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      Field Application of SD Bioline Malaria Ag Pf/Pan Rapid Diagnostic Test for Malaria in Greece

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          Abstract

          Greece, a malaria-free country since 1974, has experienced re-emergence of Plasmodium vivax autochthonous malaria cases in some agriculture areas over the last three years. In early 2012, an integrated control programme (MALWEST Project) was launched in order to prevent re-establishment of the disease. In the context of this project, the rapid diagnostic tests (RDT) of SD Bioline Malaria Ag Pf/Pan that detects hrp-2 and pan-LDH antigens were used. The aim of this study was to assess the field application of the RDT for the P. vivax diagnosis in comparison to light microscopy and polymerase chain reaction (PCR). A total of 955 samples were tested with all three diagnostic tools. Agreement of RDT against microscopy and PCR for the diagnosis of P. vivax was satisfactory (K value: 0.849 and 0.976, respectively). The sensitivity, specificity and positive predictive value of RDT against PCR was 95.6% (95% C.I.: 84.8-99.3), 100% (95% C.I.: 99.6-100.0) and 100% (95% CI: 91.7-100.0) respectively, while the sensitivity, specificity and positive predictive value of RDT against microscopic examination was 97.4% (95% C.I.: 86.1-99.6), 99.4% (95% C.I.: 98.6-99.8) and 86.1% (95% CI: 72.1-94.7), respectively. Our results indicate that RDT performed satisfactory in a non-endemic country and therefore is recommended for malaria diagnosis, especially in areas where health professionals lack experience on light microscopy.

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          A review of malaria diagnostic tools: microscopy and rapid diagnostic test (RDT).

          The absolute necessity for rational therapy in the face of rampant drug resistance places increasing importance on the accuracy of malaria diagnosis. Giemsa microscopy and rapid diagnostic tests (RDTs) represent the two diagnostics most likely to have the largest impact on malaria control today. These two methods, each with characteristic strengths and limitations, together represent the best hope for accurate diagnosis as a key component of successful malaria control. This review addresses the quality issues with current malaria diagnostics and presents data from recent rapid diagnostic test trials. Reduction of malaria morbidity and drug resistance intensity plus the associated economic loss of these two factors require urgent scaling up of the quality of parasite-based diagnostic methods. An investment in anti-malarial drug development or malaria vaccine development should be accompanied by a parallel commitment to improve diagnostic tools and their availability to people living in malarious areas.
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            Rapid diagnostic tests for malaria parasites.

            Malaria presents a diagnostic challenge to laboratories in most countries. Endemic malaria, population movements, and travelers all contribute to presenting the laboratory with diagnostic problems for which it may have little expertise available. Drug resistance and genetic variation has altered many accepted morphological appearances of malaria species, and new technology has given an opportunity to review available procedures. Concurrently the World Health Organization has opened a dialogue with scientists, clinicians, and manufacturers on the realistic possibilities for developing accurate, sensitive, and cost-effective rapid diagnostic tests for malaria, capable of detecting 100 parasites/microl from all species and with a semiquantitative measurement for monitoring successful drug treatment. New technology has to be compared with an accepted "gold standard" that makes comparisons of sensitivity and specificity between different methods. The majority of malaria is found in countries where cost-effectiveness is an important factor and ease of performance and training is a major consideration. Most new technology for malaria diagnosis incorporates immunochromatographic capture procedures, with conjugated monoclonal antibodies providing the indicator of infection. Preferred targeted antigens are those which are abundant in all asexual and sexual stages of the parasite and are currently centered on detection of HRP-2 from Plasmodium falciparum and parasite-specific lactate dehydrogenase or Plasmodium aldolase from the parasite glycolytic pathway found in all species. Clinical studies allow effective comparisons between different formats, and the reality of nonmicroscopic diagnoses of malaria is considered.
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              Update on rapid diagnostic testing for malaria.

              To help mitigate the expanding global impact of malaria, with its associated increasing drug resistance, implementation of prompt and accurate diagnosis is needed. Malaria is diagnosed predominantly by using clinical criteria, with microscopy as the current gold standard for detecting parasitemia, even though it is clearly inadequate in many health care settings. Rapid diagnostic tests (RDTs) have been recognized as an ideal method for diagnosing infectious diseases, including malaria, in recent years. There have been a number of RDTs developed and evaluated widely for malaria diagnosis, but a number of issues related to these products have arisen. This review highlights RDTs, including challenges in assessing their performance, internationally available RDTs, their effectiveness in various health care settings, and the selection of RDTs for different health care systems.
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                Author and article information

                Contributors
                Role: Academic Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                24 March 2015
                2015
                : 10
                : 3
                : e0120367
                Affiliations
                [1 ]Department of Hygiene and Epidemiology, Faculty of Medicine, University of Thessaly, Larissa, Greece
                [2 ]Hellenic Centre for Disease Control & Prevention (KEELPNO), Athens, Greece
                [3 ]General Hospital of Sparti, Lakonia, Sparti, Greece
                [4 ]Médecins Sans Frontières, Athens, Greece
                [5 ]Department of Parasitology, Entomology and Tropical Diseases, National School of Public Health, Athens, Greece
                [6 ]Department of Microbiology, Faculty of Medicine, National and Kapodistrian University of Athens, Athens, Greece
                Université Pierre et Marie Curie, FRANCE
                Author notes

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

                Conceived and designed the experiments: MT DP AB EV JK CH. Performed the experiments: MT PT OP AV IT A. Marka M. Detsis ZE. Analyzed the data: MT PT A. Marka CH. Contributed reagents/materials/analysis tools: M. Dionysopoulou A. Mpimpa EV AT. Wrote the paper: PT GR A. Marka CH. Provided expertise and editing: TG EV ST. Provided constructive comments and approved the final version of the manuscript: MT DP PT GR OP AB TG AV M. Dionysopoulou IT A. Marka M. Detsis ZE A. Mpimpa EV ST AT JK CH.

                ¶ Membership of the MALWEST Project is provided in the Acknowledgments.

                Article
                PONE-D-14-52104
                10.1371/journal.pone.0120367
                4372373
                25803815
                bfb88190-bd42-4f36-9474-758989c4680e
                Copyright @ 2015

                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
                : 27 November 2014
                : 9 February 2015
                Page count
                Figures: 1, Tables: 4, Pages: 11
                Funding
                The data collected in the context of "Integrated Surveillance and control programme for West Nile Virus and malaria in Greece MIS 365280 (MALWEST Project)" which is implemented through the Operational Programme entitled “Human Resources Development of National Strategic Reference Framework” (NSRF) 2007–2013. The programme is co-funded by Greece and the European Union—European Regional Development Fund. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. URL: http://www.malwest.gr/.
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                Research Article
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