 37.9 28.4 47.4
nmol/l 994 746 1243 SNIBE Maglumi Analysers
µg/dl 35.8 26.9 44.7
nmol/l 1243 858 1628 Siemens Centaur CP
µg/dl 44.7 30.8 58.6
nmol/l 1009 757 1261 Roche Modular E170 Gen II
µg/dl 36.3 27.3 45.3
nmol/l 1057 793 1321 Roche Cobas 4000/e411 Gen II
µg/dl 38.1 28.5 47.7
nmol/l 979 734 1224 Roche Cobas 6000/8000 Gen II
µg/dl 35.2 26.4 44.0
nmol/l 1021 766 1276 Roche Elecsys Gen II
µg/dl 36.8 27.6 46.0
DHEA-S µmol/l 22.0 17.6 26.4 Abbott Architect
µmol/l 18.4 14.7 22.1 Siemens Immulite 2000/2500
µmol/l 18.4 14.7 22.1 Siemens Immulite 1000
µmol/l 16.9 13.5 20.3 Beckman DxI800
µmol/l 26.5 21.2 31.8 Roche Elecsys
µmol/l 26.3 21.0 31.6 Roche Modular E170
µmol/l 17.6 14.1 21.1 Beckman Access
µmol/l 15.6 12.5 18.7 Diasorin Liaison
µmol/l 18.1 10.9 25.3 Siemens Centaur XP/XPT/Classic
µmol/l 26.0 20.8 31.2 Roche Cobas E411
µmol/l 26.0 20.8 31.2 Roche Cobas 6000/8000
µmol/l 16.9 13.5 20.3 SNIBE Maglumi Analysers
Digoxin nmol/l 4.17 3.34 5.00 Abbott Architect
ng/ml 3.26 2.61 3.91
nmol/l 4.78 3.82 5.74 BioMerieux Vidas
ng/ml 3.73 2.98 4.48
nmol/l 5.28 4.12 6.44 Siemens Centaur XP/XPT/Classic
ng/ml 4.12 3.21 5.03

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 6 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1818EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Digoxin nmol/l 4.80 3.84 5.76 Siemens Dimension
ng/ml 3.75 3.00 4.50
nmol/l 5.36 4.29 6.43 Siemens Immulite 2000/2500
ng/ml 4.19 3.35 5.03
nmol/l 4.89 3.91 5.87 Beckman DxI800
ng/ml 3.82 3.05 4.59
nmol/l 5.43 4.34 6.52 Roche Elecsys
ng/ml 4.24 3.39 5.09
nmol/l 4.79 3.83 5.75 Roche Integra
ng/ml 3.74 2.99 4.49
nmol/l 4.80 3.84 5.76 Vitros
ng/ml 3.75 3.00 4.50
nmol/l 4.98 3.98 5.98 Roche Cobas 6000/8000
ng/ml 3.89 3.11 4.67
nmol/l 4.22 3.38 5.06 Beckman DxC
ng/ml 3.30 2.64 3.96
nmol/l 5.10 4.08 6.12 Beckman AU400/600/640/2700/5400
ng/ml 3.98 3.19 4.77
nmol/l 4.67 3.74 5.60 Siemens ADVIA 1200/1650/1800/2400
ng/ml 3.65 2.92 4.38
nmol/l 5.71 4.57 6.85 SNIBE Maglumi Analysers
ng/ml 4.46 3.57 5.35
nmol/l 5.00 4.00 6.00 Roche Cobas 4000/E411
ng/ml 3.91 3.12 4.70
nmol/l 5.12 4.10 6.14 Gravimetric
ng/ml 4.00 3.20 4.80
Ethosuximide µmol/l 493 394 592 Gravimetric
µg/ml 69.9 55.9 83.9
Ferritin ng/ml = µg/l 353 282 424 Abbott Architect
ng/ml = µg/l 243 194 292 BioMerieux Vidas
ng/ml = µg/l 297 232 362 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 266 213 319 Siemens Dimension
ng/ml = µg/l 268 214 322 Siemens Immulite 2000/2500
ng/ml = µg/l 238 190 286 Siemens Immulite 1000
ng/ml = µg/l 221 177 265 Beckman DxI800
ng/ml = µg/l 319 255 383 Roche Elecsys
ng/ml = µg/l 304 243 365 Diasorin Liaison
ng/ml = µg/l 310 248 372 Roche Modular E170
ng/ml = µg/l 226 181 271 Beckman Access
ng/ml = µg/l 218 174 262 Tosoh Series
ng/ml = µg/l 197 158 236 Vitros ECi
ng/ml = µg/l 284 227 341 Immunotech IRMA
ng/ml = µg/l 310 248 372 Roche Cobas E411
ng/ml = µg/l 236 189 283 Siemens/Dade Behring Nephelometer
ng/ml = µg/l 235 188 282 Beckman AU400/600/640/2700/5400

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 7 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1818EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Ferritin ng/ml = µg/l 224 179 269 SNIBE Maglumi Analysers
ng/ml = µg/l 189 151 227 Fujirebio Lumipulse G Series
ng/ml = µg/l 277 216 338 Siemens Centaur CP
Folate nmol/l 17.9 13.6 22.2 Abbott Architect
ng/ml 7.89 6.00 9.78
nmol/l 38.9 23.3 54.5 Siemens Centaur XP/XPT/Classic (enhanced kit)
ng/ml 17.2 10.3 24.1
nmol/l 15.0 11.4 18.6 Siemens Immulite 2000
ng/ml 6.62 5.03 8.21
nmol/l 20.3 15.4 25.2 Beckman DxI800
ng/ml 8.95 6.79 11.1
nmol/l 19.8 15.0 24.6 Roche Elecsys
ng/ml 8.73 6.62 10.8
nmol/l 20.4 15.5 25.3 Beckman Access
ng/ml 9.00 6.84 11.2
nmol/l 30.6 23.3 37.9 Tosoh Series
ng/ml 13.5 10.3 16.7
nmol/l 13.5 10.3 16.7 Vitros ECi
ng/ml 5.95 4.54 7.36
nmol/l 14.8 11.2 18.4 MP Biomedicals RIA
ng/ml 6.53 4.94 8.12
nmol/l 19.3 14.7 23.9 Roche Cobas E411
ng/ml 8.51 6.48 10.5
nmol/l 20.6 15.7 25.5 Roche Cobas 6000/8000
ng/ml 9.08 6.92 11.2
nmol/l 12.0 9.12 14.9 Siemens Dimension
ng/ml 5.29 4.02 6.56
nmol/l 43.9 33.4 54.4 SNIBE Maglumi Analysers
ng/ml 19.4 14.7 24.1
nmol/l 44.6 26.8 62.4 Siemens Centaur CP (enhanced kit)
ng/ml 19.7 11.8 27.6
nmol/l 19.8 15.0 24.6 Roche Cobas 6000/8000 Folate III
ng/ml 8.73 6.62 10.8
nmol/l 20.7 15.7 25.7 Roche Cobas 4000/e411 Folate III
ng/ml 9.13 6.92 11.3
Free T3 pmol/l 23.0 17.3 28.8 Abbott Architect
ng/dl 1.50 1.12 1.88
pg/ml 15.0 11.3 18.7
pmol/l 23.8 17.9 29.8 BioMerieux Vidas
ng/dl 1.55 1.16 1.94
pg/ml 15.5 11.7 19.3
pmol/l 24.2 14.5 33.9 Siemens Centaur XP/XPT/Classic
ng/dl 1.57 0.942 2.20
pg/ml 15.8 9.48 22.1
pmol/l 15.9 11.9 19.9 Siemens Immulite 2000/2500
ng/dl 1.03 0.774 1.29
pg/ml 10.4 7.75 13.1

