Assessing Analytical Performance and Correct Classification for Cardiac Troponin Deltas Across Diagnostic Pathways Used for Myocardial Infarction
<b>Background:</b> In the emergency setting, many diagnostic pathways incorporate change in high-sensitivity cardiac troponin (hs-cTn) concentrations (i.e., the delta) to classify patients as low-risk (rule-out) or high-risk (rule-in) for possible myocardial infarction (MI). However, the...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2025-06-01
|
| Series: | Diagnostics |
| Subjects: | |
| Online Access: | https://www.mdpi.com/2075-4418/15/13/1652 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849704345718751232 |
|---|---|
| author | Peter A. Kavsak Sameer Sharif Wael L. Demian Won-Shik Choi Emilie P. Belley-Cote Jennifer Taher Jennifer L. Shea David W. Blank Michael Knauer Laurel Thorlacius Joshua E. Raizman Yun Huang Daniel R. Beriault Angela W. S. Fung Paul M. Yip Lorna Clark Beth L. Abramson Steven M. Friedman Jesse McLaren Paul Atkinson Annabel Chen-Tournoux Neville Suskin Marco L. A. Sivilotti Venkatesh Thiruganasambandamoorthy Frank Scheuermeyer Karin H. Humphries Kristin M. Aakre Shawn E. Mondoux Craig Ainsworth Flavia Borges Andrew Worster Andrew McRae Allan S. Jaffe |
| author_facet | Peter A. Kavsak Sameer Sharif Wael L. Demian Won-Shik Choi Emilie P. Belley-Cote Jennifer Taher Jennifer L. Shea David W. Blank Michael Knauer Laurel Thorlacius Joshua E. Raizman Yun Huang Daniel R. Beriault Angela W. S. Fung Paul M. Yip Lorna Clark Beth L. Abramson Steven M. Friedman Jesse McLaren Paul Atkinson Annabel Chen-Tournoux Neville Suskin Marco L. A. Sivilotti Venkatesh Thiruganasambandamoorthy Frank Scheuermeyer Karin H. Humphries Kristin M. Aakre Shawn E. Mondoux Craig Ainsworth Flavia Borges Andrew Worster Andrew McRae Allan S. Jaffe |
| author_sort | Peter A. Kavsak |
| collection | DOAJ |
| description | <b>Background:</b> In the emergency setting, many diagnostic pathways incorporate change in high-sensitivity cardiac troponin (hs-cTn) concentrations (i.e., the delta) to classify patients as low-risk (rule-out) or high-risk (rule-in) for possible myocardial infarction (MI). However, the impact of analytical variation on the delta for correct classification is unknown, especially at concentrations below and around the 99th percentile. Our objective was to assess the impact of delta variation for correct risk classification across the European Society of Cardiology (ESC 0/1 h and 0/2 h), the High-STEACS, and the common change criteria (3C) pathways. <b>Methods</b>: A yearlong accuracy study for hs-cTnT was performed where laboratories across Canada tested three patient-based samples (level 1 target value = 6 ng/L, level 2 target value = 9 ng/L, level 3 target value = 12 ng/L) monthly across 41 different analyzers. The assigned low-delta between levels 1 and 2 was 3 ng/L (i.e., 9 − 6 = 3 ng/L) and the assigned high-delta between levels 1 and 3 was 6 ng/L (i.e., 12 − 6 = 6 ng/L). The low- and high-deltas for each analyzer were determined monthly from the measured values, with the difference calculated from the assigned deltas. The obtained deltas were then assessed via the different pathways on correct classification (i.e., percent correct with 95% confidence intervals, CI) and using non-parametric analyses. <b>Results</b>: The median (interquartile range) difference between the measured versus assigned low-delta (n = 436) and high-delta (n = 439) was −1 ng/L (−1 to 0). The correct classification differed among the pathways. The ESC 0/1 h pathway yielded the lowest percentage of correct classification at 35.3% (95% CI: 30.8 to 40.0) for the low-delta and 90.0% (95% CI: 86.8 to 92.6) for the high-delta. The 3C and ESC 0/2 h pathways yielded higher and equivalent estimates on correct classification: 95.2% (95% CI: 92.7 to 97.0) for the low-delta and 98.2% (95% CI: 96.4 to 99.2) for the high-delta. The High-STEACS pathway yielded 99.5% (95% CI: 98.4 to 99.9) of correct classifications for the high-delta but only 36.2% (95% CI: 31.7 to 40.9) for the low-delta. <b>Conclusions</b>: Analytical variation will impact risk classification for MI when using hs-cTn deltas alone per the pathways. The 3C and ESC 0/2 h pathways have <5% misclassification when using deltas for hs-cTnT in this dataset. Additional studies with different hs-cTnI assays at concentrations below and near the 99th percentile are warranted to confirm these findings. |
| format | Article |
| id | doaj-art-6b3b8cbedf444b1b8a61cc2ba8487582 |
| institution | DOAJ |
| issn | 2075-4418 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Diagnostics |
| spelling | doaj-art-6b3b8cbedf444b1b8a61cc2ba84875822025-08-20T03:16:47ZengMDPI AGDiagnostics2075-44182025-06-011513165210.3390/diagnostics15131652Assessing Analytical Performance and Correct Classification for Cardiac Troponin Deltas Across Diagnostic Pathways Used for Myocardial InfarctionPeter A. Kavsak0Sameer Sharif1Wael L. Demian2Won-Shik Choi3Emilie P. Belley-Cote4Jennifer Taher5Jennifer L. Shea6David W. Blank7Michael Knauer8Laurel Thorlacius9Joshua E. Raizman10Yun Huang11Daniel R. Beriault12Angela W. S. Fung13Paul M. Yip14Lorna Clark15Beth L. Abramson16Steven M. Friedman17Jesse McLaren18Paul Atkinson19Annabel Chen-Tournoux20Neville Suskin21Marco L. A. Sivilotti22Venkatesh Thiruganasambandamoorthy23Frank Scheuermeyer24Karin H. Humphries25Kristin M. Aakre26Shawn E. Mondoux27Craig Ainsworth28Flavia Borges29Andrew Worster30Andrew McRae31Allan S. Jaffe32Faculty of Health Sciences, McMaster University, Hamilton, ON L8N 3Z5, CanadaFaculty of Health Sciences, McMaster University, Hamilton, ON L8N 3Z5, CanadaFaculty of Health Sciences, McMaster University, Hamilton, ON L8N 3Z5, CanadaFaculty of Health Sciences, McMaster University, Hamilton, ON L8N 3Z5, CanadaPopulation Health Research Institute, Hamilton, ON L8L 2X2, CanadaUniversity of Toronto, Toronto, ON M5T 1R8, CanadaDepartment of Laboratory Medicine, Saint John Regional Hospital, Saint John, NB E2L 4L2, CanadaMcGill University, Montréal, QC H3A 0G4, CanadaWestern University, London, ON N6A 5B9, CanadaUniversity of Manitoba, Winnipeg, MB R2H 2A6, CanadaUniversity of Alberta, Edmonton, AB T6G 2G4, CanadaQueen’s University, Kingston, ON KL7 3N6, CanadaUniversity of Toronto, Toronto, ON M5T 1R8, CanadaUniversity of British Columbia, Vancouver, BC V6S 1Z2, CanadaUniversity of Toronto, Toronto, ON M5T 1R8, CanadaFaculty of Health Sciences, McMaster University, Hamilton, ON L8N 3Z5, CanadaUniversity of Toronto, Toronto, ON M5T 1R8, CanadaUniversity of Toronto, Toronto, ON M5T 1R8, CanadaUniversity of Toronto, Toronto, ON M5T 1R8, CanadaDalhousie Medicine, Saint John, NB E2K 5E2, CanadaMcGill University, Montréal, QC H3A 0G4, CanadaWestern University, London, ON N6A 5B9, CanadaQueen’s University, Kingston, ON KL7 3N6, CanadaUniversity of Ottawa, Ottawa, ON K1N 6N5, CanadaUniversity of British