献血者混合标本与单标本核酸检测扩增效率及成本分析

Amplification efficiency and cost analysis of MP-NAT and ID-NAT in blood samples

目的比较献血者血液混合标本与单标本核酸检测性能及估算成本效益,为献血者血液安全检测提供依据。方法对本站2021年完成的95895份核酸检测结果进行分析,比较混合标本核酸检测阳性拆分单标本核酸检测阴性组、混合标本核酸检测阳性拆分单标本检测阳性组、混合标本核酸检测阴性单标本检测阳性组的Ct值;用PCR原理估算混合标本核酸检测模式与单标本核酸检测模式的扩增效率;对12份混合标本核酸检测阴性单标本检测阳性组的标本进行5~10次模拟混合标本核酸检测。结果混合标本核酸检测阳性Ct值均明显高于单标本核酸检测阳性Ct值(P<0.05),6标本混合核酸检测的扩增效率是单标本核酸检测效率的0.16~0.71倍,12份混合标本核酸检测阴性单标本检测阳性标本中11份经5~10次模拟混合标本核酸检测均至少出现1次阳性,其中11份ELISAHBsAg为0.3<S/Co<Cutoff;相对于混合标本核酸检测,单标本核酸检测将延长设备工作时间3.5倍,试剂经费投入增大5.9倍。结论混合核酸检测的扩增效率低于单标本核酸检测,低病毒载量标本采取混合标本核酸检测容易发生漏检,单标本核酸检测设备工作时长及试剂经费投入是混合标本的3.5~5.9倍。建议在HBV高流行区提倡对献血者行单标本核酸检测。

Objective To compare the performance and cost-effectiveness between ID-NAT(individual detection of NAT)mode and MP-NAT(mini-pool nucleic acid test)mode in blood screening,and to provide reference for blood sample detection.Methods The results of 95895 NAT-samples completed in 2021 were analyzed,and the Ct values of MP-NAT positive/ID-NAT negative group,MP-NAT positive/ID-NAT positive group,MP-NAT negative/ID-NAT positive group were compared.The amplification efficiency of MP-NAT and ID-NAT mode was estimated by PCR.Twelve samples from MP-NAT negative/ID-NAT positive group were simulated by MP-NAT for 5 to 10 times.Results The Ct values of samples by MP-NAT were significantly higher than those by ID-NAT(P<0.05).The amplification efficiency of MP6-NAT was 0.16-0.71 times higher than that of ID-NAT.Among the 12 samples with MP-NAT-/ID-NAT+,11 samples were tested positive at least once after simulated 5 to 10 times by MP-NAT,and ELISA-HBsAg was 0.3<S/Co<Cutoff in 11 samples.Compared with MP-NAT,ID-NAT prolonged the run time of equipment by 3.5 times and increase the cost by 5.9 times.Conclusion The amplification efficiency of MP-NAT is lower than that of ID-NAT,and samples with lower viral load are prone to be missed in MP-NAT.However,the running-time and cost of ID-NAT are 3.5-5.9 times of those of MP-NAT.It is recommended to promote ID-NAT in areas with high HBV prevalence.