An Jingna, Chen Qixia, Liu Qianqian, Rao Chenli, Li Dongdong, Wang Tingting, Tao Chuanmin, Wang Lanlan
Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan Province, People's Republic of China.
Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan Province, People's Republic of China
Clin Vaccine Immunol. 2015 Jul;22(7):817-22. doi: 10.1128/CVI.00116-15. Epub 2015 May 13.
The resurgence of syphilis in recent years has become a serious threat to public health worldwide, and the serological detection of specific antibodies against Treponema pallidum remains the most reliable method for laboratory diagnosis of syphilis. This study examined the performance of the recently launched HISCL anti-Treponema pallidum (anti-TP) assay as a screening test for syphilis in a high-volume laboratory. The HISCL anti-TP assay was tested in 300 preselected syphilis-positive samples, 704 fresh syphilis-negative samples, 48 preselected potentially interfering samples, and 30 "borderline" samples and was compared head to head with the commercially available Lumipulse G TP-N. In this study, the HISCL anti-TP assay was in perfect agreement with the applied testing algorithms with an overall agreement of 100%, comparable to that of Lumipulse G TP-N (99.63%). The sensitivity and specificity of the HISCL anti-TP assay were 100% (95% confidence interval [CI], 98.42% to 100%) and 100% (95% CI, 99.37% to 100%), respectively. Considering the excellent ease of use and automation, high throughput, and its favorable sensitivity and specificity, the HISCL anti-TP assay may represent a new choice for syphilis screening in high-volume laboratories.
近年来梅毒的再度流行已成为全球公共卫生的严重威胁，而梅毒螺旋体特异性抗体的血清学检测仍是梅毒实验室诊断最可靠的方法。本研究在一个大容量实验室中检测了最近推出的HISCL梅毒螺旋体抗体（抗-TP）检测法作为梅毒筛查试验的性能。对300份预先选定的梅毒阳性样本、704份新鲜梅毒阴性样本、48份预先选定的潜在干扰样本和30份“临界”样本进行了HISCL抗-TP检测法测试，并与市售的Lumipulse G TP-N进行了直接比较。在本研究中，HISCL抗-TP检测法与应用的检测算法完全一致，总体一致性为100%，与Lumipulse G TP-N（99.63%）相当。HISCL抗-TP检测法的灵敏度和特异性分别为100%（95%置信区间[CI]，98.42%至100%）和100%（95%CI，99.37%至100%）。考虑到其出色的易用性、自动化程度、高通量以及良好的灵敏度和特异性，HISCL抗-TP检测法可能成为大容量实验室梅毒筛查的新选择。
