不同血液筛查核酸检测模式检测结果的分析

Analysis of detection results of different nucleic acid detection modes for blood screening

目的分析不同血液筛查核酸检测系统的初筛及鉴别/拆分阳性率,探讨不同系统间实验过程的差异和影响因素,为血站制订血液筛查策略,降低输血传播疾病的残余风险提供依据。方法采用核酸单检模式和核酸混检模式分别对512267、172254份标本进行核酸检测,对两种不同模式初筛阳性率和鉴别/拆分阳性率进行统计分析,比较两种检测模式的差异及不同年度间阳性率的变化情况。结果采用核酸单检模式检测的512267份标本中,单检初筛阳性率为0.17%,鉴别阳性率为36.45%;2019年初筛阳性率最高,为0.19%,2021年最低,为0.14%;不同年度间鉴别阳性率比较,差异无统计学意义(P>0.05)。核酸混检模式检测的172254份标本(约23700 pool)中,混检阳性率为0.58%,拆分阳性率为40.15%;2018年初筛阳性率最高,为0.84%,大于2020年初筛阳性率的两倍;不同年度间拆分阳性率比较,差异有统计学意义(P<0.05),2020年拆分阳性率最高为68.00%,2021年最低,为31.58%。核酸混检模式初筛阳性率大于核酸单检模式初筛阳性率的3倍,而二者鉴别/拆分阳性率比较,差异无统计学意义(P>0.05)。结论不同核酸检测模式初筛阳性率和鉴别/拆分阳性率的比较可以有效评估实验室核酸检测系统的稳定性,分析探讨产生差异的原因并寻求解决方案,可达到质量持续改进的目的。

Objective To analyze the preliminary screening results and identification/resolution positive rates of different nucleic acid detection systems for blood screening,and to explore the differences in the experimental process and influencing factors among different systems,so as to provide evidence for blood stations to formulate blood screening strategies and reduce the residual risk of transfusion-transmitted diseases.Methods Due to the different detection requirements,512267 and 172254 samples were performed by single detection mode and mixed detection mode respectively in the samples of unpaid blood donors in Tianjin.The positive rate of the preliminary screening results and the positive rate of the identification/resolution results of the two different modes were statistically analyzed,the differences between the two detection modes and the changes of the positive rate of detection in different years were compared.Results Among 512267 samples detected by nucleic acid single detection mode,the positive rate of single detection was 0.17%,and the positive rate of identification was 36.45%,the positive rate of screening was the highest in early 2019(0.19%),and the lowest in 2021(0.14%),there was no significant difference on positive rate between different years(P>0.05).The positive rate of mixed detection was 0.58%and the positive rate of resolution was 40.15%in 172254 samples(about 23700 pool)detected by mixed detection mode.The positive rate of screening in early 2018 was the highest,with a positive rate of 0.84%,which was more than twice of 2020,the difference of resolution positive rate among different years was statistically significant(P<0.05),the highest resolution positive rate was 68.00%in 2020,and the lowest was 31.58%in 2021.The initial screening positive rate of mixed nucleic acid test was almost 3 times that of single nucleic acid test,but there was no significant difference in identification/resolution positive rate between the two modes(P>0.05).Conclusion The comparison between the positive rate of initial screening and the positive rate of identification/resolution of different nucleic acid detection modes can effectively evaluate the stability of laboratory nucleic acid detection systems,analyze and discuss the causes of differences,and seek solutions to achieve the purpose of continuous quality improvement.