Ethanol Gen.2

Catalog Number: 03183777190

SYSTEM INFORMATION

Test ETOH2, test ID 0‑611 (serum, plasma)

INTENDED USE

In vitro test for the quantitative determination of ethanol in human serum, plasma, and urine 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 12 weeks

APPLICATION FOR SERUM, PLASMA AND URINE

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 340/659 nm
Calc. first/last 44/54
Unit mmol/L

Pipetting parameters

PIPETTING PARAMETERS

 Serum, plasma, urine Diluent (H2O)
R1 50 µL -
Sample 4 µL 16 µL
SR 50 µL -
Total volume 120 µL

 Serum, plasma, urine Diluent (H2O)
R1 50 µL -
Sample 4 µL 16 µL
SR 50 µL -
Total volume 120 µL

Calibration

COBAS INTEGRA 800 TEST DEFINITION

 Measuring mode Absorbance
Abs. calculation mode Kinetic
Reaction mode R1-S-SR
Reaction direction Increase
Wavelength A/B 340/659 nm
Calc. first/last 62/79
Unit mmol/L

Pipetting parameters

PIPETTING PARAMETERS

 Serum, plasma, urine Diluent (H2O)
R1 50 µL -
Sample 4 µL 16 µL
SR 50 µL -
Total volume 120 µL

Calibration

CALIBRATION

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

 Calibrator Roche Ammonia/Ethanol/CO2CalibratorUse deionized water as zero calibrator.
Calibration mode Linear regression
Calibration replicate Duplicate recommended
Calibration interval COBAS INTEGRA 400 plus system:Each cobas c pack and as required following quality control proceduresCOBAS INTEGRA 800 system:Each cobas c pack, every 6 weeks, and as required following quality control procedures

CALIBRATION MODE

CALIBRATION REPLICATE

CALIBRATION INTERVAL

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

CONTROL AFTER CALIBRATION

DO NOT USE VOLATILE SOLVENTS IN THE WORK AREA WHEN PERFORMING ASSAYS. DO NOT PERFORM SAMPLE PREPARATION (ESPECIALLY SPIKING OF POOLS) IN THE IMMEDIATE WORK AREA. VAPOR CONTAMINATION OF REAGENTS CAN IMPACT CALIBRATION STABILITY.

LIMITS AND RANGES

Measuring range

MEASURING RANGE

2.17‑108 mmol/L (10.0‑498 mg/dL)

LOWER LIMITS OF MEASUREMENT

Lower detection limit of the test (serum, plasma, and urine): 2.17 mmol/L (10.0 mg/dL)

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

INTERMEDIATE PRECISION

METHOD COMPARISON

Serum/plasma

ANALYTICAL SPECIFICITY

COBAS INTEGRA Ethanol Gen.2 reagent is specific for ethyl alcohol. The following cross reactants were measured at 2000 mg/dL.

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.