Theophylline

Catalog Number: 04491025190

SYSTEM INFORMATION

For cobas c 501 analyzer:

INTENDED USE

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

STORAGE AND STABILITY

 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
Do not freeze.

Specimen collection and preparation

APPLICATION FOR SERUM AND PLASMA

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

CALIBRATION

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

 Calibrators S1‑6: Preciset TDM I calibrators
Calibration mode RCM
Calibration frequency 6‑point calibration• after reagent lot change• every 6 weeks• as required following quality control procedures

CALIBRATION MODE

CALIBRATION FREQUENCY

6‑POINT CALIBRATION• AFTER REAGENT LOT CHANGE• EVERY 6 WEEKS• AS REQUIRED FOLLOWING QUALITY CONTROL PROCEDURES

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

LIMITS AND RANGES

Measuring range

MEASURING RANGE

0.8‑40.0 µg/mL (4.4‑222 µmol/L)

MANUALLY DILUTE SAMPLES ABOVE THE MEASURING RANGE 1 + 1 WITH THE PRECISET TDM I DILUENT (0 ΜG/ML) AND REASSAY. MULTIPLY THE RESULT BY 2 TO OBTAIN THE SPECIMEN VALUE.

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 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.

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 501 ANALYZER.

METHOD COMPARISON

Serum/plasma

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.