Abbott ARCHITECT HIV Testing
HIV infection affects more than 1.2 million people, and nearly a third of transmissions are caused by those unaware of their status.
Early detection of HIV is critical to its successful treatment. The Centers for Disease Control and Prevention (CDC) advocate voluntary, opt-out HIV screening for all adults in healthcare settings instead of screening only traditionally high-risk patients. Talk to your Fisher Heathcare™ Sales Representative about setting up an early HIV testing initiative in your community using the excellent sensitivity and specificity of the Abbott™ ARCHITECT™ HIV Ag/Ab Combo Assay.
- ARCHITECT HIV Ag/Ab Combo Package Insert (G2-6108/R02)
- Marquez, Carina, et al., HIV Testing: An Update. MLO, February 2008
Intended Use
The ARCHITECT HIV Ag/Ab Combo Assay is a chemiluminescent microparticle immunoassay (CMIA) for the simultaneous qualitative detection of human immunodeficiency virus (HIV) p24 antigen and antibodies to HIV type 1 (HIV-1 group M and group O) and/or type 2 (HIV-2) in human serum and plasma (EDTA and heparin).
The ARCHITECT HIV Ag/Ab Combo Assay is intended for use as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection. The assay may also be used to assist in the diagnosis of HIV-1/HIV-2 infection in pregnant woman and pediatric patients (i.e., children as young as two years of age). A reactive result from the ARCHITECT HIV Ag/Ab Combo test does not distinguish between the detection of HIV p24 antigen, HIV-1 antibody, or HIV-2 antibody. The ARCHITECT HIV Ag/Ab Combo is not intended for use in screening blood or plasma donors, since the effectiveness of the test for this use has not been established. However, this assay can be used for blood donor screening in urgent situations where the use of traditional licensed blood donor screening tests are impractical or unavailable.
Carefully follow the package insert instructions. The reliability of assay results cannot be guaranteed if there are any deviations from the package insert instructions.
United States Federal Law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory; and use is restricted to, by, or on the order of a physician.
Important Safety Information
- Chemical Hazards: This product contains sodium azide, which has been reported to form lead or copper azide on laboratory plumbing. These azides can explode upon percussion, such as hammering. To prevent formation of lead or copper azide, flush drains thoroughly with water after disposing of solutions containing sodium azide.
- Biohazards: This product contains human-sourced and/or potentially infectious components and must be handled in accordance with the OSHA Standard on Bloodborne Pathogens.