梅毒血清学试剂性能评估方案的优化及应用

Optimization and application of performance evaluation protocol for syphilis serologic assays

目的制定优化的梅毒血清学试剂的评估方案,探讨新方案在发现试剂检测性能特征的价值。方法优化的评估方案首次引入最低检出限、抗干扰性、稳定性等技术参数,采用国际抗梅毒标准血清进行测量值溯源,选择国产梅毒血清学试剂及相对应的进口试剂共6种,以多中心方式进行检测性能的评价。结果 456例明确诊断样品的定性试验,梅毒免疫层析法结果与诊断100%符合;其它4种梅毒筛查试剂相互间虽然敏感性和特异性差异无统计学意义,但存在不同程度的假阳性和假阴性;最低检测限浓度由高到低分别是筛查试剂、梅毒螺旋体凝集法、免疫层析法、和酶联免疫法/化学发光法;两种促凝真空采血器96.88%干扰筛查试剂。结论国产梅毒血清学试剂的检测性能媲美进口产品。免疫层析试剂与临床诊断高度符合,且敏感性水平超过了传统的方法,为推广应用奠定了基础。新的梅毒血清学试剂的评估方案,更完整地反映以往被忽略的影响因素。

Objective To design and optimize performance evaluation protocol for syphilis serologic assays,and to investigate the significance of new protocol for discovering the characteristics of assay performance.Methods Technical parameters,such as lower limit of detection,interference and stability were introduced firstly into the optimized performance evaluation protocol,and 6 domestic and imported assay reagents for syphilis serology were evaluated according to the protocol by multi-center joint study.Results The qualitative test for 456 definite specimens showed 1 00% agreement result between point-of-care testing and clinical diagnostic test,and exhibited various degrees of false positive and false negative results among the other 4 screening assays,although their sensitivity and specificity had no statistical difference.The lower limits of detection of the reagents descended from high to low in the order of screening assays were treponema pallidum particle agglutination assay,point-of-care testing and enzyme-linked immunosorbent assay/chemiluminescence immunoassay.Two brands of procoagulant vacuum blood collection tubes interfered with non-specific antibody detection reagent for syphilis in a 96.88% proportion.Conclusions The study shows that the performance of domestic syphilis serologic assays is comparable with that of imported ones.The result by point-of-care testing exhibits a high agreement with clinical diagnostic test result,and its sensitivity is better than that of the traditional method,which lays a foundation for spreading in clinical application.The optimized performance evaluation protocol for syphilis serologic assays would reflect assay performance better.