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 8 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1818EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Free T3 pmol/l 14.7 11.0 18.4 Siemens Immulite 1000
ng/dl 0.956 0.715 1.20
pg/ml 9.57 7.16 12.0
pmol/l 18.5 13.9 23.1 Beckman DxI800
ng/dl 1.20 0.904 1.50
pg/ml 12.0 9.05 15.0
pmol/l 29.8 22.4 37.3 Roche Elecsys
ng/dl 1.94 1.46 2.42
pg/ml 19.4 14.6 24.2
pmol/l 38.1 28.6 47.6 Diasorin Liaison
ng/dl 2.48 1.86 3.10
pg/ml 24.8 18.6 31.0
pmol/l 29.1 21.8 36.4 Roche Modular E170
ng/dl 1.89 1.42 2.36
pg/ml 18.9 14.2 23.6
pmol/l 19.5 14.6 24.4 Beckman Access
ng/dl 1.27 0.949 1.59
pg/ml 12.7 9.50 15.9
pmol/l 34.2 25.7 42.8 Tosoh Series
ng/dl 2.22 1.67 2.77
pg/ml 22.3 16.7 27.9
pmol/l 35.1 26.3 43.9 Vitros ECi
ng/dl 2.28 1.71 2.85
pg/ml 22.9 17.1 28.7
pmol/l 29.8 22.4 37.3 Roche Cobas E411
ng/dl 1.94 1.46 2.42
pg/ml 19.4 14.6 24.2
pmol/l 29.6 22.2 37.0 Roche Cobas 6000/8000
ng/dl 1.92 1.44 2.40
pg/ml 19.3 14.5 24.1
pmol/l 33.3 25.0 41.6 Siemens Dimension Vista LOCI
ng/dl 2.16 1.63 2.69
pg/ml 21.7 16.3 27.1
pmol/l 27.3 20.5 34.1 SNIBE Maglumi Analysers
ng/dl 1.77 1.33 2.21
pg/ml 17.8 13.3 22.3
pmol/l 23.1 13.9 32.3 Siemens Centaur CP
ng/dl 1.50 0.900 2.10
pg/ml 15.0 9.00 21.0
Free T4 pmol/l 53.5 40.1 66.9 Abbott Architect
ng/dl 4.17 3.13 5.21
pg/ml 41.7 31.3 52.1
pmol/l 56.2 42.2 70.2 Siemens Centaur XP/XPT/Classic
ng/dl 4.38 3.29 5.47
pg/ml 43.8 32.9 54.7

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 9 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1818EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Free T4 pmol/l 62.7 47.0 78.4 CIS RIA Coated tube
ng/dl 4.89 3.67 6.11
pg/ml 48.9 36.7 61.1
pmol/l 74.9 56.2 93.6 Siemens Immulite 2000/2500
ng/dl 5.84 4.38 7.30
pg/ml 58.4 43.8 73.0
pmol/l 76.9 57.7 96.1 Siemens Immulite 1000
ng/dl 6.00 4.50 7.50
pg/ml 60.0 45.0 75.0
pmol/l 57.9 43.4 72.4 Beckman DxI800
ng/dl 4.52 3.39 5.65
pg/ml 45.2 33.9 56.5
pmol/l 83.1 62.3 104 Roche Elecsys
ng/dl 6.48 4.86 8.10
pg/ml 64.8 48.6 81.0
pmol/l 118 88.5 148 Diasorin Liaison
ng/dl 9.20 6.90 11.5
pg/ml 92.0 69.0 115
pmol/l 79.8 59.9 100 Roche Modular E170
ng/dl 6.22 4.67 7.77
pg/ml 62.2 46.7 77.7
pmol/l 54.7 41.0 68.4 Beckman Access
ng/dl 4.27 3.20 5.34
pg/ml 42.7 32.0 53.4
pmol/l 80.9 60.7 101 Tosoh Series
ng/dl 6.31 4.73 7.89
pg/ml 63.1 47.3 78.9
pmol/l 89.8 67.4 112 Vitros ECi
ng/dl 7.00 5.26 8.74
pg/ml 70.0 52.6 87.4
pmol/l 80.2 60.2 100 Roche Cobas 6000/8000
ng/dl 6.26 4.70 7.82
pg/ml 62.6 47.0 78.2
pmol/l 60.7 45.5 75.9 Immunotech IRMA
ng/dl 4.73 3.55 5.91
pg/ml 47.3 35.5 59.1
pmol/l 82.9 62.2 104 Roche Cobas E411
ng/dl 6.47 4.85 8.09
pg/ml 64.7 48.5 80.9
pmol/l 55.8 41.9 69.8 ELISA
ng/dl 4.35 3.27 5.43
pg/ml 43.5 32.7 54.3
pmol/l 93.6 70.2 117 Siemens Dimension Vista LOCI
ng/dl 7.30 5.48 9.12
pg/ml 73.0 54.8 91.2
pmol/l 124 93.0 155 SNIBE Maglumi Analysers
ng/dl 9.67 7.25 12.1
pg/ml 96.7 72.5 121

