Glucose HK Gen.3

Catalog Number: 04404483190

SYSTEM INFORMATION

INTENDED USE

In vitro test for the quantitative determination of glucose in serum, plasma, urine, and cerebrospinal fluid (CSF) on COBAS INTEGRA systems.

STORAGE AND STABILITY

COBAS INTEGRA 400 PLUS TEST DEFINITION

 Measuring mode Absorbance
Abs. calculation mode Endpoint
Reaction mode R1-S-SR
Reaction direction Increase
Wavelength A/B 340/652 nm
Calc. first/last
Test IDs 0-031, 0-141, 0-051 33/69
Test IDs 0-231, 0-241, 0-251 33/46
Unit mmol/L

Pipetting parameters

PIPETTING PARAMETERS

  Diluent (H2O)
R1 28 µL 125 µL
Sample 2 µL 16 µL
SR 10 µL 20 µL
Total volume 201 µL

  Diluent (H2O)
R1 28 µL 125 µL
Sample 2 µL 16 µL
SR 10 µL 20 µL
Total volume 201 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 340/652 nm
Calc. first/last
Test IDs 0-031, 0-141, 0-051 44/98
Test IDs 0-231, 0-241, 0-251 44/66
Unit mmol/L

Pipetting parameters

PIPETTING PARAMETERS

  Diluent (H2O)
R1 28 µL 125 µL
Sample 2 µL 16 µL
SR 10 µL 20 µL
Total volume 201 µL

 Calibration

CALIBRATION

CALIBRATION MODE

CALIBRATION REPLICATE

CALIBRATION INTERVAL

CONTROL AFTER CALIBRATION

LIMITS AND RANGES

MEASURING RANGE

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:10 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 10.

LOWER LIMITS OF MEASUREMENT

Regular applications (test IDs 0-031, 0-141, 0-051)

SPECIFIC PERFORMANCE DATA

PRECISION

PRECISION WAS DETERMINED USING HUMAN SAMPLES AND CONTROLS IN AN INTERNAL PROTOCOL WITH REPEATABILITY (N = 84) AND INTERMEDIATE PRECISION (2 ALIQUOTS PER RUN, 2 RUNS PER DAY, 21 DAYS).

INTERMEDIATE PRECISION

INTERMEDIATE PRECISION

PRECISION WAS DETERMINED USING HUMAN SAMPLES AND CONTROLS IN AN INTERNAL PROTOCOL WITH REPEATABILITY (N = 84) AND INTERMEDIATE PRECISION (2 ALIQUOTS PER RUN, 2 RUNS PER DAY, 21 DAYS).

INTERMEDIATE PRECISION

INTERMEDIATE PRECISION

PRECISION WAS DETERMINED USING HUMAN SAMPLES AND CONTROLS IN AN INTERNAL PROTOCOL WITH REPEATABILITY (N = 21).

METHOD COMPARISON

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.