From New England Pediatrics, Limited Liability Partnership, Stamford, Conn (Drs Levine and Grossberg); BBI Clinical Laboratories, New Britain, Conn (Dr Tilton); Carolinas Medical Center, Charlotte, NC (Dr Banks); Dr Rosenfeld is a consulting adult and child psychiatrist in Greenwich, Conn.
Controversies section editor: Phil B. Fontanarosa, MD, Senior Editor.
IN VITRO DIAGNOSTIC products are reagents and instruments that medical
personnel and private citizens use to diagnose disease or other health-related
conditions. No test can yield perfect results, but when used properly, a test's
false-negative and false-positive rates should be minimal (D. B. Burlington,
oral communication [testimony before the US House of Representatives' subcommittee
on Oversight and Investigations Committee on Commerce], September 1996). Although
contemporary in vitro diagnostic tests are assumed to provide valid and clinically
meaningful results, many have not been subjected to rigorous scientific evaluation.
Current regulations are inadequate to ensure that only clinically useful products
reach and remain on the market.
Levine D, Grossberg R, Tilton R, Banks P, Rosenfeld A. Are Current Regulations for Approval of In Vitro Diagnostic Devices Adequate?. JAMA. 1998;280(2):187-189. doi:10.1001/jama.280.2.187