{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,29]],"date-time":"2026-08-29T18:18:40Z","timestamp":1788027520641,"version":"build-2784847793"},"reference-count":21,"publisher":"American Society for Microbiology","issue":"11","license":[{"start":{"date-parts":[[2025,11,12]],"date-time":"2025-11-12T00:00:00Z","timestamp":1762905600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2025,11,12]],"date-time":"2025-11-12T00:00:00Z","timestamp":1762905600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["J Clin Microbiol"],"published-print":{"date-parts":[[2025,11,12]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title\/>\n                    <jats:p>\n                      Amoebiasis is a cosmopolitan parasitic disease caused by\n                      <jats:italic toggle=\"yes\">Entamoeba histolytica<\/jats:italic>\n                      . The most lethal form is extra-intestinal amoebiasis, mainly manifesting as liver abscesses. Diagnosis is based on clinical, radiological, and biological tests. However, there are currently few serology reagents still available on the European market for\n                      <jats:italic toggle=\"yes\">in vitro<\/jats:italic>\n                      diagnosis, and comparative studies of existing reagents are required. We evaluated the performances of the four currently available reagents, either as standalone tests or in combination. Two enzyme-linked immunosorbent assays (ELISAs) for the detection of\n                      <jats:italic toggle=\"yes\">E. histolytica<\/jats:italic>\n                      IgG were assessed: one manufactured by Bordier and the other by NovaTec. Additionally, an indirect hemagglutination technique, ELI.H.A\n                      <jats:italic toggle=\"yes\">Amoeba<\/jats:italic>\n                      , and a latex particle agglutination technique, ELITex Bicolor\n                      <jats:italic toggle=\"yes\">Amoeba<\/jats:italic>\n                      , both produced by ELITech Microbio, were evaluated. A total of 442 serum samples were selected from a shared centralized biobank of seven university hospitals in France. The samples included 79 from patients with amoebic abscess, 13 with amoebic colitis, and 350 from healthy donors and patients with parasitic and non-parasitic diseases, especially liver disease and immune dysfunction. The sensitivity of the four kits ranged from 87.3% to 97.5%, while their specificity ranged from 78.3% to 98.6%. Bordier ELISA demonstrated the highest sensitivity, while ELITex Bicolor\n                      <jats:italic toggle=\"yes\">Amoeba<\/jats:italic>\n                      latex reagent exhibited the highest specificity. The combination of Bordier ELISA and\/or ELI.H.A\n                      <jats:italic toggle=\"yes\">Amoeba<\/jats:italic>\n                      for screening, combined with ELITex Bicolor\n                      <jats:italic toggle=\"yes\">Amoeba<\/jats:italic>\n                      for confirmation of positive screening results, yielded the most optimal performance. This study highlights the benefits of large comparative studies of commercial assays to guide clinical microbiologists in their choices.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>IMPORTANCE<\/jats:title>\n                    <jats:p>\n                      Amoebiasis caused by\n                      <jats:italic toggle=\"yes\">Entamoeba histolytica<\/jats:italic>\n                      is common in countries with low socio-economic levels. The most lethal form is extraintestinal amoebiasis, mainly liver abscesses, which require rapid and accurate diagnosis. Diagnosis is based on clinical, radiological, and, most importantly, serological tests. Implementing a diagnostic strategy requires both knowledge of how diagnostic tests compare with each other and thorough cross-validation. To help the clinical microbiologist choose a serological reagent, we evaluated the performance of four serological reagents currently available on the European market using a large biobank of sera from seven French university hospitals. In addition to patients with amoebic abscess and healthy donors, our study included many samples from patients with other parasitic and non-parasitic pathologies (liver diseases, immune dysfunctions) in order to study particularly non-specific reactivities.