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 10 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1818EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Free T4 pmol/l 84.2 63.2 105 Biomerieux Vidas FT4N Kit
ng/dl 6.57 4.93 8.21
pg/ml 65.7 49.3 82.1
pmol/l 64.8 48.6 81.0 Siemens Centaur CP
ng/dl 5.05 3.79 6.31
pg/ml 50.5 37.9 63.1
FSH mU/ml 47.0 37.6 56.4 Abbott Architect
mU/ml 64.8 51.8 77.8 BioMerieux Vidas
mU/ml 72.3 56.4 88.2 Siemens Centaur XP/XPT/Classic
mU/ml 56.8 45.4 68.2 Siemens Immulite 2000/2500
mU/ml 55.0 44.0 66.0 Siemens Immulite 1000
mU/ml 57.7 46.2 69.2 Beckman DxI800
mU/ml 54.2 43.4 65.0 Roche/BM Elecsys
mU/ml 65.0 52.0 78.0 Diasorin Liaison
mU/ml 49.9 39.9 59.9 Roche Modular E170
mU/ml 57.7 46.2 69.2 Beckman Access
mU/ml 51.9 41.5 62.3 Tosoh Series
mU/ml 40.5 32.4 48.6 Vitros ECi
mU/ml 53.6 42.9 64.3 Roche Cobas E411
mU/ml 50.9 40.7 61.1 Roche Cobas 6000/8000
mU/ml 62.5 50.0 75.0 SNIBE Maglumi Analysers
mU/ml 43.9 35.1 52.7 Fujirebio Lumipulse G Series
mU/ml 60.9 47.5 74.3 Siemens Centaur CP
Gentamicin µmol/l 9.26 7.41 11.1 Roche Integra
µg/ml 4.43 3.54 5.32
µmol/l 12.6 9.58 15.6 Siemens Centaur XP/XPT/Classic
µg/ml 6.02 4.58 7.46
µmol/l 10.2 8.16 12.2 Siemens Dimension Vista
µg/ml 4.88 3.90 5.86
µmol/l 7.82 6.26 9.38 Roche Cobas 6000/8000
µg/ml 3.74 2.99 4.49
µmol/l 12.7 10.2 15.2 Beckman DxC
µg/ml 6.07 4.88 7.26
µmol/l 11.7 9.36 14.0 Gravimetric
µg/ml 5.59 4.47 6.69
Growth Hormone (GH) µU/ml 38.6 30.9 46.3 Siemens Immulite 2000/2500
ng/ml 12.9 10.3 15.5
µU/ml 37.2 29.8 44.6 Siemens Immulite 1000
ng/ml 12.4 9.92 14.9
µU/ml 31.5 25.2 37.8 Beckman DxI800
ng/ml 10.5 8.39 12.6
µU/ml 39.6 31.7 47.5 Roche Elecsys
ng/ml 13.2 10.6 15.8
µU/ml 33.0 26.4 39.6 Beckman Access
ng/ml 11.0 8.79 13.2

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 11 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1818EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Growth Hormone (GH) µU/ml 36.7 29.4 44.0 Tosoh Series
ng/ml 12.2 9.79 14.6
µU/ml 35.4 28.3 42.5 Diasorin Liaison
ng/ml 11.8 9.42 14.2
µU/ml 38.0 30.4 45.6 Roche Cobas E411
ng/ml 12.7 10.1 15.3
µU/ml 54.7 43.8 65.6 SNIBE Maglumi Analysers
ng/ml 18.2 14.6 21.8
µU/ml 38.2 30.6 45.8 Roche Cobas 6000/8000
ng/ml 12.7 10.2 15.2
µU/ml 33.9 27.1 40.7 IDS iSYS
ng/ml 11.3 9.02 13.6
Immunoglobulin E KIU/l = IU/ml 539 431 647 Abbott Architect
KIU/l = IU/ml 475 380 570 BioMerieux Vidas
KIU/l = IU/ml 466 280 652 Siemens Centaur XP/XPT/Classic
KIU/l = IU/ml 487 390 584 Siemens Immulite 2000/2500
KIU/l = IU/ml 511 409 613 Siemens Immulite 1000
KIU/l = IU/ml 516 413 619 Beckman DxI800
KIU/l = IU/ml 514 411 617 Roche Elecsys
KIU/l = IU/ml 456 365 547 Pharmacia Unicap
KIU/l = IU/ml 514 411 617 Roche Modular E170
KIU/l = IU/ml 486 389 583 Tosoh Series
KIU/l = IU/ml 511 409 613 Roche Cobas E411
KIU/l = IU/ml 517 414 620 Roche Cobas 6000/8000
KIU/l = IU/ml 461 369 553 SNIBE Maglumi Analysers
KIU/l = IU/ml 414 331 497 Fujirebio Lumipulse G Series
KIU/l = IU/ml 434 260 608 Siemens Centaur CP
Insulin mU/l 30.8 23.1 38.5 Siemens Centaur XP/XPT/Classic
µU/ml 30.8 23.1 38.5
mU/l 9.76 7.32 12.2 Siemens Immulite 1000
µU/ml 9.76 7.32 12.2
mU/l 36.8 27.6 46.0 Roche Modular E170
µU/ml 36.8 27.6 46.0
mU/l 34.7 26.0 43.4 Roche Elecsys
µU/ml 34.7 26.0 43.4
mU/l 27.8 20.9 34.8 Beckman Access
µU/ml 27.8 20.9 34.7
mU/l 27.2 20.4 34.0 Abbott Architect
µU/ml 27.2 20.4 34.0
mU/l 37.5 28.1 46.9 Tosoh Series
µU/ml 37.5 28.1 46.9
mU/l 35.1 26.3 43.9 Roche Cobas E411
µU/ml 35.1 26.3 43.9
mU/l 26.5 19.9 33.1 Beckman DxI 600/800
µU/ml 26.5 19.9 33.1

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 12 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1818EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Insulin mU/l 38.4 28.8 48.0 Diasorin Liaison
µU/ml 38.4 28.8 48.0
mU/l 35.6 26.7 44.5 Roche Cobas 6000/8000
µU/ml 35.6 26.7 44.5
mU/l 27.9 20.9 34.9 SNIBE Maglumi Analysers
µU/ml 27.9 20.9 34.9
mU/l 34.4 25.8 43.0 Fujirebio Lumipulse G Series
µU/ml 34.4 25.8 43.0
mU/l 30.0 22.5 37.5 Siemens Centaur CP
µU/ml 30.0 22.5 37.5
Luteinising Hormone mU/ml 30.1 24.1 36.1 Abbott Architect
(LH)
mU/ml 34.4 27.5 41.3 BioMerieux Vidas
mU/ml 36.1 27.8 44.4 Siemens Centaur XP/XPT/Classic
mU/ml 54.0 43.2 64.8 Siemens Immulite 2000
mU/ml 55.7 44.6 66.8 Siemens Immulite 1000
mU/ml 25.9 20.7 31.1 Beckman DxI800
mU/ml 37.9 30.3 45.5 Roche Elecsys
mU/ml 44.3 35.4 53.2 Diasorin Liaison
mU/ml 38.1 30.5 45.7 Roche Modular E170
mU/ml 26.4 21.1 31.7 Beckman Access
mU/ml 33.3 26.6 40.0 Tosoh Series
mU/ml 39.8 31.8 47.8 Vitros ECi
mU/ml 38.1 30.5 45.7 Roche Cobas E411
mU/ml 38.1 30.5 45.7 Roche Cobas 6000/8000
mU/ml 37.0 29.6 44.4 SNIBE Maglumi Analysers
mU/ml 33.8 27.0 40.6 Fujirebio Lumipulse G Series
mU/ml 36.2 27.9 44.5 Siemens Centaur CP
Oestradiol pmol/l 1233 986 1480 Abbott Architect
pg/ml 335 268 402
pmol/l 2477 1982 2972 BioMerieux Vidas
pg/ml 674 539 809
pmol/l 2241 1389 3093 Siemens Centaur XP/XPT/Classic
pg/ml 610 378 842
pmol/l 2047 1638 2456 Siemens Immulite 2000/2500
pg/ml 557 446 668
pmol/l 2255 1804 2706 Siemens Immulite 1000
pg/ml 613 491 735
pmol/l 2030 1624 2436 Beckman DxI800
pg/ml 552 442 662
pmol/l 1399 1119 1679 Roche Elecsys (Estradiol II)
pg/ml 381 304 458
pmol/l 2149 1719 2579 Beckman Access
pg/ml 585 468 702
pmol/l 1649 1319 1979 Tosoh (E2)
pg/ml 449 359 539
pmol/l 2171 1737 2605 Vitros ECi
pg/ml 591 472 710

