Yi Joowon, Choi Woongryong, Shin Seonhyeon, Choi Juhee, Kim Hanah, Chung Hee-Jung, Moon Hee-Won, Hur Mina, Yun Yeo-Min
Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul, Republic of Korea.
Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul, Republic of Korea.
Clin Biochem. 2019 Jan;63:121-125. doi: 10.1016/j.clinbiochem.2018.09.013. Epub 2018 Oct 2.
In South Korea, automated T. pallidum Latex Agglutination (TPLA) based on turbidoimmunoassays and immunochromatographic assay (ICA) are widely used for syphilis diagnosis. However, there is sparse data on the validation of these assays in the reverse-sequence algorithm setting.
We assessed 551 specimens submitted for syphilis testing. We compared varying reverse-sequence algorithms using combinations of the Cobas Syphilis EIA (Roche Diagnostics, Mannheim, Germany), Mediace TPLA (Sekisui Medical Co., Tokyo, Japan), TPPA (Fujirebio Inc., Tokyo, Japan), and SD Bioline ICA (Standard Diagnostic, Yongin, Korea). We also evaluated modified algorithms incorporating a cut off of high specificity for EIA and TPLA using receiver operating characteristic curves.
The agreement was almost perfect between EIA and TPLA (Kappa, 0.953) and strong between TPPA and ICA (Kappa, 0.887). Among TPPA positive and ICA negative specimens, 67% of the specimens were from individuals with syphilis histories. Compared to EIA/RPR/TPPA, the agreement with EIA/RPR/ICA, TPLA/RPR/TPPA and TPLA/RPR/ICA were almost perfect (Kappa, 0.930, 0.995 and 0.914, respectively). When a cut off of 95% specificity was applied, the number of TPPA tests could be reduced by 44% and 40% in EIA and TPLA, respectively.
TPLA showed almost perfect agreement with EIA and that it could be used in the site of EIA in a reverse sequence algorithm. ICA showed a lower detection rate than TPPA as a 2nd treponemal test and should be used with caution. With cut offs of higher specificity, more efficient reverse-sequence algorithms can be made possible.
在韩国，基于比浊免疫分析的梅毒螺旋体乳胶凝集试验（TPLA）和免疫层析法（ICA）被广泛用于梅毒诊断。然而，关于这些检测方法在反向序列算法设置中的验证数据较少。
我们评估了551份提交进行梅毒检测的标本。我们比较了使用Cobas梅毒酶免疫分析（罗氏诊断，德国曼海姆）、Mediace TPLA（积水医疗株式会社，日本东京）、TPPA（富士瑞必欧株式会社，日本东京）和SD Bioline ICA（标准诊断，韩国龙仁）组合的不同反向序列算法。我们还使用受试者工作特征曲线评估了纳入酶免疫分析和TPLA高特异性临界值的改良算法。
酶免疫分析和TPLA之间的一致性几乎完美（kappa值，0.953），TPPA和ICA之间的一致性较强（kappa值，0.887）。在TPPA阳性而ICA阴性的标本中，67%的标本来自有梅毒病史的个体。与酶免疫分析/快速血浆反应素环状卡片试验/TPPA相比，酶免疫分析/快速血浆反应素环状卡片试验/ICA、TPLA/快速血浆反应素环状卡片试验/TPPA和TPLA/快速血浆反应素环状卡片试验/ICA之间的一致性几乎完美（kappa值分别为0.930、0.995和0.914）。当应用95%特异性的临界值时，在酶免疫分析和TPLA中，TPPA检测的数量可分别减少44%和40%。
TPLA与酶免疫分析显示出几乎完美的一致性，并且它可以在反向序列算法中用于酶免疫分析的位置。作为第二种密螺旋体检测方法，ICA的检测率低于TPPA，应谨慎使用。通过更高特异性的临界值，可以实现更有效的反向序列算法。
