化学微粒子发光免疫法检测梅毒特异性抗体灰区结果的临床应用评价  

Clinical evaluation of the gray zone results of syphilis-specific antibody detection by chemiluminescent microparticle immunoassay

作　　者：贺静 常欣魁 孟彦宏 HE Jing;CHANG Xinkui;MENG Yanhong(Department of Clinical Laboratory,Peking University School and Hospital of Stomatology/National Center for Stomatology/National Clinical Research Center for Oral Diseases/National Engineering Research Center of Oral Biomaterials and Digital Medical Devices,Beijing 100081,China)

机构地区：[1]北京大学口腔医学院·口腔医院/国家口腔医学中心/国家口腔疾病临床医学研究中心/口腔生物材料和数字诊疗装备国家工程研究中心检验科,北京100081

出　　处：《国际检验医学杂志》2024年第12期1491-1495,共5页International Journal of Laboratory Medicine

摘　　要：目的评价梅毒特异性抗体化学微粒子发光免疫(CMIA)法S/CO 1~10的灰区结果在梅毒常规筛查中的应用。方法回顾性分析该院进行梅毒CMIA检测的患者119907例,从中选取两次CMIA法S/CO 1~10的患者602例纳入研究,以梅毒螺旋体颗粒凝集试验(TPPA)作为该研究的确认试验,同时使用快速血浆反应素试验(RPR)检测疾病活动度。按CMIA法S/CO的区间将患者分为3组(CMIA法S/CO 1~3组399例,CMIA法S/CO>3~6组136例,CMIA法S/CO>6~10组67例),随后依据年龄将患者分为两组(0~3岁组139例,>3岁组463例),对患者一般资料及检测结果进行组间比较,并分析组间数据差异。结果119907例进行梅毒CMIA检测的患者中,两次CMIA法初筛S/CO 1~10的标本共602例,阳性检出率为5.02‰。其中,TPPA复检阳性结果例数为186例(30.9%),16例(2.7%)为弱阳性;RPR阳性例数为7例(1.2%)。CMIA法分组统计中,CMIA法S/CO 1~3组TPPA阳性率明显低于CMIA法>3~6组及CMIA法>6~10组,差异均有统计学意义(P<0.05);RPR阳性率亦显示,CMIA法S/CO 1~3组明显低于CMIA法S/CO>6~10组(0.3%vs.4.5%,P<0.05)。0~3岁组CMIA法S/CO低于>3岁组[1.53(1.27,2.24)vs.2.30(1.48,4.15),P<0.05],0~3岁组TPPA阳性率低于>3岁组(0.7%vs.40.0%,P<0.05)。结论梅毒特异性抗体CMIA法S/CO 1~3组的标本常规筛查特异性较低,建议采用TPPA确认以协助诊断;CMIA法S/CO>6~10组经TPPA复检确认仍有10.0%以上的假阳性,因此建议TPPA复检界值定为10。0~3岁组CMIA法S/CO偏低、TPPA阳性率亦低。Objective To evaluate the utility of the gray zone results of syphilis-specific antibody detection by chemiluminescent microparticle immunoassay(CMIA)with S/CO values of 1-10 in routine screening for syphilis infection.Methods A total of 119907 patients who underwent CMIA for syphilis in the hospital were retrospectively analyzed.Among them,602 patients with S/CO values of 1-10 in the evaluation results obtained with CMIA method for two times were included in the study.Treponema pallidum particle agglutination(TPPA)test was adopted as the confirmatory test and rapid plasma reagin(RPR)was performed to assess the disease activity.The patients were divided into three groups(CMIA method S/CO 1-3 group 399 cases,CMIA method S/CO>3-6 group 136 cases,CMIA method S/CO>6-10 group 67 cases)according to different intervals of S/CO values obtained with CMIA method.Then the patients were divided into two groups(0-3 years old group 399 cases,>3 years old group 136 cases)according to their ages.The general data and test results of the patients were compared between groups to analyze the differences.Results Among 119907 patients with syphilis CMIA detection,a total of 602 cases with S/CO values of 1-10 were confirmed in the two initial screening results with CMIA method and the positive detection rate was 5.02‰.Among them,in TPPA retest,the number of cases with positive results was 186(30.9%)and 16 cases(2.7%)were suspected to be weak positive.In RPR test,the number of cases with positive was 7(1.20%).In the grouping statistics based on S/CO values of CMIA method,the positive rate of CMIA method S/CO 1-3 group in TPPA retest was significantly lower than that of CMIA method S/CO>3-6 group and CMIA method S/CO>6-10 group(P<0.05).The RPR positive rate also showed CMIA method S/CO 1-3 group significantly lower CMIA method S/CO>6-10 group(0.3%vs.3,4.5%,P<0.05).The S/CO of CMIA in 0-3 years old group were lower than those in>3 years old group[1.53(1.27,2.24)vs.2.30(1.48,4.15),P<0.05],and the positive rate of TPPA in 0-3 years old gr

关 键 词：梅毒 化学微粒子发光免疫法 假阳性 灰区 

分 类 号：R759.1[医药卫生—皮肤病学与性病学]