Tina-quant Hemoglobin A1c Gen.2 Hemolysate Application - Standardized according to IFCC transferable to DCCT/NGSP

Catalog Number: 04528123190

SYSTEM INFORMATION

Multitest A1CH2, test ID 0‑047

INTENDED USE

In vitro test for the quantitative determination of mmol/mol hemoglobin A1c (IFCC) and % hemoglobin A1c (DCCT/NGSP) in hemolysate prepared from whole blood on Roche clinical chemistry analyzers.

STORAGE AND STABILITY

Reagent

COBAS INTEGRA 400 PLUS TEST DEFINITION HB

 Abbreviated test name HB-H2
Measuring mode Absorbance
Abs. calculation mode Endpoint
Reaction mode R1-S
Reaction direction Increase
Wavelength A/B 378/659 nm
Calc. first/last 17/33
Unit g/dL

Pipetting parameters

PIPETTING PARAMETERS

 Hb Diluent (H2O)
R1 120 µL
Sample 6 µL 0 µL
Total volume 126 µL

 HbA1c Diluent (H2O)
R1 120 µL
Sample 6 µL 0 µL
SR 24 µL 0 µL
Total volume 150 µL

 Hb Diluent (H2O)
R1 120 µL
Sample 6 µL 0 µL
Total volume 126 µL

 HbA1c Diluent (H2O)
R1 120 µL
Sample 6 µL 0 µL
SR 24 µL 0 µL
Total volume 150 µL

COBAS INTEGRA 400 plus test definition HbA1c

COBAS INTEGRA 800 test definition HbA1c

Ratio definition for mmol/mol HbA1c and % HbA1c calculation

COBAS INTEGRA 400 PLUS TEST DEFINITION HBA1C

 Abbreviated test name A1-H2
Measuring mode Absorbance
Abs. calculation mode Endpoint
Reaction mode R1-S-SR
Reaction direction Increase
Wavelength A/B 340/659 nm
Calc. first/last 33/57
Unit g/dL

Pipetting parameters

PIPETTING PARAMETERS

 HbA1c Diluent (H2O)
R1 120 µL
Sample 6 µL 0 µL
SR 24 µL 0 µL
Total volume 150 µL

 Hb Diluent (H2O)
R1 120 µL
Sample 6 µL 0 µL
Total volume 126 µL

 HbA1c Diluent (H2O)
R1 120 µL
Sample 6 µL 0 µL
SR 24 µL 0 µL
Total volume 150 µL

COBAS INTEGRA 800 test definition HbA1c

Ratio definition for mmol/mol HbA1c and % HbA1c calculation

COBAS INTEGRA 800 TEST DEFINITION HB

 Abbreviated test name HB-H2
Measuring mode Absorbance
Abs. calculation mode Endpoint
Reaction mode R1-S
Reaction direction Increase
Wavelength A/B 378/659 nm
Calc. first/last 17/44
Unit g/dL

Pipetting parameters

PIPETTING PARAMETERS

 Hb Diluent (H2O)
R1 120 µL
Sample 6 µL 0 µL
Total volume 126 µL

 HbA1c Diluent (H2O)
R1 120 µL
Sample 6 µL 0 µL
SR 24 µL 0 µL
Total volume 150 µL

COBAS INTEGRA 800 test definition HbA1c

Ratio definition for mmol/mol HbA1c and % HbA1c calculation

COBAS INTEGRA 800 TEST DEFINITION HBA1C

 Abbreviated test name A1-H2
Measuring mode Absorbance
Abs. calculation mode Endpoint
Reaction mode R1-S-SR
Reaction direction Increase
Wavelength A/B 340/659 nm
Calc. first/last 44/96
Unit g/dL

Pipetting parameters

PIPETTING PARAMETERS

 HbA1c Diluent (H2O)
R1 120 µL
Sample 6 µL 0 µL
SR 24 µL 0 µL
Total volume 150 µL

Ratio definition for mmol/mol HbA1c and % HbA1c calculation

CALIBRATION

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

 Hb
Calibrator C.f.a.s. HbA1c
 HbA1c
Calibrator C.f.a.s. HbA1c
Calibration dilution ratio 1:1, 1:1.67, 1:2, 1:5, 1:25, 0, performed automatically by the instrument
Calibrator diluent COBAS INTEGRA Hemolyzing Reagent Gen.2, Cat. No. 04528328190
Calibration mode Logit/log 5
Calibration replicate Duplicate recommended
Calibration interval Each lot, every 29 days, and as required following quality control procedures

CALIBRATION DILUTION RATIO

CALIBRATION MODE

CALIBRATION REPLICATE

CALIBRATION INTERVAL

CALIBRATION INTERVAL MAY BE EXTENDED BASED ON ACCEPTABLE VERIFICATION OF CALIBRATION BY THE LABORATORY.

