Nucleic acid testing is the fastest growing field in laboratory medicine. With a rising emphasis on genetics, scientists and physicians are looking towards an individual’s biological code to explain a patient’s illness or potential for disease. However, understanding genes is not so simple, and there has been a need to make use of multiplex assays in nucleic acid testing.
Nucleic acid testing with multiple assays, or when two or more targets are detected simultaneously as set through a preparation process, is a complicated procedure. All multiplex assays present significant challenges, and laboratory personnel can develop assays in-house or use commercially available multiplex assays involving a variety of technologies and instrument platforms. CLSI MM17-Ed2 – Validation and Verification of Multiplex Nucleic Acid Assays standardizes the process of carrying-out this process.
CLSI MM17-Ed2 oversees all steps of the multiplex nucleic acid testing process, spanning development, verification, validation, control, data analysis, and implementation of the assays. It is meant to be used for a variety of laboratory purposes, including:
- detection and identification of infectious agents
- identification of genetic disorders
- choosing drug therapies and doses (for pharmacogenetic purposes)
- assessing disease progression and prognosis
CLSI MM17-Ed2 accomplishes this by giving recommendations to be used throughout the analytic verification and validation process of qualitative multiplex assays, sampled from DNA or RNA. The standard also includes a review of different types of biologic and synthetic reference materials (RM).
In addition, the document provides an overview of currently available technologies and the criteria for identifying new ones. Examples of these include polymerase chain reaction (PCR), multiple litigation-dependent probe amplification, transcription-mediated amplification, and nucleic acid sequence-based amplification.
Please note that this standard does not address assays measuring individual targets to later be evaluated simultaneously, and it is limited to analytic validation and verification of qualitative multiplex assays for genotyping and pathogen detection.
While CLSI MM17-Ed2 does address some guidelines for sample preparation, optimal guidelines for specimen labeling, collection, storage, and nucleic acid stabilization are described in detail in CLSI MM13 – Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline.
CLSI MM17-Ed2, like other clinical laboratory standards, was written and published by the Clinical and Laboratory Standards Institute (CLSI), an ANSI-accredited standards developing organization.
CLSI Standards are available on the ANSI Webstore.