ONLINE TDM Carbamazepine Gen.4

Catalog Number: 07258062190

SYSTEM INFORMATION

For cobas c 311/501 analyzers:

INTENDED USE

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

STORAGE AND STABILITY

APPLICATION FOR SERUM AND PLASMA

COBAS C TEST DEFINITION

CALIBRATION

CALIBRATION MODE

CALIBRATION FREQUENCY

LIMITS AND RANGES

MEASURING RANGE

2-20 µg/mL (8.5-85 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. LINEARITY WAS VERIFIED FOR THE MEASURING RANGE ACCORDING TO CLSI EP-6 GUIDELINES.

SPECIFIC PERFORMANCE DATA

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 501 ANALYZER:

INTERMEDIATE PRECISION

METHOD COMPARISON

ANALYTICAL SPECIFICITY

The following compounds were tested for cross-reactivity at low (3 µg/mL) and high (12 µg/mL) carbamazepine concentration.

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