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Analytic Result Variation for High-Sensitivity Cardiac Troponin: Interpretation and Consequences

Peter A. Kavsak, Lorna Clark, Saranya Arnoldo, Amy Lou, Jennifer L. Shea, Shaun Eintracht, Andrew W. Lyon, Vipin Bhayana, Laurel Thorlacius, Joshua E. Raizman, Albert K. Y. Tsui, Rose Djiana, Michael Chen, Yun Huang, Ronald A. Booth, Chris McCudden, Joel Lavoie, Daniel R. Beriault, David W. Blank, Angela W. S. Fung, Barry Hoffman, Jennifer Taher, Julie St-Cyr, Paul M. Yip, Emilie P. Belley-Cote, Beth L. Abramson, Bjug Borgundvaag, Steven M. Friedman, Susanna Mak, Jesse McLaren, Brian Steinhart, Jacob A. Udell, Harindra C. Wijeysundera, Paul Atkinson, Samuel G. Campbell, Kavish Chandra, Jafna L. Cox, Sharon Mulvagh, Ata-ur-Rehman Quraishi, Annabel Chen-Tournoux, Gregory Clark, Eli Segal, Neville Suskin, Amer M. Johri, Marco L. A. Sivilotti, Habibat Garuba, Venkatesh Thiruganasambandamoorthy, Simon Robinson, Frank Scheuermeyer, Karin H. Humphries, Martin Than, John W. Pickering, Andrew Worster, Nicholas L. Mills, P. J. Devereaux, Allan S. Jaffe

Canadian Journal of Cardiology(2023)

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摘要
A multicentre prospective observational study (36 sites in 8 Canadian provinces), imbedded in the CODE-MI trial, had clinical laboratories at these sites test 3 samples (normal, female 99th-percentile, and male 99th-percentile concentrations) monthly for 1 year on 67 instruments, producing 2142 results from 6 distinct troponin assays. Mean differences varied per assay with maximum values being & PLUSMN; 4, & PLUSMN; 8, and & PLUSMN; 9 ng/L for the normal, female 99th-percentile, and male 99th-percentile sample, respectively. Using a pragmatic approach, combining all assays, the maximum analytic result variation was & PLUSMN; 3 ng/L for target concentrations less than 10 ng/L and & PLUSMN; 30% at concen-trations slightly above.
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high-sensitivity
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