应用IU标准对HBsAg检测试剂的分析

目的应用IU标准对HBsAg检测试剂进行比较分析。方法筛选1份HBsAg阳性血浆,血清学检测证实为HBsAg adr亚型,参照WHO HBsAg标准品稀释方法进行稀释,以IU为单位的HBsAg国际标准品为标准,应用双平行线终点稀释方法对该样品进行定量标定。以标定的IU为单位样品,对国内外13家HBsAg检测试剂进行检测。结果待标定的样品经平行稀释后,测定的浓度值与理论浓度值误差均在11%以内,应用IU标准对国内外HBsAg检测试剂进行检测,国外试剂的最低检出限可达0.02~0.06IU/ml,国产试剂除1家可达0.14IU/ml外,其余试剂均在0.29~0.91IU/ml之间。结论应用IU标准检测HBsAg检测试剂,国外试剂的灵敏度明显高于国内试剂。

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.