Amphetamines II

Catalog Number: 04939425190

SYSTEM INFORMATION

For cobas c 311/501 analyzers:

INTENDED USE

Amphetamines II (AMPS2) is an in vitro diagnostic test for the qualitative and semiquantitative detection of amphetamines and methamphetamines in human urine on Roche/Hitachi cobas c systems at cutoff concentrations of 300 ng/mL, 500 ng/mL, and 1000 ng/mL when calibrated with d-methamphetamine. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Semiquantitative assays are intended to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas chromatography/mass spectrometry (GC/MS).

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.

Specimen collection and preparation

CALIBRATION

Calibrators Semiquantitative applications
300 ng/mL cutoff assay
S1-6: Preciset DAT Plus II calibrators, CAL 1-60, 150, 300, 600, 1000, 2000 ng/mL
500 and 1000 ng/mL cutoff assays
S1-6: Preciset DAT Plus I calibrators, CAL 1-60, 250, 500, 1000, 3000, 5000 ng/mL
Qualitative applications
300 ng/mL cutoff assay
S1: Preciset DAT Plus II calibrator - CAL 3300 ng/mL
500 ng/mL cutoff assay
S1: Preciset DAT Plus I calibrator - CAL 3 or C.f.a.s. DAT Qualitative Plus(Test AM5Q2)S1: C.f.a.s. DAT Qualitative Plus Clinical (Test AM5QC)500 ng/mL
1000 ng/mL cutoff assay
S1: Preciset DAT Plus I calibrator - CAL 41000 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 -1000 INTO THE CALIBRATION MENU, STATUS SCREEN, CALIBRATION RESULT WINDOW.

CALIBRATION MODE

CALIBRATION FREQUENCY

FULL (SEMIQUANTITATIVE) OR BLANK (QUALITATIVE) CALIBRATION

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.

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

The specificity of Amphetamines II for various phenethylamines and structurally similar compounds was determined by generating inhibition curves for each of the compounds listed for both semiquantitative and qualitative modes and determining the approximate quantity of each compound that is equivalent in assay reactivity to the 300 ng/mL, 500 ng/mL, and 1000 ng/mL d-methamphetamine assay cutoff. The tables below show the semiquantitative results of the study for each assay cutoff. The same samples were run in the qualitative mode and all recovered appropriately negative or positive, based on the calculated

SEE THE "SPECIFIC PERFORMANCE DATA" SECTION OF THIS DOCUMENT FOR INFORMATION ON SUBSTANCES TESTED WITH THIS ASSAY. THERE IS THE POSSIBILITY THAT OTHER SUBSTANCES AND/OR FACTORS MAY INTERFERE WITH THE TEST AND CAUSE ERRONEOUS RESULTS (E.G., TECHNICAL OR PROCEDURAL ERRORS).

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

SPECIFIC PERFORMANCE DATA

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

PRECISION

A d-methamphetamine (MAMP) solution (1 mg/mL) was added to 9 samples obtained from a human urine sample pool to achieve concentrations at approximately - 100 %,- 75 %, - 50 %, - 25 %, ± 0 %, + 25 %, + 50 %, + 75 %, and + 100 % of the cutoff value. These samples were tested for precision in qualitative and semiquantitative modes. Following a CLSI (EP5-A2) precision protocol, samples were tested in 2 replicates per run, 2 runs per day for 21 days, total n = 84. The following results were obtained on a Roche/Hitachi cobas c 501 analyzer.

INTERMEDIATE PRECISION

INTERMEDIATE PRECISION

INTERMEDIATE PRECISION

INTERMEDIATE PRECISION

INTERMEDIATE PRECISION

INTERMEDIATE PRECISION

ANALYTICAL SPECIFICITY

The specificity of Amphetamines II for various phenethylamines and structurally similar compounds was determined by generating inhibition curves for each of the compounds listed for both semiquantitative and qualitative modes and determining the approximate quantity of each compound that is equivalent in assay reactivity to the 300 ng/mL, 500 ng/mL, and 1000 ng/mL d-methamphetamine assay cutoff. The tables below show the semiquantitative results of the study for each assay cutoff. The same samples were run in the qualitative mode and all recovered appropriately negative or positive, based on the calculated

ARMBRUSTER DA, SCHWARZHOFF RH, PIERCE BL, ET AL. METHOD COMPARISON OF EMIT II AND ONLINE WITH RIA FOR DRUG SCREENING. J FORENSIC SCI 1993;38:1326-1341.