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 13 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1818EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Oestradiol pmol/l 1414 1131 1697 Roche Cobas 6000/8000 (Estradiol II)
pg/ml 385 308 462
pmol/l 1407 1126 1688 Roche Cobas 4000/E411 (Estradiol II)
pg/ml 383 306 460
pmol/l 2241 1389 3093 Siemens Centaur XP/XPT/Classic Enhanced (eE2)
pg/ml 610 378 842
pmol/l 2190 1358 3022 Siemens Centaur XP/XPT/Classic E26 III
pg/ml 596 370 822
pmol/l 2892 2314 3470 SNIBE Maglumi Analysers
pg/ml 787 629 945
pmol/l 1683 1346 2020 Tosoh (iE2-hsE2)
pg/ml 458 366 550
pmol/l 2382 1477 3287 Siemens Centaur CP
pg/ml 648 402 894
pmol/l 2205 1367 3043 Siemens Centaur CP Enhanced (eE2)
pg/ml 600 372 828
pmol/l 1951 1561 2341 Fujirebio Lumipulse G Series
pg/ml 531 425 637
pmol/l 1416 1133 1699 Roche Cobas 6000/8000 (Estradiol III)
pg/ml 385 308 462
pmol/l 1374 1099 1649 Roche Elecsys (Estradiol III)
pg/ml 374 299 449
pmol/l 1418 1134 1702 Roche Cobas 4000/E411 (Estradiol III)
pg/ml 386 308 464
pmol/l 1410 1128 1692 Roche Modular E170 (Estradiol III)
pg/ml 384 307 461
Paracetamol mmol/l 0.574 0.459 0.689 Vitros
mg/l 86.8 69.4 104
mmol/l 0.501 0.401 0.601 Abbott Architect
mg/l 75.8 60.7 90.9
mmol/l 0.463 0.370 0.556 Roche Cobas 6000/8000
mg/l 70.1 56.0 84.2
mmol/l 0.529 0.420 0.630 Gravimetric
mg/l 80.0 63.5 95.3
Phenobarbital µmol/l 121 96.8 145 Abbott Architect
µg/ml 28.1 22.5 33.7
µmol/l 112 89.6 134 Roche Cobas 6000/8000
µg/ml 26.0 20.8 31.2
µmol/l 120 96.0 144 Siemens Immulite 2000/2500
µg/ml 27.8 22.3 33.3
µmol/l 125 100 150 Beckman AU400/600/640/2700/5400
µg/ml 29.0 23.2 34.8
µmol/l 147 107 187 Siemens Centaur XP/XPT/Classic
µg/ml 34.1 24.9 43.3
µmol/l 112 89.6 134 Roche Integra
µg/ml 26.0 20.8 31.2

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 14 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1818EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Phenobarbital µmol/l 116 92.8 139 Siemens Immulite 1000
µg/ml 26.9 21.5 32.3
µmol/l 118 94.4 142 Beckman DxC
µg/ml 27.4 21.9 32.9
µmol/l 121 96.8 145 Gravimetric
µg/ml 28.1 22.5 33.6
Phenytoin µmol/l 90.1 72.1 108 Abbott Architect
µg/ml 22.8 18.2 27.4
µmol/l 114 88.9 139 Siemens Centaur XP/XPT/Classic
µg/ml 28.8 22.5 35.1
µmol/l 101 80.8 121 Siemens Dimension
µg/ml 25.5 20.4 30.6
µmol/l 87.4 69.9 105 Siemens Immulite 2000/2500
µg/ml 22.1 17.6 26.6
µmol/l 91.7 73.4 110 Siemens Immulite 1000
µg/ml 23.2 18.5 27.9
µmol/l 90.7 72.6 109 Roche Integra
µg/ml 22.9 18.3 27.5
µmol/l 92.3 73.8 111 Vitros
µg/ml 23.3 18.6 28.0
µmol/l 91.9 73.5 110 Roche Cobas E411
µg/ml 23.2 18.6 27.8
µmol/l 90.7 72.6 109 Roche Cobas 6000/8000
µg/ml 22.9 18.3 27.5
µmol/l 91.2 73.0 109 Beckman DxC
µg/ml 23.0 18.4 27.6
µmol/l 99.8 79.8 120 Gravimetric
µg/ml 25.2 20.1 30.3
Primidone µmol/l 32.7 26.2 39.2 Gravimetric
µg/ml 7.14 5.72 8.56
Progesterone nmol/l 87.0 69.6 104 Abbott Architect
ng/ml 27.2 21.8 32.6
nmol/l 135 108 162 BioMerieux Vidas
ng/ml 42.3 33.8 50.8
nmol/l 69.0 49.0 89.0 Siemens Centaur XP/XPT/Classic
ng/ml 21.6 15.3 27.9
nmol/l 64.4 51.5 77.3 Siemens Immulite 2000/2500
ng/ml 20.2 16.1 24.3
nmol/l 76.7 61.4 92.0 Siemens Immulite 1000
ng/ml 24.0 19.2 28.8
nmol/l 95.6 76.5 115 Beckman DxI Prog Cal 33555
ng/ml 29.9 23.9 35.9
nmol/l 95.5 76.4 115 Roche Elecsys (Prog. II)
ng/ml 29.9 23.9 35.9
nmol/l 98.1 78.5 118 Beckman Access Prog Cal 33555
ng/ml 30.7 24.6 36.8

