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目的对罗氏电化学发光免疫法检测梅毒螺旋体(TP)特异性抗体的系统性能和临床价值进行评估。方法随机选取2014年5—11月期间1 000例患者血清、100例快速血浆反应素环状卡片试验(RPR)和梅毒螺旋体血凝试验(TPHA)均呈阳性的临床梅毒患者血清以及50例潜在可能干扰的非梅毒患者血清进行检测,同时对其临界值、精密度、敏感度和特异度进行验证和评价。结果 100例临床梅毒患者血清TP抗体全部阳性,其灵敏度为100.00%。50例非梅毒患者的血清TP抗体全部阴性,其特异度为100.00%。1 000例随机患者血清标本中,TP抗体阳性24例,阳性率为2.40%,其阳性预测值为96.00%,阴性预测值为100.00%。罗氏电化学发光免疫法检测系统的性能验证符合指标要求。结论罗氏电化学发光免疫法检测梅毒特异性抗体具有较高的灵敏度和特异度,适合临床应用。
OBJECTIVE: To evaluate the system performance and clinical value of Roche electrochemiluminescence immunoassay for the detection of TP-specific antibodies. Methods One hundred and seventy patients with sera collected from May to November 2014, 100 patients with positive syphilis serum from 100 patients with RPR and TPHA, and 50 patients with latent Serum of non-syphilitic patients may be detected, and their critical value, precision, sensitivity and specificity are verified and evaluated. Results The serum TP antibody of 100 cases of clinical syphilis patients were all positive, the sensitivity was 100.00%. The serum TP antibody of 50 cases of non-syphilis patients were all negative, the specificity was 100.00%. Of the 1000 randomized patients, TP antibody was positive in 24 serum samples, the positive rate was 2.40%. The positive predictive value was 96.00% and the negative predictive value was 100.00%. Roche electrochemiluminescence immunoassay system performance verification in line with the indicators. Conclusion Roche electrochemiluminescence immunoassay for detecting syphilis-specific antibodies has high sensitivity and specificity, and is suitable for clinical application.