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1128\/jcm.00179-25","type":"journal-article","created":{"date-parts":[[2025,10,21]],"date-time":"2025-10-21T13:11:47Z","timestamp":1761052307000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":4,"title":["Serodiagnosis of amoebic abscess: a retrospective diagnostic accuracy study of kits marketed in Europe"],"prefix":"10.1128","volume":"63","author":[{"ORCID":"https:\/\/orcid.org\/0009-0007-4846-4639","authenticated-orcid":true,"given":"E.","family":"Pr\u00e9tot","sequence":"first","affiliation":[{"id":[{"id":"https:\/\/ror.org\/04asdee31","id-type":"ROR","asserted-by":"publisher"}],"name":"Universit\u00e9 Marie et Louis Pasteur, CHU Besan\u00e7on, CNRS, Chrono-Environnement (UMR-6249)","place":["Besan\u00e7on, France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1366-5856","authenticated-orcid":false,"given":"M-P.","family":"Brenier-Pinchart","sequence":"additional","affiliation":[{"name":"Universit\u00e9 Grenoble Alpes, CHU Grenoble","place":["Grenoble, France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6365-8174","authenticated-orcid":false,"given":"P.","family":"Tirard-Collet","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/006evg656","id-type":"ROR","asserted-by":"publisher"}],"name":"Universit\u00e9 Lyon I, Hospices Civils de Lyon, H\u00f4pital de la Croix-Rousse","place":["Lyon, France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9223-2516","authenticated-orcid":false,"given":"F.","family":"Gabriel","sequence":"additional","affiliation":[{"name":"Centre Hospitalier Universitaire de Bordeaux","place":["Bordeaux, France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-1990-1538","authenticated-orcid":false,"given":"F.","family":"Touafek","sequence":"additional","affiliation":[{"name":"Assistance Publique\u2013H\u00f4pitaux de Paris (AP-HP) - La Piti\u00e9-Salp\u00eatri\u00e8re \u2013 Charles-Foix","place":["Paris, France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-0495-1091","authenticated-orcid":false,"given":"A.","family":"Marteau","sequence":"additional","affiliation":[{"name":"Universit\u00e9 Sorbonne Paris Nord, AP-HP \u2013 Avicenne","place":["Bobigny, France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.","family":"Delcey","sequence":"additional","affiliation":[{"name":"CHU Besan\u00e7on","place":["Besan\u00e7on, France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8496-2968","authenticated-orcid":false,"given":"C.","family":"Amiot","sequence":"additional","affiliation":[{"name":"CHU Besan\u00e7on","place":["Besan\u00e7on, France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6992-1073","authenticated-orcid":true,"given":"D.","family":"Dupont","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/006evg656","id-type":"ROR","asserted-by":"publisher"}],"name":"Universit\u00e9 Lyon I, Hospices Civils de Lyon, H\u00f4pital de la Croix-Rousse","place":["Lyon, France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1932-2531","authenticated-orcid":false,"given":"H.","family":"Fricker-Hidalgo","sequence":"additional","affiliation":[{"name":"Universit\u00e9 Grenoble Alpes, CHU Grenoble","place":["Grenoble, France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2914-1822","authenticated-orcid":true,"given":"H.","family":"Sokol","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/02en5vm52","id-type":"ROR","asserted-by":"publisher"}],"name":"Sorbonne Universit\u00e9, INSERM, Centre de Recherche Saint-Antoine (CRSA), AP-HP, H\u00f4pital Saint-Antoine","place":["Paris, France"]},{"name":"INRAe, Micalis & AgroParisTech","place":["Jouy-en-Josas, France"]},{"name":"Paris Centre for Microbiome Medicine (PaCeMM) FHU","place":["Paris, France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7571-9533","authenticated-orcid":false,"given":"A.","family":"Moreno-Sabater","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/02en5vm52","id-type":"ROR","asserted-by":"publisher"}],"name":"Centre d'Immunologie et des Maladies Infectieuses, Sorbonne Universit\u00e9, INSERM, AP-HP, H\u00f4pital Saint-Antoine","place":["Paris, France"]},{"id":[{"id":"https:\/\/ror.org\/00yyw0g86","id-type":"ROR","asserted-by":"publisher"}],"name":"PaCEMM FHU","place":["Paris, France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6001-3135","authenticated-orcid":false,"given":"F.","family":"Grenouillet","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/04asdee31","id-type":"ROR","asserted-by":"publisher"}],"name":"Universit\u00e9 Marie et Louis Pasteur, CHU Besan\u00e7on, CNRS, Chrono-Environnement (UMR-6249)","place":["Besan\u00e7on, France"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_4_2_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.43.9.4801-4806.2005"},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(03)12830-9"},{"key":"e_1_3_4_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(12)61728-0"},{"key":"e_1_3_4_5_2","doi-asserted-by":"publisher","DOI":"10.1093\/ofid\/ofy161"},{"key":"e_1_3_4_6_2","unstructured":"Regulation (EU) 2017\/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98\/79\/EC and Commission Decision 2010\/227\/EU. 2017 P. 176-332. https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/HTML\/?uri=CELEX%3A32017R0746."},{"key":"e_1_3_4_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jbi.2014.02.013"},{"key":"e_1_3_4_8_2","doi-asserted-by":"publisher","DOI":"10.3347\/kjp.2018.56.1.71"},{"key":"e_1_3_4_9_2","doi-asserted-by":"publisher","DOI":"10.1128\/jcm.28.6.1422-1424.1990"},{"key":"e_1_3_4_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.diagmicrobio.2013.09.002"},{"key":"e_1_3_4_11_2","doi-asserted-by":"publisher","DOI":"10.1128\/jcm.35.6.1530-1532.1997"},{"key":"e_1_3_4_12_2","unstructured":"Entamoeba histolytica IgG ELISA. 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