Columbia, Vancouver, BC V6S 1Z2, CanadaUniversity of British Columbia, Vancouver, BC V6S 1Z2, CanadaDepartment of Medical Biochemistry and Pharmacology & Department of Heart Disease, University Hospital, Haukeland, 5007 Bergen, NorwayFaculty of Health Sciences, McMaster University, Hamilton, ON L8N 3Z5, CanadaFaculty of Health Sciences, McMaster University, Hamilton, ON L8N 3Z5, CanadaFaculty of Health Sciences, McMaster University, Hamilton, ON L8N 3Z5, CanadaFaculty of Health Sciences, McMaster University, Hamilton, ON L8N 3Z5, CanadaUniversity of Calgary, Calgary, AB T2N1N4, CanadaMayo Clinic and Medical Center, Rochester, MN 55905, USA<b>Background:</b> In the emergency setting, many diagnostic pathways incorporate change in high-sensitivity cardiac troponin (hs-cTn) concentrations (i.e., the delta) to classify patients as low-risk (rule-out) or high-risk (rule-in) for possible myocardial infarction (MI). However, the impact of analytical variation on the delta for correct classification is unknown, especially at concentrations below and around the 99th percentile. Our objective was to assess the impact of delta variation for correct risk classification across the European Society of Cardiology (ESC 0/1 h and 0/2 h), the High-STEACS, and the common change criteria (3C) pathways. <b>Methods</b>: A yearlong accuracy study for hs-cTnT was performed where laboratories across Canada tested three patient-based samples (level 1 target value = 6 ng/L, level 2 target value = 9 ng/L, level 3 target value = 12 ng/L) monthly across 41 different analyzers. The assigned low-delta between levels 1 and 2 was 3 ng/L (i.e., 9 − 6 = 3 ng/L) and the assigned high-delta between levels 1 and 3 was 6 ng/L (i.e., 12 − 6 = 6 ng/L). The low- and high-deltas for each analyzer were determined monthly from the measured values, with the difference calculated from the assigned deltas. The obtained deltas were then assessed via the different pathways on correct classification (i.e., percent correct with 95% confidence intervals, CI) and using non-parametric analyses. <b>Results</b>: The median (interquartile range) difference between the measured versus assigned low-delta (n = 436) and high-delta (n = 439) was −1 ng/L (−1 to 0). The correct classification differed among the pathways. The ESC 0/1 h pathway yielded the lowest percentage of correct classification at 35.3% (95% CI: 30.8 to 40.0) for the low-delta and 90.0% (95% CI: 86.8 to 92.6) for the high-delta. The 3C and ESC 0/2 h pathways yielded higher and equivalent estimates on correct classification: 95.2% (95% CI: 92.7 to 97.0) for the low-delta and 98.2% (95% CI: 96.4 to 99.2) for the high-delta. The High-STEACS pathway yielded 99.5% (95% CI: 98.4 to 99.9) of correct classifications for the high-delta but only 36.2% (95% CI: 31.7 to 40.9) for the low-delta. <b>Conclusions</b>: Analytical variation will impact risk classification for MI when using hs-cTn deltas alone per the pathways. The 3C and ESC 0/2 h pathways have <5% misclassification when using deltas for hs-cTnT in this dataset. Additional studies with different hs-cTnI assays at concentrations below and near the 99th percentile are warranted to confirm these findings.https://www.mdpi.com/2075-4418/15/13/1652cardiac troponin deltahigh-sensitivity cardiac troponindiagnostic pathwaysEuropean Society of Cardiology (ESC)High-STEACSCommon Change Criteria (3C) |
