Lysergic Acid Diethylamide

Catalog Number: 20763284122

ABUSCREEN ONLINE LSD CALIBRATION AND CONTROL PACK

SYSTEM INFORMATION

For cobas c 501 analyzer:

INTENDED USE

Lysergic acid diethylamide (LSD) assay is an in vitro diagnostic test for the qualitative detection of LSD and its metabolites in human urine on Roche/Hitachi cobas c systems at a cutoff concentration of 0.5 ng/mL.

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

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

 Calibrator S1: Abuscreen OnLine LSD Calibrator, 0.5 ng/mL
The drug concentration of the calibrator has been verified by LC‑MS/MS or GC‑MS.
Calibration K Factor For the qualitative application, enter the K Factor as -1000 into the Calibration menu, Status screen, Calibration Result window.
Calibration mode Linear
Calibration frequency Blank Calibration- after reagent lot change- as required following quality control procedures

CALIBRATION K FACTOR

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

CALIBRATION MODE

CALIBRATION FREQUENCY

BLANK CALIBRATION

CALIBRATION INTERVAL MAY BE EXTENDED BASED ON ACCEPTABLE VERIFICATION OF CALIBRATION BY THE LABORATORY.

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

Precision was determined in an internal protocol by running a series of calibrator and controls (repeatability n = 20, intermediate precision n = 100). For this assay, the S1 Abs was set to zero and a K factor of 1000 was entered. This caused the results to be reported as mAbs. Calibration was not performed. The following results were obtained on a Roche/Hitachi cobas c  501 analyzer.

PRECISION WAS DETERMINED IN AN INTERNAL PROTOCOL BY RUNNING A SERIES OF CALIBRATOR AND CONTROLS (REPEATABILITY N = 20, INTERMEDIATE PRECISION N = 100). FOR THIS ASSAY, THE S1 ABS WAS SET TO ZERO AND A K FACTOR OF 1000 WAS ENTERED. THIS CAUSED THE RESULTS TO BE REPORTED AS MABS. CALIBRATION WAS NOT PERFORMED. THE FOLLOWING RESULTS WERE OBTAINED ON A ROCHE/HITACHI 501 ANALYZER.

PRECISION WAS DETERMINED IN AN INTERNAL PROTOCOL BY RUNNING A SERIES OF CALIBRATOR AND CONTROLS (REPEATABILITY N = 20, INTERMEDIATE PRECISION N = 100). FOR THIS ASSAY, THE S1 ABS WAS SET TO ZERO AND A K FACTOR OF 1000 WAS ENTERED. THIS CAUSED THE RESULTS TO BE REPORTED AS MABS. CALIBRATION WAS NOT PERFORMED. THE FOLLOWING RESULTS WERE OBTAINED ON A ROCHE/HITACHI 501 ANALYZER.

ANALYTICAL SPECIFICITY

The specificity of this assay was determined by generating inhibition curves for each of the compounds listed and determining the approximate quantity of each compound that is equivalent in assay reactivity to the 0.5 ng/ml LSD assay cutoff. The following results were obtained on a Roche/Hitachi cobas c 501 analyzer.

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.