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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.

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Visit the FDA's website to find out more about their activities and publications.
 
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Reader Comments:

Comment by: Lara (MARYLAND, MD) Tue., Jan. 24, 2012 at 4:08 am EST
Is this a rapid test or a test that has to be done in a dedicated laboratory?
Can it be used cost effectively in resource-challenged sub-sahara African countries?
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Comment by: tugurun (thailand) Tue., Jun. 22, 2010 at 9:33 pm EDT
Now US is making a step foward in detecting hiv infection. i even wonder why the delay in the first place because us is like a market too many peoplee goes in and out of the state and having sex so why all this B subtype. all strain are in US.
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Comment by: Michael (San Francisco) Tue., Jun. 22, 2010 at 5:21 pm EDT
Sorry,what's the window period with this kind of test?
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