{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T21:12:53Z","timestamp":1792530773611,"version":"4.5.0"},"reference-count":41,"publisher":"American Society for Microbiology","issue":"8","license":[{"start":{"date-parts":[[2025,8,13]],"date-time":"2025-08-13T00:00:00Z","timestamp":1755043200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2025,8,13]],"date-time":"2025-08-13T00:00:00Z","timestamp":1755043200000},"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":[[2025,8,13]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title\/>\n                    <jats:p>\n                      The QIAstat-Dx Gastrointestinal Panel 2 (GI2 Panel) is a sample-to-answer multiplex PCR instrument that can detect 17 targets in a run time of about 80 minutes. The performance of the QIAstat-Dx GI2 Panel was evaluated by testing 1,939 prospective, 119 prospectively collected and then archived positive clinical samples and 750 retrospective clinical specimens across 13 sites in Europe and the United States. Specimens tested included bulk stool samples preserved in modified Cary-Blair transport medium. For most targets, results were compared to those of the FilmArray GI panel (13\/17), and discordant results were adjudicated with a third assay. For the remaining targets (4\/17), a composite comparator method was used, which included three comparator assays for each target. Before discordant resolution, the QIAstat-Dx GI2 Panel positive percent agreement (PPA) was 95% or greater for 5\/17 targets (\n                      <jats:italic toggle=\"yes\">Campylobacter<\/jats:italic>\n                      ,\n                      <jats:italic toggle=\"yes\">E. coli<\/jats:italic>\n                      O157,\n                      <jats:italic toggle=\"yes\">Cryptosporidium, Cyclospora cayetanensis,<\/jats:italic>\n                      and\n                      <jats:italic toggle=\"yes\">Giardia lamblia<\/jats:italic>\n                      ) and 90% or greater for 11\/17 targets: adenovirus F40\/F41, astrovirus, norovirus GI\/GII, rotavirus A,\n                      <jats:italic toggle=\"yes\">Plesiomonas shigelloides<\/jats:italic>\n                      , enteropathogenic\n                      <jats:italic toggle=\"yes\">Escherichia coli<\/jats:italic>\n                      , enterotoxigenic\n                      <jats:italic toggle=\"yes\">E. coli<\/jats:italic>\n                      ,\n                      <jats:italic toggle=\"yes\">Salmonella<\/jats:italic>\n                      ,\n                      <jats:italic toggle=\"yes\">Yersinia enterocolitica,<\/jats:italic>\n                      Shiga-like toxin\n                      <jats:italic toggle=\"yes\">E. coli<\/jats:italic>\n                      (STEC)\n                      <jats:italic toggle=\"yes\">stx1\/stx2<\/jats:italic>\n                      , and\n                      <jats:italic toggle=\"yes\">Shigella<\/jats:italic>\n                      \/enteroinvasive\n                      <jats:italic toggle=\"yes\">E. coli<\/jats:italic>\n                      . No cases of\n                      <jats:italic toggle=\"yes\">Entamoeba histolytica<\/jats:italic>\n                      were encountered during the clinical study. The negative percent agreement (NPA) was &gt;98.9% for all QIAstat-Dx GI2 Panel targets. The three most common pathogens identified in single and co-infections were enteropathogenic\n                      <jats:italic toggle=\"yes\">E. coli<\/jats:italic>\n                      (9.9%),\n                      <jats:italic toggle=\"yes\">Campylobacter<\/jats:italic>\n                      (5.2%), and norovirus GI\/GII (3.1%). In summary, this clinical study examined more than 2,800 samples from Europe and the U.S. using the QIAstat-Dx GI2 Panel and identified 90%\u2013100% PPA and 99% NPA for its 17 targets.\n                    <\/jats:p>\n                    <jats:sec>\n                      <jats:title>IMPORTANCE<\/jats:title>\n                      <jats:p>The manuscript highlights the significance and impact of the QIAstat-Dx GI2 Panel, a sample-to-answer multiplex PCR instrument capable of detecting 17 targets in approximately 80 minutes. This comprehensive clinical study, conducted across 13 sites in Europe and the United States, evaluated the performance of the panel using over 2,800 clinical samples. The results demonstrate a high accuracy of the QIAstat-Dx GI2 panel, with a PPA equal to or higher than 90% for all targets and an NPA greater than 98.9% for all targets. These findings underscore the reliability and effectiveness of the GI2 panel in the rapid and precise detection of gastrointestinal pathogens, which is crucial for timely diagnosis and treatment of infections.