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FDA grants Roche premarket approval for fourth-generation HIV combination antigen-antibody assay

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The FDA granted Roche premarket approval for its fourth-generation HIV combination antigen-antibody assay, the company announced today.

The Elecsys HIV combi PT assay is intended to be used as an aid in the diagnosis of HIV-1 and HIV-2, or both, including acute and primary HIV-1 infection, according to a news release. The immunoassay can detect both antigen and antibodies simultaneously, which can increase the likelihood of early detection of HIV infection, Roche said.

"The approval of this highly sensitive and specific assay demonstrates our ongoing commitment of expanding Roche's already broad testing menu for infectious diseases on the cobas e 602 analyzer, including hepatitis and ToRCH assays," Jack Phillips, president and CEO of Roche, said in the release. "With the addition of this assay, laboratories will be able to screen for common coinfections, such as hepatitis C and syphilis, which can be tested simultaneously with HIV, reducing the need for sample splitting and additional analyzers."

According to the release, the immunoassay may be used in patients aged older than aged 2 years and in pregnant women.

Disclosure: Phillips is employed by Roche.