Abbott has announced it is seeking premarket approval for its Architect HIV Ag/Ab Combo assay from the US Food and Drug Administration (FDA) for expedited review.
If approved, the assay is expected to be the first test available in the US that can simultaneously detect the combined presence of HIV antigens and antibodies, which would allow for much earlier detection and ongoing monitoring of the virus.
Studies conducted by US researchers, including the Centers for Disease Control and Prevention (CDC), show that antibody-only tests fail to identify up to 10% of HIV infections. A combined antibody and antigen test, however, will allow laboratories to diagnose HIV infections before HIV antibodies can be detected.
Abbott senior vice-president of diagnostics Michael Warmuth said that the potential to diagnose HIV in the acute phase of the disease when antibodies are not yet present is an important development.
“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,” Warmuth said.
The Architect assay was approved for use in Europe in 2004, and is an investigational device in the US.