Rapid hbsag infectious disease test kits

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INTENDED USE One Step HBsAg Serum Test is a rapid one step membrane-based immunodiagnostic assay designed for qualitative determination of hepatitis B surface antigen (HBsAg) in human serum. PERFORMANCE CHARATERISTICS One Step HBsAg Serum Test can detect HBsAg at concentration as low as 1ng/ml (including both ad and ay subtype). Clinical studies have been carried out to determine the correlation of the One Step HBsAg Test to EIA and RIA tests: Table-1: Comparison with EIA (1070 specimens) EIA Positive EIA Negative Positive 356 8 Negative 4 702 Total 360 710 Sensitivity = 98.89 % (356/360) Specificity = 98.87 %(702/710) Predictive value of a positive test = 97.80 %(356/364) Table-2: Comparison with RIA (493 specimens) RIA Positive RIA Negative Positive 138 2 Negative 0 353 Total 138 355 Sensitivity = 100.00 %(138/138) Specificity = 99.43 % (353/355) Predictive value of a positive test = 98.57 % (138/140)

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AccuBioTech Co.,Ltd

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