Quinidine

Catalog Number: 04490991190

SYSTEM INFORMATION

For cobas c 311/501 analyzers:

INTENDED USE

In vitro test for the quantitative determination of quinidine 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 quinidine in normal human serum.

Calibrators 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

LIMITS AND RANGES

Measuring range

MEASURING RANGE

0.11-8 µg/mL (0.34-24.6 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.

INTERMEDIATE PRECISION

METHOD COMPARISON

Serum/plasma

ANALYTICAL SPECIFICITY

Compound Concentration tested (µg/mL) %Cross-reactivity
Dihydroquinidine 1 53
O-desmethylquinidine 10 18.1
Quinine 20 11.3
2'-Oxoquinidinone 50 5.3
10,11-Dihydroquinidinediol 50 4.1
Hydrochlorothiazide 4.5 3.8
Isoproterenol 5 3.0
Quinidine-N-oxide 100 2.3
Disopyramide 80 0.9
Lidocaine-N-ethylbromide 50 0.5
Phenytoin (DPH) 200 0.2
N-Acetylprocainamide 200 0.1
3(S)-Hydroxyquinidine 100 0.1
Digitoxin 0.4 ND
Digoxin 0.022 ND
Ephedrine 1.2 ND
Furosemide 100 ND
Ouabain 0.002 ND
Procainamide 80 ND
Propranolol 3.4 ND
Reserpine 0.1 ND
ND = not detectable