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Medical News

OraSure Gets OK for Hepatitis Test

June 29, 2010

The U.S. Food and Drug Administration announced Friday it has approved the first rapid-result blood test for the hepatitis C virus. The test is manufactured by OraSure Technologies, which already has approval to sell it in Europe. FDA approved the OraQuick Hepatitis C Rapid Antibody Test for the testing of whole blood drawn from a vein of patients age 15 and older. Unlike existing HCV tests, the OraQuick test strip delivers results in 20 minutes and does not need to be processed by a laboratory. "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," said Jeffrey Shuren, M.D., J.D., director of FDA's Center for Devices and Radiological Health. "Getting faster treatment is an important public health step to control this dangerous disease." The new test should begin shipping to hospitals and other customers by late July or early August, said OraSure CEO Douglas Michels. The company continues to seek approval for similar HCV tests using finger-prick blood samples and oral fluid. To read FDA's announcement, visit

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Reader Comments:

Comment by: AIDS/STD Counseling (Germany) Mon., Jul. 5, 2010 at 9:11 am EDT
Important to know is, that in contrary to HIV-Tests the diagnostic window-period for HCV-antibodies is very broad.
This means, only a reactive result is meaningfull, a "no antibodies detected"-result does not mean for sure that there is no Hepatitis C in the body.
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Comment by: Dan Speers (Boston, MA) Fri., Jul. 2, 2010 at 9:31 am EDT
I am hoping home testing kits for both HCV and HIV become available soon as these will make it eaasier for some people to both admit and accept the fact that they need to be tested.

I have spoken to many people, especially men over 55 who have recently begun taking ED meds and discovered a latent if not chemical bisexuality, a group that was not intimately involved with the initial spread of HIV-AIDs and the need for safe sex beginning in the late '80s, and they are very resistant to going to clinics or even their own doctors for testing.

Many either ignore the dangers or do not believe it could happen to them. Many are married and don't want their wives to know their new sexual inclinations, thus putting their wives at risk as well. Many also feel that even opening up to a nurse or a doctor will bring their own manhood into question.

Still, I have sensed fear in these men. I suspect they really do want to know. And if a home test was available that was reactive, I think it would encourage most of these to seek professional help--especially if it involved drugs or medications that would extend their lives.

Home testing, with home results, packaged with well-written, sympathetic literature that describes support, assistance and provides information on help, medicines, support groups and dealing with chronic disease, could expose more individuals to the opportunity of finding assistance and controlling these diseases.
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