ALTERNATE MATRIX IVDs SHOULD UNDERGO CLINICAL STUDIES

ALTERNATE MATRIX IVDs SHOULD UNDERGO CLINICAL STUDIES to establish that the tests are as effective as traditional tests in detecting disease and drugs of abuse, a majority of panel members suggested at a Sept. 23 joint meeting of the Clinical Chemistry and Toxicology Devices Panel and the Microbiology Devices Panel in Gaithersburg, Maryland. Maintaining that analytical performance data would not be sufficient, panel members recommended that manufacturers demonstrate the clinical efficacy of in vitro diagnostic devices that use sweat, saliva, hair, tears, and other non-traditional matrices.