CLN Article

Roche Gets Green Light for Latest Generation of HIV Combination Assay

Regulatory Roundup: September 2017

The Food and Drug Administra-tion announced that Roche has received premarket approval for the Elecsys HIV combi PT assay, the fourth generation of the company’s HIV combination antigen-antibody test. The assay simultaneously detects the HIV-1 p24 antigen as well as HIV-1 and HIV-2 antibodies in human serum and plasma. Specifically, it identifies HIV antibodies by using recombinant antigens derived from the HIV genome, and uses targeted monoclonal antibodies and an incubation pretreatment step to detect p24 antigen. The assay is intended for use with Roche’s cobas e 602 analyzer, a testing module that also offers immunoassay capabilities in infectious diseases, cardiac markers, and other areas. Roche designed the test to aid in early detection and diagnosis of HIV-1 or HIV-2 infection in pregnant women and patients older than 2 years of age. 

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