国产抗-HBs定性试剂评估人群对乙型肝炎病毒的免疫状态

Evaluation of domestic qualitative reagents for detecting anti-HBs in assessing the immunity to hepatitis B virus

目的:探讨国产抗-HBs定性试剂在评估人群对乙型肝炎病毒(HBV)有无免疫力的应用价值。方法:对1016例HBsAg阴性血清,分别用国产定性试剂和美国雅培定量试剂检测抗-HBs,比较结果的一致性和差异。结果:639例(62.9%)血清国产试剂检测抗-HBs阳性,742例(73.0%)雅培试剂检测阳性(≥10 mIU/ml,χ2=23.98,P<0.001)。在抗-HBs≥100 mIU/ml的444例、50 mIU/ml～99 mIU/ml的83例和10 mIU/ml～49 mIU/ml的215例,国产试剂检测阳性率分别为99.1%、92.8%和52.1%。在雅培试剂检测抗-HBs<10 mIU/ml的274例中,国产试剂98.2%阴性。结论:国产抗-HBs定性试剂具有良好的特异性,虽然对低水平抗-HBs阳性血清的检出率较低,但抗-HBs≥50 mIU/ml时,具有良好的检出率。国产定性试剂抗-HBs阳性,说明对HBV有免疫力,通常无需定量检测。

Objective ： To assess the value of domestic qualitative reagents for anti - HBs in evaluating immunity to hepatitis B virus （HBV）. Methods： A total of 1016 sera with negative HBsAg were tested for anti - HBs with domestic qualitative ELISA and Abbott quantitative reagents. The agreement and differences of the results with various reagents were statistically analyzed. Results： Of the 1016 sera, 639 cases （62.9%） and 742 cases（73.0% ） were positive for anti - HBs detected by the domestic reagents and Abbott quantitative reagents respectively （X2 = 23.98, P 〈0. 001 ）. By detection with the domestic reagents, four hundred and forty （99.1%） of 444 sera with anti - HBs ≥100 mIU/ml and 77 （92.8%） of 83 sera with anti - HBs 50 -99 mIU/ml were also positive. However, domestic qualitative reagents showed positive only in 112 （52.1%） of 215 sera with anti - HBs 10 -49 mIU/ml. On the other hand, 269 （98.2%） of 274 sera with anti - HBs 〈 10 mIU/ml were also negative detected with the domestic re- agents. Conclusion： The domestic qualitative reagents for anti - HBs show high specificity and high agreement with Abbott quantitative reagents in detecting sera with anti - HBs ≥50 mIU/ml, although the formers have low sensitivity in testing sera with anti - HBs 〈 50 mIU/ml. The positive rate of anti - HBs defined by domestic qualitative reagents indicates the immunity to hepatitis B virus without further quantitative measurement.