Catalog Number: 04791959190

SYSTEM INFORMATION

For cobas c 311/501 analyzers:

INTENDED USE

In vitro test for the quantitative determination of amikacin 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

Traceability: This method has been standardized against USP reference standards. The calibrators are prepared to contain known quantities of amikacin in normal human serum.

Calibrator	S1-6: Preciset TDM II 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

DUE TO POTENTIAL CARRYOVER FROM THE LAST CALIBRATOR (CAL F) INTO THE FIRST QUALITY CONTROL SAMPLE (LEVEL 1) FOLLOWING CALIBRATION, ASSAYING A NON-REPORTABLE BLANK QUALITY CONTROL SAMPLE IS REQUIRED PRIOR TO ASSAYING THE CONTROLS. THE BLANK QUALITY CONTROL SAMPLE SHOULD BE PROGRAMMED IN THE FIRST POSITION FOLLOWED BY QUALITY CONTROL LEVELS 1-3. USE MULTICLEAN (CAT. NO. 04708725 190) AS THE BLANK QUALITY CONTROL SAMPLE.

THE BLANK QUALITY CONTROL SAMPLE IS NOT REQUIRED WHEN ASSAYING CONTROLS WITHOUT CALIBRATION.

LIMITS AND RANGES

Measuring range

MEASURING RANGE

0.8-40 µg/mL (1.4-68.4 µmol/L)

MANUALLY DILUTE SAMPLES ABOVE THE MEASURING RANGE 1 + 1 WITH THE PRECISET TDM II 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-A protocol (repeatability n = 63, intermediate precision n = 63). The following results were obtained on a Roche/Hitachi cobas c 501 analyzer.

METHOD COMPARISON

Serum/plasma

ANALYTICAL SPECIFICITY

The following compounds were tested for cross-reactivity.

Amikacin