{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,4]],"date-time":"2026-11-04T05:25:43Z","timestamp":1793769943806,"version":"4.6.1"},"reference-count":39,"publisher":"American Society for Microbiology","license":[{"start":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T00:00:00Z","timestamp":1791849600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T00:00:00Z","timestamp":1791849600000},"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"],"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title\/>\n                    <jats:p>\n                      Broth microdilution (BMD) remains the reference standard for determining minimum inhibitory concentrations (MICs) in antimicrobial susceptibility testing (AST). However, most routine laboratories rely on surrogate methods, including disk diffusion and commercial MIC-generating systems, whose results must correlate with those of reference BMD prior to clinical use. Evaluation criteria differ across standards development organizations (SDOs) and regulatory authorities, potentially affecting clinical interpretation, particularly in low- and middle-income countries (LMICs). This mini-review compares evaluation frameworks from major SDOs\u2014the Clinical and Laboratory Standards Institute (CLSI), the European Committee on Antimicrobial Susceptibility Testing (EUCAST), and the International Organization for Standardization (ISO)\u2014and regulatory frameworks, including the U.S. Food and Drug Administration (FDA) and the European\n                      <jats:italic toggle=\"yes\">In Vitro<\/jats:italic>\n                      Diagnostic Regulation (IVDR). Key performance metrics, including essential agreement, categorical agreement, error rates, reproducibility, and bias, were analyzed, alongside differences in breakpoint setting and device approval pathways. Implications for clinical microbiology and antimicrobial stewardship were considered, with explicit emphasis on challenges faced in LMIC settings. Substantial heterogeneity exists across frameworks. CLSI and FDA emphasize breakpoint-dependent categorical agreement and error rates, whereas ISO prioritizes analytical measures such as essential agreement and bias without categorical errors. EUCAST broadly aligns with ISO analytically while separately maintaining responsibility for breakpoint setting. These differences can yield discordant device assessments, especially after breakpoint revisions. Surrogate MICs often correlate with BMD near breakpoints but may show systematic bias across MIC ranges, not fully captured by essential agreement alone, with important implications for LMIC laboratories. Divergent frameworks influence susceptibility interpretation, resistance surveillance, and antimicrobial stewardship, particularly in LMICs. Greater harmonization and awareness of methodological limitations are essential to ensure reliable AST reporting and support global antimicrobial resistance efforts across LMIC healthcare systems.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1128\/jcm.00643-26","type":"journal-article","created":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T14:39:59Z","timestamp":1791902399000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":0,"title":["Performance evaluation of antimicrobial susceptibility testing devices across CLSI, EUCAST, ISO, FDA, and EMA frameworks: implications for breakpoint application"],"prefix":"10.1128","author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-2893-7640","authenticated-orcid":true,"given":"Amol","family":"Shindikar","sequence":"first","affiliation":[{"id":[{"id":"https:\/\/ror.org\/020t0j562","id-type":"ROR","asserted-by":"publisher"}],"name":"Central Research Laboratory, MGM Medical College and Hospital (Affiliated to MGM Institute of Health Sciences (MGMIHS) Deemed University, MGM Educational Campus,","place":["Chhatrapati Sambhaji Nagar, India"]},{"name":"Department of Pharmaceutical Sciences, Faculty Division III, Birla Institute of Technology and Science (BITS) Pilani campus (Deemed University)","place":["Pilani, India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8904-3845","authenticated-orcid":true,"given":"Radhakrishnan","family":"Mahesh","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Sciences, Faculty Division III, Birla Institute of Technology and Science (BITS) Pilani campus (Deemed University)","place":["Pilani, India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7191-5599","authenticated-orcid":true,"given":"Hariharan","family":"Periasamy","sequence":"additional","affiliation":[{"name":"Drug Discovery Biology group, Wockhardt Research Center","place":["Chhatrapati Sambhajinagar, India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-0280-5114","authenticated-orcid":true,"given":"Suyog","family":"Vaidya","sequence":"additional","affiliation":[{"name":"Drug Discovery Biology group, Wockhardt Research Center","place":["Chhatrapati Sambhajinagar, India"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","published-online":{"date-parts":[[2026,10,13]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1086\/647952"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpha.2015.11.005"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.3390\/antibiotics11040427"},{"key":"e_1_3_3_5_2","volume-title":"CLSI Standard M07","author":"Clinical and Laboratory Standards Institute","year":"2024","unstructured":"Clinical and Laboratory Standards Institute. 2024. Methods for dilution antimicrobial susceptibility tests for bacteria that grow aerobically, 12th ed. In CLSI Standard M07. CLSI, Wayne, PA."},{"key":"e_1_3_3_6_2","unstructured":"International organization for standardization. 2019. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices\u2014part 1: broth microdilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases. International Organization for Standardization. Geneva Switzerland ISO"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01999-17"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41579-020-0327-x"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.mayocp.2012.01.007"},{"key":"e_1_3_3_10_2","unstructured":"European. 