TY - JOUR
T1 - Discordance of High-Sensitivity Troponin Assays in Patients With Suspected Acute Coronary Syndromes
AU - Karády, Júlia
AU - Mayrhofer, Thomas
AU - Ferencik, Maros
AU - Nagurney, John T.
AU - Udelson, James E.
AU - Kammerlander, Andreas A.
AU - Fleg, Jerome L.
AU - Peacock, W. Frank
AU - Januzzi, James L.
AU - Koenig, Wolfgang
AU - Hoffmann, Udo
N1 - Funding Information:
Dr. Karády has received grant support from the Fulbright Visiting Researcher Grant (E0583118), and the Rosztoczy Foundation. Dr. Ferencik has been supported by a grant from the American Heart Association (Fellow to Faculty Award #13FTF16450001). Dr. Peacock has received grant support from Abbott, Boehringer Ingelheim, Braincheck, CSL Behring, Daiichi-Sankyo, Immunarray, Janssen, Ortho Clinical Diagnostics, Portola, Relypsa, Roche, Salix, and Siemens; has received consulting income from Abbott, AstraZeneca, Bayer, Beckman, Boehrhinger Ingelheim, Ischemia Care, Dx, Immunarray, Instrument Labs, Janssen, Nabriva, Ortho Clinical Diagnostics, Relypsa, Roche, Quidel, Salix, and Siemens; has provided expert testimony for Johnson and Johnson; and has stock/ownership interest in AseptiScope Inc., Brainbox Inc., Comprehensive Research Associates LLC, Emergencies in Medicine LLC, and Ischemia DX LLC. Dr. Nagurney has received research funds from Roche Diagnostics, Ortho Diagnostics, and Alere/Biosite to the Massachusetts General Hospital. Dr. Januzzi has been a Trustee of the American College of Cardiology, and a board member of Imbria Pharmaceuticals; has received grant support from Novartis Pharmaceuticals, Roche Diagnostics, Abbott, Singulex, and Prevencio; has received consulting income from Abbott, Janssen, Novartis, Pfizer, Merck, and Roche Diagnostics; and participates in clinical endpoint committees/data safety monitoring boards for Abbott, AbbVie, Amgen, Boehringer Ingelheim, Janssen, and Takeda. Dr. Koenig has received personal fees from AstraZeneca, Novartis, Pfizer, The Medicines Company, DalCor, Kowa, Amgen, Corvidia, Berlin-Chemie, and Sanofi; and has received grants and nonfinancial support from Beckmann, Singulex, Abbott, and Roche Diagnostics, outside the submitted work. Dr. Hoffmann has received research support on behalf of his institution from Duke University (Abbott), HeartFlow, Kowa Company Limited, and MedImmune/AstraZeneca; and has received consulting fees from Duke University (NIH), and Recor Medical, unrelated to this research. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Publisher Copyright:
© 2021 American College of Cardiology Foundation
PY - 2021/3/30
Y1 - 2021/3/30
N2 - Background: High-sensitivity cardiac troponin (hs-cTn) assays have different analytic characteristics. Objectives: The goal of this study was to quantify differences between assays for common analytical benchmarks and to determine whether they may result in differences in the management of patients with suspected acute coronary syndrome (ACS). Methods: The authors included patients with suspected ACS enrolled in the ROMICAT (Rule Out Myocardial Infarction/Ischemia Using Computer Assisted Tomography) I and II trials, with blood samples taken at emergency department presentation (ROMICAT-I and -II) or at 2 and 4 h thereafter (ROMICAT-II). hs-cTn concentrations were measured using 3 assays (Roche Diagnostics, Elecsys 2010 platform; Abbott Diagnostics, ARCHITECT i2000SR; Siemens Diagnostics, HsVista). Per blood sample, we determined concordance across analytic benchmarks (99th percentile). Per-patient, the authors determined concordance of management recommendations (rule-out/observe/rule-in) per the 0/2-h algorithm, and their association with diagnostic test findings (coronary artery stenosis >50% on coronary computed tomography angiography or inducible ischemia on perfusion imaging) and ACS. Results: Among 1,027 samples from 624 patients (52.8 ± 10.0 years; 39.4% women), samples were classified as <LOD (56.3% vs. 10.4% vs. 41.2%; p < 0.001), LOD-99th percentile (36.5% vs. 83.5% vs. 52.6; p < 0.001), >99th percentile (7.2% vs. 6.0% vs. 6.2%) by Roche, Abbott, and Siemens, respectively. A