化学发光法检测孕妇梅毒螺旋体抗体假阳性探讨  

Exploration of false-positive detection of treponema pallidum antibodies in pregnant women by chemiluminescence

作　　者：郑寿招 ZHENG Shou-zhao(Gutian County Hospital,Ningde 352200,China)

机构地区：[1]古田县医院,352200

出　　处：《中国现代药物应用》2023年第16期94-98,共5页Chinese Journal of Modern Drug Application

摘　　要：目的利用化学发光法(CLIA)初筛孕妇的梅毒螺旋体(TP)抗体,对假阳性标本用酶联免疫吸附试验(ELISA)检测TP特异性抗体的3种基因(TP15、TP47、TP17)片段,分析引起假阳性的抗体基因片段。方法选择32份CLIA检测孕妇TP抗体假阳性、而产后6个月后再次进行TP抗体检测为阴性的标本作为假阳性组,同时随机选取32份确证为TP抗体阳性的孕妇标本作为真阳性组。采用ELISA检测两组TP特异性抗体3种基因(TP15、TP47、TP17)片段。分析假阳性组TP抗体表达情况,比较两组抗体基因片段检测结果。结果32份假阳性组孕妇TP抗体检测阳性标本的截断指数(COI)值为1.03~6.09,其中29份标本梅毒螺旋体颗粒凝集试验(TPPA)为阴性,3份标本TPPA为阳性,稀释倍数在1∶80内,产后6个月后复检TP与TPPA均为阴性。假阳性组TP检测阳性标本采用单基因片段包被TP15、TP17与TP47抗原检测相应的抗体,TP15均为阴性,TP17阳性6份,TP47阳性22份;产后6个月后复查TP、TPPA、TP15、TP17与TP47均为阴性。真阳性组标本中,TP15阳性20份,TP17阳性26份,TP47阳性11份。假孕妇组孕期TP17、TP47阳性率分别为18.75%(6/32)、68.75%(22/32),高于本组产后6个月的0、0,差异具有统计学意义(χ^(2)=6.621、33.524,P=0.010、0.000<0.05)。假阳性组孕期TP15阳性率0、TP17阳性率18.75%(6/32)低于真阳性组的62.50%(20/32)、81.25%(26/32),TP47阳性率68.75%(22/32)高于真阳性组的34.38%(11/32),差异具有统计学意义(χ^(2)=29.091、25.000、7.570,P=0.000、0.000、0.006<0.05)。结论TP47基因片段是引起孕妇TP假阳性的主要原因,为下一步改进多基因重组抗原试剂盒的特异性以及研发单独包被TP47重组基因片段抗原的试剂盒提供依据,避免不必要的因素引起孕妇各种心身、家庭与社会压力。Objective To screen the treponema pallidum antibodies in pregnant women by chemiluminescence(CLIA),and the three gene fragments(TP15,TP47,TP17)of TP-specific antibodies ARE detected by enzyme-linked immunosorbent assay(ELISA)on false-positive specimens to analyze the antibody gene fragments causing false positives.Methods 32 samples of pregnant women with TP antibody false positive detected by CLIA and again tested negative for TP antibody 6 months after delivery were selected as the falsepositive group,and 32 samples of pregnant women confirmed to be positive for TP antibody were randomly selected as the true-positive group.3 gene fragments(TP15,TP47,TP17)of TP-specific antibodies were detected by ELISA.The expression of TP antibody in the false-positive group was analyzed,and the detection results of antibody gene fragments in the two groups were compared.Results The cutoff index(COI)values of 32 positive TP antibody samples of pregnant women in the false-positive group were 1.03-6.09,of which 29 specimens were negative for treponema pallidum particle agglutinaion assay(TPPA)and 3 specimens were positive for TPPA within a dilution of 1∶80,and both TP and TPPA were negative when retested 6 months after delivery.In the false-positive group,samples tested positive for TP were tested for the corresponding antibodies using single gene fragments encapsulated with TP15,TP17 and TP47 antigens;all were negative for TP15,6 samples were positive for TP17 and 22 samples were positive for TP47;all were negative for TP,TPPA,TP15,TP17 and TP47 when retested 6 months after delivery.Among the samples in the true-positive group,20 samples were positive for TP15,26 samples were positive for TP17 and 11 samples were positive for TP47.The positive rates of TP17 and TP47 during pregnancy in the false-positive group were 18.75%(6/32)and 68.75%(22/32),respectively,which were higher than those of 0 and 0 in this group at 6 months after delivery,and the differences were statistically significant(χ^(2)=6.621,33.524;P=0.010,0.000<0.05)

关 键 词：梅毒螺旋体抗体 假阳性 孕妇 化学发光法 TP47 

分 类 号：R446.6[医药卫生—诊断学] R759.154[医药卫生—临床医学]