Immunodiagnostic HIV combo test
Ortho Clinical Diagnostics received CE Mark approval for its VITROS HIV Combo test. An important addition to the company’s infectious disease portfolio, the new test is available for purchase in Europe and other countries that accept CE Mark since June 2016. The VITROS HIV Combo, a fourth-generation assay, detects both HIV-1 and HIV-2 antibodies and the p24 antigen, enabling HIV-1 acute infection detection earlier than third-generation assays. According to estimates by the World Health Organization (WHO), 37 million people worldwide are living with HIV today. Starting antiretroviral treatment as soon as possible after diagnosis can help avert millions of AIDS-related deaths and new infections. According to the U.S. Centers for Disease Control and Prevention, identifying patients in the early stages of infection is crucial. With the launch of the VITROS HIV Combo, test laboratories can provide earlier detection of HIV for the benefit of their patients. An assessment of the clinical and technical performance of the VITROS HIV Combo on VITROS Systems during routine use at two external testing laboratories in Europe and at Ortho’s research and development laboratories confirmed it provides competitive sensitivity and specificity when compared with a leading commercially available fourth-generation test. In the comparison studies, assay sensitivity was evaluated on seroconversion panels — VITROS HIV Combo showed earlier detection of acute HIV infection in five of 34 seroconversion panels (agreement for 28 of 34 panels), indicating that the assay performance is very competitive in shortening the diagnostic window (the time between HIV infection and detection) – a valuable attribute in HIV testing. The assay’s class-leading p24 sensitivity and uncompromised specificity is enhanced by the proprietary technologies and benefits only available on VITROS Systems – Intellicheck Technology with its suite of quality checks (MicroSensor, SMART Metering) and VersaTip technology – a combination that provides laboratories the accuracy needed to have the utmost trust in their results.
