目的 分析研究无偿献血者人类免疫缺陷病毒抗原抗体酶联免疫吸附法(human immunodeficiency virus antigen antibody enzyme-linked immunosorbent assay,HIV-ELISA)单试剂反应性结果的检测性能,为提高实验室的检测能力作参考.方法 采用伯乐酶联免疫吸附法(BR-HIV)试剂对笔者血站 2023 年 2 月份的 7069 例标本进行检测,其中有 120例 BR-HIV 单试剂反应性,再对其该单试剂反应性标本采用另外 3 家不同厂家 HIV-ELISA 试剂、化学发光免疫分析(chemiluminescence immunoassay,CLIA)、核酸检测技术(nucleic acid detection technology,NAT)、Western blot法进行检测,统计分析ELISA、CLIA、NAT、Western blot法其检测结果关系.结果 BR-HIV单试剂反应性阳性率出现了阶段性的增加,差异有统计学意义(χ2=4.058,P<0.05).通过电话追踪其 120 例标本信息,将BR-HIV单试剂反应性的病毒感染者与未感染者进行比较,S/CO值感染者明显高于未感染者;假阳性率 1.69%(120/7069)比 2019 年 2 月份假阳性率 0.22%(8/3619)明显增加,差异有统计学意义(χ2=44.099,P<0.05).CLIA、NAT、另外 3 家HIV-ELISA检测试剂具有一致性(Kappa=1),具有等效性.Western blot法检测结果均为阴性.结论 曾经感染过病毒的无偿献血者的标本BR-HIV 单试剂假阳性率增高,可以用 CLIA、NAT 以及其他酶免试剂暂时替代检测,减少血液的报废,提高对捐献血液的检测能力.
Objective Analyze and study the detection performance of single reagent reactivity results of human immunodeficiency virus antigen antibody enzyme-linked immunosorbent assay(HIV-ELISA)in unpaid blood donors,to provide reference for improving the laboratory's testing capabilities.Methods Detection of 7069 specimens from our station in February 2023 using the BR-HIV reagent,among them,there were 120 cases of BR-HIV single reagent reactivity,then,three different manufacturers of HIV-ELISA reagents were used for the single reagent reactivity sample,chemiluminescence immunoassay(CLIA),nucleic acid detection technology(NAT)and Western blot for detection,statistical analysis of the relationship between ELISA,CLIA,NAT and Western blot detection results.Results Phased BR-HIV single reagent reactivity increase is related to A virus A infection,the difference is statistically significant(χ2=4.058,P<0.05).Tracking the information of 120 specimens by phone,data analysis of BR-HIV single reagent reactive A virus A infected persons and uninfected persons S/CO value,infected individuals are significantly higher than uninfected individuals.Infected individuals are significantly higher than uninfected individuals,the difference is statistically significant(χ2=44.099,P<0.05).CLIA,NAT,and three other HIV-ELISA detection reagents have consistency(Kappa=1),with equivalence.The results of immunoblotting test(Western blot)were all negative.Conclusion The false positive rate of BR-HIV single reagent in the samples of unpaid blood donors who had been infected with A virus A increased,CLIA,NAT,and other enzyme exempt agents can be used instead of testing,reduce the scrapping of blood,improve the detection ability of blood.
徐伶莉;葛宇君;徐军
嘉兴市中心血站检验科,浙江嘉兴 314000
临床医学
酶联免疫吸附法;化学发光免疫分析;核酸扩增试验;无偿献血者
Enzyme linked immunosorbent assay;Chemiluminescence immunoassay;Nucleic acid amplification test;Voluntary blood donors
《中国现代医生》 2024 (014)
65-68 / 4
浙江省嘉兴市公益研究项目(2023AY11042)
10.3969/j.issn.1673-9701.2024.14.015
评论