Verification of Infectious Disease Molecular Assays: A Self-Study Module

Nucleic acid amplification tests are increasingly performed in clinical and public health laboratories in the investigation of infectious disease. They are also used extensively in the Laboratory Response Network to detect agents of bioterrorism. The 2003 revisions to the CLIA regulations included requirements for the establishment and verification of performance specifications for molecular assays. This intermediate-level program will provide the learner with information on infectious disease molecular assay verification procedures and processes. The program begins by listing and defining the CLIA requirements, and continues by providing guidance and suggestions on how to comply. The program describes how one laboratory team established the performance specifications for an in-house developed assay and verified the manufacturer’s performance specifications for an FDA-cleared assay. It concludes with suggestions on how to report results from in-house developed assays that use analyte specific reagents (ASRs). Exceptions to the CLIA requirements that may apply to public health laboratories during public health emergencies will be outlined. The program is delivered using a documentary style. Learners will hear from experts in the field of molecular diagnostics who will answer the difficult questions that many laboratory scientists have about verifying molecular assays. Learners may test their comprehension and competency by completing a post test.