Diagnostic Evaluation of a High-Sensitivity Troponin I Point-of-Care Assay

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Diagnostic Evaluation of a High-Sensitivity Troponin I Point-of-Care Assay. / Sörensen, Nils A; Neumann, Johannes T; Ojeda, Francisco; Giannitsis, Evangelos; Spanuth, Eberhard; Blankenberg, Stefan; Westermann, Dirk; Zeller, Tanja.

In: CLIN CHEM, Vol. 65, No. 12, 12.2019, p. 1592-1601.

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@article{9ffbd99dcc80476e9016bf5eb291f614,
title = "Diagnostic Evaluation of a High-Sensitivity Troponin I Point-of-Care Assay",
abstract = "BACKGROUND: Increasing numbers of patients are presenting worldwide to emergency departments with suspected myocardial infarction. The use of point-of-care troponin assays might enable faster decision-making in this high-risk population and reduce the burden on emergency facilities. Here, we evaluate the diagnostic performance of a point-of-care high-sensitivity troponin I assay.METHODS: We conducted a prospective cohort study including patients presenting to the emergency department with suspected myocardial infarction from July 2013 to July 2016. A diagnostic algorithm for a high-sensitivity troponin I point-of-care assay was developed in a derivation data set with 669 patients and validated in an additional 610 patients.RESULTS: The derived 0/1 h algorithm for the point-of-care assay consisted of an admission troponin I <4 ng/L and a δ from 0 h to 1 h <3 ng/L for rule out and an admission troponin I ≥90 ng/L or a δ from 0 h to 1 h ≥20 ng/L for rule in of non-ST-elevation myocardial infarction. Application to the validation cohort showed a negative predictive value of 99.7% (95% CI, 98.1%-100.0%) and 48.0% of patients ruled out, whereas 14.6% were ruled in with a positive predictive value of 86.5% (95% CI, 77.6%-92.8%). The diagnostic performance of the point-of-care high-sensitivity assay was highly comparable to guideline-recommended use of a laboratory-based high-sensitivity troponin assay.CONCLUSIONS: The clinical application of a 0/1 h diagnostic algorithm based on a high-sensitivity troponin I point-of-care assay is safe, and diagnostic performance is comparable to a laboratory-based high-sensitivity troponin I assay.",
author = "S{\"o}rensen, {Nils A} and Neumann, {Johannes T} and Francisco Ojeda and Evangelos Giannitsis and Eberhard Spanuth and Stefan Blankenberg and Dirk Westermann and Tanja Zeller",
note = "{\textcopyright} 2019 American Association for Clinical Chemistry.",
year = "2019",
month = dec,
doi = "10.1373/clinchem.2019.307405",
language = "English",
volume = "65",
pages = "1592--1601",
journal = "CLIN CHEM",
issn = "0009-9147",
publisher = "American Association for Clinical Chemistry Inc.",
number = "12",

}

RIS

TY - JOUR

T1 - Diagnostic Evaluation of a High-Sensitivity Troponin I Point-of-Care Assay

AU - Sörensen, Nils A

AU - Neumann, Johannes T

AU - Ojeda, Francisco

AU - Giannitsis, Evangelos

AU - Spanuth, Eberhard

AU - Blankenberg, Stefan

AU - Westermann, Dirk

AU - Zeller, Tanja

N1 - © 2019 American Association for Clinical Chemistry.

PY - 2019/12

Y1 - 2019/12

N2 - BACKGROUND: Increasing numbers of patients are presenting worldwide to emergency departments with suspected myocardial infarction. The use of point-of-care troponin assays might enable faster decision-making in this high-risk population and reduce the burden on emergency facilities. Here, we evaluate the diagnostic performance of a point-of-care high-sensitivity troponin I assay.METHODS: We conducted a prospective cohort study including patients presenting to the emergency department with suspected myocardial infarction from July 2013 to July 2016. A diagnostic algorithm for a high-sensitivity troponin I point-of-care assay was developed in a derivation data set with 669 patients and validated in an additional 610 patients.RESULTS: The derived 0/1 h algorithm for the point-of-care assay consisted of an admission troponin I <4 ng/L and a δ from 0 h to 1 h <3 ng/L for rule out and an admission troponin I ≥90 ng/L or a δ from 0 h to 1 h ≥20 ng/L for rule in of non-ST-elevation myocardial infarction. Application to the validation cohort showed a negative predictive value of 99.7% (95% CI, 98.1%-100.0%) and 48.0% of patients ruled out, whereas 14.6% were ruled in with a positive predictive value of 86.5% (95% CI, 77.6%-92.8%). The diagnostic performance of the point-of-care high-sensitivity assay was highly comparable to guideline-recommended use of a laboratory-based high-sensitivity troponin assay.CONCLUSIONS: The clinical application of a 0/1 h diagnostic algorithm based on a high-sensitivity troponin I point-of-care assay is safe, and diagnostic performance is comparable to a laboratory-based high-sensitivity troponin I assay.

AB - BACKGROUND: Increasing numbers of patients are presenting worldwide to emergency departments with suspected myocardial infarction. The use of point-of-care troponin assays might enable faster decision-making in this high-risk population and reduce the burden on emergency facilities. Here, we evaluate the diagnostic performance of a point-of-care high-sensitivity troponin I assay.METHODS: We conducted a prospective cohort study including patients presenting to the emergency department with suspected myocardial infarction from July 2013 to July 2016. A diagnostic algorithm for a high-sensitivity troponin I point-of-care assay was developed in a derivation data set with 669 patients and validated in an additional 610 patients.RESULTS: The derived 0/1 h algorithm for the point-of-care assay consisted of an admission troponin I <4 ng/L and a δ from 0 h to 1 h <3 ng/L for rule out and an admission troponin I ≥90 ng/L or a δ from 0 h to 1 h ≥20 ng/L for rule in of non-ST-elevation myocardial infarction. Application to the validation cohort showed a negative predictive value of 99.7% (95% CI, 98.1%-100.0%) and 48.0% of patients ruled out, whereas 14.6% were ruled in with a positive predictive value of 86.5% (95% CI, 77.6%-92.8%). The diagnostic performance of the point-of-care high-sensitivity assay was highly comparable to guideline-recommended use of a laboratory-based high-sensitivity troponin assay.CONCLUSIONS: The clinical application of a 0/1 h diagnostic algorithm based on a high-sensitivity troponin I point-of-care assay is safe, and diagnostic performance is comparable to a laboratory-based high-sensitivity troponin I assay.

U2 - 10.1373/clinchem.2019.307405

DO - 10.1373/clinchem.2019.307405

M3 - SCORING: Journal articles

C2 - 31699700

VL - 65

SP - 1592

EP - 1601

JO - CLIN CHEM

JF - CLIN CHEM

SN - 0009-9147

IS - 12

ER -