The Vitros immunodiagnostic products HIV combo reagent pack and calibrator from Ortho Clinical Diagnostics, Raritan, NJ, has been granted the CE mark, signifying conformity with the requirements for European Union market entry. The Vitros HIV combo test is a fourth-generation assay designed to detect both human immunodeficiency virus (HIV) 1 and 2 antibodies and the p24 antigen, to help enable HIV-1 acute infection detection earlier than third-generation assays.

The test is currently in development for US customers, according to a company spokesperson.

According to estimates by the World Health Organization, 37 million people worldwide are living with HIV.1 Starting antiretroviral treatment as soon as possible after diagnosis can help avert millions of AIDS-related deaths and new infections. According to the Centers for Disease Control and Prevention, identifying patients in the early stages of infection is crucial.2

“Ortho is committed to expanding its assay menu and is investing in a pipeline that significantly improves laboratory outcomes for our customers,” says Robert Yates, chief operating officer at Ortho Clinical Diagnostics. “With the launch of the Vitros HIV combo in Europe and other CE mark countries, test laboratories can help provide earlier detection of HIV for the benefit of their patients. Additionally, performing this test on Vitros systems provides the utmost confidence in results.”

An assessment of the clinical and technical performance of the Vitros HIV combo test on Vitros systems during routine use was completed at two external testing laboratories in Europe and at Ortho’s research and development laboratories.

For more information, visit Ortho Clinical Diagnostics.

REFERENCES

  1. HIV/AIDS [online]. Geneva, Switzerland: World Health Organization, 2016. Available at: www.who.int/about/en. Accessed June 27, 2016.
  1. HIV infection: detection, counseling, and referral [online]. Atlanta: Centers for Disease Control and Prevention, 2011. Available at: www.cdc.gov/std/treatment/2010/hiv.htm. Accessed June 27, 2016.