03333795190V7

AAGP2
Tina-quant α1-Acid Glycoprotein Gen.2
• Indicates cobas c systems on which reagents can be used
Order information Roche/Hitachi cobas c systems
Tina-quant α1-Acid Glycoprotein Gen.2 cobas c 311 cobas c 501/502
100 tests Cat. No. 03333795 190 System-ID 07 6758 1 • •
Calibrator f.a.s. Proteins (5 x 1 mL) Cat. No. 11355279 216 Code 656
Calibrator f.a.s. Proteins (5 x 1 mL, for USA) Cat. No. 11355279 160 Code 656
Precinorm Protein (3 x 1 mL) Cat. No. 10557897 122 Code 302
Precinorm Protein (3 x 1 mL, for USA) Cat. No. 10557897 160 Code 302
Precipath Protein (3 x 1 mL) Cat. No. 11333127 122 Code 303
Precipath Protein (3 x 1 mL, for USA) Cat. No. 11333127 160 Code 303
PreciControl ClinChem Multi 1 (20 x 5 mL) Cat. No. 05117003 190 Code 391
PreciControl ClinChem Multi 1 (4 x 5 mL, for USA) Cat. No. 05947626 160 Code 391
PreciControl ClinChem Multi 2 (20 x 5 mL) Cat. No. 05117216 190 Code 392
PreciControl ClinChem Multi 2 (4 x 5 mL, for USA) Cat. No. 05947774 160 Code 392
Diluent NaCl 9 % (50 mL) Cat. No. 04489357 190 System-ID 07 6869 3

English Exercise the normal precautions required for handling all laboratory reagents.
Safety data sheet available for professional user on request.
System information Disposal of all waste material should be in accordance with local guidelines.
For cobas c 311/501 analyzers:
AAGP2: ACN 229 Reagent handling
For cobas c 502 analyzer: Ready for use.
AAGP2: ACN 8229

Intended use Storage and stability

In vitro test for the quantitative determination of α1-acid glycoprotein in AAGP2
human serum and plasma on Roche/Hitachi cobas c systems. Shelf life at 2-8 °C: See expiration date on
cobas c pack label.
Summary1,2,3,4,5
α1-Acid glycoprotein is synthesized in hepatocytes and consists of a On-board in use and refrigerated on the analyzer: 12 weeks
polypeptide chain having 5 carbohydrate chains N-glycosidically bonded to it Diluent NaCl 9 %
(molar mass 41000 daltons). Structurally, it belongs to the lipocalin superfamily Shelf life at 2-8 °C: See expiration date on
of secretory proteins (such as α1-microglobulin and retinol-binding protein). cobas c pack label.
α1-Acid glycoprotein promotes fibroblast growth and interacts with collagen.
On-board in use and refrigerated on the analyzer: 12 weeks
It is a sensitive acute phase reactant whose concentration can increase
by a factor of 3 within 24-48 hours when inflammation occurs. α1-Acid Specimen collection and preparation
glycoprotein can also be used to differentiate between acute phase reactions For specimen collection and preparation, only use suitable
(elevated serum level) and estrogen effects (normal or decreased serum level) tubes or collection containers.
whereas the serum level of other positive reactants such as ceruloplasmin Only the specimens listed below were tested and found acceptable.
and haptoglobin increases during such reactions. Along with haptoglobin it is
Serum.
perhaps the best protein for identifying slight in vivo hemolysis. An increased
Plasma: Li-heparin and K2-EDTA plasma.
α1-acid glycoprotein level and normal haptoglobin values indicate an acute
phase reaction with concomitant slight in vivo hemolysis. Moderate and The sample types listed were tested with a selection of sample collection tubes
isolated increases occur when glomerular filtration is inhibited in the early that were commercially available at the time of testing, i.e. not all available
stages of uremia. The determination is used in the assessment of the activity tubes of all manufacturers were tested. Sample collection systems from
of acute and recurring inflammations as well as of tumors with cell necrosis. various manufacturers may contain differing materials which could affect
Various assay methods for α1-acid glycoprotein determination are the test results in some cases. When processing samples in primary tubes
available such as kinetic nephelometry, radial immunodiffusion (RID) (sample collection systems), follow the instructions of the tube manufacturer.
and turbidimetry. The Roche α1-acid glycoprotein assay is based on Centrifuge samples containing precipitates before performing the assay.
the principle of immunological agglutination.
Stability:3 72 hours at 2-8 °C
Test principle2 6 months at (-15)-(-25) °C
Immunoturbidimetric assay.
Anti-α1-acid glycoprotein antibodies react with antigen in the sample
to form an antigen/antibody complex. Following agglutination, Materials provided
this is measured turbidimetrically. See “Reagents - working solutions” section for reagents.