2023. Disk diffusion method for antimicrobial susceptibility testing version 11.0. EUCAST V\u00e4xj\u00f6 Sweden."},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1128\/CMR.00047-06"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01934-17"},{"key":"e_1_3_3_13_2","unstructured":"Food US Administration D. 2009. Class II special controls guidance document: antimicrobial susceptibility test systems. FDA Silver Spring MD"},{"key":"e_1_3_3_14_2","unstructured":"International organization for standardization. 2021. Clinical laboratory testing and in vitro diagnostic test systems \u2014 susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices- part 2: evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution. International Organization for Standardization. ISO Geneva Switzerland"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00139-18"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkr524"},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.1093\/ofid\/ofac007"},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciw118"},{"key":"e_1_3_3_19_2","unstructured":"World health organization. 2025. Global antibiotic resistance surveillance report 2025. World Health Organization. WHO. https:\/\/www.who.int\/publications\/i\/item\/9789240116337."},{"key":"e_1_3_3_20_2","unstructured":"Organization WH. 2022. Global antimicrobial resistance and use surveillance system (GLASS) report: 2022. WHO Geneva. https:\/\/who.int\/publications\/i\/item\/9789240062702."},{"key":"e_1_3_3_21_2","unstructured":"World Health Organization. 2025. Global antimicrobial resistance and use surveillance system (GLASS) report: antibiotic use data for 2022. WHO Geneva Switzerland. https:\/\/www.who.int\/publications\/i\/item\/9789240108127."},{"key":"e_1_3_3_22_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(21)02724-0"},{"key":"e_1_3_3_23_2","unstructured":"Food US Administration D. 2026 Antibacterial susceptibility test interpretive criteria (STIC) Available from: https:\/\/www.fda.gov\/drugs\/development-resources\/fda-recognized-antimicrobial-susceptibility-test-interpretive-criteria"},{"key":"e_1_3_3_24_2","unstructured":"Clinical and laboratory standards institute. 2023. Development of in vitro susceptibility test methods breakpoints and quality control parameters 6th ed. CLSI Guideline M23. CLSI Wayne PA"},{"key":"e_1_3_3_25_2","unstructured":"Clinical and laboratory standards institute. 2015. Verification of commercial microbial identification and antimicrobial susceptibility testing systems 1st ed. CLSI Guideline M52. CLSI Wayne PA"},{"key":"e_1_3_3_26_2","unstructured":"European Union. 2017. Regulation (EU) 2017\/746 on in vitro diagnostic medical devices. Off J Eur Union"},{"key":"e_1_3_3_27_2","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkg312"},{"key":"e_1_3_3_28_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.cmi.2017.11.020"},{"key":"e_1_3_3_29_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.00745-18"},{"key":"e_1_3_3_30_2","unstructured":"Clinical and laboratory standards institute. 2024. Procedure for optimizing disk contents (potencies) for disk diffusion testing of antimicrobial agents using harmonized CLSI and EUCAST criteria 2nd ed. CLSI Supplement M23S. Clinical and Laboratory Standards Institute Wayne PA"},{"key":"e_1_3_3_31_2","unstructured":"Clinical and laboratory standards institute. 2024. Process to submit disk content (potency) data for joint CLSI-EUCAST working group review and approval 2nd ed. Clinical and Laboratory Standards Institute Wayne PA"},{"key":"e_1_3_3_32_2","unstructured":"European Committee on Antimicrobial Susceptibility Testing. 2025. Procedure for optimizing disk contents (Potencies) for disk diffusion testing of antimicrobial agents using harmonized CLSI and EUCAST criteria. EUCAST SOP 11.1. https:\/\/www.eucast.org\/fileadmin\/eucast\/pdf\/eucast_SOPs\/SOP_11\/EUCAST_SOP_11.1_Disk_potency_selection.pdf."},{"key":"e_1_3_3_33_2","unstructured":"European Committee on Antimicrobial Susceptibility Testing. 2025. Process for submitting disk content (Potency) data for joint CLSI and EUCAST working group review and approval. EUCAST SOP 12.1. https:\/\/www.eucast.org\/fileadmin\/eucast\/pdf\/eucast_SOPs\/SOP_12\/EUCAST_SOP_12.1_Disk_potency_selection_process_250311.pdf."},{"key":"e_1_3_3_34_2","volume-title":"CLSI Supplement M100","author":"Clinical and","year":"2026","unstructured":"Clinical and. 2026. Performance standards for antimicrobial susceptibility testing, 36th ed. In CLSI Supplement M100. CLSI, Wayne, PA."},{"key":"e_1_3_3_35_2","doi-asserted-by":"publisher","DOI":"10.1128\/aac.00194-23"},{"key":"e_1_3_3_36_2","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dky232"},{"key":"e_1_3_3_37_2","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkx186"},{"key":"e_1_3_3_38_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01415-17"},{"key":"e_1_3_3_39_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00203-19"},{"key":"e_1_3_3_40_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(18)30093-8"}],"container-title":["Journal of Clinical Microbiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/jcm.00643-26","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/jcm.00643-26","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,11,4]],"date-time":"2026-11-04T04:37:03Z","timestamp":1793767023000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/jcm.00643-26"}},"subtitle":[],"editor":[{"given":"Romney M.","family":"Humphries","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2026,10,13]]},"references-count":39,"alternative-id":["10.1128\/jcm.00643-26"],"URL":"https:\/\/doi.org\/10.1128\/jcm.00643-26","relation":{},"ISSN":["0095-1137","1098-660X"],"issn-type":[{"value":"0095-1137","type":"print"},{"value":"1098-660X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,10,13]]},"assertion":[{"value":"2026-10-13","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e00643-26"}}