Rapid HBsAg Test

Hepatitis B virus (HBV) is an enveloped; double- stranded DNA virus belonging to the Hepadnaviridae family and is recognized as the major cause of blood transmitted hepatitis together with hepatitis C virus (HCV). Infection with HBV induces acute or chronic liver diseases and in some cases that can lead to cirrhosis and carcinoma of the liver. Hepatitis B surface antigen or HBsAg, which was previously described as Australia antigen is the most important protein of the envelope of Hepatitis B Virus. The surface antigen contains the determinant “a”, common to all known viral subtypes, immunologically distinguished in two distinct subgroups (ay and ad). HBV has 10 major serotypes and four HBsAg subtypes have been recognized (adw, ady, ayw, and ayr). HBsAg can be detected 2 to 4 weeks before the ALT levels become abnormal and 3 to 5 weeks before symptoms develop.

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Product Description

Producer:

Xiamen Boson Biotech Co., Ltd

Country of production:

China

Article:

1H01S2, 1H01C2

Brief description:

Hepatitis B virus (HBV) is an enveloped; double- stranded DNA virus belonging to the Hepadnaviridae family and is recognized as the major cause of blood transmitted hepatitis together with hepatitis C virus (HCV). Infection with HBV induces acute or chronic liver diseases and in some cases that can lead to cirrhosis and carcinoma of the liver. Hepatitis B surface antigen or HBsAg, which was previously described as Australia antigen is the most important protein of the envelope of Hepatitis B Virus. The surface antigen contains the determinant “a”, common to all known viral subtypes, immunologically distinguished in two distinct subgroups (ay and ad). HBV has 10 major serotypes and four HBsAg subtypes have been recognized (adw, ady, ayw, and ayr). HBsAg can be detected 2 to 4 weeks before the ALT levels become abnormal and 3 to 5 weeks before symptoms develop.

Appointment:

Qualitative detection of Hepatitis B virus surface antigen (HBsAg) in human serum, plasma or whole blood specimen.

Materials provided:

1. Rapid HBsAg Test.
2. Instruction for use.

Materials required but not provided:

1. Whole blood or plasma: Vacutainer tube, or other appropriate tube, containing heparin or EDTA as an anticoagulant
2. Serum: Vacutainer tube, or other appropriate tube, without anticoagulant
3. Timer or clock

Clinical Sensitivity

The results of the HBsAg Test in total of 1048 samples (345 ELISA confirmed positive specimens and 703 ELISA confirmed negative specimens) showed the sensitivity was 100%.

Clinical Specificity

The results of the HBsAg Test in total of 1048 samples (345 ELISA confirmed positive specimens and 703 ELISA confirmed negative specimens) showed the specificity was 99.1%.

Cross Reactivity

No cross reactivity was observed with specimens from patients infected with HAV, HCV, HEV and RF.

Interference

No interference was found with bilirubin (240 μmol/L), hemoglobin (9 g/L) or triglycerides (25 mmol/L) on the sensitivity and specificity of the test.

Sample type

whole blood / serum / plasma

Delivery

Implemented by Nova Poshta. If the order is above 1500 UAH, the sender pays the shipping cost

Instructions for use (PDF) Certificate of Compliance (PDF) Declaration of Conformity (PDF)