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 15 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1818EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Progesterone nmol/l 105 84.0 126 Tosoh Series
ng/ml 32.9 26.3 39.5
nmol/l 105 84.0 126 Vitros ECi
ng/ml 32.9 26.3 39.5
nmol/l 93.7 75.0 112 Roche Cobas 4000/e411 (Prog. II)
ng/ml 29.3 23.5 35.1
nmol/l 95.6 76.5 115 Roche Cobas 6000/8000 (Prog. II)
ng/ml 29.9 23.9 35.9
nmol/l 76.1 60.9 91.3 Diasorin Liaison
ng/ml 23.8 19.1 28.5
nmol/l 123 98.4 148 SNIBE Maglumi Analysers
ng/ml 38.5 30.8 46.2
nmol/l 87.4 69.9 105 Beckman DxI Prog DE Cal A80773
ng/ml 27.4 21.9 32.9
nmol/l 86.7 69.4 104 Beckman Access Prog DE Cal A80773
ng/ml 27.1 21.7 32.5
nmol/l 69.7 49.5 89.9 Siemens Centaur CP
ng/ml 21.8 15.5 28.1
nmol/l 100 80.0 120 Fujirebio Lumipulse G Series
ng/ml 31.3 25.0 37.6
nmol/l 95.2 76.2 114 Roche Cobas 6000/8000 (Prog. III)
ng/ml 29.8 23.9 35.7
nmol/l 95.7 76.6 115 Roche Elecsys (Prog. III)
ng/ml 30.0 24.0 36.0
nmol/l 94.9 75.9 114 Roche Cobas 4000/e411 (Prog. III)
ng/ml 29.7 23.8 35.6
nmol/l 95.0 76.0 114 Roche Modular E170 (Prog. III)
ng/ml 29.7 23.8 35.6
Prolactin µU/ml 1248 998 1498 Abbott Architect
µU/ml 1422 1138 1706 BioMerieux Vidas
µU/ml 1049 787 1311 Siemens Centaur XP/XPT/Classic
µU/ml 1143 914 1372 Siemens Immulite 2000/2500
µU/ml 1183 946 1420 Siemens Immulite 1000
µU/ml 1035 828 1242 Beckman DxI800
µU/ml 1353 1082 1624 Roche Elecsys
µU/ml 1293 1034 1552 Diasorin Liaison
µU/ml 1296 1037 1555 Roche Modular E170
µU/ml 1058 846 1270 Beckman Access
µU/ml 1233 986 1480 Tosoh Series
µU/ml 1075 860 1290 Vitros ECi
µU/ml 1313 1050 1576 Roche Elecsys/E170/Cobas 6000/8000 PRLII
µU/ml 1163 930 1396 Immunotech IRMA
µU/ml 1368 1094 1642 Roche Cobas E411
µU/ml 1319 1055 1583 Roche Cobas 6000/8000
µU/ml 1367 1094 1640 SNIBE Maglumi Analysers

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 16 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1818EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Prolactin µU/ml 1439 1151 1727 Fujirebio Lumipulse G Series
µU/ml 1205 964 1446 Abbott Architect restandardised
µU/ml 1008 756 1260 Siemens Centaur CP
PSA Free ng/ml = µg/l 24.4 18.3 30.5 Abbott Architect
ng/ml = µg/l 25.4 19.1 31.8 BioMerieux Vidas
ng/ml = µg/l 24.9 18.7 31.1 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 20.0 15.0 25.0 Siemens Dimension
ng/ml = µg/l 21.2 15.9 26.5 Siemens Immulite 2000/2500
ng/ml = µg/l 20.7 15.5 25.9 Siemens Immulite 1000
ng/ml = µg/l 28.1 21.1 35.1 Beckman DXI standardised to Hybritech
ng/ml = µg/l 23.3 17.5 29.1 Roche Elecsys
ng/ml = µg/l 7.69 5.77 9.61 Diasorin Liaison
ng/ml = µg/l 22.9 17.2 28.6 Roche Modular E170
ng/ml = µg/l 30.3 22.7 37.9 Beckman Access standardised to Hybritech
ng/ml = µg/l 22.2 16.7 27.8 Tosoh Series
ng/ml = µg/l 24.1 18.1 30.1 Roche Cobas E411
ng/ml = µg/l 23.1 17.3 28.9 Roche Cobas 6000/8000
ng/ml = µg/l 22.8 17.1 28.5 SNIBE Maglumi Analysers
ng/ml = µg/l 21.5 16.1 26.9 Ortho Vitros 3600/5600/ECi PSA II
ng/ml = µg/l 18.2 13.7 22.8 Fujirebio Lumipulse G Series
PSA Total ng/ml = µg/l 25.5 19.1 31.9 Abbott Architect
ng/ml = µg/l 28.7 21.5 35.9 BioMerieux Vidas
ng/ml = µg/l 28.2 21.2 35.3 bioMerieux VIDAS TPSA
ng/ml = µg/l 26.0 19.5 32.5 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 26.0 19.5 32.5 Siemens Immulite 2000/2500 1st generation
ng/ml = µg/l 22.5 16.9 28.1 Siemens Immulite 1000 3rd generation
ng/ml = µg/l 26.0 19.5 32.5 Siemens Immulite 2000/2500 3rd generation
ng/ml = µg/l 23.0 17.3 28.8 Siemens Immulite 1000 1st generation
ng/ml = µg/l 27.3 20.5 34.1 Beckman DxI standardisd to Hybritech
ng/ml = µg/l 21.7 16.3 27.1 Beckman DxI800 standardised to WHO IRP96/670
ng/ml = µg/l 30.6 23.0 38.3 Roche Elecsys
ng/ml = µg/l 8.97 6.73 11.2 Diasorin Liaison
ng/ml = µg/l 30.7 23.0 38.4 Roche Modular E170
ng/ml = µg/l 27.6 20.7 34.5 Beckman Access standardised to Hybritech
ng/ml = µg/l 28.1 21.1 35.1 Beckman Access standardised to WHO IRP96/670
ng/ml = µg/l 17.9 13.4 22.4 Tosoh Series
ng/ml = µg/l 29.5 22.1 36.9 Vitros ECi
ng/ml = µg/l 24.4 18.3 30.5 CIS RIA Coated tube
ng/ml = µg/l 31.2 23.4 39.0 Roche Cobas E411
ng/ml = µg/l 30.8 23.1 38.5 Roche Cobas 6000/8000
ng/ml = µg/l 33.4 25.1 41.8 SNIBE Maglumi Analysers
ng/ml = µg/l 23.1 17.3 28.9 Fujirebio Lumipulse G Series
ng/ml = µg/l 29.6 22.2 37.0 Ortho Vitros 3600/5600/ECi PSA II
ng/ml = µg/l 26.1 19.6 32.6 Siemens Centaur CP
Salicylic Acid mmol/l 2.68 2.14 3.22 Roche Integra
mg/dl 37.0 29.6 44.4

