Cleartest HCV

The CLEARTEST® HCV in cassette form is a rapid chromatographic immunoassay for the qualitative detection of antibodies against the hepatitis C virus in human whole blood, serum or plasma.

Hepatitis C is a liver disease caused by the hepatitis C virus (HCV) that leads to acute and chronic infections. The hepatitis C virus (HCV) is a small, enveloped, single-stranded RNA virus with positive polarity. HCV is now considered the main cause of parenterally transmitted non-A non-B hepatitis. Antibodies to HCV are found in over 80 % of patients with well-documented non-A-non-B hepatitis. An estimated 71 million people worldwide had chronic hepatitis C infection in 2015.

Conventional methods cannot isolate the virus in cell cultures or visualise it by electron microscopy. Cloning the viral genome enables the development of serological assays that use recombinant antigens. Compared to first-generation HCV EIAs that use a single recombinant antigen, new serological assays have added multiple antigens with recombinant proteins and/or synthetic peptides to avoid non-specific cross-reactivity and increase the sensitivity of HCV antibody tests.

The test uses colloidal gold conjugate and recombinant HCV proteins to selectively detect antibodies to HCV in whole blood, serum or plasma. The recombinant HCV proteins used in the test kit are encoded by structural (nucleocapsid) and non-structural protein genes.

Performance characteristics

Sensitivity, specificity and accuracy

HCV rapid test

• Sensitivity: 100 % (95-% CI*: 99.4 %-100 %)
• Specificity: 100 % (95-% CI*: 99.8 %-100 %)
• Accuracy: 100 % (95-% CI*: 99.9 %-100 %)

3 step procedure (sample collection, preparation, testing)

Test evaluation after 10 minutes

Can be performed with whole blood, serum or plasma

Store sealed bag at room temperature or refrigerated (2 - 30 °C). Do not freeze.