FDA Approves First Home Test for Hepatitis C Virus
April 29, 1999
FDA has approved the first over-the-counter blood collection kit for testing for antibodies to hepatitis C virus (HCV), the nation's most common blood-borne infection and a major cause of liver damage.
With the kit, which does not require a prescription, the user collects a sample of blood at home and mails it to a designated laboratory for analysis. The results are available anonymously by phone through a unique identification number.
HCV is spread primarily through contact with infected blood. It is responsible for 8,000 to 10,000 deaths in the United States annually. Many people have the disease long before it is detected.
The kit -- the Hepatitis C Check, made by Home Access Health Company of Hoffman Estates, Ill. -- contains instructions for use, the personal identification number, a lancet for obtaining a drop of blood, filter paper and a mailer. The user collects a blood sample on the filter paper and sends it to the laboratory. The lab tests the sample with a FDA-licensed test for antibodies to HCV and confirms any positive sample with a different FDA-licensed test for antibodies to HCV.
The results are available four to 10 business days from receipt of the blood sample and can be obtained anonymously by phone from an automated system or from a healthcare counselor.
The test shows whether a person has ever contracted the hepatitis C virus, unless he was exposed in the previous six months, which may be too early for the test to detect. However, it does not show whether the infection is active now. This must be determined by a physician with additional testing and evaluation of the individual.
As part of the test system, Home Access Health provides a telemedicine service, which offers education and counseling about HCV and, if desired, referral to a physician.
Approval of the collection kit was based on clinical studies to determine safety and effectiveness conducted by the manufacturer.
Home Access Health tested the product in approximately 1,200 people. Study participants used the collection kit and also had their blood obtained twice -- by a finger stick and from their vein -- by a healthcare professional.
The study showed that, when the home user collected an adequate sample of blood, the test results were similar to test results for blood that was drawn by a healthcare professional.
Hepatitis affects some 4 million Americans in its chronic form. HCV is one of five currently identified hepatitis viruses -- A, B, C, D, and E -- all of which can attack and damage the liver. HCV, one of the most serious of the five, can cause cirrhosis (irreversible and potentially fatal liver scarring), liver cancer, or liver failure. Hepatitis C is the major reason for liver transplants in the United States.
Individuals at high-risk for acquiring hepatitis C include those who: received blood transfusions or organ transplants prior to 1992 before the blood supply could be reliably screened for the virus; inject illegal drugs; get pricked with an infected needle; or engage in high-risk sexual behavior with an HCV-infected person.
Last year, the U.S. Public Health Service announced a look-back program designed to identify chronic carriers of HCV so they can receive treatment and counseling. The plan includes a direct notification effort to reach people who received a blood transfusion from a donor, mostly before 1992, who later tested positive for HCV, and an education effort directed at all people at risk for hepatitis C.
This article was provided by U.S. Food and Drug Administration. Visit the FDA's website to find out more about their activities and publications.