LIQUID ASSAYED SPECIFIC PROTEIN CONTROL - LEVEL 2

(SP CONTROL 2)
CAT. NO. PS2683 LOT NO. 676LPC
SIZE: 3 x 1ml EXPIRY: 2025-06-28
GTIN: 05055273204902

INTENDED USE
This product is intended for in vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay
systems. The Assayed Liquid Protein Controls are for the control of accuracy.

DEVICE DESCRIPTION
The Liquid Protein Controls are supplied at 3 levels, level 1, 2 and 3. Target values and ranges are supplied for the analytes
listed in the values table. Note: Free Lambda light chains are not for use in the U.S.

SAFETY PRECAUTIONS AND WARNINGS

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

Labelling according to Regulation (EC) No. 1272/2008 [CLP]

Pictogram

Warning

Hazard statement(s)
H317 May cause an allergic skin reaction.

Precautionary statement(s)
P261 Avoid breathing dust/fume/gas/mist/vapours/spray.
P272 Contaminated work clothing should not be allowed out of the workplace.
P280 Wear protective gloves/protective clothing/eye protection/face protection.

Supplemental Hazard Information (EU)

P302+P352 If on skin: Wash with plenty of water.
P321 Specific treatment (see on this label).
P333+P313 If skin irritation or rash occurs: Get medical advice/attention.

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 (+2°C to +8°C). Protein control material is stable for 30 days at +2 to +8°C, if kept capped in
original container and free from contamination. 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.

Note: Free Kappa Light Chains is present in the Liquid Assayed Specific Protein Control material but no claim is made for the
expected value or stability of this analyte.

PAGE 1 OF 6
 PS2683 – LOT NO. 676LPC

PREPARATION
The Liquid Protein Controls are supplied ready for use. Allow the control to come to room temperature before analysis.

MATERIALS PROVIDED
Liquid Protein Control - Level 2 3 x 1 ml

MATERIALS REQUIRED BUT NOT PROVIDED

N/A

LIMITATIONS
RF: Please note that the dilution of multi-controls on certain systems can result in the over recovery of R.F. compared to the
undiluted control. This is due to complex Immunoglobulin interactions.

Rheumatoid Factor Values may gradually decrease during the product’s shelf life.

ASSIGNED VALUES
Each batch of Protein Control is submitted to approximately 100 laboratories and values are assigned from a consensus of
results obtained by these laboratories. With each batch, a control range is provided for individual parameters and each
parameter method.

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

The presence of a vertical bar in the margin indicates a technical update from the previous revision

Randox Teoranta, Meenmore,

Dungloe, Donegal,
F94 TV06, Ireland

Rev. 19 Apr ’24 ld

PAGE 2 OF 6
A
LIQUID ASSAYED SPECIFIC PROTEIN CONTROL - LEVEL 2 (SP CONTROL 2)
Cat. No. PS2683 Lot. No. 676LPC Size 3 x 1 ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Albumin g/l 39.8 33.8 45.8 Bromocresol Green (IFCC Cal.)
g/dl 3.98 3.38 4.58
g/l 38.3 32.6 44.0 Bromocresol Purple (IFCC Cal.)
g/dl 3.83 3.26 4.40
g/l 39.8 33.8 45.8 Nephelometric (IFCC Cal.)
g/dl 3.98 3.38 4.58
g/l 40.8 34.7 46.9 Bromocresol Green (Non IFCC Cal.)
g/dl 4.08 3.47 4.69
g/l 38.8 33.0 44.6 Turbidimetric Assays (IFCC Cal.)
g/dl 3.88 3.30 4.46
Alpha-1-Acid g/l 1.15 0.920 1.38 Turbidimetric (IFCC Cal.)
Glycoprotein
mg/dl 115 92.0 138
g/l 1.18 0.944 1.42 Nephelometric (IFCC Cal.)
mg/dl 118 94.4 142
g/l 1.15 0.920 1.38 Turbidimetric (Non IFCC Cal.)
mg/dl 115 92.0 138
Alpha-1-Antitrypsin g/l 1.09 0.872 1.31 Turbidimetric (IFCC Cal.)
mg/dl 109 87.2 131
g/l 1.10 0.880 1.32 Turbidimetric (Non IFCC Cal.)
mg/dl 110 88.0 132
Alpha-2-Macroglobulin g/l 2.31 1.85 2.77 Nephelometric (IFCC Cal.)
mg/dl 231 185 277
Alphafoetoprotein KIU/l = lU/ml 27.8 22.2 33.4 Chemiluminescence (IFCC Cal.)
ng/ml 33.6 26.9 40.3
KIU/l = lU/ml 28.1 22.5 33.7 Chemiluminescence (Non IFCC Cal.)
ng/ml 34.0 27.2 40.8
Anti Streptolysin O IU/ml 197 158 236 Turbidimetric (Non IFCC Cal.)
IU/ml 186 149 223 Neph. others (Non IFCC Cal.)
IU/ml 130 104 156 Neph. Beckman (IFCC Cal.)
IU/ml 124 99.2 149 Neph. Beckman (Non IFCC Cal.)
Beta-2-microglobulin µg/ml = mg/l 2.31 1.85 2.77 Nephelometric (IFCC Cal.)
µg/ml = mg/l 2.32 1.86 2.78 Nephelometric (Non IFCC Cal.)
µg/ml = mg/l 2.71 2.17 3.25 Turbidimetric (IFCC Cal.)
µg/ml = mg/l 2.68 2.14 3.22 Turbidimetric (Non IFCC Cal.)
C-Reactive Protein mg/l 44.8 35.8 53.8 Vitros (IFCC Cal.)
mg/l 48.7 39.0 58.4 Turbidimetric (IFCC Cal.)
mg/l 47.4 37.9 56.9 Nephelometric (IFCC Cal.)
mg/l 46.4 37.1 55.7 Vitros (Non IFCC Cal.)
mg/l 48.5 38.8 58.2 Nephelometric (Non IFCC Cal.)
mg/l 48.6 38.9 58.3 Turbidimetric (Non IFCC Cal.)
mg/l 49.2 39.4 59.0 Roche Turbidimetric Gen 3 (IFCC Cal.)
mg/l 48.4 38.7 58.1 Roche Turbidimetric Gen 3 (non-IFCC Cal.)

