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Nucleic Acid Amplification Assays for Molecular Hematopathology, 2nd Edition

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.

This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of April 2016. The document’s next scheduled review is generally five years after the reaffirmation date.

This document is available in electronic format only.

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Chairholder: Daniel E. Sabath, MD, PhD

Date of Publication: March 30, 2012

Order Code PDF: MM05A2E
ISBN Number: 1-56238-791-X

Order Code Print: print not available

Edition: Second

Pages: 108

MM05 Additional Details

The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.