Reagents - working solutions Materials required (but not provided)

R1 TRIS buffer: 50 mmol/L, pH 8.0; NaCl: 300 mmol/L; PEG: 7 %; See “Order information” section.
preservative; stabilizer General laboratory equipment
R2 Polyclonal anti-human α1-acid glycoprotein antibody (goat): dependent on
Assay
titer; TRIS buffer: 13 mmol/L, pH 7.5; NaCl: 198 mmol/L; preservative
For optimum performance of the assay follow the directions given in
R1 is in position B and R2 is in position C. this document for the analyzer concerned. Refer to the appropriate
operator’s manual for analyzer-specific assay instructions.
Precautions and warnings The performance of applications not validated by Roche is not
For in vitro diagnostic use. warranted and must be defined by the user.
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AAGP2
Tina-quant α1-Acid Glycoprotein Gen.2
Application for serum and plasma Calculation
Roche/Hitachi cobas c systems automatically calculate the analyte
cobas c 311 test definition concentration of each sample.
Assay type 2 Point End
Conversion factors: g/L x 25 = µmol/L mg/dL x 0.01 = g/L
Reaction time / Assay points 10 / 6-32
mg/dL x 0.25 = µmol/L g/L x 100 = mg/dL
Wavelength (sub/main) 660/340 nm
Reaction direction Increase Limitations - interference
Units g/L (µmol/L, mg/dL) Criterion: Recovery within ± 10 % of initial value at an α1-acid glycoprotein
Reagent pipetting Diluent (H2O) concentration of 0.5 g/L (12.5 µmol/L, 50 mg/dL).
R1 120 µL – Icterus:7 No significant interference up to an I index of 60 (approximate
R2 40 µL – conjugated and unconjugated bilirubin concentration: 1026 µmol/L or 60 mg/dL).
Hemolysis:7 No significant interference up to an H index of 1000 (approximate
Sample volumes Sample Sample dilution
hemoglobin concentration: 621 µmol/L or 1000 mg/dL).
Sample Diluent (NaCl)
Lipemia (Intralipid):7 No significant interference up to an L index
Normal 12 µL 9 µL 180 µL
of 650. There is poor correlation between the L index (corresponds
Decreased 12 µL 4 µL 122 µL to turbidity) and triglycerides concentration.
Increased 12 µL 18 µL 180 µL
Rheumatoid factors up to 1200 IU/mL do not interfere.
High dose hook-effect: No false result occurs up to an α1-acid glycoprotein
cobas c 501/502 test definition concentration of 11 g/L (275 µmol/L, 1100 mg/dL).
Assay type 2 Point End Drugs: No interference was found at therapeutic concentrations
Reaction time / Assay points 10 / 10-48 using common drug panels.8,9
Wavelength (sub/main) 660/340 nm In very rare cases, gammopathy, in particular type IgM (Waldenström’s
Reaction direction Increase macroglobulinemia), may cause unreliable results.
Units g/L (µmol/L, mg/dL) For diagnostic purposes, the results should always be assessed in conjunction
Reagent pipetting Diluent (H2O) with the patient’s medical history, clinical examination and other findings.
R1 120 µL – ACTION REQUIRED
R2 40 µL – Special Wash Programming: The use of special wash steps is mandatory
when certain test combinations are run together on Roche/Hitachi cobas c
Sample volumes Sample Sample dilution
systems. The latest version of the carry-over evasion list can be found with
Sample Diluent (NaCl) the NaOHD/SMS/Multiclean/SCCS or the NaOHD/SMS/SmpCln1 + 2/SCCS
Normal 12 µL 9 µL 180 µL Method Sheets. For further instructions refer to the operator’s manual.
Decreased 12 µL 4 µL 122 µL cobas c 502 analyzer: All special wash programming necessary for avoiding
Increased 12 µL 18 µL 180 µL carry-over is available via the cobas link, manual input is not required.
Where required, special wash/carry-over evasion programming must
Calibration be implemented prior to reporting results with this test.
Calibrators S1: H2O Limits and ranges
S2-S6: C.f.a.s. Proteins Measuring range
Multiply the lot-specific C.f.a.s. Proteins 0.1-4.0 g/L (2.5-100 µmol/L, 10-400 mg/dL)
calibrator value by the factors below to Determine samples having higher concentrations via the rerun function. Dilution
determine the standard concentrations for the of samples via the rerun function is a 1:1.5 dilution. Results from samples
6-point calibration curve: diluted by the rerun function are automatically multiplied by a factor of 1.5.
S2: 0.140 S5: 1.40 Lower limits of measurement
S3: 0.280 S6: 2.81 Lower detection limit of the test
S4: 0.700 0.1 g/L (2.5 µmol/L, 10 mg/dL)
The lower detection limit represents the lowest measurable analyte
Calibration mode RCM2 level that can be distinguished from zero. It is calculated as the value
Calibration frequency Full calibration lying three standard deviations above that of the lowest standard
- after reagent lot change (standard 1 + 3 SD, repeatability, n = 21).
- as required following quality control
procedures Expected values10
0.5-1.2 g/L (12.5-30 µmol/L, 50-120 mg/dL)
Each laboratory should investigate the transferability of the expected values to
Traceability: This method has been standardized against the reference its own patient population and if necessary determine its own reference ranges.
preparation of the IRMM (Institute for Reference Materials and
Measurements) BCR470/CRM470 (RPPHS - Reference Preparation
for Proteins in Human Serum).6

