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U.S. Department of Health and Human Services

Medical Devices

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Hepatitis C

What does this test do? This is a home-use collection kit to determine if you may have a hepatitis C infection now or had one in the past. You collect a blood sample and send it to a testing laboratory for analysis.

What is hepatitis C infection? Hepatitis C infection is caused by the hepatitis C virus (HCV). Untreated, hepatitis C can cause liver disease.

What type of test is this? This is a qualitative test -- you find out whether or not you may have this infection, not how advanced your disease is.

Why should you do this test? You should do this test if you think you may have been infected with HCV. If you are infected with HCV, you should take steps to avoid spreading the disease to others. At least 8 out of 10 people with acute hepatitis C develop chronic liver infection, and 2 to 3 out of 10 develop cirrhosis. A small number of people may also develop liver cancer. Hepatitis C infection is the number 1 cause for liver transplantation in the US.

When should you do this test? The Centers for Disease Control (CDC) recommend that you do this test if you:

  • have ever injected illegal drugs,
  • received clotting factor concentrates produced before 1987,
  • were ever on long-term dialysis,
  • received a blood transfusion before July 1992,
  • received an organ transplant before July 1992, or
  • are a health care, emergency medicine, or public safety worker who contacted HCV-positive blood through needlesticks, sharps, or mucosal exposure.

How accurate is this test? This test is about as accurate as the test your doctor uses, but you must carefully follow the directions about getting the sample and sending it the testing laboratory. Proper sample collection is important for obtaining accurate results.  Researchers found that about 90 of 100 home users were able to obtain acceptable samples to send to the laboratory. After the laboratory got these 90 samples, it could get results for about 81 of them. Of these 81 samples, the laboratory got correct results in 77 and incorrect results in 4.

Does a positive test mean you have HCV? If you have a positive test, you either are infected with HCV now or you have been infected with HCV in the past. You need to see your doctor to find out if you have an active infection and what therapy you should have. Some people who become infected with HCV develop antibodies and then are no longer infected.

If your test results are negative, can you be sure that you do not have HCV infection?  A negative test does not guarantee that you don't have HCV infection since it takes some time for you to develop antibodies after you are infected with this virus. If you think you were exposed to the virus and might be infected, you should see your doctor for a more accurate laboratory test.

How do you do this test? The test kit comes with a small piece of filter paper, a lancet, and instructions for obtaining a blood sample and placing it on the filter paper. You first prick your finger with the lancet to get a drop of blood. Then, you put your drop of blood on a piece of filter paper and send it in a special container to the testing laboratory. You get the results of your test by phone from the laboratory. The laboratory does a preliminary (screening) test that separates the samples into three groups

  • Samples that are clearly positive,
  • Samples that might be positive, and
  • Samples that are negative.

All samples that "might be positive" receive a more specific (confirmatory) test to find those that are truly positive. All the "clearly positives" from the preliminary test and the "truly positives" from the more specific test are reported to you as positive.

You should note that a positive result does not mean that you are infected with HCV. If you receive a positive result from this test, you should see your doctor for further testing and information.