Objectives Screening for HIV and syphilis in key populations is recommended by the World Health Organization to reduce the morbidity, mortality, and transmission associated with undiagnosed and untreated infections. Rapid point-of-care tests that can detect multiple infections with a single fingerprick whole blood specimen using a single device are gaining popularity. We evaluated the field performance of a rapid dual HIV and syphilis test in persons at high risk of HIV and syphilis infections. Methods Participants included men who have sex with men and transgender women recruited in Lima, Peru. Reference standard testing for detection of HIV and syphilis infections, conducted using blood samples from venipuncture, included Treponema Pallidum Particle Agglutination and 4th-generation HIV enzyme immunoassay for which positive results had a confirmation HIV Western Blot test. For the evaluation test, SD BIOLINE HIV/Syphilis Duo test (Standard Diagnostics, Korea), a fingerprick blood specimen was used. Sensitivity and specificity were calculated and the exact binomial method was used to determine 95% confidence intervals (CI). Results A total of 415 participants were recruited for the study. The dual test sensitivity for detection of T. pallidum infection was 89.2% (95%CI: 83.5%,93.5%) and specificity 98.8% (95%CI: 96.5%,99.8%). For detection of HIV infection, the sensitivity of the dual test was 99.1% (95%CI: 94.8%,100.0%) and specificity 99.4% (95%CI: 97.7%,99.9%). Conclusion This high performing dual test should be considered for the use in clinical settings to increase uptake of simultaneous testing of HIV and syphilis and accelerate time to treatment for those who need it.

BackgroundMen who have sex with men (MSM) and transgender women in Peru are at high risk for acquiring syphilis and HIV infection. The World Health Organization highly recommends screening for HIV and syphilis to reduce morbidity and mortality associated with untreated infections. We aimed to identify factors associated with dual testing preferences for HIV and syphilis infection among MSM and transgender women in Lima, Peru.MethodsWe used conjoint analysis, an innovative method for systematically estimating consumer preferences. We created eight hypothetical test profiles varying across six dichotomous attributes: cost (free vs. $4), potential for false positive syphilis result (no false positive vs. some risk of false positive), time-to-result (20 minutes vs. 1 week), blood draw method (finger prick vs. venipuncture), test type (rapid vs. laboratory), and number of draws (1 vs. 2). We fit a conjoint analysis model for each participant using a simple main effects ANOVA. Attribute importance values were calculated using percentages from relative ranges in the attribute’s utility values. Results were summarized across participants and averages were reported.ResultsWe recruited 415 MSM/transgender women over 18 years of age from two STD clinics in Lima, Peru. No potential for syphilis false positive result (no false positive vs. some potential for false positive) had the largest average impact on willingness to use the test and on average accounted for 23.8% of test type preference, followed by cost (free vs. ~USD$4; 21.6%), time to results (20 minutes vs. 1 week; 17.4%), number of blood draws (1 draw vs. 2 draws; 13.8%), method of blood draw (fingerprick vs. venipuncture; 13.7%), and test type (rapid POC vs. laboratory; 9.7%).ConclusionMSM/transgender women in Peru prioritized accuracy, cost, timeliness and number of blood draws for HIV and syphilis testing. Implementing a low cost, accurate, rapid and dual testing strategy for HIV and syphilis could improve screening uptake and accessibility of testing to accelerate time to treatment.

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 programs, potentially increasing the numbers of people tested and allowing for same-day testing and treatment. The aim of this 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 T. pallidum and HIV. Methods The reference standard test for comparison to the T. pallidum component of the Multiplo TP/HIV Test was Treponema Pallidum Particle Agglutination assay. For the HIV component, the reference test included a 4th-generation enzyme immunoassay with a confirmatory Western blot test. Results The sensitivity and specificity for the HIV antibody component were 93.8% (95% CI: 69.8%, 99.8%) and 100% (95% CI: 97.7%, 100%), respectively. The Treponema 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 Treponema 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.

eWe assessed the laboratory performance of the Chembio dual-path platform HIV-syphilis rapid immunodiagnostic test and electronic reader for detection of HIV and Treponema pallidum antibodies in 450 previously characterized serum specimens. For visual or electronic reader HIV antibody detection, the sensitivity was 100% and the specificity was 98.7%. For visual T. pallidum antibody detection, the test sensitivity was 94.7% and the specificity was 100.0%; with the electronic reader, the sensitivity was 94.7% and the specificity was 99.7%. Rapid multiplex point-of-care tests are increasingly available means to screen for syphilis and HIV infections (1-4). Dual screening tests for antibodies to HIV and Treponema pallidum have been evaluated in serum and venipuncture whole-blood samples, showing excellent sensitivity and specificity (5-7). We assessed the laboratory performance of the Chembio dual-path platform (DPP) HIV-syphilis rapid test and the Chembio digital electronic reader with stored serum samples collected from a cohort of men who have sex with men (MSM) and transwomen at high risk for HIV and syphilis infections.Serum specimens were collected between 2013 and 2014 from MSM and transwomen who had been recruited into an ongoing cohort study in Lima, Peru, and the specimens were stored at Ϫ20°C (8). HIV positivity was determined with the Genscreen Ultra HIV Ag-Ab test (Bio-Rad, Hercules, CA), a novel enzyme immunoassay (EIA) which detects HIV p24 antigen (Ag) and HIV antibodies in the same test (9). Positive EIA results were confirmed by Western blotting (New Lav Blot I; Bio-Rad). Specimens also underwent rapid plasma reagin (RPR) testing, using the BD Macro-Vue RPR card test kit (BD, Franklin Lakes, NJ), and Treponema pallidum particle agglutination (TPPA) testing (Serodia; Fujirebio Diagnostics Inc., Tokyo, Japan). All tests were used according to the manufacturers' instructions.The Chembio DPP HIV-syphilis test is a single-use, visual and qualitative immunochromatographic, dual rapid test for the detection of antibodies to HIV types 1 and 2 and Treponema pallidum in human serum, plasma, or venous or fingerprick wholeblood samples (10). A red control line confirms test validity. Visual observation of a red line in the HIV and/or syphilis detection zone is interpreted as a reactive result (10).Immediately after visual interpretation, tests were analyzed using the small, battery-powered, Chembio electronic reader, which was designed specifically to complement the Chembio DPP technology. The electronic reader scans the DPP test cartridge and displays a numerical value based on the test line intensity. If the electronic reader value is higher than the set cutoff value, then the result for the sample is reported as positive; the test result is reported as negative if the measured value is lower than the cutoff value.We estimated the sensitivity, specificity, and 95% confidence intervals (CIs) using the exact binomial method, and we calculated the concordance between the visual results of the Chembio DPP HIV-sy...

We report the circulating genotypes and the frequency of macrolide-resistance patterns among Treponema pallidum pallidum DNA isolated from syphilitic lesions from patients who attended 2 sexual health clinics in Lima, Peru. We implemented and used a molecular typing scheme to describe local T. pallidum pallidum strains. Among 14 specimens, subtype 14d/f was the most prevalent strain in 7 fully typed T. pallidum DNA specimens obtained from men who have sex with men and transgender women presenting with chancre-like lesions. No macrolide-resistance mutations were found in T. pallidum DNA from 10 lesions.