SOURCE: Ortho Clinical Diagnostics

March 29, 2016 09:04 ET

Ortho Clinical Diagnostics Presents Scientific Poster on the Performance of a Fourth-Generation HIV Test at the 2016 HIV Diagnostics Conference

RARITAN, NJ--(Marketwired - Mar 29, 2016) - Ortho Clinical Diagnostics, a global in vitro diagnostics leader, presented a scientific poster at the 2016 HIV Diagnostics Conference on the performance of its Fourth-Generation HIV Test in development that is capable of simultaneously detecting both HIV antibodies (Ab) and p24 antigen (Ag) and is designed to help enable earlier diagnosis of HIV infection.

The Fourth-Generation HIV Test is in development, and is not currently available in the US. Submission to the European Notified Body occurred in March 2016. An important addition to the Ortho Clinical Diagnostics' assay portfolio, the new test is expected to be available for purchase in Europe later this year.

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.

"Sharing the findings of this study with our industry colleagues is an important step in our continued fight against HIV, which remains a potent threat despite several advances in medical science," said Paul Contestable, Principal Scientist in Infectious Disease Assay Development for Ortho Clinical Diagnostics. "We are fully committed to bringing this Fourth-Generation HIV test to our customers, thus helping to enable more effective patient diagnosis and treatment."

Antibody detection in the Fourth-Generation HIV Test in development is achieved using recombinant transmembrane envelope proteins for HIV-1 group M and O and HIV-2. The p24 antigen detection is accomplished using monoclonal antibodies (MAbs) against HIV p24.

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 healthcare 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, 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, Inc. 2016

Contact Information

  • Press Contact:
    Renee Giello
    Ortho Clinical Diagnostics
    908-704-3678