Tina-quant Hemoglobin A1c Gen.3 –

Catalog Number: 05336163190

SYSTEM INFORMATION

Multitest A1CW3, test ID 0‑264

INTENDED USE

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

STORAGE AND STABILITY

Reagent

COBAS INTEGRA 400 PLUS TEST DEFINITION HB

 Abbreviated test name HB-W3
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
Predilution factor 100
Unit mmol/L

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 400 plus test definition HbA1c

COBAS INTEGRA 400 PLUS TEST DEFINITION HBA1C

Abbreviated test name A1-W3
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
Predilution factor 100
Unit mmol/L

Pipetting parameters

PIPETTING PARAMETERS

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

CALIBRATION

Hb

CALIBRATION DILUTION RATIO

CALIBRATION MODE

CALIBRATION REPLICATE

CALIBRATION INTERVAL

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

ENTER THE ASSIGNED LOT-SPECIFIC AND APPLICATION-SPECIFIC VALUE OF THE CALIBRATOR. USE THE APPROPRIATE C.F.A.S. HBA1C CALIBRATOR ONLY. COBAS INTEGRA HEMOLYZING REAGENT GEN.2, 6 × 10 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

Hb: 2.48‑24.8 mmol/L (4‑40 g/dL)

THE MEASURING RANGE FOR HBA1C LIES BETWEEN 0.186 MMOL/L AND THE CONCENTRATION OF THE HIGHEST STANDARD. THE TEST RANGE STATED ABOVE IS BASED ON A TYPICAL CALIBRATOR VALUE OF 1.61 MMOL/L.

THIS CORRESPONDS TO A MEASURING RANGE OF 23‑196 MMOL/MOL HBA1C (IFCC) AND 4.2‑20.1 % HBA1C (DCCT/NGSP) AT A TYPICAL HEMOGLOBIN CONCENTRATION OF 8.2 MMOL/L (13.2 G/DL).

LOWER LIMITS OF MEASUREMENT

Limit of Blank and Limit of Detection

SPECIFIC PERFORMANCE DATA

Representative performance data on the COBAS INTEGRA analyzers are given below. Results obtained in individual laboratories may differ.

PRECISION

Repeatability and intermediate precision were determined using human samples and controls in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP5 requirements (2 aliquots per run, 2 runs per day, 21 days). The following results were obtained (data based on DCCT/NGSP values):

REPEATABILITY AND INTERMEDIATE PRECISION WERE DETERMINED USING HUMAN SAMPLES AND CONTROLS IN ACCORDANCE WITH THE CLSI (CLINICAL AND LABORATORY STANDARDS INSTITUTE) EP5 REQUIREMENTS (2 ALIQUOTS PER RUN, 2 RUNS PER DAY, 21 DAYS). THE FOLLOWING RESULTS WERE OBTAINED (DATA BASED ON DCCT/NGSP VALUES):

INTERMEDIATE PRECISION

METHOD COMPARISON

Evaluation of method comparison data is according to former NGSP certification criteria. The mean difference between the two methods and the 95 % confidence intervals of the differences in the range from 4‑10 % (DCCT/NGSP) are given. 95 % of the differences between the values obtained for individual samples with both methods fall within the range defined by the lower and upper 95 % confidence intervals of the differences.

EVALUATION OF METHOD COMPARISON DATA IS ACCORDING TO FORMER NGSP CERTIFICATION CRITERIA. THE MEAN DIFFERENCE BETWEEN THE TWO METHODS AND THE 95 % CONFIDENCE INTERVALS OF THE DIFFERENCES IN THE RANGE FROM 4‑10 % (DCCT/NGSP) ARE GIVEN. 95 % OF THE DIFFERENCES BETWEEN THE VALUES OBTAINED FOR INDIVIDUAL SAMPLES WITH BOTH METHODS FALL WITHIN THE RANGE DEFINED BY THE LOWER AND UPPER 95 % CONFIDENCE INTERVALS OF THE DIFFERENCES.

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.