Evaluation of Diagnostic Kit for HBsAg with A Quantity Standard Panel for HBsAg of International Unit

Objective To calibrate a quantity standard panel for HBsAg of international unit (IU) for evaluation of diagnostic kit for HBsAg. Methods One serum sample positive for HBsAg, which was proved as serotype adr, was screened and diluted according to the WHO requirement for dilution of HBsAg standard, then calibrated quantitatively by parallel line endpoint dilution using the quantity standard panel for HBsAg of IU as standard. Four imported and 9 domestic diagnostic kits for HBsAg were evaluated with the calibrated sample. Results All the errors between measured and theoretical concentrations of the sample to be calibrated, at various dilutions, were not more than 11%. By using the calibrated sample, the minimum detection limits of 4 imported kits were 0. 02~0. 06 IU / ml, and that of one domestic kit was 0. 14 IU / ml. However, the minimum detection limits of the other 8 domestic kits ranged from 0. 29 to 0. 91 IU / ml. Conclusion The sensitivity of imported diagnostic kit for HBsAg evaluated with the calibrated standard panel for HBsAg of IU was significantly higher than that of domestic diagnostic kit.