INTENDED USE
One Step HBsAg Whole Blood Test is a rapid, immunochromatographic assay for the qualitative detection of Hepatitis B Surface Antigen (HBSAG) in human whole blood, serum or plasma. The presence of HBsAg can be detected within 10 minutes at the concentration of 5ng/ml or higher, and 15 minutes at 1ng/ml. The test is intended for healthcare professional use.
PERFORMANCE CHARATERISTICS
One Step HBsAg Whole Blood 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)
One Step HBsAg Whole Blood Test is a rapid, immunochromatographic assay for the qualitative detection of Hepatitis B Surface Antigen (HBSAG) in human whole blood, serum or plasma. The presence of HBsAg can be detected within 10 minutes at the concentration of 5ng/ml or higher, and 15 minutes at 1ng/ml. The test is intended for healthcare professional use.
PERFORMANCE CHARATERISTICS
One Step HBsAg Whole Blood 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)
Main Products
rapid test kits,medical device,