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      Multisite Laboratory Evaluation of a Dual Human Immunodeficiency Virus (HIV)/Syphilis Point-of-Care Rapid Test for Simultaneous Detection of HIV and Syphilis Infection

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          Abstract

          Background.

           Recently, test developers have created rapid point-of-care tests that can simultaneously detect multiple infections within the same specimen using a single device. The SD BIOLINE Duo HIV/Syphilis rapid point-of-care test uses a solid-phase immunochromatographic assay to detect immunoglobulin (Ig)G, IgM, and IgA antibodies to human immunodeficiency virus (HIV)-specific antigens (HIV-1 gp41, sub O, HIV-2 gp36) and recombinant Treponema pallidum antigen (17 kDa) in human serum. This study was a multisite laboratory-based evaluation of the performance of SD BIOLINE HIV/Syphilis Duo test using previously characterized sera in 6 countries.

          Methods.

           Laboratories in Ghana, Mexico, Laos, Togo, Kenya, and Myanmar participated in the evaluation during 2012–2013. Each site characterized sera using T pallidum particle agglutination assay or T pallidum hemagglutination assay and HIV enzyme immunoassay, Western blot, and/or HIV antibody rapid tests. Those gold standard test results were compared with SD BIOLINE Duo test results. We calculated the sensitivity and specificity of test performance and used the exact binomial method to calculate 95% confidence intervals (CIs).

          Results.

           The sensitivity and specificity for the HIV antibody test component ( n = 2336) were estimated at 99.91% (95% CI, 99.51% and 100%) and 99.67% (95% CI, 99.16% and 99.91%), respectively. For the T pallidum test component ( n = 2059), the sensitivity and specificity were estimated at 99.67% (95% CI, 98.82% and 99.96%) and 99.72% (95% CI, 99.29% and 99.92%), respectively.

          Conclusions.

           The sensitivity and specificity of the SD BIOLINE HIV/Syphilis Duo test were consistently high across sera specimens from 6 countries around the world. Dual rapid tests should be considered for improved HIV and syphilis screening coverage.

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          Most cited references 20

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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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            Point-of-Care Tests to Strengthen Health Systems and Save Newborn Lives: The Case of Syphilis

            Rosanna Peeling and colleagues describe their experience of introducing point-of-care testing to screen for syphilis in pregnant women living in low- and middle-income countries.
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              Syphilis and HIV infection: an update.

              The striking increase in the prevalence of concordant human immunodeficiency virus (HIV) infection and syphilis observed by clinicians and public health officers over the past decade has renewed interest in the subject. Although the effect of HIV infection on the natural history of syphilis has been known for a long time, it was not until recently that several studies documented that syphilis may also impact the course of HIV infection. Despite an improved understanding of the interaction of these 2 conditions, many controversies still exist. In this article, we focus on the most recent literature describing the epidemiology, clinical manifestations, and treatment of syphilis in the context of HIV infection.
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                Author and article information

                Journal
                Open Forum Infect Dis
                Open Forum Infect Dis
                ofid
                ofids
                Open Forum Infectious Diseases
                Oxford University Press
                2328-8957
                March 2014
                27 May 2014
                : 1
                : 1
                Affiliations
                [1 ]Department of Epidemiology, Fielding School of Public Health, University of California Los Angeles , California
                [2 ]Department of Clinical Microbiology, School of Medical Science, College of Health Sciences, Kwame Nkrumah University of Science and Technology , Kumasi, Ghana
                [3 ]Kenya Medical Research Institute , Nairobi, Kenya
                [4 ]Jomo Kenyatta University of Agriculture and Technology, School of Health Sciences, Institute of Tropical Medicine and Infectious Diseases , Nairobi, Kenya
                [5 ]Centre National de Référence des Tests VIH, Laboratoire de Microbiologie , Lomé, Togo
                [6 ]National Health Laboratory, Yangon, Myanmar
                [7 ]NMCH, Vientiane Capital , Laos
                [8 ]Hanoi Medical University, Hanoi, Vietnam
                [9 ]Departamento de Enfermedades Emergentes y Urgencias , InDRE, Mexico
                [10 ]Department of Biostatistics, Fielding School of Public Health, University of California Los Angeles
                [11 ]David Geffen School of Medicine and Fielding School of Public Health, University of California Los Angeles , California
                Author notes
                [†]

                deceased

                Correspondence: Claire C. Bristow, MSc, UCLA Division of Infectious Diseases, 9911 West Pico Blvd, Suite 955, Los Angeles, CA 90035 ( ccbristow@ 123456gmail.com ).
                Article
                ofu015
                10.1093/ofid/ofu015
                4324189
                © The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence ( http://creativecommons.org/licenses/by-nc-nd/3.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com.

                Page count
                Pages: 5
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                Spring 2014

                hiv, syphilis, dual testing, test evaluation, rapid test

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