{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,12]],"date-time":"2026-06-12T19:15:40Z","timestamp":1781291740579,"version":"3.54.1"},"reference-count":30,"publisher":"American Society for Microbiology","issue":"6","license":[{"start":{"date-parts":[[2024,6,12]],"date-time":"2024-06-12T00:00:00Z","timestamp":1718150400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/doi.org\/10.1128\/AuthorWarrantyLicense.v1"},{"start":{"date-parts":[[2024,6,12]],"date-time":"2024-06-12T00:00:00Z","timestamp":1718150400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"funder":[{"DOI":"10.13039\/100000030","name":"HHS | Centers for Disease Control and Prevention","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100000030","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["J Clin Microbiol"],"published-print":{"date-parts":[[2024,6,12]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n          <jats:sec>\n            <jats:title\/>\n            <jats:p>\n              Botulism is a paralytic disease due to the inhibition of acetylcholine exocytosis at the neuromuscular junction, which can be lethal if left untreated. Botulinum neurotoxins (BoNTs) are produced by some spore-forming\n              <jats:italic>Clostridium<\/jats:italic>\n              bacteria. The current confirmatory assay to test for BoNTs in clinical specimens is the gold-standard mouse bioassay. However, an Endopep-MS assay method has been developed to detect BoNTs in clinical samples using benchtop mass spectrometric detection. This work demonstrates the validation of the Endopep-MS method for clinical specimens with the intent of method distribution in public health laboratories. The Endopep-MS assay was validated by assessing the sensitivity, robustness, selectivity, specificity, and reproducibility. The limit of detection was found to be equivalent to or more sensitive than the mouse bioassay. Specificity studies determined no cross-reactivity between the different serotypes and no false positives from an exclusivity panel of culture supernatants of enteric disease organisms and non-toxigenic strains of\n              <jats:italic>Clostridium<\/jats:italic>\n              . Inter-serotype specificity testing with 19 BoNT subtypes was 100% concordant with the expected results, accurately determining the presence of the correct serotype and the absence of incorrect serotypes. Additionally, a panel of potential interfering substances was used to test selectivity. Finally, clinical studies included clinical specimen stability and reproducibility, which was found to be 99.9% from a multicenter evaluation study. The multicenter validation study also included a clinical validation study, which yielded a 99.4% correct determination rate. Use of the Endopep-MS method will improve the capacity and response time for laboratory confirmation of botulism in public health laboratories.\n            <\/jats:p>\n          <\/jats:sec>","DOI":"10.1128\/jcm.01629-23","type":"journal-article","created":{"date-parts":[[2024,4,30]],"date-time":"2024-04-30T13:01:47Z","timestamp":1714482107000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":5,"title":["Validation of a clinical assay for botulinum neurotoxins through mass spectrometric detection"],"prefix":"10.1128","volume":"62","author":[{"given":"Kaitlin M.","family":"Hoyt","sequence":"first","affiliation":[{"name":"Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, Georgia, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John R.","family":"Barr","sequence":"additional","affiliation":[{"name":"Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, Georgia, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andr\u00e9 O.","family":"Hopkins","sequence":"additional","affiliation":[{"name":"Division of Foodborne, Waterborne, and Environmental Diseases, National Center for Emerging Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janet K.","family":"Dykes","sequence":"additional","affiliation":[{"name":"Division of Foodborne, Waterborne, and Environmental Diseases, National Center for Emerging Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3116-0069","authenticated-orcid":false,"given":"Carolina","family":"L\u00faquez","sequence":"additional","affiliation":[{"name":"Division of Foodborne, Waterborne, and Environmental Diseases, National Center for Emerging Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8067-136X","authenticated-orcid":false,"given":"Suzanne R.","family":"Kalb","sequence":"additional","affiliation":[{"name":"Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, Georgia, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.15585\/mmwr.rr7002a1"},{"key":"e_1_3_3_3_2","volume-title":"Botulism in the United States, 1899-1996; handbook for epidemiologists, clinicians, and laboratory workers","author":"National Center for Infectious Diseases (U.S.)","year":"1998","unstructured":"National Center for Infectious Diseases (U.S.), Division of Bacterial and Mycotic Diseases. 1998. Botulism in the United States, 1899-1996; handbook for epidemiologists, clinicians, and laboratory workers. United States."},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.285.8.1059"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1038\/365160a0"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1038\/359832a0"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1152\/physrev.2000.80.2.717"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0021-9258(20)80452-9"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/0014-5793(93)80448-4"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0021-9258(19)50230-7"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.1471-4159.1999.0720327.x"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.3201\/eid1110.041279"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00216-017-0421-8"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ab.2014.08.026"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.15585\/mmwr.mm6552a8"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01023-17"},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.3390\/toxins9030094"},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0005355"},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2091-12-58"},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ab.2006.01.027"},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.1128\/AEM.01662-10"},{"key":"e_1_3_3_22_2","doi-asserted-by":"publisher","DOI":"10.1007\/978-1-4612-3900-0"},{"key":"e_1_3_3_23_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00216-012-5767-3"},{"key":"e_1_3_3_24_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0012237"},{"key":"e_1_3_3_25_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0116381"},{"key":"e_1_3_3_26_2","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2180-12-245"},{"key":"e_1_3_3_27_2","volume-title":"Interference testing in clinical chemistry","author":"Clinical and Laboratory Standards Institute","year":"2018","unstructured":"Clinical and Laboratory Standards Institute. 2018. Interference testing in clinical chemistry. Vol. 3. Clinical and Laboratory Standards Institute."},{"key":"e_1_3_3_28_2","unstructured":"FDA. 2013. Drug database medication guides. Available from: https:\/\/www.accessdata.fda.gov\/scripts\/cder\/daf\/index.cfm?event=medguide.page"},{"key":"e_1_3_3_29_2","unstructured":"FDA. 2018. Drug Databases medication guides. Available from: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/021892s014lbl.pdf#page=13"},{"key":"e_1_3_3_30_2","unstructured":"CDC. 2023. Test order. 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