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目的探讨酶联免疫吸附试验(ELISA)与梅毒螺旋体明胶颗粒凝集试验(TPPA)的符合率。方法采用ELISA方法对住院及门诊患者血清进行梅毒抗体检测,收集阳性标本34例(包括1≤S/CO<3标本6例、3≤S/CO<6标本7例、S/CO≥6标本21例),同时随机收集ELISA法检测为阴性的样本67例,将此101例样本使用TPPA试验作为确认试验,从而判断ELISA方法与TPPA检测方法的差异性。结果两种检测方法的一致率较高。ELISA的灵敏度为100%,假阴性率是0,特异性为95.71%,假阳性率是4.29%。假阳性结果主要出现在1≤S/CO<6的区间内。结论 ELISA方法能有效应用于梅毒抗体的临床筛查,对于检测结果在1≤S/CO<6时,应进行确认试验,以减少假阳性。
Objective To investigate the coincidence rate of enzyme linked immunosorbent assay (ELISA) and Treponema pallidum gelatin particle agglutination test (TPPA). Methods Serum samples from hospitalized and outpatient patients were detected by ELISA. 34 cases were positive (including 6 cases with 1≤S / CO <3, 7 cases with 3≤S / CO <6, S / CO≥6 21 cases). At the same time, 67 cases of negative samples were collected randomly. The TPPA test was used as the confirmation test to determine the difference between ELISA method and TPPA test method. Results The consistency of the two methods was high. The sensitivity of ELISA was 100%, the false negative rate was 0, the specificity was 95.71% and the false positive rate was 4.29%. False-positive results mainly appear in the range of 1≤S / CO <6. Conclusion The ELISA method can be applied to the clinical screening of syphilis antibody. For the test result of 1≤S / CO <6, confirmation test should be carried out to reduce the false positive rate.