Ortho Clinical Diagnostics, a global provider of in vitro diagnostics, has presented the initial performance capabilities of its fourth-generation HIV Test in development, which can simultaneously detect both HIV antibodies (Ab) and p24 antigen (Ag), and is designed to help enable earlier diagnosis of HIV infection.
According to estimates by the World Health Organization, 37 million people worldwide are living with HIV today, but only 54 percent of those people are aware of their infection.
An assessment of the clinical and technical performance of the fourth-generation HIV Test on VITROS Systems confirmed that it demonstrates seroconversion sensitivity, clinical specificity and analytical performance comparable to a commercially available fourth-generation HIV test.
WHO has identified a number of reports of poor HIV testing practices with some reports showing misdiagnosis rates as high as 10.5 percent. (Credit: World Health Organization/C.Johnson)
The antibody detection in the fourth-generation HIV Test is achieved using recombinant envelope proteins for HIV-1 group M and O and HIV-2. The p24 antigen detection is accomplished using monoclonal antibodies (MAbs) against HIV-1 p24.
The fourth-generation HIV Combo Assay will be an addition to Ortho’s immunoassay portfolio. The assay is currently in the U.S. clinical trials phase and not yet available for U.S. customers. It was submitted to the European Notified Body for approval in March 2016 and is expected to be available on the European market later this year.
Ortho Clinical Diagnostics is a global provider of in vitro diagnostics serving the clinical laboratory and immunohematology communities.
