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      A Systematic Review of Point of Care Testing for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis

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          Abstract

          Objectives. Systematic review of point of care (POC) diagnostic tests for sexually transmitted infections: Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV). Methods. Literature search on PubMed for articles from January 2010 to August 2015, including original research in English on POC diagnostics for sexually transmitted CT, NG, and/or TV. Results. We identified 33 publications with original research on POC diagnostics for CT, NG, and/or TV. Thirteen articles evaluated test performance, yielding at least one test for each infection with sensitivity and specificity ≥90%. Each infection also had currently available tests with sensitivities <60%. Three articles analyzed cost effectiveness, and five publications discussed acceptability and feasibility. POC testing was acceptable to both providers and patients and was also demonstrated to be cost effective. Fourteen proof of concept articles introduced new tests. Conclusions. Highly sensitive and specific POC tests are available for CT, NG, and TV, but improvement is possible. Future research should focus on acceptability, feasibility, and cost of POC testing. While pregnant women specifically have not been studied, the results available in nonpregnant populations are encouraging for the ability to test and treat women in antenatal care to prevent adverse pregnancy and neonatal outcomes.

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          Performance of the Cepheid CT/NG Xpert Rapid PCR Test for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae.

          Charlotte Gaydos, Barbara Van Der Pol, Mary Jett-Goheen … (2013)
          Tests for Chlamydia trachomatis and Neisseria gonorrhoeae, which can provide results rapidly to guide therapeutic decision-making, offer patient care advantages over laboratory-based tests that require several days to provide results. We compared results from the Cepheid GeneXpert CT/NG (Xpert) assay to results from two currently approved nucleic acid amplification assays in 1,722 female and 1,387 male volunteers. Results for chlamydia in females demonstrated sensitivities for endocervical, vaginal, and urine samples of 97.4%, 98.7%, and 97.6%, respectively, and for urine samples from males, a sensitivity of 97.5%, with all specificity estimates being ≥ 99.4%. Results for gonorrhea in females demonstrated sensitivities for endocervical, vaginal, and urine samples of 100.0%, 100.0%, and 95.6%, respectively, and for urine samples from males, a sensitivity of 98.0%, with all estimates of specificity being ≥ 99.8%. These results indicate that this short-turnaround-time test can be used to accurately test patients and to possibly do so at the site of care, thus potentially improving chlamydia and gonorrhea control efforts.
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            Sensitive and rapid detection of Chlamydia trachomatis by recombinase polymerase amplification directly from urine samples.

            Katrin Krõlov, Jekaterina Frolova, Oana M. Tudoran … (2014)
            Chlamydia trachomatis is the most common sexually transmitted human pathogen. Infection results in minimal to no symptoms in approximately two-thirds of women and therefore often goes undiagnosed. C. trachomatis infections are a major public health concern because of the potential severe long-term consequences, including an increased risk of ectopic pregnancy, chronic pelvic pain, and infertility. To date, several point-of-care tests have been developed for C. trachomatis diagnostics. Although many of them are fast and specific, they lack the required sensitivity for large-scale application. We describe a rapid and sensitive form of detection directly from urine samples. The assay uses recombinase polymerase amplification and has a minimum detection limit of 5 to 12 pathogens per test. Furthermore, it enables detection within 20 minutes directly from urine samples without DNA purification before the amplification reaction. Initial analysis of the assay from clinical patient samples had a specificity of 100% (95% CI, 92%-100%) and a sensitivity of 83% (95% CI, 51%-97%). The whole procedure is fairly simple and does not require specific machinery, making it potentially applicable in point-of-care settings. Copyright © 2014 American Society for Investigative Pathology and the Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved.
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              Global epidemiology and control of Trichomonas vaginalis.

              D Mabey, Eric Johnston (2008)
              Trichomonas vaginalis is the most common curable sexually transmitted infection. Despite a number of serious health consequences including facilitation of HIV transmission, pelvic inflammatory disease and adverse outcomes of pregnancy it remains an under-recognized condition. This review aims to update the reader on the global epidemiology and control of T. vaginalis. The burden of T. vaginalis infection is found in resource-limited settings and high-risk groups in industrialized settings. Utilization of polymerase chain reaction-based diagnostics has enhanced our understanding of the epidemiology of T. vaginalis both at the population level and in sexual partners. High rates of asymptomatic infection in male partners of infected females and subsequent re-infection have significant implications for control programmes. Further studies investigating the role of T. vaginalis in facilitating HIV transmission has highlighted its significance and the need to develop and implement control interventions. Future research to develop cheap, point-of-care diagnostic tests will allow a greater understanding of T. vaginalis epidemiology. In addition, the effect of treatment on outcome of pregnancy and HIV acquisition requires further study. This will in turn facilitate operational studies evaluating optimal control strategies and their impact on the complications of T. vaginalis.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Infect Dis Obstet Gynecol
                Journal ID (iso-abbrev): Infect Dis Obstet Gynecol
                Journal ID (publisher-id): IDOG
                Title: Infectious Diseases in Obstetrics and Gynecology
                Publisher: Hindawi Publishing Corporation
                ISSN (Print): 1064-7449
                ISSN (Electronic): 1098-0997
                Publication date (Print): 2016
                Publication date (Electronic): 26 May 2016
                Volume: 2016
                Electronic Location Identifier: 4386127
                Affiliations
                1Division of Infectious Diseases, Department of Medicine, University of California Los Angeles, 10833 Le Conte Avenue, Los Angeles, CA 90095, USA
                2Division of Global Public Health, Department of Medicine, University of California San Diego, 9500 Gilman Drive 0507, La Jolla, CA 92093, USA
                3Department of Epidemiology, Fielding School of Public Health, University of California Los Angeles, 640 Charles E. Young Drive S., Los Angeles, CA 90024, USA
                Author notes

                Academic Editor: Louise Hafner

                Article
                DOI: 10.1155/2016/4386127
                PMC ID: 4899593
                PubMed ID: 27313440
                SO-VID: abddfc53-473f-4e40-aaa3-710e97bda424
                Copyright © Copyright © 2016 Sasha Herbst de Cortina et al.
                License:

                This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 31 December 2015
                Date accepted : 7 March 2016
                Categories
                Subject: Review Article

                ScienceOpen disciplines: Obstetrics & Gynecology
                Data availability:
                ScienceOpen disciplines: Obstetrics & Gynecology

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