Clinical and Laboratory Standards Institute (CLSI) recently published "Gas Chromatography/Mass Spectrometry Confirmation of Drugs; Approved Guideline – Second Edition" (C43-A2).

This document is intended to aid the laboratorian in developing appropriate procedures for the use of gas chromatography/mass spectrometry (GC/MS) in confirmation analyses. Its primary objective is to establish uniform practices necessary for producing quality data for quantitation and identification of a drug or drug metabolite.

Loralie J. Langman, PhD, Mayo Clinic, and chairholder of the committee that developed the document, says, "C43-A2 provides a standardized approach on how to set up GC/MS confirmation assays of drugs. It provides a foundation on which people can build their assays so there is a commonality between all the laboratories to achieve comparable results."

To support the scientific basis of the uniform practices, a brief overview of the techniques is provided. Specific quality assurance criteria for maintaining and documenting optimal instrument performance are also presented.

New information in this edition includes:

  • Clarified concepts and terminology
  • Added content for new technologies, including time-of-flight mass spectrometry and tandem mass spectrometry

Source: CLSI