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Clinical Validation of a Novel High-Sensitivity Cardiac Troponin I Assay for Early Diagnosis of Acute Myocardial Infarction

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Clinical Validation of a Novel High-Sensitivity Cardiac Troponin I Assay for Early Diagnosis of Acute Myocardial Infarction. / Boeddinghaus, Jasper; Twerenbold, Raphael; Nestelberger, Thomas; Badertscher, Patrick; Wildi, Karin; Puelacher, Christian; du Fay de Lavallaz, Jeanne; Keser, Elif; Rubini Giménez, Maria; Wussler, Desiree; Kozhuharov, Nikola; Rentsch, Katharina; Miró, Òscar; Martin-Sanchez, F Javier; Morawiec, Beata; Stefanelli, Sabrina; Geigy, Nicolas; Keller, Dagmar I; Reichlin, Tobias; Mueller, Christian; APACE Investigators.

In: CLIN CHEM, Vol. 64, No. 9, 09.2018, p. 1347-1360.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Boeddinghaus, J, Twerenbold, R, Nestelberger, T, Badertscher, P, Wildi, K, Puelacher, C, du Fay de Lavallaz, J, Keser, E, Rubini Giménez, M, Wussler, D, Kozhuharov, N, Rentsch, K, Miró, Ò, Martin-Sanchez, FJ, Morawiec, B, Stefanelli, S, Geigy, N, Keller, DI, Reichlin, T, Mueller, C & APACE Investigators 2018, 'Clinical Validation of a Novel High-Sensitivity Cardiac Troponin I Assay for Early Diagnosis of Acute Myocardial Infarction', CLIN CHEM, vol. 64, no. 9, pp. 1347-1360. https://doi.org/10.1373/clinchem.2018.286906

APA

Boeddinghaus, J., Twerenbold, R., Nestelberger, T., Badertscher, P., Wildi, K., Puelacher, C., du Fay de Lavallaz, J., Keser, E., Rubini Giménez, M., Wussler, D., Kozhuharov, N., Rentsch, K., Miró, Ò., Martin-Sanchez, F. J., Morawiec, B., Stefanelli, S., Geigy, N., Keller, D. I., Reichlin, T., ... APACE Investigators (2018). Clinical Validation of a Novel High-Sensitivity Cardiac Troponin I Assay for Early Diagnosis of Acute Myocardial Infarction. CLIN CHEM, 64(9), 1347-1360. https://doi.org/10.1373/clinchem.2018.286906

Vancouver

Boeddinghaus J, Twerenbold R, Nestelberger T, Badertscher P, Wildi K, Puelacher C et al. Clinical Validation of a Novel High-Sensitivity Cardiac Troponin I Assay for Early Diagnosis of Acute Myocardial Infarction. CLIN CHEM. 2018 Sep;64(9):1347-1360. https://doi.org/10.1373/clinchem.2018.286906

