title: Molecular methods and platforms for infectious diseases testing a review of FDA-approved and cleared assays.
abstract: The superior sensitivity and specificity associated with the use of molecular assays has greatly improved the field of infectious disease diagnostics by providing clinicians with results that are both accurate and rapidly obtained. Herein, we review molecularly based infectious disease diagnostic tests that are Food and Drug Administration approved or cleared and commercially available in the United States as of December 31, 2010. We describe specific assays and their performance, as stated in the Food and Drug Administration's Summary of Safety and Effectiveness Data or the Office of In Vitro Diagnostic Device Evaluation and Safety's decision summaries, product inserts, or peer-reviewed literature. We summarize indications for testing, limitations, and challenges related to implementation in a clinical laboratory setting for a wide variety of common pathogens. The information presented in this review will be particularly useful for laboratories that plan to implement or expand their molecular offerings in the near term.
authors.affiliation: Department of Pathology, University of Illinois at Chicago, Chicago, IL, USA. emmadi@uic.edu
authors.forename: Rajyasree
authors.initials: R
authors.lastname: Emmadi
authors.forename: Jerry B
authors.initials: JB
authors.lastname: Boonyaratanakornkit
authors.forename: Rangaraj
authors.initials: R
authors.lastname: Selvarangan
authors.forename: Venkatakrishna
authors.initials: V
authors.lastname: Shyamala
authors.forename: Barbara L
authors.initials: BL
authors.lastname: Zimmer
authors.forename: Laurina
authors.initials: L
authors.lastname: Williams
authors.forename: Bonita
authors.initials: B
authors.lastname: Bryant
authors.forename: Ted
authors.initials: T
authors.lastname: Schutzbank
authors.forename: Michele M
authors.initials: MM
authors.lastname: Schoonmaker
authors.forename: Jean A
authors.initials: JA
authors.lastname: Amos Wilson
authors.forename: Leslie
authors.initials: L
authors.lastname: Hall
authors.forename: Preeti
authors.initials: P
authors.lastname: Pancholi
authors.forename: Kathryn
authors.initials: K
authors.lastname: Bernard
mesh_terms: D019411:Clinical Laboratory Techniques; D003141:Communicable Diseases / Q000175:diagnosis* / Q000235:genetics; D057069:Diagnostic Test Approval; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D011933:Reagent Kits, Diagnostic