CLSI MM05A addresses guidelines for a variety of amplification-based laboratory tests, including polymerase chain reaction (PCR), transcription-based amplification system (TAS), strand displacement amplification (SDA), ligase chain reaction (LCR), and other methods now widely used in diagnostic hematopathology. This guideline provides a basis for laboratory implementation and quality assurance in this important area of diagnostic molecular medicine.

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