Acetaminophen

Catalog Number: 20767174160

*LEVEL I CANNOT BE USED IN THE US BASED ON REVISED MEASURING RANGE.

SYSTEM INFORMATION

For cobas c 311/501 analyzers:

INTENDED USE

In vitro test for the quantitative determination of toxic levels of acetaminophen in serum and plasma on Roche/Hitachi cobas c systems.

STORAGE AND STABILITY

Shelf life at 2 to 8° C:Do not freeze. See expiration date on cobas c pack label
On-board in use and refrigerated on the analyzer: 21 weeks

Specimen collection and preparation

APPLICATION FOR SERUM AND PLASMA

Deselect Automatic Rerun for these applications in the Utility menu, Application screen, Range tab.

CALIBRATION

Traceability: This method has been standardized against USP reference materials. The calibrators are prepared to contain known quantities of acetaminophen in buffer.

Calibrators S1-2: COBAS Acetaminophen Calibrators
Calibration mode Linear
Calibration frequency 2 point calibration- after cobas c pack change- as required following quality control procedures

CALIBRATION MODE

CALIBRATION FREQUENCY

2 POINT CALIBRATION

ALL ACETAMINOPHEN RESULTS MUST BE REVIEWED AT THE ANALYZER OR AT THE HOST (LIS OR MIDDLEWARE) BEFORE BEING RELEASED. AN ACETAMINOPHEN RESULT CANNOT BE RELEASED IF IT IS BELOW THE MEASURING RANGE OR HAS AN ASSOCIATED BILIRUBIN LEVEL ABOVE THE I INDEX OF 8.

LIMITS AND RANGES

Measuring range

MEASURING RANGE

15.0-500 µg/mL (99.3-3310 µmol/L)

MANUALLY DILUTE SAMPLES ABOVE THE MEASURING RANGE 1 + 2 WITH THE 0 ΜG/ML CALIBRATOR AND REASSAY. MULTIPLY THE RESULT BY 3 TO OBTAIN THE SPECIMEN VALUE.

LOWER LIMITS OF MEASUREMENT

Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ)

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 a modified NCCLS EP5-T2 protocol (repeatability n = 63, intermediate precision n = 63). The following results were obtained on a Roche/Hitachi cobas c 501 analyzer.

INTERMEDIATE PRECISION

METHOD COMPARISON

Acetaminophen values for human serum and plasma samples obtained on Roche/Hitachi cobas c 501 analyzer (y) were compared to those determined with the same reagent on COBAS INTEGRA 800 analyzer (x) and Roche/Hitachi 917 analyzer (x).

ANALYTICAL SPECIFICITY

The following compounds were tested for cross-reactivity.

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.