title: Laboratory evaluation of three dual rapid diagnostic tests for HIV and syphilis in China and Nigeria.
abstract: OBJECTIVE
  To determine the laboratory-based performance and operational characteristics of three dual rapid diagnostic tests (RDTs) for testing HIV and syphilis.
  
  
  METHODS
  Three dual RDTs (SD Bioline, Chembio, and MedMira) were evaluated using 1514 serum specimens archived at laboratories or collected from clinics in China and Nigeria to determine sensitivity and specificity, with 95% confidence intervals. Concordance of testing results read by two technicians, stability of testing results read at two time points, and test operation characteristics were also assessed.
  
  
  RESULTS
  All three of the evaluated RDTs gave excellent performance with a combined sensitivity ranging from 99.0%-99.6% for HIV and 98.3%-99.0% for syphilis, and a combined specificity ranging from 97.9%-99.0% for HIV and 97.2%-99.6% for syphilis. Concordance of testing results between two technicians and stability of testing results read within and one hour past the recommended reading period showed excellent agreement, with Kappa greater than or equal to 0.98.
  
  
  CONCLUSIONS
  All the tests were found to be very or fairly easy to use and easy to interpret the results. Further evaluations of these dual RDTs with whole blood in field settings, and more studies on the implication of introduction of these tests in HIV and syphilis control programs are needed.
authors.affiliation: National Center for STD Control and Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing, China.
authors.forename: Yue-Ping
authors.initials: YP
authors.lastname: Yin
authors.affiliation: National AIDS and STIs Control Program, Federal Ministry of Health, Abuja, Nigeria.
authors.forename: Evelyn
authors.initials: E
authors.lastname: Ngige
authors.affiliation: National AIDS and STIs Control Program, Federal Ministry of Health, Abuja, Nigeria.
authors.forename: Chukwuma
authors.initials: C
authors.lastname: Anyaike
authors.affiliation: National AIDS and STIs Control Program, Federal Ministry of Health, Abuja, Nigeria.
authors.forename: Gbenga
authors.initials: G
authors.lastname: Ijaodola
authors.affiliation: World Health Organization, Abuja, Nigeria.
authors.forename: Taiwo A
authors.initials: TA
authors.lastname: Oyelade
authors.affiliation: World Health Organization, Abuja, Nigeria.
authors.forename: Rui Gama
authors.initials: RG
authors.lastname: Vaz
authors.affiliation: World Health Organization, Geneva, Switzerland.
authors.forename: Lori M
authors.initials: LM
authors.lastname: Newman
authors.affiliation: National Center for STD Control and Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing, China. Electronic address: chenxs@ncstdlc.org.
authors.forename: Xiang-Sheng
authors.initials: XS
authors.lastname: Chen
mesh_terms: D015492:AIDS Serodiagnosis / Q000295:instrumentation* / Q000379:methods / Q000706:statistics & numerical data; D002681:China; D005260:Female; D015658:HIV Infections / Q000175:diagnosis*; D006801:Humans; D009549:Nigeria; D000067716:Point-of-Care Testing; D011247:Pregnancy; D011296:Prenatal Diagnosis / Q000295:instrumentation / Q000379:methods / Q000706:statistics & numerical data; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D013587:Syphilis / Q000175:diagnosis*; D013588:Syphilis Serodiagnosis / Q000295:instrumentation* / Q000379:methods / Q000706:statistics & numerical data
chemical_list: D011933:Reagent Kits, Diagnostic
keywords: HIV; Rapid tests; Sensitivity; Specificity; Syphilis