Rapid Hepatitis C Testing Now Available

The Food and Drug Administration (FDA) has just approved a rapid test to detect hepatitis C infection. This test, called OraQuick HCV Rapid Antibody Test, utilizes whole blood from a venous blood draw to generate a test result within 20 minutes. It does not require an instrument for diagnosis.

Orasure Technologies, the manufacturer of the test, hopes to receive FDA approval of the test version that utilizes oral fluid or whole blood from a fingerstick. This will make the test more palatable for individuals put off by a venous blood draw. The test is already approved in Europe for use with oral fluid and whole blood from a fingerstick.

In any case, this is a marked step forward in the fight to identify the many individuals who are unknowingly infected with hepatitis C. According to the Centers for Disease Control and Prevention, there are approximately 3.2 million people in the United States chronically infected with HCV and each year, about 17,000 people are newly infected. It is speculated that the majority of the 3.2 million individuals are unaware of their infection status. Earlier detection can lead to better treatment outcomes. Hepatitis C is a major cause of liver disease, leading to 12,000 deaths annually in the United States.

With more than 350 million people chronically infected with hepatitis B, it is hoped that progress can be made in developing rapid testing for hepatitis B as well. In the United States, an estimated 1.25 million individuals are infected with hepatitis B. The majority of these individuals are Asian Americans and Pacific Islanders and, as with hepatitis C, most individuals are unaware of their infection status.

-Doug Hirano, MPH, APCA Executive Director