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 3 OF 6
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
LIQUID ASSAYED SPECIFIC PROTEIN CONTROL - LEVEL 2 (SP CONTROL 2)
Cat. No. PS2683 Lot. No. 676LPC Size 3 x 1 ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
C-Reactive Protein mg/l 48.8 39.0 58.6 Roche Turbidimetric Latex (IFCC Cal.)
mg/l 49.3 39.4 59.2 Roche Turbidimetric Latex (non-IFCC Cal.)
mg/l 49.0 39.2 58.8 Beckman Turb Latex (IFCC Cal)
mg/l 48.4 38.7 58.1 Roche Turbidimetric CRP4 (IFCC Cal.)
Caeruloplasmin g/l 0.495 0.371 0.619 Nephelometric (IFCC Cal.)
mg/dl 49.5 37.1 61.9
g/l 0.430 0.323 0.538 Nephelometric (Non IFCC Cal.)
mg/dl 43.0 32.3 53.8
g/l 0.338 0.254 0.423 Turbidimetric (Non IFCC Cal.)
mg/dl 33.8 25.4 42.3
Complement C3 g/l 2.06 1.65 2.47 Turbidimetric (IFCC Cal.)
mg/dl 206 165 247
g/l 2.03 1.62 2.44 Nephelometric (IFCC Cal.)
mg/dl 203 162 244
g/l 2.01 1.61 2.41 Nephelometric (Non IFCC Cal.)
mg/dl 201 161 241
g/l 2.11 1.69 2.53 Turbidimetric (Non IFCC Cal.)
mg/dl 211 169 253
g/l 1.98 1.58 2.38 Vitros 5.1 FS microtip assay
mg/dl 198 158 238
Complement C4 g/l 0.380 0.304 0.456 Turbidimetric (IFCC Cal.)
mg/dl 38.0 30.4 45.6
g/l 0.395 0.316 0.474 Nephelometric (IFCC Cal.)
mg/dl 39.5 31.6 47.4
g/l 0.399 0.319 0.479 Nephelometric (Non IFCC Cal.)
mg/dl 39.9 31.9 47.9
g/l 0.365 0.292 0.438 Turbidimetric (Non IFCC Cal.)
mg/dl 36.5 29.2 43.8
g/l 0.364 0.291 0.437 Vitros 5.1 FS microtip assay
mg/dl 36.4 29.1 43.7
Ferritin ng/ml = µg/l 165 132 198 Turbidimetric (IFCC Cal.)
ng/ml = µg/l 143 114 172 Turbidimetric (Non IFCC Cal.)
ng/ml = µg/l 192 154 230 Chemiluminescence (Non IFCC Cal.)
ng/ml = µg/l 136 109 163 Nephelometric (IFCC Cal.)
Free Lambda Light mg/L 15.7 12.6 18.8 Nephelometric - Binding Site
Chains
mg/L 15.0 12.0 18.0 Nephelometric - Siemens
mg/L 14.4 11.5 17.3 Turbidimetric
Haptoglobin g/l 1.27 1.02 1.52 Nephelometric (IFCC Cal.)
mg/dl 127 102 152
g/l 1.27 1.02 1.52 Turbidimetric (IFCC Cal.)
mg/dl 127 102 152
g/l 1.29 1.03 1.55 Turbidimetric (Non IFCC Cal.)
mg/dl 129 103 155
Immunoglobulin A g/l 3.42 2.57 4.28 Turbidimetric (IFCC Cal.)
mg/dl 342 257 427
g/l 3.67 2.75 4.59 Nephelometric (IFCC Cal.)
mg/dl 367 275 459

