{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,9]],"date-time":"2026-05-09T16:10:22Z","timestamp":1778343022943,"version":"3.51.4"},"reference-count":26,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"8","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["JAHA"],"published-print":{"date-parts":[[2026,4,21]]},"abstract":"\n Background<\/jats:title>\n There is major uncertainty among physicians on how to best use the novel hs\u2010cTnI (high sensitivity\u2010cardiac troponin I)\u2010VITROS assay, as the limit of quantification (2\u2009ng\/L), applied by the US Food and Drug Administration and other regulators, is higher than the limit of detection (1\u2009ng\/L)\u2010based rule\u2010out cutoffs from recent pilot studies for 0\/1\u2010hour and 0\/2\u2010hour algorithms.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n This prospective, multicenter study aimed to derive and validate higher limit of quantification\u2010based assay\u2010specific cutoffs for safe and efficient rule\u2010out of myocardial infarction among adult patients presenting with acute chest discomfort to the emergency department. Final diagnoses of myocardial infarction were centrally adjudicated by 2 independent cardiologists, blinded to hs\u2010cTnI\u2010VITROS concentrations.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n Among 2931 eligible patients, 467 (16%) were diagnosed with myocardial infarction. In the derivation cohort (n=1466), a cutoff \u22642\u2009ng\/L at presentation in patients with chest pain onset >3 hours (direct rule\u2010out) and \u22642\u2009ng\/L in combination with a 1\u2010hour absolute change of \u22641\u2009ng\/L ruled out 51% of patients, with a sensitivity of 99.1% (96.9%\u201399.8%). Predefined rule\u2010in thresholds (0 hour\u2010value \u226540\u2009ng\/L [direct rule\u2010in] or an absolute change within 1 hour of \u22654\u2009ng\/L) identified 16.9% of patients, with a specificity of 95.9% (94.7%\u201396.9%). Very high sensitivity and specificity were confirmed in the validation cohort (n=1465). Comparable findings were observed for the alternative 0\/2\u2010hour algorithm with \u22642\u2009ng\/L as the rule\u2010out threshold.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n The alternative 0\/1\u2010hour and 0\/2\u2010hour algorithms using limit of quantification\u2010based rule\u2010out cutoffs of \u22642\u2009ng\/L with the hs\u2010cTnI\u2010VITROS assay demonstrated very high safety and efficacy in suspected myocardial infarction.<\/jats:p>\n <\/jats:sec>\n \n Registration<\/jats:title>\n \n URL:\n https:\/\/www.clinicaltrials.gov\/<\/jats:ext-link>\n ; Identifier: NCT00470587.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1161\/jaha.125.045517","type":"journal-article","created":{"date-parts":[[2026,4,16]],"date-time":"2026-04-16T11:11:55Z","timestamp":1776337915000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Alternative Rule\u2010Out Cutoffs for a Novel High\u2010Sensitivity Cardiac Troponin I 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