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A Laboratory-Based Evaluation of Four Rapid Point-of-Care Tests for Syphilis

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      Abstract

      Background

      Syphilis point-of-care tests may reduce morbidity and ongoing transmission by increasing the proportion of people rapidly treated. Syphilis stage and co-infection with HIV may influence test performance. We evaluated four commercially available syphilis point-of-care devices in a head-to-head comparison using sera from laboratories in Australia.

      Methods

      Point-of-care tests were evaluated using sera stored at Sydney and Melbourne laboratories. Sensitivity and specificity were calculated by standard methods, comparing point-of-care results to treponemal immunoassay (IA) reference test results. Additional analyses by clinical syphilis stage, HIV status, and non-treponemal antibody titre were performed. Non-overlapping 95% confidence intervals (CI) were considered statistically significant differences in estimates.

      Results

      In total 1203 specimens were tested (736 IA-reactive, 467 IA-nonreactive). Point-of-care test sensitivities were: Determine 97.3%(95%CI:95.8–98.3), Onsite 92.5%(90.3–94.3), DPP 89.8%(87.3–91.9) and Bioline 87.8%(85.1–90.0). Specificities were: Determine 96.4%(94.1–97.8), Onsite 92.5%(90.3–94.3), DPP 98.3%(96.5–99.2), and Bioline 98.5%(96.8–99.3). Sensitivity of the Determine test was 100% for primary and 100% for secondary syphilis. The three other tests had reduced sensitivity among primary (80.4–90.2%) compared to secondary syphilis (94.3–98.6%). No significant differences in sensitivity were observed by HIV status. Test sensitivities were significantly higher among high-RPR titre (RPR≥8) (range: 94.6–99.5%) than RPR non-reactive infections (range: 76.3–92.9%).

      Conclusions

      The Determine test had the highest sensitivity overall. All tests were most sensitive among high-RPR titre infections. Point-of-care tests have a role in syphilis control programs however in developed countries with established laboratory infrastructures, the lower sensitivities of some tests observed in primary syphilis suggest these would need to be supplemented with additional tests among populations where syphilis incidence is high to avoid missing early syphilis cases.

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      Most cited references 32

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      Epidemiological synergy. Interrelationships between human immunodeficiency virus infection and other sexually transmitted diseases.

      Understanding the role of other sexually transmitted diseases (STDs) in the transmission of human immunodeficiency virus (HIV), the role of STDs in progression of HIV disease, and the role of HIV infection in alterations of natural history, diagnosis, or response to therapy of STDs is critical to the development of optimal strategies for HIV control. One hundred sixty-three studies on the interrelationships between HIV infection and other STDs were examined. Of 75 studies on the role of STDs in HIV transmission, the 15 analyses of examination or laboratory evidence of STDs adjusted for sexual behavior showed that both ulcerative and nonulcerative STDs increase the risk of HIV transmission approximately 3- to 5-fold. Due to limited data, the role of STDs in progression of disease remains unclear. Preliminary data from 83 reports on the impact of HIV infection on STDs suggest that, at a community level, HIV infection may increase the prevalence of some STDs (e.g., genital ulcers). If coinfection with HIV prolongs or augments the infectiousness of individuals with STDs, and if the same STDs facilitate transmission of HIV, these infections may greatly amplify one another. This "epidemiological synergy" may be responsible for the explosive growth of the HIV pandemic in some populations. Effective STD control programs will be essential to HIV prevention in these communities.
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        Rapid tests for sexually transmitted infections (STIs): the way forward.