Bibtex

@article{3c9703b571ac432aa258e0ae4e1f31d0,
title = "Clinical Validation of a Novel High-Sensitivity Cardiac Troponin I Assay for Early Diagnosis of Acute Myocardial Infarction",
abstract = "BACKGROUND: Clinical performance of the novel high-sensitivity cardiac troponin I (Siemens-hs-cTnI-Centaur) assay is unknown. We aimed to clinically validate the Siemens-hs-cTnI-Centaur assay and develop 0/1-h and 0/2-h algorithms.METHODS: We enrolled patients presenting to the emergency department with symptoms suggestive of acute myocardial infarction (AMI). Final diagnoses were centrally adjudicated by 2 independent cardiologists including all clinical information twice: first, using serial hs-cTnT (Roche-Elecsys, primary analysis); second, using hs-cTnI (Abbott-Architect, secondary analysis) measurements in addition to the clinically applied (hs)-cTn. Siemens-hs-cTnI-Centaur was measured at presentation, 1 h, and 2 h. The primary objective was a direct comparison of diagnostic accuracy, quantified by the area under the ROC curve (AUC), of Siemens-hs-cTnI-Centaur vs the 2 established hs-cTn assays (Roche-hs-cTnT-Elecsys, Abbott-hs-cTnI-Architect). Secondary objectives included the development of Siemens-hs-cTnI-Centaur-specific 0/1-h and 0/2-h algorithms.RESULTS: AMI was the final diagnosis in 318 of 1755 (18%) patients (using Roche-hs-cTnT-Elecsys for adjudication). The AUC at presentation for Siemens-hs-cTnI-Centaur was 0.94 (95% CI, 0.92-0.96) and comparable with 0.95 (95% CI, 0.93-0.97) for Roche-hs-cTnT-Elecsys and 0.93 (95% CI, 0.90-0.96) for Abbott-hs-cTnI-Architect. Applying the derived Siemens-hs-cTnI-Centaur 0/1-h algorithm to the validation cohort, 46% of patients were ruled out (sensitivity, 99.1%; 95% CI, 95.3-100), and 18% of patients were ruled in (specificity, 94.1%; 95% CI, 91.8-95.9). The Siemens-hs-cTnI-Centaur 0/2-h algorithm ruled out 55% of patients (sensitivity, 100%; 95% CI, 94.1-100), and ruled in 18% of patients (specificity, 96.0%; 95% CI, 93.1-97.9). Findings were confirmed in the secondary analyses using serial measurements of Abbott-hs-cTnI-Architect for adjudication.CONCLUSIONS: Diagnostic accuracy and clinical utility of the novel Siemens-hs-cTnI-Centaur assay are high and comparable with the established hs-cTn assays. ClinicalTrials.gov Identifier: NCT00470587.",
keywords = "Algorithms, Chest Pain, Early Diagnosis, Electrocardiography, Female, Humans, Male, Myocardial Infarction/diagnosis, Reproducibility of Results, Sensitivity and Specificity, Troponin I/blood",
author = "Jasper Boeddinghaus and Raphael Twerenbold and Thomas Nestelberger and Patrick Badertscher and Karin Wildi and Christian Puelacher and {du Fay de Lavallaz}, Jeanne and Elif Keser and {Rubini Gim{\'e}nez}, Maria and Desiree Wussler and Nikola Kozhuharov and Katharina Rentsch and {\`O}scar Mir{\'o} and Martin-Sanchez, {F Javier} and Beata Morawiec and Sabrina Stefanelli and Nicolas Geigy and Keller, {Dagmar I} and Tobias Reichlin and Christian Mueller and {APACE Investigators}",
note = "{\textcopyright} 2018 American Association for Clinical Chemistry.",
year = "2018",
month = sep,
doi = "10.1373/clinchem.2018.286906",
language = "English",
volume = "64",
pages = "1347--1360",
journal = "CLIN CHEM",
issn = "0009-9147",
publisher = "American Association for Clinical Chemistry Inc.",
number = "9",

}

RIS

TY - JOUR

T1 - Clinical Validation of a Novel High-Sensitivity Cardiac Troponin I Assay for Early Diagnosis of Acute Myocardial Infarction

AU - Boeddinghaus, Jasper

AU - Twerenbold, Raphael

AU - Nestelberger, Thomas

AU - Badertscher, Patrick

AU - Wildi, Karin

AU - Puelacher, Christian

AU - du Fay de Lavallaz, Jeanne

AU - Keser, Elif

AU - Rubini Giménez, Maria

AU - Wussler, Desiree

AU - Kozhuharov, Nikola

AU - Rentsch, Katharina

AU - Miró, Òscar

AU - Martin-Sanchez, F Javier

AU - Morawiec, Beata

AU - Stefanelli, Sabrina

AU - Geigy, Nicolas

AU - Keller, Dagmar I

AU - Reichlin, Tobias

AU - Mueller, Christian

AU - APACE Investigators

N1 - © 2018 American Association for Clinical Chemistry.

