Diagnostic accuracy of 4th generation ARCHITECT HIV Ag/Ab Combo assay and utility of signal-to-cutoff ratio to predict false positive HIV tests in pregnancy

False positive HIV screening tests in pregnancy may lead to unnecessary interventions in labor. In 2014, the Centers for Disease Control and Prevention released a new algorithm for HIV diagnosis using a 4th generation screening test, which detects antibodies to HIV as well as p24 antigen and has a shorter window period compared with prior generations. A reactive screen requires a differentiation assay, and supplemental qualitative RNA testing is necessary for nonreactive differentiation assay. One screening test, the ARCHITECT Ag/Ab Combo assay, is described to have 100% sensitivity and>99% specificity in non-pregnant populations; however, its clinical performance in pregnancy has not been well described.
Source: American Journal of Obstetrics and Gynecology - Category: OBGYN Authors: Source Type: research