GOLD STANDARD FOR NUCLEIC ACID AMPLIFICATION STUDIES SHOULD INCLUDE TESTS OTHER THAN CULTURE, PANEL MEMBERS SUGGEST; FDA POLICY UNDER DEVELOPMENT
This article was originally published in The Gray Sheet
Executive Summary
Culture testing should be augmented by alternative diagnostic techniques in establishing a gold standard of comparison for nucleic acid-based tests for chlamydia and other diseases, FDA panel members said at a Feb. 11 meeting in Rockville, Maryland. FDA called the joint meeting of its Microbiology, Clinical Chemistry/ Toxicology, Hematology/Pathology and Immunology Panels to gain input on how to evaluate emerging in vitro diagnostic technologies.