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 17 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1818EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Salicylic Acid mmol/l 2.79 2.23 3.35 Abbott Architect
mg/dl 38.5 30.8 46.2
mmol/l 2.95 2.36 3.54 Beckman DxC
mg/dl 40.7 32.6 48.8
mmol/l 2.88 2.30 3.46 Gravimetric
mg/dl 39.8 31.8 47.8
SHBG nmol/l 46.2 37.0 55.4 Siemens Centaur XP/XPT/Classic
nmol/l 33.3 26.6 40.0 Siemens Immulite 1000
nmol/l 36.1 28.9 43.3 Siemens Immulite 2000/2500
nmol/l 41.1 32.9 49.3 Roche Elecsys
nmol/l 35.4 28.3 42.5 Abbott Architect
nmol/l 38.6 30.9 46.3 Roche Cobas E411
nmol/l 38.7 31.0 46.4 Roche Cobas 6000/8000
nmol/l 35.4 28.3 42.5 Beckman DxI800
nmol/l 30.1 24.1 36.1 SNIBE Maglumi Analysers
T Uptake %U 38.7 31.7 45.7 Siemens Immulite 2000
Testosterone nmol/l 30.3 24.2 36.4 Abbott Architect
ng/ml 8.73 6.97 10.5
ng/dl 873 697 1049
nmol/l 24.6 19.7 29.5 BioMerieux Vidas
ng/ml 7.08 5.67 8.49
ng/dl 708 567 849
nmol/l 25.8 18.8 32.8 Siemens Centaur XP/XPT/Classic
ng/ml 7.43 5.42 9.44
ng/dl 743 542 944
nmol/l 31.1 24.9 37.3 CIS RIA Coated tube
ng/ml 8.96 7.17 10.8
ng/dl 896 717 1075
nmol/l 36.4 29.1 43.7 Siemens Immulite 2000/2500
ng/ml 10.5 8.38 12.6
ng/dl 1048 838 1258
nmol/l 47.4 37.9 56.9 Siemens Immulite 1000
ng/ml 13.7 10.9 16.5
ng/dl 1365 1092 1638
nmol/l 25.4 20.3 30.5 Beckman DxI800
ng/ml 7.32 5.85 8.79
ng/dl 732 585 879
nmol/l 26.9 21.5 32.3 Beckman Access
ng/ml 7.75 6.19 9.31
ng/dl 775 619 931
nmol/l 45.3 36.2 54.4 Tosoh Series
ng/ml 13.0 10.4 15.6
ng/dl 1305 1043 1567
nmol/l 40.4 32.3 48.5 Vitros ECi
ng/ml 11.6 9.30 13.9
ng/dl 1164 930 1398

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 18 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1818EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Testosterone nmol/l 30.2 24.2 36.2 Roche Cobas 6000 Test 2
ng/ml 8.70 6.97 10.4
ng/dl 870 697 1043
nmol/l 30.1 24.1 36.1 Roche Elecsys Test II
ng/ml 8.67 6.94 10.4
ng/dl 867 694 1040
nmol/l 30.7 24.6 36.8 Roche Modular E170 Test II
ng/ml 8.84 7.08 10.6
ng/dl 884 708 1060
nmol/l 30.0 24.0 36.0 Roche Cobas 4000/e411 Test II
ng/ml 8.64 6.91 10.4
ng/dl 864 691 1037
nmol/l 30.3 24.2 36.4 SNIBE Maglumi Analysers
ng/ml 8.73 6.97 10.5
ng/dl 873 697 1049
nmol/l 30.5 24.4 36.6 Abbott Architect 2nd Generation
ng/ml 8.78 7.03 10.5
ng/dl 878 703 1053
nmol/l 24.8 18.1 31.5 Siemens Centaur CP
ng/ml 7.14 5.21 9.07
ng/dl 714 521 907
nmol/l 25.1 20.1 30.1 BioMerieux Vidas Testosterone II
ng/ml 7.23 5.79 8.67
ng/dl 723 579 867
nmol/l 26.2 19.1 33.3 Siemens Centaur TST II
ng/ml 7.55 5.51 9.59
ng/dl 755 551 959
Theophylline µmol/l 143 114 172 Siemens Centaur XP/XPT/Classic
µg/ml 25.8 20.5 31.1
µmol/l 163 130 196 Siemens Dimension
µg/ml 29.4 23.4 35.4
µmol/l 157 126 188 Roche Integra
µg/ml 28.3 22.7 33.9
µmol/l 140 112 168 Abbott Architect
µg/ml 25.2 20.2 30.2
µmol/l 149 119 179 Roche Cobas 6000/8000
µg/ml 26.8 21.4 32.2
µmol/l 155 124 186 Beckman DxC
µg/ml 27.9 22.3 33.5
µmol/l 144 115 173 Beckman AU400/600/640/2700/5400
µg/ml 25.9 20.7 31.1
µmol/l 166 133 199 Gravimetric
µg/ml 29.9 24.0 35.9
Thyroglobulin ng/ml 43.6 32.7 54.5 Siemens Immulite 1000
ng/ml 39.4 29.6 49.3 Siemens Immulite 2000
ng/ml 64.2 48.2 80.3 Roche Elecsys

