Oxycodone

Catalog Number: 05179459190

SYSTEM INFORMATION

For cobas c 311/501 analyzers:

INTENDED USE

DRI Oxycodone assay (OXY) is an in vitro diagnostic test for the semiquantitative and qualitative detection of oxycodone and its metabolite, oxymorphone, in human urine at cutoff concentrations of 100 ng/mL and 300 ng/mL 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: 8 weeks
Do not freeze.

CALIBRATION

 Calibrators Semiquantitative applications
100 ng/mL and 300 ng/mL cutoff assays
S1: DRI Oxycodone Calibrator 0S2: DRI Oxycodone Calibrator 100S3: DRI Oxycodone Calibrator 300S4: DRI Oxycodone Calibrator 500S5: DRI Oxycodone Calibrator 10000, 100, 300, 500, 1000 ng/mL
Qualitative applications
100 ng/mL cutoff assay
S1: DRI Oxycodone Calibrator 100100 ng/mL
300 ng/mL cutoff assay
S1: DRI Oxycodone Calibrator 300300 ng/mL
The drug concentrations of the calibrators have been verified by GC/MS.
Calibration K Factor For the qualitative applications, enter the K Factor as positive 1000 into the Calibration menu, Status screen, Calibration Result window.
Calibration mode Semiquantitative applications
Result Calculation Mode (RCM)b
Qualitative applications
Linear

CALIBRATION K FACTOR

FOR THE QUALITATIVE APPLICATIONS, ENTER THE K FACTOR AS POSITIVE 1000 INTO THE CALIBRATION MENU, STATUS SCREEN, CALIBRATION RESULT WINDOW.

CALIBRATION MODE

CALIBRATION FREQUENCY

FULL (SEMIQUANTITATIVE) OR BLANK (QUALITATIVE) CALIBRATION• EVERY 28 DAYS• AFTER REAGENT LOT CHANGE• AS REQUIRED FOLLOWING QUALITY CONTROL PROCEDURES

FOR THE SEMIQUANTITATIVE ASSAY, THE ANALYZER COMPUTER CONSTRUCTS A CALIBRATION CURVE FROM ABSORBANCE MEASUREMENTS OF THE STANDARDS USING A 4 PARAMETER LOGIT‑LOG FITTING FUNCTION (RCM). THE LOGIT‑LOG FUNCTION FITS A SMOOTH LINE THROUGH THE DATA POINTS. THE ANALYZER COMPUTER USES ABSORBANCE MEASUREMENTS OF SAMPLES TO CALCULATE DRUG OR DRUG METABOLITE CONCENTRATION BY INTERPOLATION OF THE LOGIT‑LOG FITTING FUNCTION.

SEE THE "ANALYTICAL SPECIFICITY" SECTION OF THIS DOCUMENT FOR INFORMATION ON SUBSTANCES TESTED WITH THIS ASSAY. THERE IS THE POSSIBILITY THAT OTHER SUBSTANCES AND/OR FACTORS, ESPECIALLY SUBSTANCES THAT ABSORB LIGHT AT 340 NM, MAY INTERFERE WITH THE TEST AND CAUSE >ABS ALARMS OR ERRONEOUS RESULTS (E.G., TECHNICAL OR PROCEDURAL ERRORS). SAMPLES FLAGGED WITH >ABS ALARMS SHOULD BE MANUALLY DILUTED (SEE "RESULTS" SECTION). A PRELIMINARY POSITIVE RESULT WITH THIS ASSAY INDICATES THE PRESENCE OF OXYCODONE AND/OR ITS METABOLITE, OXYMORPHONE, IN URINE. IT DOES NOT MEASURE THE LEVEL OF INTOXICATION.

The cross‑reactivity of oxycodone metabolites, oxymorphone, noroxymorphone, and noroxycodone, was evaluated, on a Roche/Hitachi 717 analyzer, by adding known amounts of each metabolite to oxycodone free urine. As indicated by the results in the table below, oxymorphone exhibits 103 % cross reactivity with oxycodone; noroxymorphone and noroxycodone show no evidence of significant cross‑reactivity.

RESULTS OF THIS ASSAY YIELD ONLY APPROXIMATE CUMULATIVE CONCENTRATIONS OF THE DRUG AND ITS METABOLITES (SEE "ANALYTICAL SPECIFICITY" SECTION).

The cross‑reactivity of oxycodone metabolites, oxymorphone, noroxymorphone, and noroxycodone, was evaluated, on a Roche/Hitachi 717 analyzer, by adding known amounts of each metabolite to oxycodone free urine. As indicated by the results in the table below, oxymorphone exhibits 103 % cross reactivity with oxycodone; noroxymorphone and noroxycodone show no evidence of significant cross‑reactivity.

SPECIFIC PERFORMANCE DATA

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

PRECISION

Precision was determined in an internal protocol by running 6 replicates of each level of control and cutoff calibrator. The samples were measured in random order, twice a day, for 5 days, for a total of 10 runs (n = 60). The following results were obtained on a Roche/Hitachi cobas c 501 analyzer.

PRECISION WAS DETERMINED IN AN INTERNAL PROTOCOL BY RUNNING 6 REPLICATES OF EACH LEVEL OF CONTROL AND CUTOFF CALIBRATOR. THE SAMPLES WERE MEASURED IN RANDOM ORDER, TWICE A DAY, FOR 5 DAYS, FOR A TOTAL OF 10 RUNS (N = 60). THE FOLLOWING RESULTS WERE OBTAINED ON A ROCHE/HITACHI 501 ANALYZER.

QUALITATIVE PRECISION - 100 NG/ML

SEMIQUANTITATIVE PRECISION - 300 NG/ML

QUALITATIVE PRECISION - 300 NG/ML

ANALYTICAL SPECIFICITY

The cross‑reactivity of oxycodone metabolites, oxymorphone, noroxymorphone, and noroxycodone, was evaluated, on a Roche/Hitachi 717 analyzer, by adding known amounts of each metabolite to oxycodone free urine. As indicated by the results in the table below, oxymorphone exhibits 103 % cross reactivity with oxycodone; noroxymorphone and noroxycodone show no evidence of significant cross‑reactivity.