Tonje R Johannessen, Odd Martin Vallersnes, Anne Cecilie K Larstorp, Sigrun Halvorsen, Dan Atar
{"title":"在紧急初级保健中使用高灵敏度即时检测一小时肌钙蛋白:OUT-POC试点研究","authors":"Tonje R Johannessen, Odd Martin Vallersnes, Anne Cecilie K Larstorp, Sigrun Halvorsen, Dan Atar","doi":"10.1159/000545127","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Novel point-of-care (POC) high-sensitivity cardiac troponin (hs-cTn) tests could enhance acute myocardial infarction (MI) assessment outside hospital. This pilot study evaluates the efficacy, feasibility, and precision of the QuidelOrtho TriageTrue hs-cTnI POC assay when used by non-laboratory personnel in emergency primary care.</p><p><strong>Methods: </strong>A prospective pilot study was conducted from April to June 2024 at the main emergency primary care clinic in Oslo, Norway. Patients ≥18 years with acute nontraumatic chest pain were eligible. The 0/1-h diagnostic algorithms for the POC TriageTrue hs-cTnI and the Roche Elecsys hs-cTnT central laboratory assay (routine protocol) were compared to assess the efficacy and potential safety issues for patients triaged to MI rule-out.</p><p><strong>Results: </strong>Over 2 months, 199 patients (median age 54 years [interquartile range 45-70]; 52.8% female) were included. Five (2.5%) patients were hospitalised with acute MI. After a single hs-cTnI measurement, the POC algorithm categorised more patients to direct rule-out than the hs-cTnT assay (65% vs. 32%). The rule-out efficacy was similar for both assays after adding the 1-hour measurement (hs-cTnT 74%; POC hs-cTnI 73%). Device-related error rates were low (0.5%), with high reproducibility and repeatability (coefficients of variation < 10%) when performed by non-laboratory personnel.</p><p><strong>Conclusion: </strong>The 0/1-h algorithm for the TriageTrue hs-cTnI POC assay appears efficient, feasible, and robust when applied by personnel without laboratory expertise in an emergency primary care setting. Further research is warranted, but given the high proportion of single-sample rule-out cases, 1-h measurements could likely be avoided, improving patient management.</p>","PeriodicalId":9391,"journal":{"name":"Cardiology","volume":" ","pages":"1-13"},"PeriodicalIF":1.9000,"publicationDate":"2025-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"One-Hour Troponin Using a High-Sensitivity Point-of-Care Assay in Emergency Primary Care: The OUT-POC Pilot Study.\",\"authors\":\"Tonje R Johannessen, Odd Martin Vallersnes, Anne Cecilie K Larstorp, Sigrun Halvorsen, Dan Atar\",\"doi\":\"10.1159/000545127\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Novel point-of-care (POC) high-sensitivity cardiac troponin (hs-cTn) tests could enhance acute myocardial infarction (MI) assessment outside hospital. This pilot study evaluates the efficacy, feasibility, and precision of the QuidelOrtho TriageTrue hs-cTnI POC assay when used by non-laboratory personnel in emergency primary care.</p><p><strong>Methods: </strong>A prospective pilot study was conducted from April to June 2024 at the main emergency primary care clinic in Oslo, Norway. Patients ≥18 years with acute nontraumatic chest pain were eligible. The 0/1-h diagnostic algorithms for the POC TriageTrue hs-cTnI and the Roche Elecsys hs-cTnT central laboratory assay (routine protocol) were compared to assess the efficacy and potential safety issues for patients triaged to MI rule-out.</p><p><strong>Results: </strong>Over 2 months, 199 patients (median age 54 years [interquartile range 45-70]; 52.8% female) were included. Five (2.5%) patients were hospitalised with acute MI. After a single hs-cTnI measurement, the POC algorithm categorised more patients to direct rule-out than the hs-cTnT assay (65% vs. 32%). The rule-out efficacy was similar for both assays after adding the 1-hour measurement (hs-cTnT 74%; POC hs-cTnI 73%). Device-related error rates were low (0.5%), with high reproducibility and repeatability (coefficients of variation < 10%) when performed by non-laboratory personnel.</p><p><strong>Conclusion: </strong>The 0/1-h algorithm for the TriageTrue hs-cTnI POC assay appears efficient, feasible, and robust when applied by personnel without laboratory expertise in an emergency primary care setting. 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One-Hour Troponin Using a High-Sensitivity Point-of-Care Assay in Emergency Primary Care: The OUT-POC Pilot Study.
Introduction: Novel point-of-care (POC) high-sensitivity cardiac troponin (hs-cTn) tests could enhance acute myocardial infarction (MI) assessment outside hospital. This pilot study evaluates the efficacy, feasibility, and precision of the QuidelOrtho TriageTrue hs-cTnI POC assay when used by non-laboratory personnel in emergency primary care.
Methods: A prospective pilot study was conducted from April to June 2024 at the main emergency primary care clinic in Oslo, Norway. Patients ≥18 years with acute nontraumatic chest pain were eligible. The 0/1-h diagnostic algorithms for the POC TriageTrue hs-cTnI and the Roche Elecsys hs-cTnT central laboratory assay (routine protocol) were compared to assess the efficacy and potential safety issues for patients triaged to MI rule-out.
Results: Over 2 months, 199 patients (median age 54 years [interquartile range 45-70]; 52.8% female) were included. Five (2.5%) patients were hospitalised with acute MI. After a single hs-cTnI measurement, the POC algorithm categorised more patients to direct rule-out than the hs-cTnT assay (65% vs. 32%). The rule-out efficacy was similar for both assays after adding the 1-hour measurement (hs-cTnT 74%; POC hs-cTnI 73%). Device-related error rates were low (0.5%), with high reproducibility and repeatability (coefficients of variation < 10%) when performed by non-laboratory personnel.
Conclusion: The 0/1-h algorithm for the TriageTrue hs-cTnI POC assay appears efficient, feasible, and robust when applied by personnel without laboratory expertise in an emergency primary care setting. Further research is warranted, but given the high proportion of single-sample rule-out cases, 1-h measurements could likely be avoided, improving patient management.
期刊介绍:
''Cardiology'' features first reports on original clinical, preclinical and fundamental research as well as ''Novel Insights from Clinical Experience'' and topical comprehensive reviews in selected areas of cardiovascular disease. ''Editorial Comments'' provide a critical but positive evaluation of a recent article. Papers not only describe but offer critical appraisals of new developments in non-invasive and invasive diagnostic methods and in pharmacologic, nutritional and mechanical/surgical therapies. Readers are thus kept informed of current strategies in the prevention, recognition and treatment of heart disease. Special sections in a variety of subspecialty areas reinforce the journal''s value as a complete record of recent progress for all cardiologists, internists, cardiac surgeons, clinical physiologists, pharmacologists and professionals in other areas of medicine interested in current activity in cardiovascular diseases.