Abbott has submitted a Premarket Approval (PMA) application for the Architect HIV Ag/Ab Combo assay to the FDA for expedited review. Upon approval, the assay is used 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 company claims that the studies conducted by researchers in the US, including the Centers for Disease Control and Prevention (CDC), showed that antibody-only tests fail to identify up to 10% of HIV infections in some high-incidence populations.
However, the detection of the HIV p24 antigen enables laboratories to diagnose HIV infection before HIV antibodies are able to be detected. A combined antibody and antigen test holds considerable promise for HIV screening and could assist in detecting infections before antibodies can be identified.
The Architect assay was approved for use in Europe in 2004, and is currently an investigational device in the US. The US submission comes as Abbott marks the 25th year since the company developed the first FDA approved test for HIV.
Michael Warmuth, senior vice president of diagnostics at Abbott, said: “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. 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.”