CLSI releases new molecular methods standards—MM09-A2 and MM22-A

March 13, 2014

The Clinical and Laboratory Standards Institute (CLSI) has released an updated edition of Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline—Second Edition (MM09-A2) and published a new document entitled Microarrays for Diagnosis and Monitoring of Infectious Diseases; Approved Guideline (MM22-A).

MM09-A2 addresses diagnostic sequencing using both automated capillary-based sequencers and massively parallel sequencing instruments. Topics in this guideline include specimen collection and handling; isolation and extraction of nucleic acid; template preparation; sequence generation, alignment, and assembly; validation and verification; ongoing quality assurance; and reporting results.

This revised guideline provides information for clinical laboratories about the recent and significant advances in clinical diagnostic sequencing. The document describes a broad range of sequencing technologies that are now available, including massively parallel sequencing.

MM22-A is a new guideline that focuses on the use of nucleic acid microarrays in microbiology and immunology laboratories. It provides detailed recommendations for assay performance validation and verification processes unique to microarrays, and includes recommended target types and numbers for diagnosis and monitoring of infectious diseases. This document contains information necessary for clinical laboratories performing qualitative, multiplexed nucleic acid-based testing, which includes but is not limited to bacteriology, mycobacteriology, mycology, parasitology, and virology. It helps users select and validate commercially available microarray-based diagnostic devices and assays. It provides guidance for the laboratory development and use of qualitative nucleic acid microarray methods for the diagnosis and monitoring of infectious diseases. It also presents recommendations for validation and verification, quality control, and interpretation of results. Learn more about services offered by CLSI.

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