title: Molecular diagnostics: harmonization through reference materials, documentary standards and proficiency testing.
abstract: There is a great need for harmonization in nucleic acid testing for infectious disease and clinical genetics. The proliferation of assay methods, the number of targets for molecular diagnostics and the absence of standard reference materials contribute to variability in test results among laboratories. This article provides a comprehensive overview of reference materials, related documentary standards and proficiency testing programs. The article explores the relationships among these resources and provides necessary information for people practicing in this area that is not taught in formal courses and frequently is obtained on an ad hoc basis. The aim of this article is to provide helpful tools for molecular diagnostic laboratories.
authors: National Institute of Standards and Technology, 100 Bureau Drive, MS 8312, Gaithersburg, MD 20899-8312, USA. marcia.holden@nist.gov
authors: Marcia J
authors: MJ
authors: Holden
authors: Roberta M
authors: RM
authors: Madej
authors: Philip
authors: P
authors: Minor
authors: Lisa V
authors: LV
authors: Kalman
mesh_terms: D003141:Communicable Diseases / Q000175:diagnosis; D004282:Documentation / Q000592:standards*; D030342:Genetic Diseases, Inborn / Q000175:diagnosis; D006801:Humans; D059021:Laboratory Proficiency Testing / Q000592:standards*; D025202:Molecular Diagnostic Techniques / Q000592:standards*; D011786:Quality Control; D012015:Reference Standards