Lipase colorimetric

Catalog Number: 03029590322

SYSTEM INFORMATION

Test LIPC, test ID 0-100

INTENDED USE

In vitro test for the quantitative determination of the catalytic activity of lipase (EC 3.1.1.3; triacylglycerol acyl-hydrolase) in human serum and plasma on COBAS INTEGRA systems

STORAGE AND STABILITY

Shelf life at 2-8 °C See expiration date on cobas c pack label
 COBAS INTEGRA 400 plus system
On-board in use at 10-15 °C 4 weeks
COBAS INTEGRA 800 system
On-board in use at 8 °C 4 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 Kinetic
Reaction mode R1-S-SR
Reaction direction Increase
Wavelength A/B 583/659 nm
Calc. first/last 43/51
Unit U/L

Pipetting parameters

PIPETTING PARAMETERS

Diluent (H2O)
R1 80 µL
Sample 2 µL 20 µL
SR 48 µL
Total volume 150 µL

Diluent (H2O)
R1 80 µL
Sample 2 µL 20 µL
SR 48 µL
Total volume 150 µL

COBAS INTEGRA 800 test definition

COBAS INTEGRA 800 TEST DEFINITION

Measuring mode Absorbance
Abs. calculation mode Kinetic
Reaction mode R1-S-SR
 Reaction direction Increase
Wavelength A/B 583/659 nm
Calc. first/last 62/75
Unit U/L

Pipetting parameters

PIPETTING PARAMETERS

Diluent (H2O)
R1 80 µL
Sample 2 µL 20 µL
SR 48 µL
Total volume 150 µL

CALIBRATION

Traceability: This method has been standardized manually against Roche reagent.

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

CALIBRATION MODE

CALIBRATION REPLICATE

CALIBRATION INTERVAL

CONTROL AFTER CALIBRATION

LIMITS AND RANGES

Measuring range

MEASURING RANGE

3.0-300 U/L (0.05-5.0 µkat/L)

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 and intermediate precision (3 aliquots 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 AND INTERMEDIATE PRECISION (3 ALIQUOTS PER RUN, 1 RUN PER DAY, 21 DAYS). THE FOLLOWING RESULTS WERE OBTAINED:

CV INTERMEDIATE PRECISION

METHOD COMPARISON

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