摘要
目的比较一种待批准上市的国产2混样血液筛查核酸检测试剂(考核试剂)与另一种已广泛应用于我国采供血机构的进口6混样血液筛查核酸检测试剂(参比试剂)对相同样本检测结果的符合率和阳性检出率,评估其用于血液筛查的安全性及有效性。方法随机选取21669例献血者的血液样本,采用配套的核酸检测系统,对献血者样本乙型肝炎病毒(HBV)DNA、丙型肝炎病毒(HCV)RNA和人类免疫缺陷病毒(HIV)RNA进行平行检测,比较两种试剂的检测结果符合率和初测阳性检出率;对初测结果不一致样本进行复测、第三方核酸试剂复核及乙肝五项检测分析。结果21669例献血者样本中,HBV DNA检测的阳性符合率为75.00%,阴性符合率为99.81%,总符合率为99.80%。考核试剂初测HBV DNA阳性率为2.31‰,高于参比试剂的0.55‰,差异具有统计学意义(P<0.05)。以病毒感染状态的符合率统计,考核试剂HBV DNA阳性符合率为94.23%,阴性符合率为99.99%,总符合率为99.98%。HCV RNA和HIV RNA检测中,考核试剂与参比试剂均未检测出阳性样本,阴性符合率为100.00%,总符合率为100.00%。结论该国产2混样血液筛查核酸检测试剂(考核试剂)与参比试剂在阴性符合率和总体一致性方面表现良好,且考核试剂对于低病毒载量HBV DNA的阳性检出率更高,用于血液筛查具有较好的安全性及有效性。
Objective To compare the coincidence rate and positive detection rate of the same sample test results between a domestic 2 mixed sample blood screening nucleic acid detection reagent(assessment reagent)to be approved for listing and another imported 6 mixed sample blood screening nucleic acid detection reagent(reference reagent)that has been widely used in China's blood collection and supply institutions,and to evaluate its safety and effectiveness for blood screening.Methods A total of 21669 blood samples were randomly selected from blood donors.The hepatitis B virus(HBV)DNA,hepatitis C virus(HCV)RNA and human immunodeficiency virus(HIV)RNA were detected by the nucleic acid detection system,the coincidence rate and the positive detection rate of the initial test of the two reagents were compared;for samples with inconsistent initial test results,retesting,third-party nucleic acid reagents verification and five tests of hepatitis B were performed.Results Among the 21669 samples of blood donors,the positive coincidence rate of HBV DNA detection was 75.00%,the negative coincidence rate was 99.81%,and the total coincidence rate was 99.80%.The positive rate of HBV DNA in the initial test was 2.31‰,which was higher than 0.55‰ of the reference reagent,and the difference was statistically significant(P<0.05).According to the coincidence rate of viral infection status,the positive coincidence rate of HBV DNA was 94.23%,the negative coincidence rate was 99.99%,and the total coincidence rate was 99.98%.In the detection of HCV RNA and HIV RNA,no positive samples were detected by the assessment reagent and the reference reagent,the negative coincidence rate was 100.00%,and the total coincidence rate was 100.00%.Conclusion The domestic 2 mixed sample blood screening nucleic acid detection reagent(assessment reagent)and the reference reagent performed well in the negative coincidence rate and overall consistency,and the assessment reagent had a higher positive detection rate for low viral load HBV DNA,which had good safety and effectiveness for blood screening.
作者
邱昌文
庞栋
梁进恒
覃俊基
QIU Changwen;PANG Dong;LIANG Jinheng;QIN Junji(Nanning Blood Center,Nanning 530003,China)
出处
《临床医学研究与实践》
2026年第3期97-100,共4页
Clinical Research and Practice
关键词
核酸检测试剂
混样模式
血液筛查
残余风险
nucleic acid detection reagent
mixed sample mode
blood screening
residual risk
