两种HBsAg检测试剂用于献血人群筛查的功效及其对血液安全的影响

The efficacy of two HBsAg test reagents for the screening of blood donors and their impact on blood safety

目的回顾性分析献血人群两种HBsAg试剂检测的结果,并探讨其对血液安全的影响。方法采用两个不同厂家的ELISA法试剂检测献血者HBsAg,并采用核酸技术检测HBV DNA。结果献血者共540372例,HBsAg总反应性比例为0.314%。HBsAg检测反应性标本中核酸HBV DNA有反应性为891例(52.57%)。HBsAg检测阴性标本中,核酸HBV DNA有反应性为608例(0.11%)。单独选用ELISA法试剂一或试剂二,有10例或38例HBsAg阳性标本未检出。结论两种HBsAg试剂检测模式存在一定比例的假阳性和假阴性风险,联合血液核酸检测可进一步提升用血安全。

Objective To retrospectively analyze the efficacy of two HBsAg reagents in blood donors and explore their effects on blood safety.Methods ELISA method reagents from two different manufacturers were used for blood donor HBsAg detection and HBV DNA detection by nucleic acid technique.Results A total of 540,372 blood donors occurred,and the total HBsAg reactivity ratio was 0.314%.Reactivity in HBsAg samples was 891 cases(52.57%).Among the negative specimens of HBsAg test,608 cases(0.11%)of nucleic acid HBV DNA were reactive.Using ELISA method reagent 1 or reagent 2 alone,10 cases or 38 cases of HBsAg-positive specimens were not detected.Conclusion The two HBsAg reagent detection modes have a certain proportion of false positive and false negative risk,and the combined blood nucleic acid testing can further improve blood safety.