title: A dual point-of-care test shows good performance in simultaneously detecting nontreponemal and treponemal antibodies in patients with syphilis: a multisite evaluation study in China.
abstract: BACKGROUND
  Rapid point-of-care (POC) syphilis tests based on simultaneous detection of treponemal and nontreponemal antibodies (dual POC tests) offer the opportunity to increase coverage of syphilis screening and treatment. This study aimed to conduct a multisite performance evaluation of a dual POC syphilis test in China.
  
  
  METHODS
  Participants were recruited from patients at sexually transmitted infection clinics and high-risk groups in outreach settings in 6 sites in China. Three kinds of specimens (whole blood [WB], fingerprick blood [FB], and blood plasma [BP]) were used for evaluating sensitivity and specificity of the Dual Path Platform (DPP) Syphilis Screen and Confirm test using its treponemal and nontreponemal lines to compare Treponema pallidum particle agglutination (TPPA) assay and toluidine red unheated serum test (TRUST) as reference standards.
  
  
  RESULTS
  A total of 3134 specimens (WB 1323, FB 488, and BP 1323) from 1323 individuals were collected. The sensitivities as compared with TPPA were 96.7% for WB, 96.4% for FB, and 94.6% for BP, and the specificities were 99.3%, 99.1%, and 99.6%, respectively. The sensitivities as compared with TRUST were 87.2% for WB, 85.8% for FB, and 88.4% for BP, and the specificities were 94.4%, 96.1%, and 95.0%, respectively. For specimens with a TRUST titer of 1:4 or higher, the sensitivities were 100.0% for WB, 97.8% for FB, and 99.6% for BP.
  
  
  CONCLUSIONS
  DPP test shows good sensitivity and specificity in detecting treponemal and nontreponemal antibodies in 3 kinds of specimens. It is hoped that this assay can be considered as an alternative in the diagnosis of syphilis, particularly in resource-limited areas.
authors.affiliation: National Center for STD Control, China Center for Disease Control and Prevention.
authors.forename: Yue-Ping
authors.initials: YP
authors.lastname: Yin
authors.forename: Xiang-Sheng
authors.initials: XS
authors.lastname: Chen
authors.forename: Wan-Hui
authors.initials: WH
authors.lastname: Wei
authors.forename: Kuang-Long
authors.initials: KL
authors.lastname: Gong
authors.forename: Wen-Ling
authors.initials: WL
authors.lastname: Cao
authors.forename: Gang
authors.initials: G
authors.lastname: Yong
authors.forename: Liang
authors.initials: L
authors.lastname: Feng
authors.forename: Shu-Jie
authors.initials: SJ
authors.lastname: Huang
authors.forename: Dong-Mei
authors.initials: DM
authors.lastname: Wang
authors.forename: Yan
authors.initials: Y
authors.lastname: Han
authors.forename: Shao-Chun
authors.initials: SC
authors.lastname: Chen
authors.forename: David
authors.initials: D
authors.lastname: Mabey
authors.forename: Rosanna W
authors.initials: RW
authors.lastname: Peeling
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000372:Agglutination Tests; D000907:Antibodies, Bacterial / Q000097:blood*; D002681:China; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D019095:Point-of-Care Systems; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity; D013587:Syphilis / Q000175:diagnosis* / Q000276:immunology; D013588:Syphilis Serodiagnosis / Q000379:methods*; D014210:Treponema pallidum / Q000276:immunology*; D055815:Young Adult
chemical_list: D000907:Antibodies, Bacterial