高敏化学发光法检测梅毒特异性抗体的评价

Evaluation of Specific Treponema Pallidum Antibody Detection by High Sensitivity Chemiluminescence Enzyme Immunoassay

目的评价高敏化学发光法(high sensitivity chemiluminescence enzyme immunoassay,HISCL)检测血清梅毒特异性抗体的临床应用价值。方法盲法平行检测2 014例梅毒可疑或筛查患者血清的梅毒特异性抗体;以梅毒螺旋体明胶凝集试验(TPPA)方法为金标准,评价HISCL法临床应用价值。结果HISCL法灵敏度、特异性、阳性预测值、阴性预测值、阳性似然比、阴性似然比、总符合率和Kappa值分别为97.53%,99.73%,96.93%,99.78%,361.25,0.02,99.55%和0.970。交叉反应试验及干扰试验中,未观察到交叉反应或干扰因素的存在。HISCL法较TPPA具有更强实用性。HISCL法与TPPA结果不符9例,均出现在COI值5.0以下或TPPA滴度为160以下的抗体低效价标本,重组抗原印迹法检测均为梅毒抗体非阴性标本。结论 HISCL法检测梅毒特异性抗体结果与TPPA法有很好一致性,有很高的诊断效能,并具有自动化、高通量、低劳动力成本等优点,可以作为梅毒初筛试验。

Objective To evaluate the performance of high sensitivity chemiluminescence enzyme immunoassay for detecting specific antibody of Treponema Pallidum and explore its clinical application. Methods A total of 2014 serum samples of suspected syphilis patients were detected for specific antibody of Treponema Pallidum by both HISCL and TPPA. Methods This was a double-blinded test. HISCL performance was compared with TPPA result which was used as the gold standard. Results The sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio, total coincidence rate and Kappa values of HISCL were 97.53%, 99.73%, 96.93%, 99.78%, 361.25,0.02, 99.55% and 0. 970, respectively. HISCL had no cross reactivity with other diseases. HISCL was more applicable than TPPA in a clinic setting. Results of 9 cases were found to be inconsistent between HISCL and TPPA. ALL of them were low titer antibodies specimens which either had COl values lower than 5.0 or TPPA titer less than 160. Their recombinant blot Treponema IgG/IgM were non - negative. Conclusion Results of HISCL are highly consistent with those of TPPA in detecting specific antibody of Treponema Pallidum. HISCL will be applicable in syphilis diagnosis and suitable for automation with higher throughput and lower labor costs. Detecting specific antibody of Treponema Pallidum by HISCL for screening syphilis is feasible.