Hot on the heels of approving the first rapid HIV antigen and antibody combo test, the FDA announced today the approval of the first rapid hepatitis C virus (HCV) test.

The OraQuick HCV Rapid Antibody Test is a simple point-of-care test for diagnosis of HCV infection. The user swabs the mouth to collect a sample and places the device into a buffer solution. The results appear 20-40 minutes later. Akin to a pregnancy test, the test strip shows a faint bar representing the “control” and a possible second bar indicating a “positive” result. The test kit is portable and for one-time use only; there are no laboratory instruments needed.

The OraQuick HCV Rapid Antibody Test is produced by OraSure Technologies, the same manufacturer of the OraQuick Advance HIV-1/2 Antibody Test used in clinics and emergency departments for the rapid detection of HIV. Similar to its HIV counterpart, the OraQuick HCV test is unable to detect early HCV infections prior to the development of antibodies (the recently approved HIV combo assay mentioned above addresses this limitation). The HCV test is also not approved for screening of the general population.

Although a key advantage of the test will be more rapid identification of HCV-infected individuals, particularly among those without primary care providers, it is unclear whether this will reduce the time between infection to initiation of treatment (compared to those diagnosed via traditional methods). Current hepatitis C therapy is difficult to tolerate and requires a 24- to 48-week commitment. Before drugs are even initiated, there are hurdles of persuading the patient to undergo the arduous therapy, demonstrating compliance, and securing financial (insurance) authorization. I suppose it would be interesting to study how much the rapid HCV antibody test will eventually influence clinical outcomes.