Cleartest HAV IgG/IgM

The CLEARTEST® HAV IgG/IgM Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies against hepatitis A virus (HAV) in whole blood, serum or plasma samples. The test is intended for professional in vitro diagnostic use only.

HAV is an RNA virus of positive polarity, a unique member of Picornavirdae. Its transmission depends primarily on serial person-to-person passage by the faecal-oral route. Although hepatitis A is not normally a sexually transmitted disease, the rate of infection among male homosexuals is high, due to oral-anal contact.

The test is based on proprietary technology and combines the principles of immunochromatography and fluid dynamics.

Performance characteristics

Sensitivity, specificity and accuracy

HAV IgG/IgM rapid test

IgG results:

• Sensitivity: 97.9 % (95 % CI*: 95.5 %-99.0 %)
• Specificity: 99.1 % (95 % CI*: 97.3 %-99.8 %)
• Accuracy: 98.4 % (95 % CI*: 97.2 %-99.2 %)

IgM results:

• Sensitivity: 95.7 % (95 % CI*: 90.2 %-98.6 %)
• Specificity: 99.1 % (95 % CI*: 98.0 %-99.7 %)
• Accuracy: 98.6 % (95 % CI*: 97.4 %-99.3 %)

3-step procedure (sample collection, preparation, testing)

Test evaluation after 15 minutes

Can be performed with whole blood, serum or plasma

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