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 4 OF 6
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
LIQUID ASSAYED SPECIFIC PROTEIN CONTROL - LEVEL 2 (SP CONTROL 2)
Cat. No. PS2683 Lot. No. 676LPC Size 3 x 1 ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Immunoglobulin A g/l 3.67 2.75 4.59 Nephelometric (Non IFCC Cal.)
mg/dl 367 275 459
g/l 3.43 2.57 4.29 Turbidimetric (Non IFCC Cal.)
mg/dl 343 257 429
g/l 3.57 2.68 4.46 Vitros 5.1 FS Microtip (IFCC)
mg/dl 357 268 446
Immunoglobulin E KIU/l = IU/ml 165 132 198 Chemiluminescence (Non IFCC Cal.)
KIU/l = IU/ml 139 111 167 Nephelometric (Non IFCC Cal.)
KIU/l = IU/ml 130 104 156 Turbidimetric (Non IFCC Cal.)
Immunoglobulin G g/l 17.6 14.4 20.8 Turbidimetric (IFCC Cal.)
mg/dl 1760 1440 2080
g/l 17.5 14.4 20.7 Nephelometric (IFCC Cal.)
mg/dl 1750 1440 2060
g/l 17.2 14.1 20.3 Nephelometric (Non IFCC Cal.)
mg/dl 1720 1410 2030
g/l 17.7 14.5 20.9 Turbidimetric (Non IFCC Cal.)
mg/dl 1770 1450 2090
g/l 18.5 15.2 21.8 Vitros 5.1 FS Microtip (IFCC)
mg/dl 1850 1520 2180
Immunoglobulin M g/l 1.48 1.18 1.78 Turbidimetric (IFCC Cal.)
mg/dl 148 118 178
g/l 1.59 1.27 1.91 Nephelometric (IFCC Cal.)
mg/dl 159 127 191
g/l 1.61 1.29 1.93 Nephelometric (Non IFCC Cal.)
mg/dl 161 129 193
g/l 1.46 1.17 1.75 Turbidimetric (Non IFCC Cal.)
mg/dl 146 117 175
g/l 1.47 1.18 1.76 Vitros 5.1 FS Microtip (IFCC)
mg/dl 147 118 176
Kappa Light Chain g/l 4.14 3.31 4.97 Nephelometric - Siemens
mg/dl 414 331 497
g/l 4.20 3.36 5.04 Turbidimetric
mg/dl 420 336 504
Lambda Light Chain g/l 2.30 1.84 2.76 Turbidimetric
mg/dl 230 184 276
g/l 2.26 1.81 2.71 Nephelometric - Siemens
mg/dl 226 181 271
Prealbumin g/l 0.210 0.168 0.252 Nephelometric (IFCC Cal.)
mg/dl 21.0 16.8 25.2
g/l 0.200 0.160 0.240 Turbidimetric (IFCC Cal.)
mg/dl 20.0 16.0 24.0
g/l 0.210 0.168 0.252 Turbidimetric (Non IFCC Cal.)
mg/dl 21.0 16.8 25.2

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 5 OF 6
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
LIQUID ASSAYED SPECIFIC PROTEIN CONTROL - LEVEL 2 (SP CONTROL 2)
Cat. No. PS2683 Lot. No. 676LPC Size 3 x 1 ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Protein Total g/l 69.5 55.6 83.4 Biuret reaction end point
g/dl 6.95 5.56 8.34
Retinol Binding Protein mg/l 41.8 33.4 50.2 Nephelometric (IFCC Cal.)
Rheumatoid Factor U/ml 31.8 23.9 39.8 Turbidimetric (Non IFCC Cal.)
U/ml 26.6 20.0 33.3 Nephelometric (Non IFCC Cal.)
U/ml 32.7 24.5 40.9 Latex (Non-IFCC Cal.)
Transferrin g/l 2.53 2.02 3.04 Turbidimetric (IFCC Cal.)
mg/dl 253 202 304
g/l 2.56 2.05 3.07 Turbidimetric (Non IFCC Cal.)
mg/dl 256 205 307
g/l 2.50 2.00 3.00 Nephelometric (IFCC Cal.)
mg/dl 250 200 300

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 6 OF 6
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com