河南省18家血站实验室2019年血筛4项单试剂反应率调查与分析

Single-ELISA reactive rate of four blood screening items in 18 blood station laboratories:Henan,2019

目的统计河南省18家血站实验室血清学筛查4项的单ELISA试剂反应率情况,分析反应率差异的原因,为提高血液筛查质量提供依据。方法计算河南省18家血站实验室,2019年HBsAg、抗-HCV、HIV抗原/抗体、抗-TP单ELISA试剂反应率,并根据各实验室使用的ELISA试剂组合差异、灰区设置,分析导致单ELISA反应率差异的原因。结果河南省18家血站实验室2019年ELISA单试剂反应率:HBsAg 1.740‰(2154/1237789)、抗-HCV 0.564‰(698/1237789)、HIV抗原/抗体1.421‰(1759/1237789)、抗-TP 1.561‰(1932/1237789)。4个项目的单试剂反应率间有统计学差异(P<0.05)。Person相关性分析显示,ELISA单试剂反应率和灰区的设置值无关。而与实验室和试剂组合有相关性,D实验室HBsAg/抗-HCV/抗-TP单ELISA试剂反应率均最高,且高于使用同一试剂的其他实验室。HBsAg单ELISA试剂反应率高的实验室,多为使用某进口试剂和国产试剂相结合的实验室,最高的前6名均为此模式。抗-HCV单ELISA试剂反应率高的实验室,多为使用某国产试剂的实验室。HIV Ag/Ab试剂没有明显的试剂规律。抗-TP单ELISA试剂反应率高的实验室,多为使用组合4的实验室。结论河南省血站实验室血筛4项单试剂中,HBsAg项目的单ELISA试剂反应率最高。单ELISA试剂反应率与实验室和使用的试剂厂家有一定关系。提示应加强实验室质量管理,并选择合适的试剂组合减少血液浪费。

Objective To analyze the cause of single-ELISA reactive of four blood screening items in 18 blood stations in Henan,so as to provide the basis for improving the quality of blood screening.Methods The single-ELISA reactive rate of HBsAg,anti-HCV,HIV Ag/Ab and anti-TP of 18 blood station laboratories in Henan throughout 2019 was calculated,and the causes were analyzed according to different ELISA reagent combinations and gray area settings in each laboratory.Results The overall single-ELISA reactive rates of HBsAg,anti-HCV,HIV Ag/Ab and anti-TP were 1.740(2154/1237789),0.564‰(698/1237789),1.421‰(1759/1237789)and 1.561‰(1932/1237789),respectively,showing significant differences by detection items(P<0.05).Person correlation analysis showed that the single-ELISA reactive rate was independent of the gray area settings.but dependent on laboratories and reagent combinations.The single-ELISA reactive rate of HBsAg,anti-HCV,HIV Ag/Ab and anti-TP in D laboratory was the highest and higher than that in other labs using the same reagent.The laboratories with high HBsAg single-ELISA reactive rate were mostly those using a combination of imported reagents and domestic reagents,including the top 6 laboratories.The laboratories with high anti-HCV single-ELISA reactive rate were mostly those using certain domestic reagents.No obvious rules was noticed by single-ELISA reactive for anti-HIV.Laboratories with high anti-TP single-ELISA reactive rate were mostly those using combination 4.Conclusion The HBsAg single-ELISA reactive rate was the highest in the four blood screening items of blood station laboratories in Henan.The single-ELISA reactive rate is related to the laboratory itself and the reagent manufacturer,suggesting that laboratory quality control should be strengthened and proper reagent combination should be selected to reduce the waste of blood.