使用甲苯胺红不加热血清试验（TPLA）作为梅毒初筛试验对新算法进行评估。
Evaluation of new algorithm using TPLA as an initial syphilis screening test.
作者信息
Murai Ryosei, Yamada Koji, Yonezawa Hitoshi, Yanagihara Nozomi, Takahashi Satoshi
机构信息
Division of Laboratory Medicine, Sapporo Medical University Hospital, Sapporo, Japan.
Division of Laboratory Medicine, Sapporo Medical University Hospital, Sapporo, Japan; Department of Infection Control and Laboratory Medicine, Sapporo Medical University School of Medicine, Sapporo, Japan.
出版信息
J Infect Chemother. 2019 Jan;25(1):68-70. doi: 10.1016/j.jiac.2018.07.002. Epub 2018 Jul 24.
We retrospectively compared the performance of an existing syphilis diagnostic algorithm with a new algorithm that analyzes the results of Treponema pallidum latex agglutination (TPLA) tests. Of the 100 clinical blood samples, 51 were classified as positive through both Mediace TPLA and ESPLINE TP; 2/51 were classified as negative by Architect Syphilis TP, whereas 1/51 was negative as per LUMIPULSE Presto TP. The false positive rate when the results of Mediace TPLA and ESPLINE TP were combined was 1.96% versus 0% for both Architect Syphilis TP and LUMIPULSE Presto TP. The sensitivity of Mediace TPLA (98%) was comparable to that of Architect Syphilis TP (98%) but lower than that of LUMIPULSE Presto TP (100%). The specificity of Mediace TPLA was 98.0% versus 100% for Architect Syphilis TP, and versus 100% for LUMIPULSE Presto TP. We conclude that the performance of Mediace TPLA in combination with a reverse algorithm is nearly equal to that of enzyme immunoassay (EIA) or chemiluminescence immunoassay (CIA). Because TPLA is low cost, highly sensitive method for IgM detection, and is easy to operate, we have recommended its adoption for initial syphilis screening tests.
我们回顾性地比较了现有梅毒诊断算法与一种新算法的性能，新算法分析梅毒螺旋体乳胶凝集试验（TPLA）的结果。在100份临床血样中，51份通过梅毒螺旋体乳胶凝集试验（Mediace TPLA）和酶联免疫吸附试验（ESPLINE TP）均被分类为阳性；其中2/51通过Architect梅毒螺旋体检测（Architect Syphilis TP）被分类为阴性，而1/51通过LUMIPULSE Presto梅毒螺旋体检测（LUMIPULSE Presto TP）为阴性。当将梅毒螺旋体乳胶凝集试验（Mediace TPLA）和酶联免疫吸附试验（ESPLINE TP）的结果合并时，假阳性率为1.96%，而Architect梅毒螺旋体检测（Architect Syphilis TP）和LUMIPULSE Presto梅毒螺旋体检测（LUMIPULSE Presto TP）的假阳性率均为0%。梅毒螺旋体乳胶凝集试验（Mediace TPLA）的敏感性（98%）与Architect梅毒螺旋体检测（Architect Syphilis TP）的敏感性（98%）相当，但低于LUMIPULSE Presto梅毒螺旋体检测（LUMIPULSE Presto TP）的敏感性（100%）。梅毒螺旋体乳胶凝集试验（Mediace TPLA）的特异性为98.0%，而Architect梅毒螺旋体检测（Architect Syphilis TP）的特异性为100%，LUMIPULSE Presto梅毒螺旋体检测（LUMIPULSE Presto TP）的特异性也为100%。我们得出结论，梅毒螺旋体乳胶凝集试验（Mediace TPLA）与反向算法相结合的性能几乎等同于酶免疫测定（EIA）或化学发光免疫测定（CIA）。由于TPLA是一种低成本、高灵敏度的IgM检测方法，且易于操作，我们建议将其用于梅毒初筛试验。
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