Ortho Clinical Diagnostics, Raritan, NJ, has submitted a premarket approval (PMA) application to FDA for the Vitros Immunodiagnostic Products human immunodeficiency virus (HIV) combo assay for use on the Vitros 3600 immunodiagnostic system.

The company has also submitted PMA supplements for the Vitros HBeAg and Anti-HBe assays, for use on the Vitros 3600 immunodiagnostic system and Vitros 5600 integrated system.


Robert Yates, Ortho-Clinical Diagnostics.

“We are committed to designing assays to help our laboratory customers diagnose infectious diseases as early as possible in the disease cycle, while also supporting labs in managing their workloads as effectively and efficiently as possible,” says Robert Yates, chief operating officer at Ortho. “By seeking to expand our clinical labs menu, and making existing immunoassays available on multiple Vitros systems, we aim to help our customers achieve both of those goals.”

A fourth-generation HIV assay, the Vitros HIV combo is designed to detect acute HIV-1 infection earlier than previous generations of HIV assays. The assay was CE marked in 2016 and is currently available in Europe and other countries that accept the CE mark.

Developed to diagnose hepatitis B, the Vitros HBeAg and Anti-HBe assays are currently approved for use on Ortho’s Vitros ECi/ECiQ immunodiagnostic system. Ortho submitted two PMA supplements for review to migrate these existing assays onto Ortho’s Vitros 5600 and Vitros 3600 systems, which would potentially expand their use.

For more information, visit Ortho Clinical Diagnostics.