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      Point-of-Care Testing for Infectious Diseases: Diversity, Complexity, and Barriers in Low- And Middle-Income Countries

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          Abstract

          Madhukar Pai and colleagues discuss a framework for envisioning how point-of-care testing can be applied to infectious diseases in low- and middle-income countries.

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          Point-of-care nucleic acid testing for infectious diseases.

          Angelika Niemz, Tanya Ferguson, David S. Boyle (2011)
          Nucleic acid testing for infectious diseases at the point of care is beginning to enter clinical practice in developed and developing countries; especially for applications requiring fast turnaround times, and in settings where a centralized laboratory approach faces limitations. Current systems for clinical diagnostic applications are mainly PCR-based, can only be used in hospitals, and are still relatively complex and expensive. Integrating sample preparation with nucleic acid amplification and detection in a cost-effective, robust, and user-friendly format remains challenging. This review describes recent technical advances that might be able to address these limitations, with a focus on isothermal nucleic acid amplification methods. It briefly discusses selected applications related to the diagnosis and management of tuberculosis, HIV, and perinatal and nosocomial infections. Copyright © 2011. Published by Elsevier Ltd.
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            Point-of-care diagnostics for global health.

            Paul Yager, Gonzalo Domingo, John L. Gerdes (2008)
            Biomedical engineers have traditionally developed technologies in response to the needs of the developed world's medical community. As a result, the diagnostic systems on which they have worked have met the requirements of well-funded laboratories in highly regulated and quality-assessed environments. However, such approaches do not address the needs of the majority of the world's people afflicted with infectious diseases, who have, at best, access to poorly resourced health care facilities with almost no supporting clinical laboratory infrastructure. A major challenge for the biomedical engineering community is to develop diagnostic tests to meet the needs of these people, the majority of whom are in the developing world. We here review the context in which the diagnostics must operate, some of the appropriate diagnostic technologies already in distribution, and some emerging technologies that promise to address this challenge. However, there is much room for innovation, adaptation, and cost reduction before these technologies can impact health care in the developing world.
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              Point-of-care tests for diagnosing infections in the developing world.

              R Peeling, David Mabey (2010)
              Infectious diseases continue to cause an enormous burden of death and disability in developing countries. Increasing access to appropriate treatment for infectious diseases could have a major impact on disease burden. Some common infections can be managed syndromically without the need for diagnostic tests, but this is not appropriate for many infectious diseases, in which a positive diagnostic test is needed before treatment can be given. Since many people in developing countries do not have access to laboratory services, diagnosis depends on the availability of point of care (POC) tests. Historically there has been little investment in POC tests for diseases that are common in developing countries, but that is now changing. Lack of regulation of diagnostic tests in many countries has resulted in the widespread use of sub-standard POC tests, especially for malaria, making it difficult for manufacturers of reliable POC tests to compete. In recent years increased investment, technological advances, and greater awareness about the importance of reliable diagnostic tests has resulted in rapid progress. Rapid, reliable and affordable POC tests, requiring no equipment and minimal training, are now available for HIV infection, syphilis and malaria, but POC tests for other infections are urgently needed. Many countries do not have established criteria for licensing and introducing new diagnostic tests, and many clinicians in developing countries have become disillusioned with diagnostic tests and prefer to rely on clinical judgment. Continuing advocacy and training in the use of POC tests are needed, and systems for quality control of POC tests need to be developed if they are to achieve their maximum potential.
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                Author and article information

                Journal
                Journal ID (nlm-ta): PLoS Med
                Journal ID (iso-abbrev): PLoS Med
                Journal ID (publisher-id): PLoS
                Journal ID (pmc): plosmed
                Title: PLoS Medicine
                Publisher: Public Library of Science (San Francisco, USA )
                ISSN (Print): 1549-1277
                ISSN (Electronic): 1549-1676
                Publication date Collection: September 2012
                Publication date (Print): September 2012
                Publication date (Electronic): 4 September 2012
                Volume: 9
                Issue: 9
                Electronic Location Identifier: e1001306
                Affiliations
                [1 ]Division of Clinical Epidemiology, Department of Medicine, McGill University, Montreal, Canada
                [2 ]Respiratory Epidemiology & Clinical Research Unit, Montreal Chest Institute, Montreal, Canada
                [3 ]Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States of America
                [4 ]Department of Health, Ethics and Society/Caphri, Faculty of Health, Medicine and Life Sciences, Maastricht University, The Netherlands
                [5 ]Department of Epidemiology & Biostatistics, McGill University, Montreal, Canada
                Author notes

                No financial or industry conflicts. MP serves as a consultant for the Bill & Melinda Gates Foundation. BMGF had no involvement in this manuscript. NPP is an Academic Editor with PLOS ONE. MP is on the editorial boards of PLOS ONE and PLOS Medicine. The other authors have declared that no competing interests exist.

                Wrote the first draft of the manuscript: NPP MP. Contributed to the writing of the manuscript: CV CD NE. ICMJE criteria for authorship read and met: NPP CV CD NE MP. Agree with manuscript results and conclusions: NPP CV CD NE MP.

                Provenance: Not commissioned; externally peer reviewed.

                The Policy Forum allows health policy makers around the world to discuss challenges and opportunities for improving health care in their societies.

                Article
                Publisher ID: PMEDICINE-D-12-01227
                DOI: 10.1371/journal.pmed.1001306
                PMC ID: 3433407
                PubMed ID: 22973183
                SO-VID: e14b650b-fc94-44b0-a435-db303d827935
                Copyright statement: Copyright @ 2012
                License:

                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.

                History
                Page count
                Pages: 7
                Funding
                NPP and MP are supported by the Bill & Melinda Gates Foundation (grant OPP1061487), Grand Challenges Canada (Canadian Rising Stars in Global Health grants) and Canadian Institutes of Health Research (grants MOP-89918 & HBF-103210). MP is also supported by the European and Developing Countries Clinical Trials Partnership (EDCTP - TBNEAT grant) and the Fonds de recherche du Québec – Santé (FRQS). The funders had no role in the analysis of data and decision to publish.
                Categories
                Subject: Policy Forum
                Subject: Medicine
                Subject: Diagnostic Medicine
                Subject: Test Evaluation
                Subject: Global Health
                Subject: Infectious Diseases
                Subject: Infectious Disease Control
                Subject: Neglected Tropical Diseases

                ScienceOpen disciplines: Medicine
                Data availability:
                ScienceOpen disciplines: Medicine

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