TP-ELISA和TRUST法在基层梅毒实验室检测的应用分析
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摘要
目的探讨梅毒螺旋体抗体的酶联免疫吸附试验(Enzyme linked immunosorbent assay,TP-ELISA)和梅毒甲苯胺红不加热血清试验(toluidine red unheated serum test,TRUST)联合检测在梅毒初筛中的应用。方法将280例TPPA(Treponema pallidum particle agglutination assay)检测阳性的梅毒病例作为病例组,295例TPPA法检测阴性的健康者作为对照组,同时分别用TP-ELISA法和TRUST法两种方法进行检测,然后将两种方法检出的初筛阳性的血清用梅毒螺旋体明胶颗粒凝集试验(TPPA)验证。结果在280份经TPPA法验证的阳性标本中,TRUST法检出263份阳性,假阳性19份,敏感性和特异性分别为87. 14%和93. 56%; TP-ELISA法检出272份阳性,假阳性9份,敏感性和特异性分别为93. 93%和96. 95%; TRUST法与TP-ELISA法两法联合检出277份阳性,假阳性3份,敏感性和特异性分别为97. 86%和98. 98%。结论此次试验是将TPPA法作为确诊检测方法,通过TP-ELISA法、TRUST法与该方法进行比较,得到特异性和敏感性。多种检测方法联合使用,避免漏诊和误诊,提高阳性率,利于梅毒的诊断、治疗及预后的判断。
Objective To investigate the application of Enzyme-linked immunosorbent assay for Treponema pallidum antibody( Enzyme linked immunosorbent assay,TP-ELISA) and syphilis toluidine red unheated serum test( toluidine red unheated serum test,TRUST) in the primary screening of syphilis. Methods A total of 280 cases of syphilis with positive TPPA( Treponema pallidum particle agglutination assay) were used as the case group,and 295 healthy subjects with negative TPPA test were used as the control group,which were all detected by TP-ELISA and TRUST,respectively. The primary screening positive serum detected by the two methods was verified by the Treponema pallidum gelatin particle agglutination test( TPPA). Results Among280 positive samples confirmed by TPPA method,263 positive and 19 false positives were detected by TRUST,the sensitivity and specificity were 87. 14% and 93. 56%,respectively; 272 positive and false positives were detected by TP-ELISA,and the sensitivity and specificity were 93. 93% and 96. 95%,respectively. Encouragingly,277 positive and 3 false positive samples were detected by TRUST and TP-ELISA. The sensitivity and specificity were 97. 86% and 98. 98% respectively. Conclusion In this test,the TPPA method was used as a diagnostic test method,and the specificity and sensitivity were obtained by comparing the method with the TP-ELISA method and the TRUST method. A variety of detection methods are used in combination to avoid missed diagnosis and misdiagnosis,improve the positive rate,and facilitate the diagnosis,treatment and prognosis of syphilis.
Objective To investigate the application of Enzyme-linked immunosorbent assay for Treponema pallidum antibody( Enzyme linked immunosorbent assay,TP-ELISA) and syphilis toluidine red unheated serum test( toluidine red unheated serum test,TRUST) in the primary screening of syphilis. Methods A total of 280 cases of syphilis with positive TPPA( Treponema pallidum particle agglutination assay) were used as the case group,and 295 healthy subjects with negative TPPA test were used as the control group,which were all detected by TP-ELISA and TRUST,respectively. The primary screening positive serum detected by the two methods was verified by the Treponema pallidum gelatin particle agglutination test( TPPA). Results Among280 positive samples confirmed by TPPA method,263 positive and 19 false positives were detected by TRUST,the sensitivity and specificity were 87. 14% and 93. 56%,respectively; 272 positive and false positives were detected by TP-ELISA,and the sensitivity and specificity were 93. 93% and 96. 95%,respectively. Encouragingly,277 positive and 3 false positive samples were detected by TRUST and TP-ELISA. The sensitivity and specificity were 97. 86% and 98. 98% respectively. Conclusion In this test,the TPPA method was used as a diagnostic test method,and the specificity and sensitivity were obtained by comparing the method with the TP-ELISA method and the TRUST method. A variety of detection methods are used in combination to avoid missed diagnosis and misdiagnosis,improve the positive rate,and facilitate the diagnosis,treatment and prognosis of syphilis.
引文
[1]孟保福,宋红林,李翠芬. ELISA法在诊断梅毒螺旋体感染中的临床检验价值[J].中华医院感染学杂志,2016,26(20):4611-4613.
[2]高凯.梅毒检测的ELISA法、TPPA法、TRUST法比较[J].中国医药指南,2013,11(34):108-109.
