A confirming test for HIV that uses saliva and other oral fluids instead of blood is nearing approval by the Food and Drug Administration, a company that makes the test announced on Tuesday.
The company, Epitope Inc., said that it had received a letter from the FDA announcing that the firm’s application to market the HIV test was “approvable.”
An FDA spokesman declined to verify that such a letter had been sent to Epitope, but explained that in the normal process of agency action, such a letter was “tantamount to approval, provided the company meets the requests contained in the approvable letter.”
Epitope last year received approval to market an oral specimen HIV test through health care providers. That test uses a treated cotton pad placed between the gum and cheek to collect oral fluid. The pad is then placed into a container with a preservative and sent to a laboratory for an enzyme-linked immunosorbent assay, or ELISA test, which can detect antibodies to HIV.
The test detects antibodies, not the virus itself. HIV usually is not found in saliva.
Positive results from the ELISA test are confirmed with the more sensitive Western blot blood test.
Now Epitope is seeking permission to market a Western blot test that also uses oral fluids instead of blood.