Blood test for early detection of HIV infection Architect HIV Ag/Ab Combo assay under review in US

A blood test for early detection of HIV infection by identifying both antibody and antigen of the virus – Architect HIV Ag/Ab Combo assay – may soon be available in the United States, Abbott said.

Abbott has submitted a premarket approval application for the Architect HIV Ag/Ab Combo assay to the U.S. Food and Drug Administration for expedited review.

Architect HIV Ag/Ab Combo assay is expected to be the first test available in the United States to simultaneously detect the combined presence of HIV antigens (proteins produced by the HIV virus) and antibodies (proteins produced by the body to fight HIV antigens).

The new Architect HIV Ag/Ab Combo assay would allow for the early detection and ongoing monitoring of the virus, Abbott announced in a press release.

Architect HIV Ag/Ab Combo assay is designed for the simultaneous qualitative detection of human immunodeficiency virus (HIV) p24 antigen and antibodies to HIV type 1 (HIV1 group M and group O) and/or type 2 (HIV-2) in adult and pediatric serum and plasma.

Antibody-only tests fail to identify up to 10 percent of HIV infections in some high-incidence populations, studies conducted by researchers in the United States, including the Centers for Disease Control and Prevention (CDC), showed.

However, the detection of the HIV p24 antigen enables laboratories to diagnose HIV infection before HIV antibodies are able to be detected.

Therefore, a combined antibody and antigen test holds considerable promise for HIV screening and could assist in detecting infections before antibodies can be identified.

“The potential to diagnose HIV in the acute phase of the disease when antibodies are not yet present would be an important development in the fight against HIV,” said Michael Warmuth, senior vice president, diagnostics, Abbott.

The earlier a patient can be diagnosed, the sooner the patient can be placed into care and the better chance there is to stop further spread of the virus, he added.

Architect HIV Ag/Ab Combo assay was approved for use in Europe in 2004.

Architect HIV Ag/Ab Combo assayis intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection.

The test is also intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection in pregnant women.

Architect HIV Ag/Ab Combo assay, however, cannot be used in screening blood, plasma or tissue donors, the Abbott release stated.

The effectiveness of Architect HIV Ag/Ab Combo assay for use in screening blood, plasma or tissue donors has not been established.

The assay result does not distinguish between the detection of HIV p24 antigen, HIV-1 antibody, or HIV-2 antibody.

There are 56,000 new cases of HIV in the United States annually, according to the CDC estimates.

In 2008, UNAIDS estimated that 2.7 million people throughout the world are newly infected with HIV each year.

Leading risk factors for HIV infection include male-to-male sexual contact, high-risk heterosexual contact and intravenous drug use.

Abbott Diagnostics Businesses is a global leader in in vitro diagnostics and offers a broad range of instrument systems and tests for hospitals, reference labs, molecular labs, blood banks, physician offices and clinics.

Abbott has been doing research in HIV/AIDS since the early years of the epidemic.

In 1985, the company developed the first licensed test to detect HIV antibodies in the blood and has marketed more than 20 HIV tests on six testing platforms to meet the unique customer needs in the United States and internationally.

Abbott has also developed two protease inhibitors for the treatment of HIV.