        In the developing world, laboratory services for sexually transmitted infections (STIs) are either not available, or where limited services are available, patients may not be able to pay for or physically access those services. Despite the existence of national policy for antenatal screening to prevent congenital syphilis and substantial evidence that antenatal screening is cost-effective, implementation of syphilis screening programmes remains unacceptably low because of lack of screening tools that can be used in primary health care settings. The World Health Organization Sexually Transmitted Diseases Diagnostics Initiative (SDI) has developed the ASSURED criteria as a benchmark to decide if tests address disease control needs: Affordable, Sensitive, Specific, User-friendly, Rapid and robust, Equipment-free and Deliverable to end-users. Rapid syphilis tests that can be used with whole blood approach the ASSURED criteria and can now be deployed in areas where no previous screening has been possible. Although rapid tests for chlamydia and gonorrhoea lack sensitivity, more tests are in development. The way forward for STI diagnostics requires a continuing quest for ASSURED tests, the development of a road map for test introduction, sustainable programmes for quality assurance, and the creation of a robust infrastructure linked to HIV prevention that ensures sustainability of STI control efforts that includes viral STIs.
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          Syphilis and HIV: a dangerous combination.

          HIV and syphilis affect similar patient groups and co-infection is common. All patients presenting with syphilis should be offered HIV testing and all HIV-positive patients should be regularly screened for syphilis. Syphilis agent may enhance the transmission of the other, probably through increased incidence of genital ulcers. Detection and treatment of syphilis can, therefore, help to reduce HIV transmission. Syphilis may present with non-typical features in the HIV-positive patient: there is a higher rate of symptomless primary syphilis and proportionately more HIV-positive patients present with secondary disease. Secondary infection may be more aggressive and there is an increased rate of early neurological and ophthalmic involvement. Diagnosis is generally made with serology but the clinician should be aware of the potential for false-negative serology in both primary and, less commonly, in secondary syphilis. All HIV-positive patients should be treated with a penicillin-based regimen that is adequate for the treatment of neurosyphilis. Relapse of infection is more likely in the HIV-positive patient and careful follow-up is required.
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            Author and article information

            Affiliations
            [1 ]Kirby Institute, University of New South Wales, Sydney, Australia
            [2 ]School of Population and Global Health, University of Melbourne, Carlton, Australia
            [3 ]Victorian Infectious Diseases Reference Laboratory, Melbourne, Australia
            [4 ]SEALS Area Serology Laboratory, Prince of Wales Hospital, Randwick, Australia
            [5 ]Sydney Sexual Health Centre, Sydney, Australia
            [6 ]Burnet Institute, Melbourne, Australia
            [7 ]Melbourne Sexual Health Centre, Carlton, Australia
            California Department of Public Health, United States of America
            Author notes

            Competing Interests: The authors have declared that no competing interests exist.

            Conceived and designed the experiments: LC JK CF BD DL PR DA AM HW CR RG. Performed the experiments: LC TK DC ID CR DL PR CF. Analyzed the data: LC JK RG HW TK ID DC CR DA. Contributed reagents/materials/analysis tools: PR DL TK CF AM ID DC. Wrote the paper: LC JK CF TK BD DL PR DA AM HW CR ID DC RG.

            Contributors
            Role: Editor
            Journal
            PLoS One
            PLoS ONE
            plos
            plosone
            PLoS ONE
            Public Library of Science (San Francisco, USA )
            1932-6203
            2014
            11 March 2014
            : 9
            : 3
            3950184 PONE-D-13-47429 10.1371/journal.pone.0091504

            This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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            Pages: 7
            Funding
            This work was supported by the Nation Health and Medical Research Council, Australia [application # 568971; http://www.nhmrc.gov.au/]. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
            Categories
            Research Article
            Biology
            Microbiology
            Virology
            Co-Infections
            Medicine
            Clinical Immunology
            Immunologic Techniques
            Immunoassays
            Clinical Research Design
            Retrospective Studies
            Diagnostic Medicine
            Clinical Laboratory Sciences
            Test Evaluation
            Epidemiology
            Clinical Epidemiology
            Infectious Disease Epidemiology
            Infectious Diseases
            Sexually Transmitted Diseases
            Syphilis
            Viral Diseases
            HIV
            Infectious Disease Control

            Uncategorized

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