Fourth Generation HIV Diagnostic Test Approved, Permitting Earlier Detection of Infection
June 18, 2010
On June 18, 2010, FDA approved a new, "4th generation" HIV diagnostic assay. The ARCHITECT HIV Ag/Ab Combo Assay is the first HIV diagnostic assay that simultaneously detects both antigen and antibodies for the Human Immunodeficiency Virus (HIV). The new test is also the first diagnostic test approved by FDA for use in children as young as 2 years of age, and pregnant women.
This single, automated test, known as the ARCHITECT HIV Ag/Ab Combo Assay, is a highly sensitive chemiluminescent microparticle immunoassay intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection. It is specific for the detection of the HIV-1 p24 antigen (the substance found on the virus that triggers the production of antibodies), as well as antibodies to HIV-1 groups M and O, and as antibodies to HIV-2.View Full Article
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