无偿献血者ELISA-NAT+标本核酸鉴别/拆分结果分析

Analysis of the nucleic acid identified/resolved results of ELISA-NAT+samples in voluntary blood donors

目的分析无偿献血者ELISA-NAT+标本的核酸鉴别/拆分结果在不同信号比值(SR)/循环周期(CT)值区间内的分布情况,为完善检验策略和给予献血者更加准确合理的告知提供依据。方法本研究将2017年1月-2018年1月102176例ELISA检测无反应性的献血者标本分为A、B两组进行HBV/HCV/HIV三项的核酸定性检测,A组采用盖立复Procleix TIGRIS系统(三联检),B组采用上海浩源CHitas Bss1200系统(8人份混检),对初次检测有反应性的标本分别进行鉴别/拆分试验,最后对结果按区间进行分析。结果A组阳性率(0.46%,185/39884)明显高于B组(0.13%,80/62292)(P<0.05);A组系统中的鉴别率15≤SR<20组明显高于10≤SR<15组(P<0.05);B组系统的拆分率39≤CT值<41组明显低于37≤CT值<39组(P<0.05),CT值<37组和37≤CT值<39组之间的差异不具统计学意义(P>0.05)。A、B组间的阳性率差异具统计学意义,且两种核酸检测系统各自对应的鉴别/拆分率在部分不同SR/CT值区间的差异具统计学意义。结论本研究能够为更加准确合理的告知献血者提供依据,同时,有必要完善检验策略。

Objective To analyze the distributions of nucleic acid identified/resolved results from ELISA-NAT+donations in different ranges of signal ratio(SR)/cycle time(CT)value,and to provide the basis for optimizing the detection strategy and giving more accurate and reasonable information to blood donors.Methods In this study,102176 samples of blood donors from January 2017 to January 2018,tested negative by ELISA,were divided into group A and group B for nucleic acid qualitative detection of HBV/HCV/HIV.Procleix TIGRIS system was adopted in group A and CHitas Bss1200 system was adopted in group B(8 samples per pool),then the initially reactive samples were identified/resolved,and the results were analyzed according to the different ranges.Results The positive rate(0.46%,185/39884)of group A was significantly higher than that of group B(0.13%,80/62292)(P<0.05).In group A,the identification rate of the samples with SR value in the range of 15≤SR<20 was significantly higher than that of 10≤SR<15(P<0.05).In group B,the resolution rate of the samples with CT value in the range of 39≤CT<41 was significantly lower than that of 37≤CT<39(P<0.05);no significant differences between the samples with CT value<37 and 37≤CT<39(P>0.05)were observed.The difference of the positive rates between group A and B was statistically significant.The difference of the identification/resolution rares of two nucleic acid detection systems between some different ranges was statistically significant.Conclusion The results of our study can provide basis for a more accurate and reasonable information revealing to blood donors.At the same time,it is necessary to optimize the current detection strategy.