Today the FDA approved Abbott's ARCHITECT HIV Ag/Ab Combo assay, the first test approved in the United States that can simultaneously detect both HIV antigen and antibodies. Whereas current tests only detect antibodies produced by the body days after infection in response to the virus, the combo assay recognizes the p24 antigen, a protein produced by the virus immediately after infection. According to Abbott, “studies have demonstrated that Abbott’s new test may detect HIV days earlier than antibody-only tests, which is important in controlling the spread of the virus.” The ARCHITECT HIV Ag/Ab Combo assay is already used regularly in Europe and testing guidelines in the United Kingdom recently made the combo assay the first-line test.
We welcome the thoughts of members of the community about this new development and the combo assay in general. Given that individuals are highly infectious immediately after HIV acquisition, and that CDC studies show that current antibody-only tests miss up to 10 percent of infections by not detecting antigens, what are the implications of the combo assay for HIV control?
Do you think this test will become widely used in resource-limited settings? Has it already? Will the cost be prohibitive? If the combo assay does make it to resource-limited settings, what policies and strategies would best leverage its unique ability to detect infection early in global efforts to control the spread of HIV?
For the full press release, please see: http://www.abbott.com/global/url/pressRelease/en_US/60.5:5/Press_Release_0875...