| spellingShingle | Peter A. Kavsak Sameer Sharif Wael L. Demian Won-Shik Choi Emilie P. Belley-Cote Jennifer Taher Jennifer L. Shea David W. Blank Michael Knauer Laurel Thorlacius Joshua E. Raizman Yun Huang Daniel R. Beriault Angela W. S. Fung Paul M. Yip Lorna Clark Beth L. Abramson Steven M. Friedman Jesse McLaren Paul Atkinson Annabel Chen-Tournoux Neville Suskin Marco L. A. Sivilotti Venkatesh Thiruganasambandamoorthy Frank Scheuermeyer Karin H. Humphries Kristin M. Aakre Shawn E. Mondoux Craig Ainsworth Flavia Borges Andrew Worster Andrew McRae Allan S. Jaffe Assessing Analytical Performance and Correct Classification for Cardiac Troponin Deltas Across Diagnostic Pathways Used for Myocardial Infarction Diagnostics cardiac troponin delta high-sensitivity cardiac troponin diagnostic pathways European Society of Cardiology (ESC) High-STEACS Common Change Criteria (3C) |
| title | Assessing Analytical Performance and Correct Classification for Cardiac Troponin Deltas Across Diagnostic Pathways Used for Myocardial Infarction |
| title_full | Assessing Analytical Performance and Correct Classification for Cardiac Troponin Deltas Across Diagnostic Pathways Used for Myocardial Infarction |
| title_fullStr | Assessing Analytical Performance and Correct Classification for Cardiac Troponin Deltas Across Diagnostic Pathways Used for Myocardial Infarction |
| title_full_unstemmed | Assessing Analytical Performance and Correct Classification for Cardiac Troponin Deltas Across Diagnostic Pathways Used for Myocardial Infarction |
| title_short | Assessing Analytical Performance and Correct Classification for Cardiac Troponin Deltas Across Diagnostic Pathways Used for Myocardial Infarction |
| title_sort | assessing analytical performance and correct classification for cardiac troponin deltas across diagnostic pathways used for myocardial infarction |
| topic | cardiac troponin delta high-sensitivity cardiac troponin diagnostic pathways European Society of Cardiology (ESC) High-STEACS Common Change Criteria (3C) |
| url | https://www.mdpi.com/2075-4418/15/13/1652 |
| work_keys_str_mv | AT peterakavsak assessinganalyticalperformanceandcorrectclassificationforcardiactroponindeltasacrossdiagnosticpathwaysusedformyocardialinfarction AT sameersharif assessinganalyticalperformanceandcorrectclassificationforcardiactroponindeltasacrossdiagnosticpathwaysusedformyocardialinfarction AT waelldemian assessinganalyticalperformanceandcorrectclassificationforcardiactroponindeltasacrossdiagnosticpathwaysusedformyocardialinfarction AT wonshikchoi assessinganalyticalperformanceandcorrectclassificationforcardiactroponindeltasacrossdiagnosticpathwaysusedformyocardialinfarction AT emiliepbelleycote assessinganalyticalperformanceandcorrectclassificationforcardiactroponindeltasacrossdiagnosticpathwaysusedformyocardialinfarction AT jennifertaher assessinganalyticalperformanceandcorrectclassificationforcardiactroponindeltasacrossdiagnosticpathwaysusedformyocardialinfarction AT jenniferlshea assessinganalyticalperformanceandcorrectclassificationforcardiactroponindeltasacrossdiagnosticpathwaysusedformyocardialinfarction AT davidwblank assessinganalyticalperformanceandcorrectclassificationforcardiactroponindeltasacrossdiagnosticpathwaysusedformyocardialinfarction AT michaelknauer assessinganalyticalperformanceandcorrectclassificationforcardiactroponindeltasacrossdiagnosticpathwaysusedformyocardialinfarction AT laurelthorlacius assessinganalyticalperformanceandcorrectclassificationforcardiactroponindeltasacrossdiagnosticpathwaysusedformyocardialinfarction