Ortho Clinical gets FDA approval for HIV diagnostic test
In-vitro diagnostics maker Ortho Clinical Diagnostics has received approval from the US Food and Drug Administration (FDA) for its Vitros Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator (Vitros HIV Combo test).
Indicated for use on the firm’s Vitros 3600 Immunodiagnostic System, the fourth-generation test is designed to identify HIV-1 and HIV-2 antibodies (Ab).
The test could also detect the p24 antigen (Ag), leading to early identification of acute HIV-1 infection, compared with third-generation tests.
Ortho Clinical Diagnostics chief operating officer Robert Yates said: “Ortho is committed to expanding its assay menu and improving laboratory workflow efficiencies for its customers.
“With the launch of the Vitros HIV Combo test, laboratories can help provide earlier detection of HIV, while operating efficiently.”
The firm assessed the clinical and technical performance of the HIV Combo test during routine use on Vitros Systems at three external testing laboratories, as well as its research and development laboratories.
Results from these studies indicated competitive sensitivity and specificity compared with an undisclosed, commercially available fourth-generation Ag/Ab test.
The Vitros test is reported to have demonstrated earlier identification of acute HIV infection in six of a total of 32 seroconversion panels used during the comparison studies.
In combination with the firm’s technologies and Vitros Systems’ features, the specificity of the new test is claimed to have been enhanced for p24 detection.
The firm is planning to submit premarket approval (PMA) supplements for the use of the combo test on the Vitros ECi/ECiQ Immunodiagnostic and 5600 Integrated Systems.