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.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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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.
KW - Aged
KW - Algorithms
KW - Biomarkers
KW - Cohort Studies
KW - Emergency Service, Hospital
KW - Female
KW - Humans
KW - Male
KW - Middle Aged
KW - Myocardial Infarction/diagnosis
KW - Non-ST Elevated Myocardial Infarction/diagnosis
KW - Point-of-Care Systems/trends
KW - Point-of-Care Testing/trends
KW - Prospective Studies
KW - Risk Factors
KW - Sensitivity and Specificity
KW - Time Factors
KW - Troponin I/analysis
KW - Troponin T/analysis
U2 - 10.1373/clinchem.2019.307405
DO - 10.1373/clinchem.2019.307405
M3 - SCORING: Journal article
C2 - 31699700
VL - 65
SP - 1592
EP - 1601
JO - CLIN CHEM
JF - CLIN CHEM
SN - 0009-9147
IS - 12
ER -
