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

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

"Early detection of HIV-1 is essential for patients to receive treatment as soon as possible after infection," said Jennifer Paine, MS, head of Ortho Clinical Diagnostics' product portfolio and quality manager. , regulation and compliance, in a statement. "Ortho is proud to work to provide our VITROS HIV Combo test to its customers around the world."

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

The VITROS HIV Combo Test was evaluated for clinical and technical performance in 3 external testing laboratories in the United States and in the research and development laboratories of Ortho Clinical Diagnostics.

Studies comparing the VITROS HIV Combo assay to other tests of antigens or 4th generation antibodies have shown early detection of acute HIV infection in 6 of 32 panels of seroconversion and concordance between 25 of the 32 panels.

According to data from the VITROS HIV Combo Instructions for Use, the specificity of the VITROS HIV Combo test in adults at low risk of HIV infection was 99.58% (95% confidence interval). [CI]99.38% to 99.73%). The sensitivity of the test in HIV-2 positive seropositive samples was 100.00% (95% CI, 98.40% to 100.00%). The sensitivity of seropositive subjects for HIV-1 was 100.00% (95% CI, 99.62% to 100.00%).

The FDA had previously approved the use of the VIRTOS HIV Combo test along 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 testing menu to meet test guidelines and needs," Paine said in a statement, at the time of test approval, for use with the VITROS 5600 integrated system. "With the availability of the VITROS HIV Combo test on the VITROS 5600 system, labs can improve workflow efficiency while helping to detect HIV infection faster."