Cleartest HBsAg

Cleartest HBsAg

Performance characteristics

Sensitivity, specificity and accuracy

HBsAg rapid test

Sensitivity: 99.87 % (95 % CI*: 99.28 % -> 99.99 %)

Specificity: 99.86 % (95 % CI*: 99.63 % - 99.96 %)

Accuracy: 99.86 % (95 % CI*: 99.67 %-99.95 %)

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

Test evaluation after 15 minutes

Can be carried out with whole blood, serum or plasma

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

The CLEARTEST® HBsAg Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of hepatitis B surface antigen in human whole blood, serum or plasma to aid in the diagnosis of HBsAg infection. The detection limit is 500 ng/ml.

The product is intended for use by trained laboratory personnel.

Viral hepatitis is a systemic disease that mainly affects the liver. Most cases of acute viral hepatitis are caused by the hepatitis A virus, the hepatitis B virus (HBV) or the hepatitis C virus. The complex antigen on the surface of HBV is called HBsAg. In the past, this was called the Australia antigen or the Au antigen, among other names. In a typical hepatitis B infection, chronic HBV infection is defined as either the presence of HBsAg in serum for at least 6 months or the presence of HBsAg in a person who has tested negative for immunoglobulin M antibodies to the hepatitis B core antigen. Unlike individuals who recover from acute HBV infection, individuals with chronic HBV infection do not develop anti-HBs, and HBsAg typically persists for decades. The presence of HBsAg in the serum indicates that the patient has contracted HBV infection. HBsAg is divided into the four main subtypes adw, ayw, adr and ayr. Due to the antigenic heterogeneity of the determinant, there are 10 major serotypes of the hepatitis B virus.

The CLEARTEST® HBsAg rapid test works with a combination of monoclonal and polyclonal antibodies and provides selective detection of elevated HBsAg levels in whole blood, serum or plasma.