CLSI C43
Gas Chromatography/Mass Spectrometry Confirmation of Drugs
CLSI C43 provides essential guidance for laboratories developing standardized procedures for drug and metabolite confirmation using gas chromatography/mass spectrometry (GC/MS). This guideline establishes uniform practices to ensure accurate quantitation and identification, supported by an overview of GC/MS techniques. It also includes quality assurance criteria for maintaining optimal instrument performance, ensuring reliable and reproducible results in forensic, clinical, and toxicology testing.
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{{FormatPrice(nonMemberPrice)}} List PriceClinical and Laboratory Standards Institute document C43-A2—Gas Chromatography/Mass Spectrometry Confirmation of Drugs; Approved Guideline—Second Edition is intended to aid the laboratorian in developing appropriate procedures for the use of gas chromatography/mass spectrometry 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. 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 presented.
This edition of C43 was revised to clarify concepts and terminology. Some minor content additions were also made, such as MS/MS and time-of-flight (TOF) mass spectrometry.
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 C52 for recommendations on sample collection and screening testing.
This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid and because of its value to the laboratory community, it is being retained in CLSI’s library.
This document is available in electronic format only.
Clinical and Laboratory Standards Institute document C43-A2—Gas Chromatography/Mass Spectrometry Confirmation of Drugs; Approved Guideline—Second Edition is intended to aid the laboratorian in developing appropriate procedures for the use of gas chromatography/mass spectrometry 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. 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 presented.
This edition of C43 was revised to clarify concepts and terminology. Some minor content additions were also made, such as MS/MS and time-of-flight (TOF) mass spectrometry.
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 C52 for recommendations on sample collection and screening testing.
This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid and because of its value to the laboratory community, it is being retained in CLSI’s library.
This document is available in electronic format only.