Acute HIV often goes undetected. In fact, between 5,000 to 75,000 patients are misdiagnosed annually. This doesn’t have to be the case. Early detection provides vital information that can lead to early treatment and prevention. So if you feel like you have the flu, make sure that it isn’t something more serious.

The Abbott ARCHITECT HIV Ag/Ab Combo assay is the first HIV test approved in the United States that can simultaneously detect both HIV antigens and antibodies —up to 20 days earlier than traditional antibody-only tests.

Ask for the ARCHITECT HIV Ag/Ab Combo 4th Generation HIV Test.

VIDEOS.

Dr. Peter Leone, MD, outlines the risks of spreading HIV during its acute stage, and how ARCHITECT HIV Ag/Ab Combo can reduce those risks.

Learn more about why Acute HIV often goes undetected, and why the virus is highly infectious during this stage.

See how ARCHITECT HIV Ag/Ab Combo detects HIV in its acute stage—up to 20 days sooner than antibody-only tests.

 
 
 

Intended Use and Important Safety Information

For In Vitro Diagnostic Use

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 to be used 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 as an aid in the diagnosis of HIV-1/HIV-2 infection in pediatric subjects (i.e., children as young as two years of age) and in pregnant women.

An ARCHITECT HIV Ag/Ab Combo reactive result does not distinguish between the detection of HIV-1 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. The effectiveness of ARCHITECT HIV Ag/Ab Combo for use in screening blood or plasma donors has not been established. However, this assay can be used as a blood donor screening assay in urgent situations where traditional licensed blood donor screening tests are unavailable or their use is impractical.

IMPORTANT SAFETY INFORMATION: Assay results should be interpreted in conjunction with the patient’s clinical presentation, history, and other laboratory results. If the results are inconsistent with clinical evidence, additional testing is suggested to confirm the result. The performance of this assay has not been established for individuals younger than two years of age.

CAUTION: United States Federal law restricts this device to sale and distribution by or on the order of physician, or to a clinical laboratory.

For complete information, see the assay specific package insert on www.abbottdiagnostics.com.

Quick Facts References:

1. Schacker et al. Clinical Epidemiologic Features of Primary HIV Infection. Ann Intern Med. 1996;125:257-264

2. Branson, J Acquir Immune Defic Synd Vol. 55, Supplement 2, December 15, 2010
    Infectious Disease Market Monitor 2010

3. HIV in the United States* http://www.cdc.gov/hiv/resources/factsheets/us.htm Accessed on 1/26/12
    Marks, et al. AIDS 2006; 20: 1447-5

4. HIV in the United States* http://www.cdc.gov/hiv/resources/factsheets/us.htm Accessed on 1/26/12
    Marks, et al. AIDS 2006; 20: 1447-5