FDA Approves HIV Test for Use with VITROS 5600 Integrated System

Jennifer Paine

The US Food and Drug Administration has approved VITROS Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator (VITROS HIV Combo test) for use on the VITROS 5600 Integrated System, according to a press release from Ortho Clinical Diagnostics.

The 4^th generation test detects both HIV-1 and HIV-2 antibodies as well as the p24 antigen, which provides a shorter diagnostic window compared to 3^rd generation assays.

"Ortho is committed to expanding its assay menu to meet current guidelines and testing needs," said Jennifer Paine, Executive Vice President, Chief Product Portfolio and Quality, Regulatory and Compliance Officer, Ortho Clinical Diagnostics, in a statement. "With the availability of the VITROS HIV Combo test on the VITROS 5600 System, laboratories can improve workflow efficiencies while helping to provide earlier detection of HIV infection."

The VITROS HIV Combo test was evaluated for clinical and technical performance at 3 external testing laboratories in the US as well as at Ortho Clinical Diagnostics’ research and development laboratories.

Comparison studies of the VITROS HIV Combo test showed earlier detection of acute HIV infection in 6 of 32 seroconversion panels and agreement for 25 of the 32 panels, compared to other 4^th generation antigen/antibody tests.

The specificity of the VITROS HIV Combo test in the adults at low risk for HIV infection was 99.58% (95% confidence interval [CI], 99.38% to 99.73%), according to data in the VITROS HIV Combo Instructions for Use.

The sensitivity of the assay in samples from US HIV-positive subjects infected with HIV-1 was 100.00% (95% CI, 99.62% to 100.00%). The sensitivity for those positive for HIV-2 was 100.00% (95% CI, 98.40% to 100.00%).

The VITROS HIV Combo test was previously approved in December 2017 for use with the VITROS 3600 Immunodiagnostic System.

“With the launch of VITROS HIV Combo test, laboratories can help provide earlier detection of HIV, while operating efficiently,” Robert Yates, currently President and Executive Advisor on Strategy, Partnerships and M&A Transactions, Ortho Clinical Diagnostics, said in a statement at the time of the earlier approval.