New HIV Test Approved

On June 21, 2010, the FDA approved a new blood test that detects both HIV antigen and HIV antibodies within a single specimen, thus enabling, for the first time in the U.S., the diagnosis of acute as well as chronic HIV infection. The Architect HIV Ag/Ab Combo assay can detect the p24 antigen days before HIV antibodies emerge, whereas most other diagnostic HIV tests detect only antibodies.

Notably, the test requires a substantial laboratory infrastructure that has the test platform equipment in place (which may limit its immediate use in public health clinics). Furthermore, the new test does not distinguish between acute and chronic infection (i.e., a reactive result simply indicates infection), and it is not a point-of-care rapid test. Howe…