<\/jats:p>\n                    <\/jats:sec>\n                  <\/jats:sec>","DOI":"10.1128\/jcm.01983-24","type":"journal-article","created":{"date-parts":[[2025,7,11]],"date-time":"2025-07-11T13:01:28Z","timestamp":1752238888000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":6,"title":["Multicenter evaluation of the QIAstat-Dx Gastrointestinal Panel 2, a multiplex PCR platform for the diagnosis of acute gastroenteritis"],"prefix":"10.1128","volume":"63","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0747-1169","authenticated-orcid":true,"given":"Wendy A.","family":"Szymczak","sequence":"first","affiliation":[{"id":[{"id":"https:\/\/ror.org\/05cf8a891","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Pathology, Albert Einstein College of Medicine and Montefiore Medical Center","place":["Bronx, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne Line","family":"Engsbro","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/051dzw862","id-type":"ROR","asserted-by":"publisher"}],"name":"Copenhagen University Hospital and Hvidovre","place":["Copenhagen, Denmark"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan Gorm","family":"Lisby","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/051dzw862","id-type":"ROR","asserted-by":"publisher"}],"name":"Copenhagen University Hospital and Hvidovre","place":["Copenhagen, Denmark"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan Jos\u00e9","family":"Gonz\u00e1lez-L\u00f3pez","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/00ca2c886","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Clinical Microbiology, Hospital Universitari Vall d'Hebron","place":["Barcelona, Spain"]},{"id":[{"id":"https:\/\/ror.org\/00ca2c886","id-type":"ROR","asserted-by":"publisher"}],"name":"CIBER de Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III","place":["Madrid, Spain"]},{"id":[{"id":"https:\/\/ror.org\/052g8jq94","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Genetics and Microbiology, Universitat Aut\u00f2noma de Barcelona","place":["Bellaterra, Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5068-1137","authenticated-orcid":true,"given":"Paul","family":"Granato","sequence":"additional","affiliation":[{"name":"Laboratory Alliance of Central","place":["Liverpool, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathan","family":"Ledeboer","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/00qqv6244","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Pathology, Medical College of Wisconsin","place":["Milwaukee, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2828-5135","authenticated-orcid":true,"given":"Donna M.","family":"Wolk","sequence":"additional","affiliation":[{"name":"Geisinger Diagnostic Medicine Institute","place":["Danville, USA"]},{"name":"Geisinger Commonwealth School of Medicine","place":["Scranton, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Young","sequence":"additional","affiliation":[{"name":"TriCore Reference Laboratories","place":["Albuquerque, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7636-5191","authenticated-orcid":true,"given":"Daniel D.","family":"Rhoads","sequence":"additional","affiliation":[{"name":"Department of Pathology and Laboratory Medicine, Cleveland Clinic","place":["Cleveland, USA"]},{"id":[{"id":"https:\/\/ror.org\/051fd9666","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Pathology, Cleveland Clinic Lerner College of Medicine, Case Western University School of Medicine","place":["Cleveland, USA"]},{"name":"Infection Biology Program, Lerner Research Institute","place":["Cleveland, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8332-9383","authenticated-orcid":true,"given":"Yvan","family":"Caspar","sequence":"additional","affiliation":[{"name":"Laboratoire de Bacteriologie - Hygiene Hospitaliere, CHU Grenoble Alpes","place":["La Tronche, France"]},{"name":"Universit\u00e9 Grenoble Alpes, CEA, CNRS, IBS","place":["Grenoble, France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa","family":"Steed","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/012jban78","id-type":"ROR","asserted-by":"publisher"}],"name":"Medical University of South Carolina","place":["Charleston, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6568-156X","authenticated-orcid":true,"given":"Romney","family":"Humphries","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/05dq2gs74","id-type":"ROR","asserted-by":"publisher"}],"name":"Vanderbilt University Medical Center","place":["Nashville, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher","family":"Bielefeldt","sequence":"additional","affiliation":[{"name":"Christus Health","place":["Beaumont, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Markus","family":"Hermanowski","sequence":"additional","affiliation":[{"name":"Labor Berlin - Charite Vivantes GmbH","place":["Berlin, Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juana L.","family":"de Diego","sequence":"additional","affiliation":[{"name":"Labor Berlin - Charite Vivantes GmbH","place":["Berlin, Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hendrik","family":"Leibhan","sequence":"additional","affiliation":[{"name":"Labor Berlin - Charite Vivantes GmbH","place":["Berlin, Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pau","family":"Boher","sequence":"additional","affiliation":[{"name":"STAT-Dx Life, S.L. (a QIAGEN Company), Baldiri Reixac","place":["Barcelona, Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carla","family":"Camprub\u00ed","sequence":"additional","affiliation":[{"name":"STAT-Dx Life, S.L. (a QIAGEN Company), Baldiri Reixac","place":["Barcelona, Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Orthodoxou","sequence":"additional","affiliation":[{"name":"QIAGEN Manchester Ltd, Citylabs 2.0","place":["Manchester, United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2376-6231","authenticated-orcid":true,"given":"Ester","family":"Sala","sequence":"additional","affiliation":[{"name":"STAT-Dx Life, S.L. (a QIAGEN Company), Baldiri Reixac","place":["Barcelona, Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Johnson","sequence":"additional","affiliation":[{"name":"QIAGEN