[3] LAMBERT NL,FISHER M,IMRIE J,et al. Community based syphilis screening:feasibility, acceptability, and effectiveness in case finding[J]. Sex Transm Infect,2005,81(3):213-216.
[4] LEVELT PN,FONSECA K,TSANG RSW,et al. Canadian Public Health Laboratory Network laboratory guidelines for the use of serological tests(excluding point-of-car tests)for the diagnosis of syphilis in Canada[J]. The Canadian Journal of Infections Diseases&Medical Microbiology,2015,26(SA):6A-12A.
[5]粟明丽.延长反应时间提高梅毒TRUST试验的阳性率[J].检验医学与临床,2013,10(4):487-488.
[6]潘小平,洪晓绿,赖金国,等.梅毒抗体不同血清学诊断方法的临床评估[J].实验与检验医学,2013,31(2):175-177.
[7]杨安芳.梅毒血清学检验中不同方法检定结果的观察分析[J].中国医药导刊,2014,11(1):211-214.
[8]徐进春,许秀文,周明忠,等.贵阳地区无偿献血人群梅毒抗体筛查结果分析[J].中国输血杂志,2004,17(1):48-49.
[9]秦红群,马顺高.梅毒螺旋体筛查实验的选择[J].中国现代医生,2008,46(28):146-148.
[10]李胡焕,潘宝龙.梅毒螺旋体酶联免疫吸附试验和甲苯胺红不加热血清试验在梅毒检测中的应用[J].医疗装备,2016,29(17):60-62.
[11]吴立春,代黄梅,谷仕艳,等. 13万份住院肿瘤患者的梅毒抗体血清学检测结果分析[J].现代预防医学,2016,43(3):765-768.
[12]孔海芳,闫伯英,杨华,等.三种梅毒血清学检测方法的临床评价[J].中国皮肤性病学杂志,2016,30(2):164-166.
[13]彭慧芬.四种梅毒血清学检测方法的适用性探讨[J].国际检验医学杂志,2013,31(21):2929-2931.
[14]中华人民共和国国家质量监督检验检疫总局. GB 19489-2008实验室生物安全通用要求[S].北京:中国标准出版社,2008.
[15]卫生部. WS 233-2017病原微生物实验室生物安全通用准则[S].北京:中国标准出版社,2017.
[2]高凯.梅毒检测的ELISA法、TPPA法、TRUST法比较[J].中国医药指南,2013,11(34):108-109.
[3] LAMBERT NL,FISHER M,IMRIE J,et al. Community based syphilis screening:feasibility, acceptability, and effectiveness in case finding[J]. Sex Transm Infect,2005,81(3):213-216.
[4] LEVELT PN,FONSECA K,TSANG RSW,et al. Canadian Public Health Laboratory Network laboratory guidelines for the use of serological tests(excluding point-of-car tests)for the diagnosis of syphilis in Canada[J]. The Canadian Journal of Infections Diseases&Medical Microbiology,2015,26(SA):6A-12A.
[5]粟明丽.延长反应时间提高梅毒TRUST试验的阳性率[J].检验医学与临床,2013,10(4):487-488.
[6]潘小平,洪晓绿,赖金国,等.梅毒抗体不同血清学诊断方法的临床评估[J].实验与检验医学,2013,31(2):175-177.
[7]杨安芳.梅毒血清学检验中不同方法检定结果的观察分析[J].中国医药导刊,2014,11(1):211-214.
[8]徐进春,许秀文,周明忠,等.贵阳地区无偿献血人群梅毒抗体筛查结果分析[J].中国输血杂志,2004,17(1):48-49.
[9]秦红群,马顺高.梅毒螺旋体筛查实验的选择[J].中国现代医生,2008,46(28):146-148.
[10]李胡焕,潘宝龙.梅毒螺旋体酶联免疫吸附试验和甲苯胺红不加热血清试验在梅毒检测中的应用[J].医疗装备,2016,29(17):60-62.
[11]吴立春,代黄梅,谷仕艳,等. 13万份住院肿瘤患者的梅毒抗体血清学检测结果分析[J].现代预防医学,2016,43(3):765-768.
[12]孔海芳,闫伯英,杨华,等.三种梅毒血清学检测方法的临床评价[J].中国皮肤性病学杂志,2016,30(2):164-166.
[13]彭慧芬.四种梅毒血清学检测方法的适用性探讨[J].国际检验医学杂志,2013,31(21):2929-2931.
[14]中华人民共和国国家质量监督检验检疫总局. GB 19489-2008实验室生物安全通用要求[S].北京:中国标准出版社,2008.
[15]卫生部. WS 233-2017病原微生物实验室生物安全通用准则[S].北京:中国标准出版社,2017.