Evaluation of risk stratification at presentation using the Alinity high-sensitivity cardiac troponin I assay
- 1The University of Edinburgh
Abstract
O_ST_ABSBackgroundC_ST_ABSHigh-sensitivity cardiac troponin (hs-cTn) assays enable safe early discharge of patients at very low risk for myocardial infarction. We previously developed a single-sample rule-out pathway using the ARCHITECT hs-cTnI assay to risk stratify patients with suspected acute coronary syndrome. In a secondary analysis of the POC-ET (Point of Care Evaluation of High-sensitivity Cardiac Troponin) study, we evaluated performance of risk stratification with the Alinity hs-cTnI assay.
MethodsPatients presenting with possible myocardial infarction in the POC-ET (NCT05665127) study were included. The primary outcome was type 1, 4b or 4c myocardial infarction or cardiac death at 30 days. Cardiac troponin I (cTnI) was measured in stored materials using the ARCHITECT and Alinity hs-cTnI assays. The sex-specific 99th percentile upper reference limit (URL) are 34 ng/L in men and 16 ng/L in women for both assays. Agreement was assessed with Bland-and-Altman limit of agreement method, Passing Bablok regression, and Pearsons correlation coefficient. Distributions of presentation measurements were compared with Kolmogorov-Smirnov test. Performance was evaluated in the overall population and prespecified subgroups. The negative predictive value (NPV) and sensitivity were determined and proportion of patients identified as low, intermediate, and high risk were calculated and modelled using ordinal logistic regression.
ResultsIn 986 patients (60 [51-70] years, 38% female), 78 (7.9%) had a primary outcome. Strong agreement was found in the raw cTnI measurements (99% samples within the Bland-Altman limit of agreement; correlation coefficient: 0.967 (95% CI 0.964-0.969, P<0.001); Passing Bablok regression: slope 1.12 [1.11-1.13], intercept-0.16 [-0.18 to-0.13]). At presentation, distributions of cTnI measurements by the two assays were similar (P=0.810). Both assays showed comparable diagnostic performance using a risk stratification threshold of <5 ng/L and the sex-specific diagnostic threshold, with the same NPV (Alinity 100 [99.7-100]% versus ARCHITECT 100 [99.7-100]%) and sensitivity (Alinity 100 [97.3-100]% versus ARCHITECT 100 [97.3-100]%). Similar proportions of patients stratified as low-(Alinity 67% versus ARCHITECT 67%), intermediate-risk (23% versus 24%) and high-risk (10% versus 9%) at presentation with minor reclassification. Similar efficacy was observed across subgroups stratified by sex, age, history of myocardial infarction, renal function, and symptom duration.
ConclusionsThe Alinity hs-cTnI and the ARCHITECT hs-cTnI assays can be used interchangeably in the assessment of suspected myocardial infarction with comparable safety and efficacy.
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BibTeX
@misc{li2026evaluation,
title = {{Evaluation of risk stratification at presentation using the Alinity high-sensitivity cardiac troponin I assay}},
author = {Z. Li and T. Fujisawa and O. Skadberg and P. Fineran and A. J. Thurston and Y. Y. Tew and K. M. Aakre and N. L. Mills and R. Wereski and the POC-ET Investigators},
howpublished = {medRxiv},
year = {2026},
month = aug,
doi = {10.64898/2026.08.29.26361405},
url = {https://www.medrxiv.org/content/10.64898/2026.08.29.26361405v1},
note = {CC BY},
}
RIS
TY - UNPB
TI - Evaluation of risk stratification at presentation using the Alinity high-sensitivity cardiac troponin I assay
AU - Z. Li
AU - T. Fujisawa
AU - O. Skadberg
AU - P. Fineran
AU - A. J. Thurston
AU - Y. Y. Tew
AU - K. M. Aakre
AU - N. L. Mills
AU - R. Wereski
AU - the POC-ET Investigators
PY - 2026
DA - 2026/08/29
PB - medRxiv
DO - 10.64898/2026.08.29.26361405
UR - https://www.medrxiv.org/content/10.64898/2026.08.29.26361405v1
AB - O_ST_ABSBackgroundC_ST_ABSHigh-sensitivity cardiac troponin (hs-cTn) assays enable safe early discharge of patients at very low risk for myocardial infarction. We previously developed a single-sample rule-out pathway using the ARCHITECT hs-cTnI assay to risk stratify patients with suspected acute coronary syndrome. In a secondary analysis of the POC-ET (Point of Care Evaluation of High-sensitivity Cardiac Troponin) study, we evaluated performance of risk stratification with the Alinity hs-cTnI assay. MethodsPatients presenting with possible myocardial infarction in the POC-ET (NCT05665127) study were included. The primary outcome was type 1, 4b or 4c myocardial infarction or cardiac death at 30 days. Cardiac troponin I (cTnI) was measured in stored materials using the ARCHITECT and Alinity hs-cTnI assays. The sex-specific 99th percentile upper reference limit (URL) are 34 ng/L in men and 16 ng/L in women for both assays. Agreement was assessed with Bland-and-Altman limit of agreement method, Passing Bablok regression, and Pearsons correlation coefficient. Distributions of presentation measurements were compared with Kolmogorov-Smirnov test. Performance was evaluated in the overall population and prespecified subgroups. The negative predictive value (NPV) and sensitivity were determined and proportion of patients identified as low, intermediate, and high risk were calculated and modelled using ordinal logistic regression. ResultsIn 986 patients (60 [51-70] years, 38% female), 78 (7.9%) had a primary outcome. Strong agreement was found in the raw cTnI measurements (99% samples within the Bland-Altman limit of agreement; correlation coefficient: 0.967 (95% CI 0.964-0.969, P<0.001); Passing Bablok regression: slope 1.12 [1.11-1.13], intercept-0.16 [-0.18 to-0.13]). At presentation, distributions of cTnI measurements by the two assays were similar (P=0.810). Both assays showed comparable diagnostic performance using a risk stratification threshold of <5 ng/L and the sex-specific diagnostic threshold, with the same NPV (Alinity 100 [99.7-100]% versus ARCHITECT 100 [99.7-100]%) and sensitivity (Alinity 100 [97.3-100]% versus ARCHITECT 100 [97.3-100]%). Similar proportions of patients stratified as low-(Alinity 67% versus ARCHITECT 67%), intermediate-risk (23% versus 24%) and high-risk (10% versus 9%) at presentation with minor reclassification. Similar efficacy was observed across subgroups stratified by sex, age, history of myocardial infarction, renal function, and symptom duration. ConclusionsThe Alinity hs-cTnI and the ARCHITECT hs-cTnI assays can be used interchangeably in the assessment of suspected myocardial infarction with comparable safety and efficacy.
ER -