HIV Detective: ARCHITECT HIV Ag/Ab combo catches HIV even earlier

Abbott Laboratories announced on June 21st that it received FDA approval for the ARCHITECT HIV Ag/Ab Combo assay, shown in studies to simultaneously detect both antigens and antibodies in individuals infected with HIV.

The HIV virus produces a protein in the body, called an antigen, immediately after transmission. Production of this antigen then triggers the body’s immune system to create antibodies to fight the infection.  Most current HIV testing methods detect only the antibodies’ existence, which take an average of 25 days to develop after exposure to the HIV virus.

Although rare, it can take up to six months for antibodies to HIV to develop.

It makes perfect sense that early detection of any disease is ideal, as it affords the ability to choose the most effective, efficient course of treatment.

Early detection of HIV is especially important because:

  • A person infected with HIV is most infectious immediately after becoming infected themselves
  • The U.S. reports 56,000 new cases of HIV annually
  • 20% of those infected with HIV are unaware of their HIV status (that’s 11,200 people per year!)
  • It is believed that undetected HIV infections are a significant cause of HIV transmission
  • Behavioral changes and proper medical treatment offer greatly improved long-term health projections and life expectancy for people living with HIV

CDC studies show that current antibody-only tests, as a result of not detecting the HIV virus until the body produces antibodies, overlook about 10% of HIV infections in some high-risk populations.

Currently, the only other FDA-approved HIV test that identifies HIV infections prior to antibody development requires costly technology not widely used in diagnostic laboratories.  By detecting the HIV virus directly several days to weeks before antibodies begin to develop, the ARCHITECT HIV Ag/Ab Combo assay will help patients get proper care for HIV as soon as possible.

The ARCHITECT HIV Ag/Ab Combo assay is also the first test approved by the FDA for use by pregnant women, which, if promptly administered, can help reduce transmission of the HIV virus during pregnancy.  Additionally, babies diagnosed as HIV positive are often not identified to a degree of certainty until 18 months of age, as they carry HIV antibodies from their mother regardless of their own HIV status.

Use of the ARCHITECT HIV Ag/Ab Combo assay is approved in pediatric patients to effectively diagnose HIV by identifying HIV antigens and distinguishing the virus’ antigens from the virus’ antibodies.

The ARCHITECT HIV Ag/Ab Combo assay is expected to be available by the end of 2010, and will have a comparable cost to current standard HIV tests.

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