Department of Pathology, University of Texas Medical Branch, Galveston, Texas, USA.
Department of Pathology, University of Texas Medical Branch, Galveston, Texas, USA
J Clin Microbiol. 2017 Nov;55(11):3236-3241. doi: 10.1128/JCM.00966-17. Epub 2017 Sep 6.
A syphilis diagnosis is often aided by the detection of treponemal and nontreponemal antibodies. Automated treponemal antibody detection systems enable high-volume clinical laboratories to perform syphilis screening at a faster pace with lower labor costs. The Lumipulse G TP-N chemiluminescent immunoassay is an automated system that qualitatively detects IgG and IgM antibodies against antigens in human serum and plasma. To assess performance characteristics and workflow efficiency, the Lumipulse G TP-N assay was compared to the Bioplex 2200 Syphilis IgG multiplex flow immunoassay. Among the 4,134 routine and HIV samples tested by the two automated assays, the percentage of agreement was excellent at 99.0% (95% confidence interval [CI], 98.6% to 99.2%; κ, 0.89), with the Lumipulse G TP-N having a shorter time to first and subsequent results. All specimens with reactive syphilis screening results were further tested by rapid plasma reagin (RPR) and particle agglutination (TP·PA) testing ( = 231). The results from the RPR-reactive samples ( = 82) showed complete concordance with the two automated assays, while the TP·PA assay displayed some discrepancies. The positive percent agreement (PPA) and negative percent agreement (NPA) between the TP·PA test and the Lumipulse G TP-N test were 98.9% and 77.3%, respectively. The Bioplex 2200 Syphilis IgG immunoassay displayed a similar PPA (100%) but a substantially lower NPA (15.9%). Patient chart reviews of discrepant results suggested that the Lumipulse G TP-N assay produced 27 fewer falsely reactive results and can reduce the amount of additional confirmatory RPR and TP·PA testing needed. The analogous performance characteristics of the two automated systems indicate that the Lumipulse G TP-N assay is suitable for high-throughput syphilis screening.
梅毒的诊断通常通过检测梅毒螺旋体和非梅毒螺旋体抗体来辅助。自动化梅毒螺旋体抗体检测系统使大容量临床实验室能够以更低的劳动力成本更快地进行梅毒筛查。Lumipulse G TP-N 化学发光免疫分析是一种自动化系统，可定性检测人血清和血浆中针对抗原的 IgG 和 IgM 抗体。为了评估性能特征和工作流程效率，将 Lumipulse G TP-N 检测与 Bioplex 2200 梅毒 IgG 多重流式免疫检测进行了比较。在两种自动化检测方法检测的 4134 例常规和 HIV 样本中，一致性百分比非常高，为 99.0%（95%置信区间[CI]，98.6%至 99.2%；κ，0.89），Lumipulse G TP-N 的首次和后续结果时间更短。所有反应性梅毒筛查结果的标本均进一步用快速血浆反应素（RPR）和梅毒螺旋体颗粒凝集（TP·PA）检测进行测试（=231）。RPR 反应性样本（=82）的结果与两种自动化检测方法完全一致，而 TP·PA 检测则存在一些差异。TP·PA 检测与 Lumipulse G TP-N 检测的阳性符合率（PPA）和阴性符合率（NPA）分别为 98.9%和 77.3%。Bioplex 2200 梅毒 IgG 免疫检测显示出相似的 PPA（100%），但 NPA 明显较低（15.9%）。对不一致结果的患者病历回顾表明，Lumipulse G TP-N 检测产生了 27 个假阳性结果，可减少所需的额外 RPR 和 TP·PA 确认检测量。两种自动化系统的相似性能特征表明，Lumipulse G TP-N 检测适用于高通量梅毒筛查。