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 19 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1818EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Thyroglobulin ng/ml 61.2 45.9 76.5 Beckman DxI800
ng/ml 65.7 49.3 82.1 Roche Cobas E411
ng/ml 22.0 16.5 27.5 Diesse Chorus
ng/ml 65.1 48.8 81.4 Roche Cobas 6000/8000
ng/ml 61.5 46.1 76.9 Beckman Access
ng/ml 45.9 34.4 57.4 SNIBE Maglumi Analysers
ng/ml 69.0 51.8 86.3 Tosoh Series
ng/ml 64.1 48.1 80.1 Roche Cobas 6000 TGII
ng/ml 65.3 49.0 81.6 Roche Elecsys TGII
ng/ml 65.3 49.0 81.6 Roche Cobas 4000/E411 TGII
ng/ml 60.8 45.6 76.0 Roche Modular E170 TGII
Thyroid Stimulating µU/ml = mlU/l 16.0 12.8 19.2 Abbott Architect
Hormone
µU/ml = mlU/l 18.8 15.0 22.6 bioMerieux VIDAS TSH
µU/ml = mlU/l 16.2 13.0 19.4 bioMerieux VIDAS TSH3 Ultrasensitive
µU/ml = mlU/l 20.3 13.8 26.8 Siemens Centaur XP/XPT/Classic
µU/ml = mlU/l 19.6 15.7 23.5 CIS IRMA
µU/ml = mlU/l 20.0 13.6 26.4 Siemens Centaur XP/XPT/Classic 3rd Generation
µU/ml = mlU/l 18.5 14.8 22.2 Siemens Immulite 2000/2500
µU/ml = mlU/l 18.4 14.7 22.1 Siemens Immulite 1000
µU/ml = mlU/l 17.2 13.8 20.6 Beckman DxI800 Fast TSH
µU/ml = mlU/l 17.5 14.0 21.0 Beckman DxI800
µU/ml = mlU/l 18.9 15.1 22.7 Roche Elecsys
µU/ml = mlU/l 22.8 18.2 27.4 Diasorin Liaison
µU/ml = mlU/l 18.7 15.0 22.4 Roche Modular E170
µU/ml = mlU/l 17.0 13.6 20.4 Beckman Access Fast TSH
µU/ml = mlU/l 17.4 13.9 20.9 Beckman Access hyperTSH 3rd Generation
µU/ml = mlU/l 19.7 15.8 23.6 Tosoh Series
µU/ml = mlU/l 26.2 21.0 31.4 Vitros ECi
µU/ml = mlU/l 19.0 15.2 22.8 Roche Cobas E411
µU/ml = mlU/l 18.9 15.1 22.7 Roche Cobas 6000/8000
µU/ml = mlU/l 17.0 13.6 20.4 Beckman DxI800 Hyper TSH
µU/ml = mlU/l 17.7 14.2 21.2 Siemens Dimension Vista LOCI
µU/ml = mlU/l 21.2 17.0 25.4 SNIBE Maglumi Analysers
µU/ml = mlU/l 20.0 13.6 26.4 Siemens Centaur XP/XPT/Classic TSH3-Ultra
µU/ml = mlU/l 19.7 13.4 26.0 Siemens Centaur CP
µU/ml = mlU/l 19.5 13.3 25.7 Siemens Centaur CP TSH3-Ultra
µU/ml = mlU/l 17.1 13.7 20.5 Beckman DxI 600/800 Access (3rd IS)
Tobramycin µmol/l 10.3 8.24 12.4 Gravimetric
µg/ml 4.82 3.86 5.80
Total Beta hCG mU/ml=IU/l 210 168 252 Abbott Architect
IU/ml 0.210 0.168 0.252
mU/ml=IU/l 536 429 643 BioMerieux Vidas
IU/ml 0.536 0.429 0.643
mU/ml=IU/l 187 112 262 Siemens Centaur XP/XPT/Classic
IU/ml 0.187 0.112 0.262
mU/ml=IU/l 484 387 581 Siemens Dimension
IU/ml 0.484 0.387 0.581

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 20 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1818EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Total Beta hCG mU/ml=IU/l 599 479 719 Siemens Immulite 2000
IU/ml 0.599 0.479 0.719
mU/ml=IU/l 609 487 731 Siemens Immulite 1000
IU/ml 0.609 0.487 0.731
mU/ml=IU/l 203 162 244 Beckman DxI800
IU/ml 0.203 0.162 0.244
mU/ml=IU/l 207 166 248 Diasorin Liaison
IU/ml 0.207 0.166 0.248
mU/ml=IU/l 289 231 347 Roche Cobas Core EIA
IU/ml 0.289 0.231 0.347
mU/ml=IU/l 198 158 238 Beckman Access
IU/ml 0.198 0.158 0.238
mU/ml=IU/l 498 398 598 Tosoh Series
IU/ml 0.498 0.398 0.598
mU/ml=IU/l 538 430 646 Vitros ECi
IU/ml 0.538 0.430 0.646
mU/ml=IU/l 333 266 400 Roche STAT (Intact)
IU/ml 0.333 0.266 0.400
mU/ml=IU/l 287 230 344 Roche hCG+Beta
IU/ml 0.287 0.230 0.344
mU/ml=IU/l 428 342 514 SNIBE Maglumi Analysers
IU/ml 0.428 0.342 0.514
mU/ml=IU/l 173 138 208 Fujirebio Lumipulse G Series
IU/ml 0.173 0.138 0.208
mU/ml=IU/l 216 173 259 Radiometer AQT90 Flex
IU/ml 0.216 0.173 0.259
mU/ml=IU/l 198 158 238 Beckman Access Total BhCG (5th IS)
IU/ml 0.198 0.158 0.238
mU/ml=IU/l 207 166 248 Beckman DxI Total BhCG (5th IS)
IU/ml 0.207 0.166 0.248
mU/ml=IU/l 188 113 263 Siemens Centaur CP
IU/ml 0.188 0.113 0.263
Total T3 nmol/l 5.28 3.96 6.60 Abbott Architect
ng/ml 3.44 2.58 4.30
ng/dl 344 258 430
nmol/l 6.37 4.78 7.96 BioMerieux Vidas
ng/ml 4.15 3.11 5.19
ng/dl 415 311 519
nmol/l 7.45 5.59 9.31 Siemens Centaur XP/XPT/Classic
ng/ml 4.85 3.64 6.06
ng/dl 485 364 606
nmol/l 6.11 4.58 7.64 Siemens Immulite 2000/2500
ng/ml 3.98 2.98 4.98
ng/dl 398 298 498
nmol/l 6.24 4.68 7.80 Siemens Immulite 1000
ng/ml 4.06 3.05 5.07
ng/dl 406 305 507

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 21 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1818EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Total T3 nmol/l 5.36 4.02 6.70 Beckman DxI800
ng/ml 3.49 2.62 4.36
ng/dl 349 262 436
nmol/l 6.63 4.97 8.29 Roche Elecsys
ng/ml 4.32 3.24 5.40
ng/dl 432 324 540
nmol/l 5.65 4.24 7.06 Diasorin Liaison
ng/ml 3.68 2.76 4.60
ng/dl 368 276 460
nmol/l 6.40 4.80 8.00 Roche Modular E170
ng/ml 4.17 3.12 5.22
ng/dl 417 312 522
nmol/l 5.52 4.14 6.90 Beckman Access
ng/ml 3.59 2.70 4.48
ng/dl 359 270 448
nmol/l 5.99 4.49 7.49 Tosoh Series
ng/ml 3.90 2.92 4.88
ng/dl 390 292 488
nmol/l 7.29 5.47 9.11 Vitros ECi
ng/ml 4.75 3.56 5.94
ng/dl 475 356 594
nmol/l 5.03 3.77 6.29 CIS RIA Coated tube
ng/ml 3.27 2.45 4.09
ng/dl 327 245 409
nmol/l 6.63 4.97 8.29 Roche Cobas E411
ng/ml 4.32 3.24 5.40
ng/dl 432 324 540
nmol/l 6.40 4.80 8.00 Roche Cobas 6000/8000
ng/ml 4.17 3.12 5.22
ng/dl 417 312 522
nmol/l 6.27 4.70 7.84 ELISA
ng/ml 4.08 3.06 5.10
ng/dl 408 306 510
nmol/l 8.57 6.43 10.7 SNIBE Maglumi Analysers
ng/ml 5.58 4.19 6.97
ng/dl 558 419 697
nmol/l 7.97 5.98 9.96 Siemens Centaur CP
ng/ml 5.19 3.89 6.49
ng/dl 519 389 649
Total T4 nmol/l 203 152 254 Abbott Architect
µg/dl 15.8 11.9 19.7
ng/ml 158 119 197
nmol/l 236 177 295 BioMerieux Vidas
µg/dl 18.4 13.8 23.0
ng/ml 184 138 230

