FDA Okays Finger Stick for Hep C Test

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FDA Okays Finger Stick for Hep C Test

By Cole Petrochko, Staff Writer, MedPage Today

Published: February 23, 2011

WASHINGTON -- The FDA has approved the use of blood obtained through a finger

stick for a hepatitis C virus (HCV) test.

The OraQuick HCV Rapid Antibody Test was initially approved in June 2010 for use

with a venous whole blood sample.

The device is the only point-of-care detection device for hepatitis C with FDA

approval, according to a statement from maker OraSure Technologies.

" By eliminating the need for a blood draw, healthcare providers will be able to

identify more individuals infected with hepatitis C and get them into care, "

A. Michels, president and CEO of OraSure, said in the statement.

Blood samples are mixed in a buffer and sampled by the machine, which reads out

whether the blood is reactive or nonreactive on the device face. The test takes

approximately 20 to 40 minutes to analyze for hepatitis C with 99% accuracy.

Approximately 4.1 million Americans are or have been infected with HCV. New

infections are estimated at about 20,000 per year.