This medical device was FDA approved on June 25, 2010. The medical device is used to detect hepatitis C virus (HCV). It works by detecting if a patient has been exposed to the hepatitis C virus. If this is the case the body elicits an immune response and produces antibodies to fight off the virus. The test allows clinicians to determine if the antibodies are present in the blood.
The medical device works by attaching themselves to the antibodies – a chemical reaction causes the test strip to change color indicating the presence.
False positives should be verified with other tests to rule out error.
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