Liang Jianbo, Wan Jianxin, Huang Chumei, Cai Gaorong, Li Laisheng, Liu Min
Department of Laboratory Medicine, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
J Clin Lab Anal. 2020 May;34(5):e23194. doi: 10.1002/jcla.23194. Epub 2020 Jan 24.
Syphilis is a sexually transmitted disease caused by Treponema pallidum (TP) infection. In recent years, diagnostic reagents with fully automated immunoassay instruments have become mainstream. However, these positive screening tests with high sensitivity, which are performed with full automation, need confirmation by Treponema pallidum particle agglutination (TPPA) to be judged as positive.
We evaluated the diagnostic performance of Lumipulse G TP-N assay (Lumi-TP, Fujirebio Inc) in 223 preselected TP-positive samples and 1041 TP-negative samples, compared it with that of the TP gold standard test (TPPA) and Architect Syphilis TP test (Archi-TP, Abbott).
The concordance rates for the results for the positive and negative samples between Lumi-TP and TPPA were 100%. On the other hand, the rates for the results between Archi-TP and TPPA were 100% for positive samples and 99.14% (1032/1041) for negative samples. Correlation tendency and rate between Archi-TP and Lumi-TP were 2.549 and 0.841 in positive specimens up to 160 detected values in Lumi-TP. However, the detection value of Archi-TP reached a plateau when it exceeded about 40. Furthermore, according to the comparison of each value obtained from Archi-TP and Lumi-TP with the strength of the staining of each line in the immune-chromatography assay kit, ESPLINE TP (Fujirebio Inc) for TP major antigens, Tp15-17 and TpN47, it was found that Lumi-TP obtained higher values than Archi-TP, particularly for TpN 47.
Lumi-TP has high specificity and is useful not only for screening but also for determining the amount of anti-TP antibodies.
梅毒是一种由梅毒螺旋体（TP）感染引起的性传播疾病。近年来，配备全自动免疫分析仪器的诊断试剂已成为主流。然而，这些通过全自动操作进行的高灵敏度阳性筛查试验，需要通过梅毒螺旋体颗粒凝集试验（TPPA）进行确认才能判定为阳性。
我们评估了Lumipulse G TP-N检测法（Lumi-TP，富士瑞必欧株式会社）在223份预先选定的TP阳性样本和1041份TP阴性样本中的诊断性能，并将其与TP金标准检测法（TPPA）和Architect梅毒螺旋体TP检测法（Archi-TP，雅培公司）进行比较。
Lumi-TP与TPPA之间阳性和阴性样本结果的一致性率均为100%。另一方面，Archi-TP与TPPA之间阳性样本结果的一致性率为100%，阴性样本为99.14%（1032/1041）。在Lumi-TP检测值高达160的阳性标本中，Archi-TP与Lumi-TP之间的相关趋势和率分别为2.549和0.841。然而，当Archi-TP超过约40时，其检测值达到平台期。此外，根据将Archi-TP和Lumi-TP获得的每个值与免疫层析检测试剂盒ESPLINE TP（富士瑞必欧株式会社）中针对TP主要抗原Tp15-17和TpN47的每条线的染色强度进行比较，发现Lumi-TP获得的值高于Archi-TP，尤其是对于TpN 47。
Lumi-TP具有高特异性，不仅可用于筛查，还可用于测定抗TP抗体的量。
