title: Field Evaluation of a Dual Rapid Immunodiagnostic Test for HIV and Syphilis Infection in Peru.
abstract: BACKGROUND
  Integrated prevention for HIV and syphilis is warranted because both syphilis and HIV infections have evidence-based, scalable interventions using current health care mechanisms. The advent of dual rapid point-of-care tests, single devices that can detect multiple infections using the same specimen, provides the opportunity to integrate the screening of syphilis into HIV prevention programs, potentially increasing the numbers of people tested and allowing for same-day testing and treatment. The aim of our study was to evaluate the MedMira Multiplo Rapid TP/HIV Antibody Test (MedMira Inc, Halifax, Nova Scotia, Canada), a qualitative, rapid immunoassay that detects antibodies to Treponema pallidum and HIV.
  
  
  METHODS
  The reference test for comparison to the T. pallidum component of the Multiplo TP/HIV Test was the T. pallidum particle agglutination assay. For the HIV component, the reference test included a fourth-generation enzyme immunoassay with a confirmatory Western blot test.
  
  
  RESULTS
  The sensitivity and specificity for the HIV antibody component were 93.8% (95% confidence interval [CI], 69.8%-99.8%) and 100% (95% CI, 97.7%-100%), respectively. The T. pallidum component of the test had a sensitivity of 81.0% (95% CI, 68.1%-94.6%) and a specificity of 100% (95% CI, 97.6%-100%).
  
  
  CONCLUSIONS
  Our study showed excellent performance of the HIV antibody component of the test and very good performance for the T. pallidum antibody component of the MedMira Multiplo Rapid TP/HIV Antibody Test, which should be considered to improve screening coverage. Use of effective dual tests will create improved access to more comprehensive care by integrating the screening of syphilis into HIV prevention programs.
authors.affiliation: From the *Division of Global Public Health, Department of Medicine, University of California San Diego, La Jolla, CA; †Unit of Health, Sexuality and Human Development, and Laboratory of Sexual Health, Universidad Peruana Cayetano Heredia, Lima, Peru; ‡Department of Global Health, University of Washington, Seattle, WA; §Division of Infectious Disease: Global Health, Department of Medicine, University of California Los Angeles, Los Angeles, CA.
authors.forename: Claire C
authors.initials: CC
authors.lastname: Bristow
authors.forename: Segundo R
authors.initials: SR
authors.lastname: Leon
authors.forename: Emily
authors.initials: E
authors.lastname: Huang
authors.forename: Lourdes B
authors.initials: LB
authors.lastname: Ramos
authors.forename: Silver K
authors.initials: SK
authors.lastname: Vargas
authors.forename: Juan A
authors.initials: JA
authors.lastname: Flores
authors.forename: Kelika A
authors.initials: KA
authors.lastname: Konda
authors.forename: Carlos F
authors.initials: CF
authors.lastname: Caceres
authors.forename: Jeffrey D
authors.initials: JD
authors.lastname: Klausner
mesh_terms: D000293:Adolescent; D000328:Adult; D000907:Antibodies, Bacterial / Q000276:immunology*; D016001:Confidence Intervals; D005260:Female; D015483:HIV Antibodies / Q000276:immunology*; D015658:HIV Infections / Q000175:diagnosis*; D018451:Homosexuality, Male; D006801:Humans; D007124:Immunoenzyme Techniques; D008297:Male; D010568:Peru / Q000453:epidemiology; D019095:Point-of-Care Systems; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D060386:Sex Workers; D013587:Syphilis / Q000175:diagnosis*; D063106:Transgender Persons; D014210:Treponema pallidum / Q000276:immunology*; D055815:Young Adult
chemical_list: D000907:Antibodies, Bacterial; D015483:HIV Antibodies; D011933:Reagent Kits, Diagnostic