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

March Field Application of SD Bioline Malaria Ag Pf/ Pan Rapid Diagnostic Test for Malaria in Greece Data Availability Statement: All relevant data are within the paper. 0 1 Maria Tseroni 0 1 Danai Pervanidou 0 1 Persefoni Tserkezou 0 1 George Rachiotis 0 1 Ourania Pinaka 0 1 Agoritsa Baka 0 1 Theano Georgakopoulou 0 1 Annita Vakali 0 1 Martha Dionysopoulou 0 1 Irene Terzaki 0 1 Andriani Marka 0 1 Marios Detsis 0 1 Zafiroula Evlampidou 0 1 Anastasia Mpimpa 0 1 Evdokia Vassalou 0 1 Sotirios Tsiodras 0 1 Athanasios Tsakris 0 1 Jenny Kremastinou 0 1 Christos Hadjichristodoulou 0 1 MALWEST Project 0 1 0 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 Medecins Sans Frontieres, 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 1 Academic Editor: Georges Snounou, Universite Pierre et Marie Curie , FRANCE 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: 91.7100.0) 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.: 98.6satisfactory in a non-endemic country and therefore is recommended for malaria diagnosis, especially in areas where health professionals lack experience on light microscopy. - 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) 20072013. The programme is co-funded by Greece and the European UnionEuropean Regional Development Fund. The funders had no role in study design, data collection and analysis, decision to publish, or Competing Interests: The authors have declared that no competing interests exist. Malaria remains the most important parasitic disease as over one hundred countries worldwide are endemic [1]; the World Health Organization (WHO) estimates that malaria caused 197 million cases and 584 thousand deaths during 2013 [2]. Greece has been malaria-free since 1974 [3,4]. Until 1999, a number of imported cases have been reported each year and only sporadic autochthonous cases during the following decade [5]. During the 2011 and 2012 transmission seasons (May to November), outbreaks took place in an agricultural area (Evrotas municipality, Lakonia regional unit, South Greece), while sporadic locally acquired cases were recorded throughout the country. Forty two autochthonous cases were reported in 2011 and 20 autochthonous malaria vivax cases were recorded in 2012 [6]. The estimated incidence of malaria cases in Greece was extremely low in specific agricultural areas of the country where immigrants from endemic countries lived and worked. In particular, the cumulative incidence of autochthonous malaria cases in Evrotas municipality was 0.26% from 2011 to 2012. For the same period, the cumulative incidence of autochthonous malaria cases in other areas (e.g. Marathon municipality in East Attica region unit) was even lower than Evrotas and was estimated at 0.009%. In January 2012, an Integrated surveillance and control programme for West Nile virus and malaria in Greece (MALWEST Project) was launched. Regarding malaria, the following actions were implemented: a) focus investigation in all autochthonous cases, b) an active case detection programme in areas with autochthonous cases, c) a mass screening program in immigrant and native populations in the Evrotas municipality and at points of entry. The main goal was to detect and treat malaria cases or carriers of the malaria parasite. SD Bioline Malaria Ag Pf/Pan Rapid Diagnostic Test (RDT) that detects hrp-2 and panLDH antigens was introduced in the above interventions for malaria diagnosis, while laboratory confirmation of suspected malaria cases was obtained by the examination of blood specimen sent to the National Malarial Reference Center (National School of Public Health, NMRC). RDT is a lateral flow test that can detect malaria antigens in a small amount of blood (5 L) and is based on the immunochromatographic principlescapture of parasite antigen using monoclonal antibodies against a malaria antigen [7]. It is estimated that over 200 different RDTs are commercially available [8], while a number of over 74 million RDTs were distributed during 2011, 72% of them in Africa, 22% in Southeast Asia and 4% in Eastern Mediterranean [9]. However, information is limited in regards to the evaluation of the use and performance of RDTs in non-endemic areas [8]. As Greece had been malaria-free for over 35 years, current experience on light microscopy regarding malaria diagnosis is quite low. Therefore, the effectiveness of RDT was assessed in order to find out whether this diagnostic tool could be routinely used for the diagnosis of malaria in a non-endemic country. Conventional microscopic examination of both thick and thin Giemsa stained blood smears has been widely accepted as the examination of choice for malaria diagnosis [10,11,12], but since the quality of microscopy-based diagnosis is frequently compromised [13], PCR seems to have been gaining ground in accurate malaria diagnosis [14]. Thus, this study compares the field application of the RDT for malaria diagnosis against light microscopy and PCR. Materials and Methods Study populationSample collection Our study population included immigrants and Greek population tested for malaria with RTDs, microscopy and PCR during active case detection (visits for fever/symptoms screening every 15 days in immigrants quarters), focus investigation (investigation of all residents around the cases h (...truncated)