天津地区核酸检测重复无反应性献血者HBV感染指标分析

Analysis of HBV infection indexes in repeated non-reactive blood donors with nucleic acid Test in Tianjin area

目的使用不同类型的NAT法对HBsAg阴性的核酸检测重复无反应性(NRR)献血者样本进行检测,同时使用ELISA法对HBV DNA阳性样本进行相关标志物检测,确认HBV DNA阳性样本的血清学感染指标的模式,保障用血安全。方法使用TMA原理的单人份核酸检测(ID-NAT)对82278例献血者样本进行检测后,总共收集60例NRR样本血浆,采用3种NAT方法对HBV DNA进行检测:方法①采用TMA原理的NAT法进行3次HBV DNA鉴别试验;方法②使用A、B不同的PCR试剂对HBV DNA进行检测;方法③使用Q-PCR对HBV DNA进行定量检测,得到3种方法的总阳性数及比率。使用ELISA法对确认HBV DNA阳性组进行血清学标志物检测,并与未确认HBV DNA阳性组进行比较,分析两组抗体和血清学组合模式阳性率有无差异。结果60例NRR样本,方法①检出HBV DNA阳性样本19例(31.67%,19/60),方法②检出HBV DNA阳性样本23例(38.33%,23/60),方法③检出HBV DNA阳性样本9例(15%,9/60)且病毒载量均较低。3种方法检测出感染HBV的NRR样本共32例(53.33%,32/60),其中仅方法①6例(18.758%,6/32)、仅方法②10例(31.25%,10/32)、仅方法③3例(9.37%,3/32)。确认组的HBcAb和阳性率高于未确认组,高达84.38%和9.38%,两组比较具有统计学差异。确认组HBcAb(+)且HBeAb(+)比率为6.25%而未确认组无此模式,所有抗体全阴性的组合模式确认组比率6.25%低于未确认组28.57%。结论多种类型的NAT法联合检测可以提高NRR样本中HBV DNA的检出率,NRR人群中确认HBV DNA阳性献血者感染标志物HBcAb阳性率、HBcAb(+)且HBeAb(+)比率均升高,所有抗体全阴性的组合模式比率降低。

Objective To use different types of NAT method to detect the HBsAg negative repeated non-reactive(NRR)donor samples,and ELISA method to detect the relative markers of HBV DNA positive samples,so as to confirm the changes of serological infection indexes of HBV DNA positive samples and ensure the safety of blood use.Methods A total of 60 NRR samples were collected after the detection of 82278 blood donor samples using the TMA ID-NAT.Three different types of NAT methods were used to detect HBV DNA.Methods①HBV DNA identification tests were performed three times.Methods②HBV DNA was detected with different PCR reagents A and B.Methods③Q-PCR was used to quantitatively detect HBV DNA,and the total positive number and ratio of the three methods were obtained.ELISA method was used to detect relevant markers in the HBV NRR donor population infected with the virus,and OBI infection situation was obtained,and then compared with the qualified donor population to analyze whether there was any difference in the ratio of antibody and serological combination mode between the two populations.Results Among the 60 NRR samples,method①19 cases(31.67%,19/60)were detected positive for HBV DNA,method②23 cases(38.33%,23/60)were detected positive for HBV DNA,method③9 cases(15%,9/60)were detected positive for HBV DNA,with low viral load.A total of 32 cases(53.33%,32/60)of HBV-infected NRR samples were detected by the three methods,including 19 cases(59.38%,19/32)with the method①,8 cases(25%,8/32)with the method②and 3 cases(9.37%,3/32)with the method③alone.The positive rates of HBcAb(+)and combination mode 1 were statistically different between the two groups.Conclusion Multi-type NAT combined detection can improve the detection rate of HBV DNA in NRR samples and increase the detection of markers,changes in the positive rate of HBV infection markers were identified in NRR donors with positive HBV DNA.