30例献血者ELISA检测HBsAg高S/CO值阴性标本在血液核酸混检与单检中的结果分析  

HBsAg high S/CO negative samples:A comparative analysis between nucleic acid minipool test and individual test

作　　者：陈少彬[1] 陈庆恺[1] 何子毅[1] 余霖[1] 王庆[1] CHEN Shaobin;CHEN Qingkai;HE Ziyi;YU Lin;WANG Qing(Dongguan Blood Center,Dongguan 523000,China)

机构地区：[1]东莞市中心血站,广东东莞523000

出　　处：《中国输血杂志》2021年第5期528-531,共4页Chinese Journal of Blood Transfusion

基　　金：2019年东莞市社会科技发展一般项目(201950715026721)。

摘　　要：目的比较某核酸检测系统混检和单检2种模式对ELISA法HBsAg检测S/CO值在0.25~0.90的献血者血液标本的结果,为重新评估此类标本的核酸检测安全性和优化检测流程提供参考。方法收集本站2020年2~10月献血者血液标本进行2遍ELISA法HBsAg检测均为无反应性且任1种试剂S/CO值在0.25~0.90(定义为"高S/CO值阴性")的标本共30例,分别进行核酸6人份混检和单检;对其中混检阴性而单检阳性的11例标本再次进行多次重复的核酸混检,记录和分析各检测结果。结果30例标本在2种ELISA试剂的S/CO值中位数分别为:0.565和0.320,差异有统计学意义(P<0.01);进行首次核酸混检阳性率为13.33%(4/30),核酸单检的阳性率为76.67%(23/30),2种模式的阳性率差异有统计学意义(P<0.05);11例核酸混检阴性而单检阳性的标本再次进行多次重复混检,有1例重复10次混检均为阴性结果,有10(90.91%)例标本能重现至少1次阳性结果,重复阳性率范围是5.88%(1/17)~70.00%(7/10);核酸检测的Ct值在首次混检时范围是34.4~38.5(中位数36.76),在单检的Ct值范围29.6~42.8(中位数36.50),而在多次重复混检的Ct值范围36.1~56.0(中位数37.75),重复混检Ct值与首次混检Ct值的差异无统计学意义(P>0.05),而与单检Ct值的差异有统计学意义(P<0.01)。结论酶免检测HBsAg高阴性值标本进行核酸混检的阳性检出率低,而单检的阳性检出率高,多次重复核酸混检能重现出一定比例阳性检出率;因此,以核酸混检模式为主的血站应重新评估HBsAg高阴性值标本的核酸检测安全性,在没有其他更高灵敏度的检测方法作为辅助诊断时,建议此类标本直接采用核酸单检模式,以提高血液安全性。Objective To compare the results by minipool and individual NAT on blood samples with HBsAg detection S/CO value between 0.25-0.90 by ELISA,in order to re-evaluate the safety of NAT for such negative samples with high HBsAg S/CO value and provide references for the optimization of detection process.Methods A total of 30 blood samples which were non-reactive for HBsAg by ELISA twice and with the S/CO value of any reagent between 0.25-0.90(defined as"high S/CO value negative")from our center from February to October 2020 were collected,and minipool test of 6 samples and individual test were performed in parallel.11 samples which were negative by minipool tests but positive by individual test were submitted to repeated NAT minipool tests,and the results of each test were recorded and analyzed.Results The median S/CO values of the 30 samples by two ELISA reagents were 0.565 and 0.320,respectively,and the differences were statistically significant(P<0.01).The NAT yield of primary minipool and individual NAT was 13.33%(4/30)and 76.67%(23/30),respectively,and the differences were statistically significant(P<0.05).Eleven samples,minipool NAT negative but individual NAT positive,were subjected to repeated minipool NAT.One remained negative throughout the 10 times of repeated minipool NAT test,and 10(90.91%)presented positive results at least once.The repeated positive rate was 5.88%(1/17)-70.00%(7/10).The Ct value of NAT ranged 34.4-38.5(median 36.76)in the primary minipool test,29.6-42.8(median 36.50)in the individual test,and 36.1-56.0(median 37.75)in repeated minipool test afterwards.The Ct value was significantly different between repeated minipool tests and individual tests(P<0.01),but not between repeated minipool tests and primary ones(P>0.05).Conclusion The NAT-yield of samples with high ELISA HBsAg S/CO value was high in individual test and low in minipool test,and the NAT-yield in minipool test could be improved by repetitive test.Therefore,the safety of NAT for samples with high HBsAg S/CO value should be re-ev

关 键 词：HBSAG 高S/CO值阴性标本 核酸检测 混检 单检 献血者 

分 类 号：R457.1[医药卫生—治疗学] R446.6[医药卫生—临床医学]