ONLINE TDM Acetaminophen Gen.2

Catalog Number: 06769942190

SYSTEM INFORMATION

For cobas c 311/501 analyzers:

INTENDED USE

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

STORAGE AND STABILITY

ACET2

APPLICATION FOR SERUM AND PLASMA

 cobas c 311 test definition
Assay type Rate‑A
Reaction time / Assay points 10 / 14‑26
Wavelength (sub/main) 415 / 340 nm
Reaction direction Increase
Units µg/mL (µmol/L)
Reagent pipetting Diluent (H2O)
R1 100 µL
R2 50 µL
Sample volumes Sample Sample dilution
Sample Diluent (NaCl)
Normal 2 µL
Decreased 2 µL 30 µL 120 µL
Increased 2 µL
  cobas c 501/502 test definition
Assay type Rate‑A
Reaction time / Assay points 10 / 21‑39
Wavelength (sub/main) 415 / 340 nm
Reaction direction Increase
Units µg/mL (µmol/L)
Reagent pipetting Diluent (H2O)
R1 100 µL
R2 50 µL
Sample volumes Sample Sample dilution
Sample Diluent (NaCl)
Normal 2 µL
Decreased 2 µL 30 µL 120 µL
Increased 2 µL

Caibration

CALIBRATION MODE

CALIBRATION FREQUENCY

FULL CALIBRATION‑ AFTER REAGENT LOT CHANGE‑ AS REQUIRED FOLLOWING QUALITY CONTROL PROCEDURES

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

MEASURING RANGE

5‑200 µg/mL (33.1‑1324 µmol/L)

SPECIFIC PERFORMANCE DATA

Representative performance data on a Roche/Hitachi cobas c analyzer are given below. Results obtained in individual laboratories may differ.

PRECISION

Precision was determined using human samples and controls in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP5‑A2 requirements with repeatability (n = 84) and intermediate precision (2 aliquots per run, 2 runs per day, 21 days). The following results were obtained on a Roche/Hitachi cobas c 501 analyzer:

PRECISION WAS DETERMINED USING HUMAN SAMPLES AND CONTROLS IN ACCORDANCE WITH THE CLSI (CLINICAL AND LABORATORY STANDARDS INSTITUTE) EP5‑A2 REQUIREMENTS WITH REPEATABILITY (N = 84) AND INTERMEDIATE PRECISION (2 ALIQUOTS PER RUN, 2 RUNS PER DAY, 21 DAYS). THE FOLLOWING RESULTS WERE OBTAINED ON A ROCHE/HITACHI 501 ANALYZER:

INTERMEDIATE PRECISION

METHOD COMPARISON

Serum/plasma

ANALYTICAL SPECIFICITY

The following compounds were tested for cross‑reactivity:

LINNET, K. EVALUATION OF REGRESSION PROCEDURES FOR METHOD COMPARISON STUDIES. CLINICAL CHEMISTRY 1993 MAR;39(3):424-432.