Albumin Gen.2

Catalog Number: 03183688122

SYSTEM INFORMATION

Test ALB2, test ID 0-592

INTENDED USE

In vitro test for the quantitative determination of the albumin concentration in human serum and plasma on COBAS INTEGRA systems.

STORAGE AND STABILITY

Shelf life at 15-25 °C See expiration date on cobas c pack label
COBAS INTEGRA 400 plus system
On-board in use at 10-15 °C 12 weeks
COBAS INTEGRA 800 system
On-board in use at 8 °C 12 weeks

Specimen collection and preparation

APPLICATION FOR SERUM AND PLASMA

COBAS INTEGRA 400 plus test definition

COBAS INTEGRA 400 PLUS TEST DEFINITION

Measuring mode Absorbance
Abs. calculation mode Endpoint
Reaction mode R1-S-SR
Reaction direction Increase
Wavelength A/B 583/512 nm
Calc. first/last 33/35
Unit g/L

Pipetting parameters

PIPETTING PARAMETERS

Diluent (H2O)
R1 100 µL
Sample 2 µL 20 µL
SR 20 µL 10 µL
Total volume 152 µL

Diluent (H2O)
R1 100 µL
Sample 2 µL 20 µL
SR 20 µL 10 µL
Total volume 152 µL

COBAS INTEGRA 800 test definition

Calibration

COBAS INTEGRA 800 TEST DEFINITION

Measuring mode Absorbance
Abs. calculation mode Endpoint
Reaction mode R1-S-SR
Reaction direction Increase
Wavelength A/B 583/512 nm
Calc. first/last 44/46
Unit g/L

Pipetting parameters

PIPETTING PARAMETERS

Diluent (H2O)
R1 100 µL
Sample 2 µL 20 µL
SR 20 µL 10 µL
Total volume 152 µL

Calibration

CALIBRATION

Traceability: This method has been standardized against the CRM 470 reference preparation.

Calibrator Calibrator f.a.s.Use deionized water as zero calibrator.
Calibration mode Linear regression
Calibration replicate Duplicate recommended
Calibration interval Each cassette, every 4 weeks, and as required following quality control procedures

CALIBRATION MODE

CALIBRATION REPLICATE

CALIBRATION INTERVAL

CONTROL AFTER CALIBRATION

LIMITS AND RANGES

Measuring range

MEASURING RANGE

2-60 g/L (30.4-912 µmol/L or 0.2-6 g/dL)

LOWER LIMITS OF MEASUREMENT

Lower detection limit of the test:

SPECIFIC PERFORMANCE DATA

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

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:

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:

INTERMEDIATE PRECISION

METHOD COMPARISON

Albumin values values for human serum and plasma samples obtained on a COBAS INTEGRA 700 analyzer with the COBAS INTEGRA Albumin Gen.2 reagent (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi 917 analyzer (x) and to the previous reagent (ALB) on a COBAS INTEGRA 700 analyzer (x).

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.