Gas Chromatography/Mass Spectrometry Confirmation of Drugs; Approved Guideline
|Publication Date:||1 March 2010|
This document is intended to aid the laboratorian in developing appropriate procedures for the use of GC/MS in drug confirmation analyses. By definition, it is assumed that the user is attempting to confirm a result obtained using a screening method such as immunoassay. It addresses the instrumental and methodological issues in developing a chromatographic mass spectrometric method, routine performance of the analysis, and continued quality assurance.
Guidance documents exist for laboratories involved in regulatory workplace drug-testing programs and are used in laboratories certified by these programs. Additionally, each laboratory needs to consult its own country's regulatory requirements.a However, confirmatory assays are also used in settings outside federal workplace drug testing programs, eg, by laboratories engaged in clinical toxicology, other types of forensic testing, and athletic testing. The present guideline was developed to provide assistance in developing GC/MS confirmation tests that are fit for the analytical purpose in each of these areas.
The chain of custody, although an important part of any test result to be submitted to the judicial system, is not discussed here. Guidelines for sample collection and screening testing have been published. Refer to CLSI document C521 for recommendations on sample collection and screening testing.
aIn the United States, the Division of Workplace Programs, Substance Abuse and Mental Health Services Administration of the United States Department of Health and Human Services oversees the best-known drug testing program. The US National Laboratory Certification Program provides guidance for laboratories involved in federal workplace drug testing programs.