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 22 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1818EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Total T4 nmol/l 219 153 285 Siemens Centaur XP/XPT/Classic
µg/dl 17.1 12.0 22.2
ng/ml 171 120 222
nmol/l 211 158 264 Siemens Immulite 2000/2500
µg/dl 16.5 12.3 20.7
ng/ml 165 123 207
nmol/l 222 167 278 Siemens Immulite 1000
µg/dl 17.3 13.0 21.6
ng/ml 173 130 216
nmol/l 220 165 275 Beckman DxI800
µg/dl 17.2 12.9 21.5
ng/ml 172 129 215
nmol/l 186 140 233 Roche Elecsys
µg/dl 14.5 10.9 18.1
ng/ml 145 109 181
nmol/l 196 147 245 Diasorin Liaison
µg/dl 15.3 11.5 19.1
ng/ml 153 115 191
nmol/l 191 143 239 Roche Modular E170
µg/dl 14.9 11.2 18.6
ng/ml 149 112 186
nmol/l 233 175 291 Beckman Access
µg/dl 18.2 13.7 22.7
ng/ml 182 137 227
nmol/l 200 150 250 Tosoh Series
µg/dl 15.6 11.7 19.5
ng/ml 156 117 195
nmol/l 220 165 275 Vitros ECi
µg/dl 17.2 12.9 21.5
ng/ml 172 129 215
nmol/l 260 195 325 CIS RIA Coated tube
µg/dl 20.3 15.2 25.4
ng/ml 203 152 254
nmol/l 191 143 239 Roche Cobas E411
µg/dl 14.9 11.2 18.6
ng/ml 149 112 186
nmol/l 186 140 233 Roche Cobas 6000/8000
µg/dl 14.5 10.9 18.1
ng/ml 145 109 181
nmol/l 164 123 205 Immunotech IRMA
µg/dl 12.8 9.59 16.0
ng/ml 128 95.9 160
nmol/l 198 149 248 SNIBE Maglumi Analysers
µg/dl 15.4 11.6 19.2
ng/ml 154 116 192

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 23 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1818EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Total T4 nmol/l 232 162 302 Siemens Centaur CP
µg/dl 18.1 12.7 23.5
ng/ml 181 127 235
Valproic Acid µmol/l 893 714 1072 Abbott Architect
µg/ml 129 103 155
µmol/l 936 749 1123 Siemens Centaur XP/XPT/Classic
µg/ml 135 108 162
µmol/l 889 711 1067 Siemens Dimension
µg/ml 128 103 153
µmol/l 960 768 1152 Siemens Immulite 2000/2500
µg/ml 139 111 167
µmol/l 961 769 1153 Siemens Immulite 1000
µg/ml 139 111 167
µmol/l 895 716 1074 Roche Integra
µg/ml 129 103 155
µmol/l 890 712 1068 Vitros
µg/ml 128 103 153
µmol/l 952 762 1142 Roche Cobas E411
µg/ml 137 110 164
µmol/l 899 719 1079 Roche Cobas 6000/8000
µg/ml 130 104 156
µmol/l 852 682 1022 Beckman DxC
µg/ml 123 98.4 148
µmol/l 994 795 1193 Beckman AU400/600/640/2700/5400
µg/ml 143 115 171
µmol/l 909 727 1091 Siemens ADVIA 1200/1650/1800/2400
µg/ml 131 105 157
µmol/l 1116 893 1339 Gravimetric
µg/ml 161 129 193
Vancomycin µmol/l 11.6 9.28 13.9 Roche Integra
µg/ml 17.2 13.8 20.6
µmol/l 10.8 8.64 13.0 Abbott Architect
µg/ml 16.0 12.8 19.2
µmol/l 8.35 6.68 10.0 Siemens Centaur XP/XPT/Classic
µg/ml 12.4 9.92 14.9
µmol/l 9.82 7.86 11.8 Siemens Dimension
µg/ml 14.6 11.7 17.5
µmol/l 10.0 8.00 12.0 Roche Cobas 6000/8000
µg/ml 14.9 11.9 17.9
µmol/l 9.91 7.93 11.9 Beckman DxC
µg/ml 14.7 11.8 17.6
µmol/l 10.3 8.24 12.4 Thermo Scientific QMS Vancomycin
µg/ml 15.3 12.2 18.4
µmol/l 10.8 8.64 13.0 Gravimetric
µg/ml 16.0 12.8 19.3
Vitamin B12 pmol/l 735 588 882 Abbott Architect
pg/ml 996 797 1195

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 24 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1818EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2021-05-28
Range
Analyte unit Target low high methods
Vitamin B12 pmol/l 858 644 1072 Siemens Centaur XP/XPT/Classic
pg/ml 1163 872 1454
pmol/l 668 534 802 Siemens Immulite 2000
pg/ml 905 724 1086
pmol/l 702 562 842 Beckman DxI800
pg/ml 951 762 1140
pmol/l 819 655 983 Roche Elecsys
pg/ml 1110 888 1332
pmol/l 803 642 964 Roche Modular E170
pg/ml 1088 870 1306
pmol/l 711 569 853 Beckman Access
pg/ml 963 771 1155
pmol/l 958 766 1150 Tosoh Series
pg/ml 1298 1038 1558
pmol/l 662 530 794 Vitros ECi
pg/ml 897 718 1076
pmol/l 834 667 1001 MP Biomedicals RIA
pg/ml 1130 904 1356
pmol/l 788 630 946 Roche Cobas E411
pg/ml 1068 854 1282
pmol/l 815 652 978 Roche Cobas 6000/8000
pg/ml 1104 883 1325
pmol/l 724 579 869 Siemens Dimension
pg/ml 981 785 1177
pmol/l 718 574 862 SNIBE Maglumi Analysers
pg/ml 973 778 1168
pmol/l 842 632 1052 Siemens Centaur CP
pg/ml 1141 856 1426

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 25 OF 25
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com

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