RARITAN, N.J., May 23, 2016 /PRNewswire/ -- Ortho Clinical Diagnostics (Ortho), a global leader 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. Only 54 percent of those people are aware of their infectioni.
"The fourth-generation HIV Combo Assay is a testament to Ortho's longstanding commitment to the diagnosis of infectious diseases," said Paul Contestable, principal scientist in infectious disease assay development for Ortho Clinical Diagnostics. "Today's announcement marks the next step in our ongoing mission to develop cutting-edge, high-quality and innovative solutions in immunoassays."
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. 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 important addition to Ortho's immunoassay portfolio. The assay is currently in the US clinical trials phase and not yet available for US 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.
About Ortho Clinical Diagnostics
Ortho Clinical Diagnostics is a global leader of in vitro diagnostics serving the global clinical laboratory and immunohematology communities. Across hospitals, hospital networks, blood banks, and labs in more than 120 countries, Ortho's high-quality products and services enable health care professionals to make better-informed treatment decisions. For the immunohematology community, Ortho's blood typing products help ensure every patient receives blood that is safe, the right type and the right unit. Ortho brings sophisticated testing technologies, automation, information management and interpretation tools to clinical laboratories around the world to help them run more efficiently and effectively and improve patient care. Ortho's purpose is to improve and save lives with diagnostics, and it does that by reimagining what's possible. This is what has defined Ortho for more than 75 years, and it's what drives Ortho forward. For more information, visit www.orthoclinicaldiagnostics.com.
VITROS® is a trademark of Ortho Clinical Diagnostics.
© Ortho Clinical Diagnostics 2016
i http://www.who.int/hiv/en/, May 10, 2016
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SOURCE Ortho Clinical Diagnostics