The TestGene company has received a medical device registration certificate for the “HEPA-C-test-Q” kit for quantitative detection of the hepatitis C virus RNA.

The test system is used for determination of the viral load, choosing the appropriate therapy, monitoring the effectiveness of the treatment, and prediction of the course and outcome of the disease. This is especially important because the hepatitis C infection is one of the main causes of cirrhosis and liver cancer.

The hepatitis C virus can elude the immune system and stay in the body for a long time, it has a high mutational variability. In this connection, highly conserved genome regions are used as targets for detection of the hepatitis C virus RNA in the “HEPA-C-test-Q” kit.

Determination of the virus concentration in blood (plasma) allows to judge the replication of the virus in the body and serves as one of the criteria for the effectiveness of the antiviral therapy. An 85% decrease in the viral RNA concentration within a few days (often the reference point is 3 days) after starting the therapy indicates a favorable prognosis of the treatment.

Informative, highly specific test system "HEPA-C-test-Q" significantly saves labor, time and material resources of the laboratory. The material for the assay is plasma or whole peripheral blood. The test system is compatible with all open-type amplifiers (with 2 detection channels).
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