title: Evaluation of the HISCL Anti-Treponema pallidum Assay as a Screening Test for Syphilis.
abstract: 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.
authors.affiliation: Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan Province, People's Republic of China.
authors.forename: Jingna
authors.initials: J
authors.lastname: An
authors.affiliation: Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan Province, People's Republic of China.
authors.forename: Qixia
authors.initials: Q
authors.lastname: Chen
authors.affiliation: Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan Province, People's Republic of China.
authors.forename: Qianqian
authors.initials: Q
authors.lastname: Liu
authors.affiliation: Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan Province, People's Republic of China.
authors.forename: Chenli
authors.initials: C
authors.lastname: Rao
authors.affiliation: Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan Province, People's Republic of China.
authors.forename: Dongdong
authors.initials: D
authors.lastname: Li
authors.affiliation: Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan Province, People's Republic of China.
authors.forename: Tingting
authors.initials: T
authors.lastname: Wang
authors.affiliation: Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan Province, People's Republic of China taochuanmin@sina.com wangll87@126.com.
authors.forename: Chuanmin
authors.initials: C
authors.lastname: Tao
authors.affiliation: Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan Province, People's Republic of China taochuanmin@sina.com wangll87@126.com.
authors.forename: Lanlan
authors.initials: L
authors.lastname: Wang
mesh_terms: D006801:Humans; D008403:Mass Screening / Q000379:methods*; D012680:Sensitivity and Specificity; D012698:Serologic Tests / Q000379:methods*; D013587:Syphilis / Q000175:diagnosis*; D014210:Treponema pallidum / Q000276:immunology