New HIV Test Approved by FDA

The US Food and Drug Administration (FDA) has approved Ortho Clinical Diagnostics' VITROS Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator on the VITROS 3600 Immunodiagnostic System.

In vitro diagnostics company, Ortho Clinical Diagnostics, announced today that the US Food and Drug Administration has approved their VITROS Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator on the VITROS 3600 Immunodiagnostic System. According to a press release from Ortho, the Vitros HIV Combo test is a fourth-generation test that can detect both HIV-1 and HIV-2 antibodies (Ab) and the p24 antigen (Ag). This enables the test to detect HIV-1 acute infection earlier than the previous third-generation test.

About 37 million individuals are living with HIV, according to the World Health Organization (WHO). However, a Centers for Disease Control and Prevention (CDC) Vital Signs report, released November 28, 2017, noted that roughly half of those with the disease have been positive for an average of 3 years before they are diagnosed, and about 15% of those with HIV in the United States don’t know they have the disease. An early diagnosis is crucial so that an infected individual can start life-saving antiretroviral therapy (ART). According to Robert Yates, Ortho's chief operating officer, “With the launch of the VITROS HIV Combo test, laboratories can help provide earlier detection of HIV."

Three external testing laboratories throughout the United States confirmed that the VITROS test, “provides competitive sensitivity and specificity when compared to a leading commercially available fourth-generation test,” according to the press release. Indeed, comparison studies revealed that, “The VITROS HIV Combo test showed earlier detection of acute HIV infection in six of 32 seroconversion panels (agreement for 25 of 32 panels) when compared to a leading commercially available fourth-generation Ag/Ab test, indicating that the assay performance is very competitive in shortening the diagnostic window (the time between HIV infection and detection).”

Ortho plans to file Premarket Approval (PMA) supplements for the use of the VITROS HIV Combo test on the VITROS ECi/ECiQ Immunodiagnostic Systems, and the VITROS 5600 Integrated Systemi.