FDA Approves New HIV VITROS Combo Test

The US Food and Drug Administration (FDA) has approved VITROS Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator (VITROS HIV Combo test) for use on Ortho’s VITROS 3600 Immunodiagnostic System, announced Ortho Clinical Diagnostics.

The fourth-generation HIV Combo assay detects both HIV-1 and HIV-2 antibodies (Ab) and the p24 antigen (Ag), detecting an HIV-1 acute infection earlier than third-generation assays.

“With the launch of VITROS HIV Combo test, laboratories can help provide earlier detection of HIV, while operating efficiently,” Robert Yates, chief operating officer, Ortho, said in a statement.

The clinical and technical performance of the test on VITROS Systems was evaluated in routine use at Ortho’s research and development laboratories, as well as 3 external testing laboratories. The assessment confirms that the test provides competitive sensitivity and specificity as opposed to an unspecified commercially available fourth-generation test.

In comparison studies, researchers evaluated the assay’s sensitivity on seroconversion panels.

The VITROS HIV Combo test showed earlier detection of acute HIV infection in 6 of 32 seroconversion panels (agreement for 25 of 32 panels) when compared to the fourth-generation Ag/Ab test.

Test findings indicate that the assay performance is competitive and shortens the diagnostic window.

The results of the test, in conjunction with other serological evidence and clinical information, may be used to aid in the diagnosis of HIV-1 and/or HIV-2 infections.

The test’s p24 sensitivity with uncompromised specificity is enhanced by various technologies: MicroWell technology combined with the Enhanced Chemiluminescence Detection Technology that improves signal detection with outstanding sensitivity, precision and a wide dynamic range; and the Intellicheck Technology which includes MicroSensor technology that detects endogenous interferences, and SMART Metering and VersaTIp technology that helps exclude carryover and cross-contamination through disposable tips.

The VITROS 3600 System is built to handle peak testing workloads, while maximizing turnaround and system walk-away times.

The US Centers for Disease Prevention and Control (CDC) stresses the importance of identifying patients in early infection stages. According to estimates provided by the World Health Organization (WHO), approximately 37 million people are living with HIV and by starting antiretroviral treatment (ART) as close to diagnosis as possible, millions of AIDS-related deaths and new infections could be averted.

Ortho plans to file Premarket Approval (PMA) supplements for the use of the test on the VITROS ECi/ECiQ Immunodiagnostic Systems and the VITROS 5600 Integrated System.

An earlier version of this article appeared on Contagion Live.