The U.S. Food and Drug Administration approved the first rapid Human Immunodeficiency Virus test for the simultaneous detection of HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma, and venous or fingerstick whole blood specimens. Approved for use as an aid in the diagnosis of HIV-1 and HIV-2 infection, the Alere Determine HIV-1/2 Ag/Ab Combo test is the first FDA-approved test that independently distinguishes results for HIV-1 p24 antigen and HIV antibodies in a single test. The Alere Determine HIV-1/2 Ag/Ab Combo test is manufactured by Orgenics, an Alere company. :theflyont
A BIG SO WHAT! OraSure's went OTC with there's. Alere has had the Clearview Complete HIV test for years. Just wondering how Alere is going to streamline their HIV tests into their patient shelf testing / home monitoring business.