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目的比较酶联免疫吸附试验(ELISA)和梅毒甲苯胺红不加热血清试验(TRUST)检测方法的敏感性和特异性,评价其在临床诊断中的应用价值。方法应用ELISA和TRUST联合检测1913例血清标本,包括手术前和输血前筛查的1715例以及门诊内镜检查前的198例血清标本,可疑阳性结果采用梅毒螺旋体明胶凝集试验(TPPA)确诊。结果共检测1913例,用TPPA法确诊32例为阳性。用TRUST法检出29例阳性,其中26例确诊阳性,3例为假阳性,敏感性为81.3%(26/32),特异性为89.7%(26/29)。用ELISA法检出33例阳性,其中32例确诊阳性,1例为假阳性,敏感性为100.0%(32/32),特异性为97.0%(32/33)。结论 ELISA法操作相对简单,结果判定可标准化,特异性和敏感性好,可作为梅毒抗体检测较理想的方法 ,适合大批量标本检测。TRUST法可作为梅毒筛查方法之一,配合ELISA法使用,特别适合作为临床观察效果的治疗指标。
Objective To compare the sensitivity and specificity of the enzyme linked immunosorbent assay (ELISA) and the TRUST assay of syphilis, and evaluate its value in clinical diagnosis. Methods Totally 1913 serum specimens were tested by ELISA and TRUST, including 1715 pre-transfusion and pre-transfusion screening and 198 serum samples before out-patient endoscopy. The suspicious positive results were confirmed by Treponema Pallidum Gelatin Agglutination Test (TPPA). Results A total of 1913 cases were detected, 32 cases were diagnosed as positive by TPPA method. Twenty-nine patients were confirmed positive by TRUST, of which 26 were confirmed positive, 3 were false-positive, with a sensitivity of 81.3% (26/32) and a specificity of 89.7% (26/29). 33 cases were positive by ELISA, of which 32 cases were confirmed positive, one case was false positive, the sensitivity was 100.0% (32/32) and the specificity was 97.0% (32/33). Conclusion ELISA method is relatively simple, the results can be judged standardization, specificity and sensitivity, and can be used as an ideal method for the detection of syphilis antibodies, suitable for large quantities of specimens. TRUST method can be used as one of syphilis screening methods, with the ELISA method, especially suitable as a clinical observation of the effect of treatment.