FDA Approves HIV Test for Use with VITROS ECi/ECiQ Immunodiagnostic System

The US Food and Drug Administration (FDA) has approved the VITROS Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator (VITROS HIV Combo test) for use with Ortho Clinical Diagnostics’ VITROS ECi/ECiQ Immunodiagnostic System.

"Early detection of HIV-1 is critical in getting patients into treatment as soon as possible after infection," said Jennifer Paine, MS, Ortho Clinical Diagnostics' chief product portfolio and quality, regulatory and compliance officer, in a statement. "Ortho is proud to be working to deliver our VITROS HIV Combo test to customers worldwide."

The VITROS HIV Combo test is a 4^th generation assay that detects both HIV-1 and HIV-2 antibodies as well as the p24 antigen. Detection of the p24 antigen, rather than just the antibodies to the antigen, allows the test to detect HIV-1 acute infection earlier than other generations of tests.

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

Studies comparing the VITROS HIV Combo test to other 4th generation antigen or antibody tests showed earlier detection of acute HIV infection in 6 of 32 seroconversion panels and agreement for 25 of the 32 panels.

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

The FDA has previously approved the use of the VIRTOS HIV Combo test with other Ortho Clinical Diagnostics systems, including the VITROS 5600 Integrated System earlier this year and the VITROS 3600 Immunodiagnostic System in December 2017.

"Ortho is committed to expanding its assay menu to meet current guidelines and testing needs," said Paine in a statement at the time of the test’s approval for use with the VITROS 5600 Integrated System. "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."