Category Archives: ELISA Kits

HBsAg ELISA Kit

20f8d240-ELISA

High Sensitivity & Mutant Detection

HBsAg is the most important serological marker for acute or chronic  hepatitis B. The existence of HBsAg mutants has been well documented in various regions of the world.

 Gentaur high-sensitivity HBsAg ELISA kit recognizes most of HbsAg  mutants, which together with the highest analytical sensitivity and  specificity, the kit provides excellent solution in HBV diagnosis, and  in protecting the safety of the blood supply.

Analytical Sensitivity 0.1 IU/ml
Clinical Sensitivity > % 99
Specificity > % 99
CE Marked CE (1293)

Features

High sensitivity and mutants detection

Sandwich ELISA method

Shorter incubation time

Easy working procedure

Separate well columns

Colored kit components

Compatible with automated systems 

Performance

Specificity: When evaluated on European blood donors (n=5038), the overall diagnostic specificity of the kit was 99.78%.

Sensitivity: Gentaur HBsAg ELISA Kit was evaluated for sensitivity on 22 HBV commercial available HBV seroconversion panels, and on total 403 HBsAg positive including 146 HBsAg HBV genotyped and HBsAg subtyped plasma samples available at the Paul-Ehrlich-Institut. With respect to seroconversion sensitivity, the results for RTA HBsAg ELISA Kit on the 22 HBV seroconversion panels showed a sensitivity level at least equivalent with the range of current CE marked HBsAg screening assays for which PEI holds data. 10 additional seroconversion panels were tested in-house. The seroconversion sensitivity was comparable to other CE-marked HBsAg screening test. With respect to diagnostic sensitivity RTA HBsAg ELISA Kit detected all positive samples as positive, including the HBV genotypes A-F or HBsAg subtypes examined.

In conclusion, the overall score of Gentaur HBsAg ELISA Kit for the seroconversion sensitivity was comparable with other CE marked HBsAg test kits for which PEI holds data and all 403 HBsAg positive samples were reactive giving an overall sensitivity of 100%.

Analytical sensitivity: 0.1IU/ml (NIBSC 00/588)