First Test to Detect Both HIV Antigen and Antibodies

FDA recently approved the first diagnostic test that simultaneously detects HIV antigen and antibodies. The test, called the ARCHITECT HIV Ag/Ab Combo assay, is made by Abbott Laboratories.

Most tests that are presently used in diagnostic settings only detect antibodies to HIV. The new test is more sensitive in detecting HIV infection, because it actually detects the p24 antigen of the virus. That means it can help diagnose HIV infection before antibodies appear in the blood. The test is approved for use with adults, including pregnant women, as well as children as young as two years old.

The test can be used in clinical and public health labs. It should not be used for routine screening of blood donors, except in urgent situations where licensed screening tests aren't available, or using them is impractical.