© 1999 by Oxford University Press
Journal of the National Cancer Institute, Vol. 91, No. 11, 908,
June 2, 1999
© 1999 Oxford University Press
NEWS |
At Home HCV Test Gains FDA Approval
The first over-the-counter test of its kind, called "Hepatitis C Check," has been approved by the U.S. Food and Drug Administration. It is made by the Home Access Health Company of Hoffman Estates, Ill., and will be sold nationwide at pharmacies in the United States.
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With the kit, users will collect a sample of their blood on filter paper and send it to a designated laboratory for analysis. Unless a person has contracted HCV within the last 6 months, which can be too soon for there to be antibody formation, the test will detect whether there has ever been an HCV infection.
Purchasers of the kit will get a unique number so that they can obtain the results anonymously when they call an automated phone system or, if they prefer, get them from a health care counselor, a service that will be provided without extra charge. That service will also include further education and counseling about HCV and referral to a physician, if desired.
The company does not now plan to market the kit outside the United States.
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