The Food and Drug Administration has approved the first over-the-counter (OTC) blood collection kit for testing for antibodies to hepatitis C virus (HCV). HCV is spread primarily through contact with infected blood. Many people have the disease long before it is detected and it is a major cause of liver damage.

The kit: the Hepatitis C Check manufactured by Home Access Health: contains instructions for use, the personal identification number, a lancet for obtaining a drop of blood, filter paper and a mailer. 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 counsellor.

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 currently active. 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 counselling about HCV and, if desired, referral to a physician.

HCV, one of the most serious of five currently identified types of hepatitis virus, 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 behaviour with an HCV- infected person.

In 1998 the US Public Health Service announced a look-back programme designed to identify chronic carriers of HCV so that they can receive treatment and counselling. 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.

Reference: FDA Talk Paper T99-20, dated 29 April 1999.