Description

SD Bioline HBsAg Rapid test Kit

Hepatitis B Rapid Test Kit

SD bioline Hbsag rapid test kit

Pack Size 40 Rapid Test

Buy 10 Kits and get easy EMI at zero percent interest

Specimen : Serum or Plasma(100μL),  Whole blood ( 01FK11W, 100μL)

HBs Ag : Sensitivity : 100%   Specificity : 100% (2003 WHO Evaluation report)

HBs Ag WB : Sensitivity : 100%   Specificity : 100%

24month at 1-30℃ (01FK11W: 1-40℃)

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SD BIOLINE HBsAg WB with product code 01FK10W, manufactured by Standard
Diagnostics, Inc., rest-of-world (ROW) regulatory version, was accepted for the WHO list
of prequalified in vitro diagnostics and was listed on 22 December 2017.

Intended use:
SD BIOLINE HBsAg WB is an in vitro immunochromatographic, rapid assay designed for the
qualitative detection of Hepatitis B surface antigen, in human serum, plasma (heparin,
EDTA and sodium citrate) or venous whole blood (heparin, EDTA and sodium citrate). SD
BIOLINE HBsAg WB is intended only for professional use as an aid to diagnosis.

Reactive specimens should be reflexed for additional testing, either by enzyme
immunoassay (EIA) to identify current HBV infection. This product is intended for use in a
population with high HBV prevalence. This test may not be suitable for diagnosis of early
infection or blood donation screening. Because false non-reactive results may also arise
due to the lack of ability of the assay to detect HBsAg mutants. The performance of SD
BIOLINE HBsAg WB in infants or children has not been validated

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