total of 37.4% (n = 384 of 1,027) of blood samples were classified into the same analytical benchmark category, with low concordance across benchmarks (<LOD 11.1%; LOD-99th percentile 29.3%; >99th percentile 43.6%). Serial samples were available in 242 patients (40.1% women; mean age: 52.8 ± 8.0 years). The concordance of management recommendations across assays was 74.8% (n = 181 of 242) considering serial hs-cTn measurements. Of patients who were recommended to discharge, 19.6% to 21.1% had positive diagnostic test findings and 2.8% to 4.3% had ACS at presentation. Conclusions: Caregivers should be aware that there are significant differences between hs-cTn assays in stratifying individual samples and patients with intermediate likelihood of ACS according to analytical benchmarks that may result in different management recommendations. (Rule Out Myocardial Infarction by Computer Assisted Tomography [ROMICAT]; NCT00990262) (Multicenter Study to Rule Out Myocardial Infarction by Cardiac Computed Tomography [ROMICAT-II]; NCT01084239)
AB - Background: High-sensitivity cardiac troponin (hs-cTn) assays have different analytic characteristics. Objectives: The goal of this study was to quantify differences between assays for common analytical benchmarks and to determine whether they may result in differences in the management of patients with suspected acute coronary syndrome (ACS). Methods: The authors included patients with suspected ACS enrolled in the ROMICAT (Rule Out Myocardial Infarction/Ischemia Using Computer Assisted Tomography) I and II trials, with blood samples taken at emergency department presentation (ROMICAT-I and -II) or at 2 and 4 h thereafter (ROMICAT-II). hs-cTn concentrations were measured using 3 assays (Roche Diagnostics, Elecsys 2010 platform; Abbott Diagnostics, ARCHITECT i2000SR; Siemens Diagnostics, HsVista). Per blood sample, we determined concordance across analytic benchmarks (99th percentile). Per-patient, the authors determined concordance of management recommendations (rule-out/observe/rule-in) per the 0/2-h algorithm, and their association with diagnostic test findings (coronary artery stenosis >50% on coronary computed tomography angiography or inducible ischemia on perfusion imaging) and ACS. Results: Among 1,027 samples from 624 patients (52.8 ± 10.0 years; 39.4% women), samples were classified as <LOD (56.3% vs. 10.4% vs. 41.2%; p < 0.001), LOD-99th percentile (36.5% vs. 83.5% vs. 52.6; p < 0.001), >99th percentile (7.2% vs. 6.0% vs. 6.2%) by Roche, Abbott, and Siemens, respectively. A total of 37.4% (n = 384 of 1,027) of blood samples were classified into the same analytical benchmark category, with low concordance across benchmarks (<LOD 11.1%; LOD-99th percentile 29.3%; >99th percentile 43.6%). Serial samples were available in 242 patients (40.1% women; mean age: 52.8 ± 8.0 years). The concordance of management recommendations across assays was 74.8% (n = 181 of 242) considering serial hs-cTn measurements. Of patients who were recommended to discharge, 19.6% to 21.1% had positive diagnostic test findings and 2.8% to 4.3% had ACS at presentation. Conclusions: Caregivers should be aware that there are significant differences between hs-cTn assays in stratifying individual samples and patients with intermediate likelihood of ACS according to analytical benchmarks that may result in different management recommendations. (Rule Out Myocardial Infarction by Computer Assisted Tomography [ROMICAT]; NCT00990262) (Multicenter Study to Rule Out Myocardial Infarction by Cardiac Computed Tomography [ROMICAT-II]; NCT01084239)
KW - acute coronary syndrome
KW - concordance
KW - high-sensitivity cardiac troponin
KW - high-sensitivity cardiac troponin assays
UR - http://www.scopus.com/inward/record.url?scp=85102590124&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85102590124&partnerID=8YFLogxK
U2 - 10.1016/j.jacc.2021.01.046
DO - 10.1016/j.jacc.2021.01.046
M3 - Article
C2 - 33766254
AN - SCOPUS:85102590124
VL - 77
SP - 1487
EP - 1499
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
SN - 0735-1097
IS - 12
ER -