Manchester Ltd, Citylabs 2.0","place":["Manchester, United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4566-7154","authenticated-orcid":true,"given":"Mart\u00ed","family":"Juanola-Falgarona","sequence":"additional","affiliation":[{"name":"STAT-Dx Life, S.L. (a QIAGEN Company), Baldiri Reixac","place":["Barcelona, Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Davide","family":"Manissero","sequence":"additional","affiliation":[{"name":"QIAGEN Manchester Ltd, Citylabs 2.0","place":["Manchester, United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johanna","family":"Bialas","sequence":"additional","affiliation":[{"name":"Labor Berlin - Charite Vivantes GmbH","place":["Berlin, Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_5_2_2","doi-asserted-by":"publisher","DOI":"10.1097\/MCG.0b013e31826df662"},{"key":"e_1_3_5_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(18)30362-1"},{"key":"e_1_3_5_4_2","doi-asserted-by":"publisher","DOI":"10.4315\/0362-028X.JFP-11-417"},{"key":"e_1_3_5_5_2","doi-asserted-by":"publisher","DOI":"10.1017\/S0950268816000467"},{"key":"e_1_3_5_6_2","doi-asserted-by":"publisher","DOI":"10.1038\/srep22144"},{"key":"e_1_3_5_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhin.2017.05.015"},{"key":"e_1_3_5_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(10)60549-1"},{"key":"e_1_3_5_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/0168-1605(96)00996-8"},{"key":"e_1_3_5_10_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12876-014-0211-0"},{"key":"e_1_3_5_11_2","doi-asserted-by":"publisher","DOI":"10.1097\/MOG.0000000000000405"},{"key":"e_1_3_5_12_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01775-18"},{"key":"e_1_3_5_13_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10096-021-04266-7"},{"key":"e_1_3_5_14_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00148-18"},{"key":"e_1_3_5_15_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0228596"},{"key":"e_1_3_5_16_2","doi-asserted-by":"publisher","DOI":"10.1177\/2049936120959561"},{"key":"e_1_3_5_17_2","doi-asserted-by":"publisher","DOI":"10.1111\/jgh.15581"},{"key":"e_1_3_5_18_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12876-020-01394-w"},{"key":"e_1_3_5_19_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.02103-15"},{"key":"e_1_3_5_20_2","doi-asserted-by":"publisher","DOI":"10.1017\/S0950268813002367"},{"key":"e_1_3_5_21_2","doi-asserted-by":"publisher","DOI":"10.1128\/CMR.00024-17"},{"key":"e_1_3_5_22_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.cll.2022.09.008"},{"key":"e_1_3_5_23_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.cll.2015.02.006"},{"key":"e_1_3_5_24_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.02674-14"},{"key":"e_1_3_5_25_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10096-016-2858-7"},{"key":"e_1_3_5_26_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.cmi.2015.04.007"},{"key":"e_1_3_5_27_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.trstmh.2008.03.017"},{"key":"e_1_3_5_28_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10096-023-04642-5"},{"key":"e_1_3_5_29_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.cmi.2015.01.015"},{"key":"e_1_3_5_30_2","doi-asserted-by":"publisher","DOI":"10.1128\/CMR.00006-15"},{"key":"e_1_3_5_31_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-020-70593-y"},{"key":"e_1_3_5_32_2","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2020.01383"},{"key":"e_1_3_5_33_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMsa1206589"},{"key":"e_1_3_5_34_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/cix669"},{"key":"e_1_3_5_35_2","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2016.126"},{"key":"e_1_3_5_36_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01637-14"},{"key":"e_1_3_5_37_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10096-013-1825-9"},{"key":"e_1_3_5_38_2","doi-asserted-by":"publisher","DOI":"10.1093\/ofid\/ofab445"},{"key":"e_1_3_5_39_2","doi-asserted-by":"publisher","DOI":"10.1111\/1469-0691.12698"},{"key":"e_1_3_5_40_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0089496"},{"key":"e_1_3_5_41_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(97)11257-0"},{"key":"e_1_3_5_42_2","doi-asserted-by":"publisher","DOI":"10.3201\/eid1410.080117"}],"container-title":["Journal of Clinical Microbiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/jcm.01983-24","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/jcm.01983-24","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,8,13]],"date-time":"2025-08-13T13:00:42Z","timestamp":1755090042000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/jcm.01983-24"}},"subtitle":[],"editor":[{"given":"John P.","family":"Dekker","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2025,8,13]]},"references-count":41,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2025,8,13]]}},"alternative-id":["10.1128\/jcm.01983-24"],"URL":"https:\/\/doi.org\/10.1128\/jcm.01983-24","relation":{},"ISSN":["0095-1137","1098-660X"],"issn-type":[{"value":"0095-1137","type":"print"},{"value":"1098-660X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,8,13]]},"assertion":[{"value":"2024-12-16","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-06-03","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-07-11","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e01983-24"}}