Ethanol Gen.2

Catalog Number: 05967104190

SYSTEM INFORMATION

INTENDED USE

In vitro test for the quantitative determination of ethanol in human serum, plasma and urine on Roche/Hitachi cobas c systems.

STORAGE AND STABILITY

 ETOH2
Shelf life at 2‑8 °C: See expiration date on cobas c pack label.
On‑board in use and refrigerated on the analyzer: 12 weeks
On‑board on the Reagent Manager: 24 hours

APPLICATION FOR SERUM, PLASMA AND URINE

 cobas c 701/702 test definition
Assay type 2‑Point End
Reaction time / Assay points 10/25‑32 (STAT 6/11‑18)
Wavelength (sub/main) 700/340 nm
Reaction direction Increase
Units mmol/L (g/L, mg/dL)
Reagent pipetting Diluent (H2O)
R1 50 µL
R3 (STAT R2) 50 µL
Sample volumes Sample Sample dilution
Sample Diluent (H2O)
Normal 4 µL
Decreased 2 µL
Increased 8 µL

Calibration

CALIBRATION

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

 Calibrators S1: H2OS2: Ammonia/Ethanol /CO2 Calibrator
Calibration mode Linear
Calibration frequency 2‑point calibration- after cobas c pack change- after 6 weeks on board- as required following quality control procedures

CALIBRATION MODE

CALIBRATION FREQUENCY

2‑POINT CALIBRATION- AFTERPACK CHANGE- AFTER 6 WEEKS ON BOARD- AS REQUIRED FOLLOWING QUALITY CONTROL PROCEDURES

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

CAUTION: 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

Serum/plasma/urine

LOWER LIMITS OF MEASUREMENT

Lower detection limit of the test

SPECIFIC PERFORMANCE DATA

Representative performance data on the 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 (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 (N = 21) AND INTERMEDIATE PRECISION (3 ALIQUOTS PER RUN, 1 RUN PER DAY, 21 DAYS). THE FOLLOWING RESULTS WERE OBTAINED:

INTERMEDIATE PRECISION

INTERMEDIATE PRECISION

RESULTS FOR INTERMEDIATE PRECISION WERE OBTAINED ON THE MASTER SYSTEM 501 ANALYZER.

METHOD COMPARISON

Ethanol values for human serum, plasma and urine samples obtained on a Roche/Hitachi cobas c 701 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi cobas c 501 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.