This guideline addresses the performance and application of assays for gene rearrangement and translocations by both polymerase chain reaction (PCR) and reverse-transcriptase PCR techniques, and includes information on specimen collection, sample preparation, test reporting, test validation, and quality assurance.
CLSI Publishes Revised Guideline on Nucleic Acid Amplification Assays for Molecular Hematopathology
Wayne, Pennsylvania, USA—March, 2012—The Clinical and Laboratory Standards Institute (CLSI) recently published Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline—Second Edition (MM05-A2). This guideline addresses the performance and application of assays for gene rearrangement and translocations by both polymerase chain reaction (PCR) and reverse-transcriptase PCR techniques, and includes information on specimen collection, sample preparation, test reporting, test validation, and quality assurance.
MM05 addresses the needs of the laboratory by providing recommendations on a variety of laboratory tests based on analysis of nucleic acids. It addresses preexamination and examination issues affecting assay performance, reporting of laboratory results, and quality assurance (QA). The guideline is designed to assist a molecular diagnostic laboratory in acquiring a new assay or new technology, as well as serve as a refresher for those already experienced with a particular area of analysis.
“We are pleased to provide an updated version of these guidelines for molecular testing in hematopathology,” states Daniel E. Sabath, MD, PhD, University of Washington Department of Laboratory Medicine Seattle Cancer Care Alliance and Chairholder of the document development committee.” “This is a rapidly changing area of laboratory medicine, and we have assembled leaders in this field to produce a document that will be a useful reference guide for laboratories performing molecular hematopathology tests. We would also recommend it for hematologists and oncologists who order these tests for their patients.”
This guideline is intended to assist laboratories that rely on nucleic acid–based hematology assay systems to properly implement these techniques, together with the appropriate controls in their laboratories. Furthermore, it is intended to help the laboratorian determine what types of materials and records must be preserved following the laboratory procedure, and for how long. Finally, it is intended to assist those responsible for monitoring compliance with QA programs.
“This updated CLSI document reflects the many improvements that have occurred in the molecular characterization of hematological malignancies since the last edition was published,” says Emily S. Winn-Deen, PhD, President, Rx Dx Advisors, Inc., and a member of document development committee. “It provides laboratories with a solid foundation for personalizing management of these cancers for their oncologists and patients.”
Details of the current state of molecular diagnostic techniques used for the diagnosis of hematological disorders, including clonality analysis, detection of mutations and chromosomal rearrangements associated with specific neoplasms, and assays used for prognostication and clinical monitoring of patients with hematological neoplasms are included in this revision.
Specifically, MM05 addresses the following topics as they relate to molecular detection of lymphoid and myeloid clonality, chromosomal translocations, somatic mutations in lymphoid and myeloid neoplasms, and quantification of donor/recipient cell populations after allogeneic transplants, mutations/translocations, and normal RNA species:
A variety of individuals may find this document useful, including laboratory directors, surgical pathologists, medical technologists, other laboratory personnel, hematopathologists, hematologists, oncologists, and those involved in the promulgation of regulations under which laboratories and manufacturers must operate.
CLSI is a volunteer-driven, membership-supported, nonprofit organization dedicated to developing standards and guidelines for the health care and medical testing community through a consensus process that balances the perspectives of industry, government, and the health care professions. For additional information, visit the CLSI website at www.clsi.org or call 610.688.0100.
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