Quality control
For quality control, use control materials as listed in the
“Order information” section.
In addition, other suitable control material can be used.
The control intervals and limits should be adapted to each laboratory’s
individual requirements. Values obtained should fall within the defined
limits. Each laboratory should establish corrective measures to be
taken if values fall outside the defined limits.
Follow the applicable government regulations and local guidelines
for quality control.
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03333795190V7

AAGP2
Tina-quant α1-Acid Glycoprotein Gen.2
Specific performance data References
Representative performance data on the analyzers are given below. 1. Schmid K. α1-Acid glycoprotein. In: The Plasma Proteins, 2nd ed.
Results obtained in individual laboratories may differ. Putnam FW, ed. New York: Academic Press, 1975:183-228.
2. Greiling H, Gressner AM, eds. Lehrbuch der klinischen Chemie und
Precision Pathobiochemie, 3rd ed. Stuttgart/New York: Schattauer, 1995:236.
Precision was determined using human samples and controls in an internal 3. Tietz NW, ed. Clinical Guide to Laboratory Tests, 3rd ed.
protocol with repeatability* (n = 21) and intermediate precision** (3 aliquots Philadelphia, PA: WB Saunders, 1995:66-67.
per run, 1 run per day, 21 days). The following results were obtained: 4. Ganrot K. Plasma protein pattern in acute infectious disease.
Repeatability* Mean SD CV Scand J Clin Lab Invest 1974;34:75-81.
g/L g/L % 5. Lievens M, Bienvenu J, Buitrago JMG et al. Evaluation of four
(µmol/L, mg/dL) (µmol/L, mg/dL) new Tina-quant assays for determination of α1-acid glycoprotein,
Precinorm Protein 0.724 (18.1, 72.4) 0.00 (0.0, 0.0) 0.6 α1-antitrypsin, haptoglobin and prealbumin. Clin Lab 1996;42: 515-520.
Precipath Protein 1.21 (30.3, 121) 0.01 (0.3, 1) 0.5 6. Baudner S, Bienvenu J, Blirup-Jensen S, et al. The Certification of a
Matrix Reference Material for Immunochemical Measurement of 14
Human serum 1 0.642 (16.1, 64.2) 0.00 (0.0, 0.0) 0.7
Human Serum Proteins, CRM470, Report EUR 15243 EN, 1993:1-186.
Human serum 2 1.07 (26.8, 107) 0.01 (0.3, 1) 0.7
7. Glick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences
Intermediate Mean SD CV in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
precision** g/L g/L % 8. Breuer J. Report on the Symposium “Drug effects in Clinical Chemistry
(µmol/L, mg/dL) (µmol/L, mg/dL) Methods”. Eur J Clin Chem Clin Biochem 1996;34:385-386.
9. Sonntag O, Scholer A. Drug interference in clinical chemistry:
Precinorm Protein 0.710 (17.8, 71.0) 0.007 (0.2, 1.0) 0.9 recommendation of drugs and their concentrations to be used in drug
Precipath Protein 1.19 (30.0, 119) 0.01 (0.3, 1) 0.9 interference studies. Ann Clin Biochem 2001;38:376-385.
Human serum 3 0.660 (16.5, 66.0) 0.010 (0.3, 1.0) 1.5 10. Consensus values of the Deutsche Gesellschaft für Laboratoriumsmedizin,
Human serum 4 1.21 (30.3, 121) 0.02 (0.5, 2) 1.5 the Deutsche Gesellschaft für Klinische Chemie and the Verband
* repeatability = within-run precision der Diagnostica-Industrie e.V. (VDGH). DG Klinische Chemie
** intermediate precision = total precision / between run precision / between day precision Mitteilungen 1995; 26:119-122.
11. Passing H, Bablok W, Bender R, et al. A General
Method comparison Regression Procedure for Method Transformation.
α1-Acid glycoprotein values for human serum and plasma samples obtained J Clin Chem Clin Biochem 1988;Nov:26(11);783-790.
on a Roche/Hitachi cobas c 501 analyzer (y) were compared with those
determined using the same reagent on a Roche/Hitachi 917 analyzer (x). A point (period/stop) is always used in this Method Sheet as the decimal
Sample size (n) = 119 separator to mark the border between the integral and the fractional parts
of a decimal numeral. Separators for thousands are not used.
Passing/Bablok11 Linear regression
y = 1.012x - 0.070 g/L y = 0.998x - 0.056 g/L FOR US CUSTOMERS ONLY: LIMITED WARRANTY
τ = 0.973 r = 0.999 Roche Diagnostics warrants that this product will meet the specifications
The sample concentrations were between 0.489 and 3.25 g/L stated in the labeling when used in accordance with such labeling and
(12.2 and 81.3 µmol/L, 48.9 and 325 mg/dL). will be free from defects in material and workmanship until the expiration
date printed on the label. THIS LIMITED WARRANTY IS IN LIEU OF ANY
OTHER WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED
WARRANTY OF MERCHANTABILITY OR FITNESS FOR PARTICULAR
PURPOSE. IN NO EVENT SHALL ROCHE DIAGNOSTICS BE LIABLE FOR
INCIDENTAL, INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES.

COBAS, COBAS C, PRECINORM, PRECIPATH and TINA-QUANT are trademarks of Roche.

Other brand or product names are trademarks of their respective holders.
Significant additions or changes are indicated by a change bar in the margin.
© 2012, Roche Diagnostics

Roche Diagnostics GmbH, Sandhofer Strasse 116, D-68305 Mannheim

www.roche.com
Distribution in USA by:
Roche Diagnostics, Indianapolis, IN
US Customer Technical Support 1-800-428-2336

2012-03, V 7 English 3/3 cobas c systems