PY - 2018/9

Y1 - 2018/9

N2 - BACKGROUND: Clinical performance of the novel high-sensitivity cardiac troponin I (Siemens-hs-cTnI-Centaur) assay is unknown. We aimed to clinically validate the Siemens-hs-cTnI-Centaur assay and develop 0/1-h and 0/2-h algorithms.METHODS: We enrolled patients presenting to the emergency department with symptoms suggestive of acute myocardial infarction (AMI). Final diagnoses were centrally adjudicated by 2 independent cardiologists including all clinical information twice: first, using serial hs-cTnT (Roche-Elecsys, primary analysis); second, using hs-cTnI (Abbott-Architect, secondary analysis) measurements in addition to the clinically applied (hs)-cTn. Siemens-hs-cTnI-Centaur was measured at presentation, 1 h, and 2 h. The primary objective was a direct comparison of diagnostic accuracy, quantified by the area under the ROC curve (AUC), of Siemens-hs-cTnI-Centaur vs the 2 established hs-cTn assays (Roche-hs-cTnT-Elecsys, Abbott-hs-cTnI-Architect). Secondary objectives included the development of Siemens-hs-cTnI-Centaur-specific 0/1-h and 0/2-h algorithms.RESULTS: AMI was the final diagnosis in 318 of 1755 (18%) patients (using Roche-hs-cTnT-Elecsys for adjudication). The AUC at presentation for Siemens-hs-cTnI-Centaur was 0.94 (95% CI, 0.92-0.96) and comparable with 0.95 (95% CI, 0.93-0.97) for Roche-hs-cTnT-Elecsys and 0.93 (95% CI, 0.90-0.96) for Abbott-hs-cTnI-Architect. Applying the derived Siemens-hs-cTnI-Centaur 0/1-h algorithm to the validation cohort, 46% of patients were ruled out (sensitivity, 99.1%; 95% CI, 95.3-100), and 18% of patients were ruled in (specificity, 94.1%; 95% CI, 91.8-95.9). The Siemens-hs-cTnI-Centaur 0/2-h algorithm ruled out 55% of patients (sensitivity, 100%; 95% CI, 94.1-100), and ruled in 18% of patients (specificity, 96.0%; 95% CI, 93.1-97.9). Findings were confirmed in the secondary analyses using serial measurements of Abbott-hs-cTnI-Architect for adjudication.CONCLUSIONS: Diagnostic accuracy and clinical utility of the novel Siemens-hs-cTnI-Centaur assay are high and comparable with the established hs-cTn assays. ClinicalTrials.gov Identifier: NCT00470587.

AB - BACKGROUND: Clinical performance of the novel high-sensitivity cardiac troponin I (Siemens-hs-cTnI-Centaur) assay is unknown. We aimed to clinically validate the Siemens-hs-cTnI-Centaur assay and develop 0/1-h and 0/2-h algorithms.METHODS: We enrolled patients presenting to the emergency department with symptoms suggestive of acute myocardial infarction (AMI). Final diagnoses were centrally adjudicated by 2 independent cardiologists including all clinical information twice: first, using serial hs-cTnT (Roche-Elecsys, primary analysis); second, using hs-cTnI (Abbott-Architect, secondary analysis) measurements in addition to the clinically applied (hs)-cTn. Siemens-hs-cTnI-Centaur was measured at presentation, 1 h, and 2 h. The primary objective was a direct comparison of diagnostic accuracy, quantified by the area under the ROC curve (AUC), of Siemens-hs-cTnI-Centaur vs the 2 established hs-cTn assays (Roche-hs-cTnT-Elecsys, Abbott-hs-cTnI-Architect). Secondary objectives included the development of Siemens-hs-cTnI-Centaur-specific 0/1-h and 0/2-h algorithms.RESULTS: AMI was the final diagnosis in 318 of 1755 (18%) patients (using Roche-hs-cTnT-Elecsys for adjudication). The AUC at presentation for Siemens-hs-cTnI-Centaur was 0.94 (95% CI, 0.92-0.96) and comparable with 0.95 (95% CI, 0.93-0.97) for Roche-hs-cTnT-Elecsys and 0.93 (95% CI, 0.90-0.96) for Abbott-hs-cTnI-Architect. Applying the derived Siemens-hs-cTnI-Centaur 0/1-h algorithm to the validation cohort, 46% of patients were ruled out (sensitivity, 99.1%; 95% CI, 95.3-100), and 18% of patients were ruled in (specificity, 94.1%; 95% CI, 91.8-95.9). The Siemens-hs-cTnI-Centaur 0/2-h algorithm ruled out 55% of patients (sensitivity, 100%; 95% CI, 94.1-100), and ruled in 18% of patients (specificity, 96.0%; 95% CI, 93.1-97.9). Findings were confirmed in the secondary analyses using serial measurements of Abbott-hs-cTnI-Architect for adjudication.CONCLUSIONS: Diagnostic accuracy and clinical utility of the novel Siemens-hs-cTnI-Centaur assay are high and comparable with the established hs-cTn assays. ClinicalTrials.gov Identifier: NCT00470587.

KW - Algorithms

KW - Chest Pain

KW - Early Diagnosis

KW - Electrocardiography

KW - Female

KW - Humans

KW - Male

KW - Myocardial Infarction/diagnosis

KW - Reproducibility of Results

KW - Sensitivity and Specificity

KW - Troponin I/blood

U2 - 10.1373/clinchem.2018.286906

DO - 10.1373/clinchem.2018.286906

M3 - SCORING: Journal article

C2 - 29941469

VL - 64

SP - 1347

EP - 1360

JO - CLIN CHEM

JF - CLIN CHEM

SN - 0009-9147

IS - 9

ER -