CLN - Regulatory Roundup

FDA OKs Ortho’s Fourth-Generation HIV Test

Regulatory Roundup: March 2018

Ortho Clinical Diagnostics has received Food and Drug Administration approval for its Vitros Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator (Vitros HIV Combo). Designed for use on Ortho’s Vitros 3600 Immuno-diagnostic system, the Vitros HIV Combo is a fourth-generation test that detects both HIV-1 and HIV-2 anti--
bodies (Ab) as well as the p24 antigen (Ag). The clinical and technical performance of this test was evaluated during routine use at three external testing laboratories in the U.S. and at Ortho’s research and development labs. When compared with a leading commercially available fourth-generation- Ag/Ab test, the Vitros HIV Combo showed earlier detection of acute HIV infection in six of 32 sero-conversion panels and agreement in 25 of 32 panels. The test also features Ortho’s proprietary MicroWell technology combined with enhanced chemiluminescence detection technology to improve signal detection; MicroSensor technology to detect endogenous interferences; and Smart Metering and VersaTip technology to help exclude carryover and cross-contamination- when using disposable tips.