The FDA recently approved the use of blood obtained from a finger stick for a hepatitis C virus (HCV) test, potentially enabling health care providers to identify more individuals who have the infection, more quickly.
OraQuick HCV Rapid Antibody test first received FDA approval in June 2010 for use with venous whole blood samples in individuals aged 15 years and older who are at high risk for infection.
The test takes approximately 20 to 40 minutes to diagnose HCV and is 99% accurate. Blood samples are mixed in a buffer and sampled by the machine, which then indicates whether the blood is reactive or nonreactive on a display face.
“Approval of OraQuick means that more patients can be notified of their HCV infection faster so that they can consult with their physicians for appropriate health measures,” director of the FDA’s Center for Devices and Radiological Health Jeffrey Shuren, MD, JD, said in a press release.
The CDC estimates that about 20,000 people become newly infected with HCV each year, and approximately 4.1 million Americans currently are, or have been infected with the disease.