■为了评估半定量荧光素酶免疫吸附测定(LISA)用于检测针对梅毒螺旋体抗原TP0171(TP15)的抗体的临床适用性,TP0435(TP17),和TP0574(TP47)在梅毒诊断和监测中的作用。
■开发了用于检测抗TP15,TP17和TP47抗体的LISA,并使用261份血清样本(161份梅毒,100非梅毒)。来自六个梅毒兔模型的90份系列血清样本(三个治疗,通过使用TRUST作为参考,使用来自55名梅毒患者的3份未治疗)和110份配对血清样本来评估治疗效果。
■与TPPA相比,LISA-TP15、LISA-TP17和LISA-TP47的灵敏度为91.9%,96.9%,98.8%,99%的特异性,99%,98%,和AUC分别为0.971、0.992和0.995,诊断梅毒。观察到与TPPA的强相关性(rs=0.89-0.93)。在兔模型的系列血清样本中,在LISA-TP17(第31-51天)和LISA-TP47(第41天)的治疗组和对照组之间观察到相对光单位(RLU)的显着差异。在梅毒患者的配对血清样本中,治疗后LISA-TP15、LISA-TP17和LISA-TP47的TRUST滴度和RLU降低(P<0.001)。当TRUST滴度降低0、2、4或≥8倍时,RLU下降了17.53%,31.34%,48.62%,LISA-TP15为72.79%;8.84%,17.00%,28.37%,LISA-TP17为50.57%;22.25%,29.79%,51.75%,LISA-TP47分别为70.28%。
■半定量LISA对梅毒诊断表现良好,而LISA-TP17对监测兔模型和临床患者的梅毒治疗更有效。
To assess the clinical applicability of a semi-quantitative luciferase immunosorbent assay (LISA) for detecting antibodies against Treponema pallidum antigens TP0171 (TP15), TP0435 (TP17), and TP0574 (TP47) in diagnosing and monitoring syphilis. LISA for detection of anti-TP15, TP17, and TP47 antibodies were developed and evaluated for syphilis diagnosis using 261 serum samples (161 syphilis, 100 non-syphilis). Ninety serial serum samples from 6 syphilis rabbit models (3 treated, 3 untreated) and 110 paired serum samples from 55 syphilis patients were used to assess treatment effects by utilizing TRUST as a reference. Compared to TPPA, LISA-TP15, LISA-TP17, and LISA-TP47 showed a sensitivity of 91.9%, 96.9%, and 98.8%, specificity of 99%, 99%, and 98%, and AUC of 0.971, 0.992, and 0.995, respectively, in diagnosing syphilis. Strong correlations (rs = 0.89-0.93) with TPPA were observed. In serial serum samples from rabbit models, significant differences in the relative light unit (RLU) were observed between the treatment and control group for LISA-TP17 (days 31-51) and LISA-TP47 (day 41). In paired serum samples from syphilis patients, TRUST titres and the RLU of LISA-TP15, LISA-TP17, and LISA-TP47 decreased post-treatment (P < .001). When TRUST titres decreased by 0, 2, 4, or ≥8-folds, the RLU decreased by 17.53%, 31.34%, 48.62%, and 72.79% for LISA-TP15; 8.84%, 17.00%, 28.37%, and 50.57% for LISA-TP17; 22.25%, 29.79%, 51.75%, and 70.28% for LISA-TP47, respectively. Semi-quantitative LISA performs well for syphilis diagnosis while LISA-TP17 is more effective for monitoring syphilis treatment in rabbit models and clinical patients.