深圳无偿献血乙肝筛查阳性结果确证分析

Analysis on HBsAg Confirmatory Results of Blood Donors in Shenzhen

目的了解无偿献血乙肝筛查阳性样本确证实验结果,提高输血安全。方法采用进口和国产试剂酶联免疫吸附实验(ELISA)进行血液筛查,并以中和实验及分子生物学聚合酶联反应(PCR)方法对阳性结果进行确证分析,评估试剂的灵敏度。结果深圳市无偿献血人群共计检出ELISA阳性103例(含进口或国产单一试剂检测阳性),确证阳性91例。HBV阳性率为0.68%。进口试剂检出率0.68%,国产试剂0.55%,统计上无显著差异(χ2=1.76,P>0.05)。结论有必要提高目前国产试剂的特异性和灵敏度;为减少输血后乙肝感染,血液筛查有必要采用高灵敏度特异性较好的进口试剂。

Objective To investigate the HBsAg confirmatory results of blood donors in Shenzhen, and to improve the safety of blood transfusion. Methods The home made and imported reagents were used to screen the blood donors, and the positive samples were further confirmed by HBsAg neutral test and PCR, the data were used to evaluate the sensitivity of the reagents. Results The rate of HBsAg in Shenzhen blood donors was 0. 68%, 91 of 103 ELISA positive samples were confirmed positive. The imported reagent revealed 0.68 % and the home made reagent revealed 0.55 % positive HBsAg （X^2 = 1.76, P 〉0.05）. Although the difference did not reach statistical significance, the absolute sensitivity of the imported reagent is better, however. Conclusions The imported reagents of high sensitivity and specificity should be applied in blood screening to further blood transfusion safety, and efforts to improve the quality of home made reagents are needed.