COBAS INTEGRA HEMOLYZING REAGENT GEN.2, 6 × 11 ML, CAT. NO. 04528328190, SYSTEM‑ID 07 6851 0, NEEDS TO BE AVAILABLE ON THE ANALYZER. OTHERWISE THE CALIBRATION CANNOT BE CARRIED OUT.

CONTROL AFTER CALIBRATION

LIMITS AND RANGES

Measuring range

MEASURING RANGE

COBAS INTEGRA 400 plus analyzer:

*THE MEASURING RANGE FOR HBA1C LIES BETWEEN 0.3 G/DL AND THE CONCENTRATION OF THE HIGHEST STANDARD. THE TEST RANGE STATED ABOVE IS BASED ON A TYPICAL CALIBRATOR VALUE OF 2.6 G/DL.

THIS CORRESPONDS TO A MEASURING RANGE OF 23‑197 MMOL/MOL HBA1C (IFCC) AND 4.3‑20.2 % HBA1C (DCCT/NGSP) AT A TYPICAL HEMOGLOBIN CONCENTRATION OF 13.2 G/DL.

THIS CORRESPONDS TO A MEASURING RANGE OF 23‑258 MMOL/MOL HBA1C (IFCC) AND 4.3‑25.8 % HBA1C (DCCT/NGSP) AT A TYPICAL HEMOGLOBIN CONCENTRATION OF 13.2 G/DL.

LOWER LIMITS OF MEASUREMENT

Limit of Blank and Limit of Detection

SPECIFIC PERFORMANCE DATA

Representative performance data on the analyzers are given below.

PRECISION

Precision was determined using human samples and controls in an internal protocol with repeatability (n = 21) and intermediate precision (1 aliquot per run, 1 run per day, 21 days). The following results were obtained (data based on DCCT/NGSP values):

PRECISION WAS DETERMINED USING HUMAN SAMPLES AND CONTROLS IN AN INTERNAL PROTOCOL WITH REPEATABILITY (N = 21) AND INTERMEDIATE PRECISION (1 ALIQUOT PER RUN, 1 RUN PER DAY, 21 DAYS). THE FOLLOWING RESULTS WERE OBTAINED (DATA BASED ON DCCT/NGSP VALUES):

INTERMEDIATE PRECISION

METHOD COMPARISON

% HbA1c (DCCT/NGSP) values for human blood samples obtained on a COBAS INTEGRA 400 analyzer using the COBAS INTEGRA Tina‑quant Hemoglobin A1c Gen.2 reagent system (y) were compared with those determined using the COBAS INTEGRA Tina‑quant Hemoglobin A1c Gen.2 reagent system (hemolysate application) on a COBAS INTEGRA 800 analyzer (x). Samples were measured individually.

ANALYTICAL SPECIFICITY

Please note:

 Hb derivatives Labile HbA1c (pre-HbA1c), acetylated Hb, and carbamylated Hb do not affect the assay result.
Hb variants Specimens containing high amounts of HbF (> 10 %) may yield lower than expected HbA1c results.

HOELZEL W, WEYKAMP C, JEPPSSON JO, ET AL. IFCC REFERENCE SYSTEM FOR MEASUREMENT OF HEMOGLOBIN A1C IN HUMAN BLOOD AND THE NATIONAL STANDARDIZATION SCHEMES IN THE UNITED STATES, JAPAN, AND SWEDEN: A METHOD COMPARISON STUDY. CLIN CHEM 2004;50:166-174.

BABLOK W, PASSING H, BENDER R, ET AL. A GENERAL REGRESSION PROCEDURE FOR METHOD TRANSFORMATION. APPLICATION OF LINEAR REGRESSION PROCEDURES FOR METHOD COMPARISON STUDIES IN CLINICAL CHEMISTRY, PART III. J CLIN CHEM CLIN BIOCHEM 1988 NOV;26(11):783-790.