HBsAg ELISA

Analytical sensitivity against WHO 3rdInternational Standard (12/226):0.10 IU/mL.
Sensitivity:100% (95% CI: 97.34% 100%).
Specificity:100% (95% CI: 98.73% 100%).
Intra Assay Precision:CV 23% (negative), 9% (weak positive),7% (medium positive).
Inter Assay Precision:CV 25% (negative), 10% (weak positive),7% (medium positive).
Cross Reactivity:No false positive results were observed on 3-10 positive specimens of dengue, HAV, HCV, HIV,pylori, syphilis, ANA, HAMA, RF (up to 8400 IU/mL), respectively.
Interference:No interference was seen with bilirubin (6.7-20 mg/dL), EDTA (1.1-3.4 M), salicylic acid (1.3-3.8%), creatinine (147-442 M), heparin (1000-3000 U/L), glucose (18-55 mmol/L).
Shelf life:15 months.
Open vial stability: 8 weeks at 2-8C, or until the expiration date.