Discordance of High-Sensitivity Troponin Assays in Patients With Suspected Acute Coronary Syndromes
Key result
Three high-sensitivity troponin assays align on benchmark classification in only ~37% of suspected ACS samples.
- n=624
Why the study?
High-sensitivity cardiac troponin assays have different analytic characteristics that may lead to differences in management of patients with suspected ACS.
Does the choice of high-sensitivity troponin assay affect analytical classification and management recommendations in patients with suspected acute coronary syndrome?
Study Design
Type
Observational (n=624)
Blinding
Blinded for clinical information
Structured PICO
Does the choice of high-sensitivity troponin assay affect analytical classification and management recommendations in patients with suspected acute coronary syndrome?
P
Population
624 patients (mean age 52.8, 39.4% female) with suspected acute coronary syndrome referred for non-invasive testing after inconclusive initial triage.
E
Exposure
High-sensitivity cardiac troponin (hs-cTn) assays (Roche Elecsys, Abbott ARCHITECT, Siemens HsVista)
C
Comparator
Direct comparison between the three assays
O
Outcome
Concordance across analytic benchmarks (99th percentile) per blood sample and concordance of management recommendations (rule-out/observe/rule-in) per the 0/2 hour algorithm per patientsurrogate
Limitations
- Patient cohort does not reflect the entire spectrum of patients presenting with suspicion for ACS to EDs in the US
- Only patients in ROMICAT-II underwent serial troponin measurements
- The 0/2 hour algorithm was developed for the Siemens Centaur platform, not for the Siemens Dimension Vista used in the study
- The majority of ACS in the ROMICAT trials was unstable angina pectoris rather than myocardial infarction
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“In case these hospitals have different assay types, probably the receiving center needs to reassess the clinical background and maybe add further noninvasive diagnostic testing just to be sure that the troponin findings are treated appropriately.”
“Problems can theoretically arise when the high-sensitivity cardiac troponin (hs-cTn) tests used in primary and tertiary care hospitals differ in terms of sensitivity and/or specificity. This concern led to the performance of the study by Karády et al. in this issue of the Journal.”
Implication
Significant discordance exists between different high-sensitivity troponin assays in classifying patients with suspected ACS, which may lead to different clinical management recommendations.
Abstract
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: We included patients with suspected ACS enrolled in the Rule Out Myocardial Infarction/ Ischemia Using Computer-Assisted Tomography (ROMICAT) I and II trials, with blood samples taken at ED presentation (ROMICAT-I and II) or at two and four hours thereafter (ROMICAT-II). Hs-cTn concentrations were measured using three 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, we determined concordance of management recommendations (rule-out/observe/rule-in) per the 0/2 hour algorithm, and their association with diagnostic test findings (coronary artery stenosis >50% on coronary CT angiography or inducible ischemia on perfusion imaging) and ACS. Results: Among 1,027 samples from 624 patients (52.8 ± 10.0 years, 39.4% female), samples classified as 99th percentile (7.2% vs 6.0% vs 6.2%) by Roche, Abbott, and Siemens, respectively. 37.4% (n=384/1,027) of blood samples were classified into the same analytical benchmark category, with low concordance across benchmarks (99th percentile 43.6%). Serial samples were available in 242 patients (40.1% female; mean age: 52.8±8.0 years). The concordance of management recommendations across assays was 74.8% (n=181/242) considering serial hs-cTn measurements. 19.6–21.1% of patients who were recommended to discharge had positive diagnostic test findings and 2.8–4.3% had ACS at presentation. Conclusion: 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.
Discussion
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Cite This Study
Karády et al. (2021) conducted an observational in Suspected acute coronary syndrome (n=624). High-sensitivity cardiac troponin assays (Roche, Abbott, Siemens) vs. Direct comparison between assays was evaluated on Concordance of classification into the same analytical benchmark category per blood sample. Among 1,027 samples from 624 patients with suspected acute coronary syndrome, only 37.4% of blood samples were classified into the same analytical benchmark category across three high-sensitivity troponin assays.