Every nine and a half minutes, someone in the United States is infected with HIV, and one out of every five of these individuals doesn't know it. To help stem the spread of this disease, FDA approved an innovative new diagnostic tool, which will allow patients to be diagnosed earlier than ever before.

Abbott's Architect HIV Ag/Ab Combo assay is the first test approved in the United States that can simultaneously detect both HIV antigen and antibodies. HIV antigen is a protein produced by the virus immediately after infection, whereas antibodies are developed days later as the body works to fight off the infection. 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.

Studies conducted by CDC show that current antibody-only tests miss up to 10 percent of HIV infections in some high-risk populations because they do not detect antigens. However, Abbott’s new assay detects the HIV p24 antigen, or the direct presence of HIV, allowing for diagnosis of early infections days before antibodies emerge.

This new test will run on Abbott's ARCHITECT family of diagnostic testing instruments. It is already approved for use outside the United States. In Europe, HIV antigen-antibody combination testing is routine in public health settings and HIV testing guidelines in the United Kingdom now direct clinicians to use the HIV combination test as the first-line test.