Detection Kit for Hepatitis B Surface Antigen (Colloidal Gold)

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【INTENDED USE】

   The HBsAg Rapid Test is a colloidal gold immunochromatography assay for direct qualitative detection of Hepatitis B type virus surface antigen (HBsAg) in human whole blood, serum or plasma.

 

【Performance Characteristics】

1. Sensitivity

    3 subtypes(adr,adw,ay) could be detected by our national reference standard. The lowest detection of adr subtype is 1.0 ng/ml The lowest detection of adw subtype is 2.0 ng/ml The lowest detection of ay subtype is 2.0 ng/ml The positive reference and negative reference coincidence rate and specificity comply to national standard.

2. Specificity

   The cholesterol concentration(lower than 7.6 g/L) in sample would not inflect the result. The triglyceride concentration(lower than 9.5 g/L) in sample would not inflect the result The bilirubin concentration(lower than 190 mg/L) in sample would not inflect the result The test device will not appear cross-reaction with HCV, HIV and TB.