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)