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Haemozoin-detecting assays have been suggested as an alternative to immunoassay platforms but to date have not reached successful field deployment. Haemozoin is a paramagnetic crystal by-product of haemoglobin digestion by malaria parasites and is present in the food vacuole of malaria parasite-infected erythrocytes. This study aimed to compare the diagnostic capability of a new haemozoin-detecting platform, the Gazelle\u2122 device with optical microscopy, RDT and PCR in a vivax malaria-endemic region.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A comparative, double-blind study evaluating symptomatic malaria patients seeking medical care was conducted at an infectious diseases reference hospital in the western Brazilian Amazon. Optical microscopy, PCR, RDT, and Gazelle\u2122 were used to analyse blood samples. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and Kappa values were calculated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Out of 300 patients, 24 test results were excluded from the final analysis due to protocol violation (6) and inconclusive and\/or irretrievable results (18). Gazelle\u2122 sensitivity was 96.1\u2009% (91.3\u201398.3) and 72.1\u2009% (65.0\u201378.3) when compared to optical microscopy and PCR, respectively whereas it was 83.9\u2009% and 62.8\u2009% for RDTs. The platform presented specificity of 100\u2009% (97.4\u2013100), and 99.0\u2009% (94.8\u201399.9) when compared to optical microscopy, and PCR, respectively, which \u00a0was the same for RDTs. Its correct classification rate was 98.2\u2009% when compared to optical microscopy and 82.3\u2009% for PCR; the test\u2019s accuracy when compared to optical microscopy was 98.1\u2009% (96.4\u201399.7), when compared to RDT was 95.2\u2009% (93.0\u201397.5), and when compared to PCR was 85.6\u2009% (82.1\u201389.1). Kappa (95\u2009% CI) values for Gazelle\u2122 were 96.4 (93.2\u201399.5), 88.2 (82.6\u201393.8) and 65.3 (57.0\u201373.6) for optical microscopy, RDT and PCR, respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The Gazelle\u2122 device was shown to have faster, easier, good sensitivity, specificity, and accuracy when compared to microscopy and was superior to RDT, demonstrating to be an alternative for vivax malaria screening particularly in areas where malaria is concomitant with other febrile infections (including dengue fever, zika, chikungunya, Chagas, yellow fever, babesiosis).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s12936-021-03688-0","type":"journal-article","created":{"date-parts":[[2021,3,12]],"date-time":"2021-03-12T07:06:50Z","timestamp":1615532810000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":19,"title":["Performance of a sensitive haemozoin\u2010based malaria diagnostic test validated for vivax malaria diagnosis in Brazilian Amazon"],"prefix":"10.1186","volume":"20","author":[{"given":"Gisely Cardoso","family":"de Melo","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rebeca Linhares Abreu","family":"Netto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Victor Irungu","family":"Mwangi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yanka Evellyn Alves Rodrigues","family":"Salazar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vanderson","family":"de Souza Sampaio","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0848-1940","authenticated-orcid":false,"given":"Wuelton Marcelo","family":"Monteiro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fernando Fonseca","family":"de Almeida e Val","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne","family":"Rocheleau","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Priyaleela","family":"Thota","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcus Vin\u00edcius Guimar\u00e3es","family":"Lacerda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,3,12]]},"reference":[{"key":"3688_CR1","unstructured":"WHO. 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