{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T22:39:34Z","timestamp":1789079974480,"version":"build-2803163510"},"reference-count":14,"publisher":"American Society for Microbiology","issue":"12","license":[{"start":{"date-parts":[[2025,12,17]],"date-time":"2025-12-17T00:00:00Z","timestamp":1765929600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2025,12,17]],"date-time":"2025-12-17T00:00:00Z","timestamp":1765929600000},"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":[[2025,12,17]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title\/>\n                    <jats:p>\n                      Historic detection methods for diarrheal pathogens are time-consuming, laborious, and may lack specificity and sensitivity. Multiplexed molecular panels for enteric pathogens are widely used for rapid and accurate results. We evaluated the performance of the investigational use only (IUO) Hologic Panther Fusion GI Bacterial and Expanded Bacterial assays (Fusion GI Bac), the Verigene Enteric Pathogens (EP), and BioFire FilmArray Gastrointestinal (BioFire GI) panels for the detection of primary bacterial causes of gastrointestinal infection. We conducted a multi-platform evaluation for the detection of\n                      <jats:italic toggle=\"yes\">Salmonella<\/jats:italic>\n                      ,\n                      <jats:italic toggle=\"yes\">Shigella<\/jats:italic>\n                      \/Enteroinvasive\n                      <jats:italic toggle=\"yes\">Escherichia coli<\/jats:italic>\n                      ,\n                      <jats:italic toggle=\"yes\">Campylobacter<\/jats:italic>\n                      , Shiga toxin-producing\n                      <jats:italic toggle=\"yes\">E. coli<\/jats:italic>\n                      ,\n                      <jats:italic toggle=\"yes\">Vibrio<\/jats:italic>\n                      , and\n                      <jats:italic toggle=\"yes\">Yersinia enterocolitica<\/jats:italic>\n                      . Limited analysis of\n                      <jats:italic toggle=\"yes\">Plesiomonas shigelloides<\/jats:italic>\n                      and\n                      <jats:italic toggle=\"yes\">E. coli<\/jats:italic>\n                      O157 was also performed. A total of 591 stool specimens underwent complete analysis: 263 frozen positive specimens and 328 freshly collected samples. We used a 2-out-of-3 consensus as the reference for assay performance. Positive and negative percent agreement (PPA and NPA) were high for most pathogen\/assay pairs. Individual false-positive (FP) or false-negative (FN) results were seen for all pathogens and assays. PPAs below 95% in the retrospective samples were seen for Shiga toxin (Verigene EP, 89.3%) and\n                      <jats:italic toggle=\"yes\">Y. enterocolitica<\/jats:italic>\n                      (Verigene EP, 88.9% and Fusion GI Bac, 72.2%). There were 12 FP results for\n                      <jats:italic toggle=\"yes\">Vibrio<\/jats:italic>\n                      affecting all assays. Factors contributing to erroneous results, including freeze\/thaw effects, are discussed. Overall, the IUO Panther Fusion GI Bacterial and Expanded Bacterial assays were comparable to two commercially available GI panels with a straightforward workflow using a high-throughput instrument.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>IMPORTANCE<\/jats:title>\n                    <jats:p>Bacterial causes of diarrhea lead to significant morbidity and mortality around the world. Historic testing methods, for example, antigens and culture. For these reasons, molecular testing for enteric bacterial pathogens has become widely used, but there are limited numbers of commercially available tests on the market, especially those suitable for higher-throughput testing. We show that the high-throughput, random- access investigational use only Hologic Panther Fusion Gastrointestinal (GI) Bacterial assay and Panther Fusion GI Expanded Bacterial assay perform comparably to existing assays.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1128\/jcm.00730-25","type":"journal-article","created":{"date-parts":[[2025,11,14]],"date-time":"2025-11-14T14:00:15Z","timestamp":1763128815000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":1,"title":["Evaluation of the Hologic Panther Fusion investigational use only assays for gastrointestinal bacterial pathogens"],"prefix":"10.1128","volume":"63","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0298-6734","authenticated-orcid":true,"given":"Rama R.","family":"Yakubu","sequence":"first","affiliation":[{"id":[{"id":"https:\/\/ror.org\/03v76x132","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Laboratory Medicine, Yale University","place":["New Haven, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacob","family":"Merwede","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/05tszed37","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Laboratory Medicine, Yale New Haven Hospital","place":["New Haven, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brianna","family":"Viglione","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/05tszed37","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Laboratory Medicine, Yale New Haven Hospital","place":["New Haven, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vikas","family":"Patel","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/05tszed37","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Laboratory Medicine, Yale New Haven Hospital","place":["New Haven, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9952-5012","authenticated-orcid":true,"given":"David R.","family":"Peaper","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/03v76x132","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Laboratory Medicine, Yale University","place":["New Haven, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1097\/MOG.0b013e32831ba094"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.cll.2015.02.006"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01457-17"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciy357"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.02674-14"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-021-82490-z"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.diagmicrobio.2016.09.013"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/cix730"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/cix669"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1093\/ofid\/ofab247"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01899-15"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1086\/518573"},{"key":"e_1_3_3_14_2","unstructured":"FDA Recalls - CDRH Res. 2025. Available from: https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfRES\/res.cfm. Retrieved 6 Mar 2025."},{"key":"e_1_3_3_15_2","volume-title":"The Sanford guide to antimicrobial therapy 2025","author":"Gilbert DN","year":"2025","unstructured":"Gilbert DN, Chambers HF, Eliopoulos GM, Saag MS, Pavia AT. 2025. The Sanford guide to antimicrobial therapy 2025. 55th ed. Antimicrobial Therapy, Inc, Sperryville, VA.","edition":"55"}],"container-title":["Journal of Clinical Microbiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/jcm.00730-25","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/jcm.00730-25","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,17]],"date-time":"2025-12-17T14:01:01Z","timestamp":1765980061000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/jcm.00730-25"}},"subtitle":[],"editor":[{"given":"Daniel D.","family":"Rhoads","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2025,12,17]]},"references-count":14,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2025,12,17]]}},"alternative-id":["10.1128\/jcm.00730-25"],"URL":"https:\/\/doi.org\/10.1128\/jcm.00730-25","relation":{},"ISSN":["0095-1137","1098-660X"],"issn-type":[{"value":"0095-1137","type":"print"},{"value":"1098-660X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,12,17]]},"assertion":[{"value":"2025-05-13","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-10-23","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-11-14","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e00730-25"}}