AT joshuaeraizman assessinganalyticalperformanceandcorrectclassificationforcardiactroponindeltasacrossdiagnosticpathwaysusedformyocardialinfarction AT yunhuang assessinganalyticalperformanceandcorrectclassificationforcardiactroponindeltasacrossdiagnosticpathwaysusedformyocardialinfarction AT danielrberiault assessinganalyticalperformanceandcorrectclassificationforcardiactroponindeltasacrossdiagnosticpathwaysusedformyocardialinfarction AT angelawsfung assessinganalyticalperformanceandcorrectclassificationforcardiactroponindeltasacrossdiagnosticpathwaysusedformyocardialinfarction AT paulmyip assessinganalyticalperformanceandcorrectclassificationforcardiactroponindeltasacrossdiagnosticpathwaysusedformyocardialinfarction AT lornaclark assessinganalyticalperformanceandcorrectclassificationforcardiactroponindeltasacrossdiagnosticpathwaysusedformyocardialinfarction AT bethlabramson assessinganalyticalperformanceandcorrectclassificationforcardiactroponindeltasacrossdiagnosticpathwaysusedformyocardialinfarction AT stevenmfriedman assessinganalyticalperformanceandcorrectclassificationforcardiactroponindeltasacrossdiagnosticpathwaysusedformyocardialinfarction AT jessemclaren assessinganalyticalperformanceandcorrectclassificationforcardiactroponindeltasacrossdiagnosticpathwaysusedformyocardialinfarction AT paulatkinson assessinganalyticalperformanceandcorrectclassificationforcardiactroponindeltasacrossdiagnosticpathwaysusedformyocardialinfarction AT annabelchentournoux assessinganalyticalperformanceandcorrectclassificationforcardiactroponindeltasacrossdiagnosticpathwaysusedformyocardialinfarction AT nevillesuskin assessinganalyticalperformanceandcorrectclassificationforcardiactroponindeltasacrossdiagnosticpathwaysusedformyocardialinfarction AT marcolasivilotti assessinganalyticalperformanceandcorrectclassificationforcardiactroponindeltasacrossdiagnosticpathwaysusedformyocardialinfarction AT venkateshthiruganasambandamoorthy assessinganalyticalperformanceandcorrectclassificationforcardiactroponindeltasacrossdiagnosticpathwaysusedformyocardialinfarction AT frankscheuermeyer assessinganalyticalperformanceandcorrectclassificationforcardiactroponindeltasacrossdiagnosticpathwaysusedformyocardialinfarction AT karinhhumphries assessinganalyticalperformanceandcorrectclassificationforcardiactroponindeltasacrossdiagnosticpathwaysusedformyocardialinfarction AT kristinmaakre assessinganalyticalperformanceandcorrectclassificationforcardiactroponindeltasacrossdiagnosticpathwaysusedformyocardialinfarction AT shawnemondoux assessinganalyticalperformanceandcorrectclassificationforcardiactroponindeltasacrossdiagnosticpathwaysusedformyocardialinfarction AT craigainsworth assessinganalyticalperformanceandcorrectclassificationforcardiactroponindeltasacrossdiagnosticpathwaysusedformyocardialinfarction AT flaviaborges assessinganalyticalperformanceandcorrectclassificationforcardiactroponindeltasacrossdiagnosticpathwaysusedformyocardialinfarction AT andrewworster assessinganalyticalperformanceandcorrectclassificationforcardiactroponindeltasacrossdiagnosticpathwaysusedformyocardialinfarction AT andrewmcrae assessinganalyticalperformanceandcorrectclassificationforcardiactroponindeltasacrossdiagnosticpathwaysusedformyocardialinfarction AT allansjaffe assessinganalyticalperformanceandcorrectclassificationforcardiactroponindeltasacrossdiagnosticpathwaysusedformyocardialinfarction |