Ortho Clinical Diagnostics has secured US Food and Drug Administration (FDA) approval for the expanded use of its HIV Combo Test.
The FDA has approved the company’s VITROS Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator (VITROS HIV Combo test) for use on Ortho’s VITROS ECi/ECiQ Immunodiagnostic Systems.
Previously, the test was approved for usage on Ortho’s VITROS 5600 Integrated System and Ortho’s VITROS 3600 Immunodiagnostic System.
As a fourth generation test, VITROS HIV Combo is capable of detecting HIV-1 and HIV-2 antibodies (Ab) and the p24 antigen (Ag).
The combo test is said to detect the HIV-1 acute infection faster than the earlier tests by identifying the antigen, rather than spotting the antibodies to the antigen.
Globally, around 37 million people are living with HIV, according to the World Health Organization (WHO).
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The early detection of the infection will enable doctors to start immediate treatment and help in preventing AIDS-related deaths and new infections.
Ortho Clinical Diagnostics chief product portfolio and quality, regulatory and compliance officer Jennifer Paine said: “Early detection of HIV-1 is critical in getting patients into treatment as soon as possible after infection.
“Ortho is proud to be working to deliver our VITROS HIV Combo test to customers worldwide.”
The VITROS HIV Combo test on VITROS Systems was assessed at three external testing laboratories in the US as well as at Ortho’s research and development laboratories in Rochester to review its clinical and technical performance.
Ortho Clinical Diagnostics noted that the assessments confirmed that the test offers competitive sensitivity and specificity over another available fourth-generation test.