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Estimation of Values below the Limit of Detection of a Contemporary Sensitive Troponin I Assay Improves Diagnosis of Acute Myocardial Infarction

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Estimation of Values below the Limit of Detection of a Contemporary Sensitive Troponin I Assay Improves Diagnosis of Acute Myocardial Infarction. / Boeckel, Jes-Niels; Palapies, Lars; Zeller, Tanja; Reis, Sophia M; von Jeinsen, Beatrice; Tzikas, Stergios; Bickel, Christoph; Baldus, Stephan; Blankenberg, Stefan; Münzel, Thomas; Zeiher, Andreas M; Lackner, Karl J; Keller, Till.

In: CLIN CHEM, Vol. 61, No. 9, 09.2015, p. 1197-1206.

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

Harvard

Boeckel, J-N, Palapies, L, Zeller, T, Reis, SM, von Jeinsen, B, Tzikas, S, Bickel, C, Baldus, S, Blankenberg, S, Münzel, T, Zeiher, AM, Lackner, KJ & Keller, T 2015, 'Estimation of Values below the Limit of Detection of a Contemporary Sensitive Troponin I Assay Improves Diagnosis of Acute Myocardial Infarction', CLIN CHEM, vol. 61, no. 9, pp. 1197-1206. https://doi.org/10.1373/clinchem.2015.238949

APA

Boeckel, J-N., Palapies, L., Zeller, T., Reis, S. M., von Jeinsen, B., Tzikas, S., Bickel, C., Baldus, S., Blankenberg, S., Münzel, T., Zeiher, A. M., Lackner, K. J., & Keller, T. (2015). Estimation of Values below the Limit of Detection of a Contemporary Sensitive Troponin I Assay Improves Diagnosis of Acute Myocardial Infarction. CLIN CHEM, 61(9), 1197-1206. https://doi.org/10.1373/clinchem.2015.238949

Vancouver

Boeckel J-N, Palapies L, Zeller T, Reis SM, von Jeinsen B, Tzikas S et al. Estimation of Values below the Limit of Detection of a Contemporary Sensitive Troponin I Assay Improves Diagnosis of Acute Myocardial Infarction. CLIN CHEM. 2015 Sep;61(9):1197-1206. https://doi.org/10.1373/clinchem.2015.238949

Bibtex

@article{78bf2d17305349d4a63ca4a834728dfa,
title = "Estimation of Values below the Limit of Detection of a Contemporary Sensitive Troponin I Assay Improves Diagnosis of Acute Myocardial Infarction",
abstract = "BACKGROUND: The limit of detection (LoD) is the minimal amount of a substance that can be consistently detected. In the diagnosis of acute myocardial infarction (AMI) many patients present with troponin concentrations below the LoD of contemporary sensitive cardiac troponin I (cs-cTnI) assays. These censored values below the LoD influence the diagnostic performance of these assays compared to highly sensitive cTnI (hs-cTnI) assays. Therefore we assessed the impact of a new approach for interpolation of the left-censored data of a cs-cTnI assay in the evaluation of patients with suspected AMI.METHODS: Our posthoc analysis used a real world cohort of 1818 patients with suspected MI. Data on cs-cTnI was available in 1786 patients. As a comparator the hs-cTnI version of the assay was used. To reconstruct quantities below the LoD of the cs-cTnI assay, a gamma regression approach incorporating the GRACE (Global Registry of Acute Coronary Events) score variables was used.RESULTS: Censoring of cs-cTnI data below the LoD yielded weaker diagnostic information [area under the curve (AUC), 0.781; 95% CI, 0.731-0.831] regarding AMI compared to the hs-cTnI assay (AUC, 0.949; CI, 0.936-0.961). Use of our model to estimate cs-cTnI values below the LoD showed an AUC improvement to 0.921 (CI, 0.902-0.940). The cs-cTnI LoD concentration had a negative predictive value (NPV) of 0.950. An estimated concentration that was to be undercut by 25% of patients presenting with suspected AMI was associated with an improvement of the NPV to 0.979.CONCLUSIONS: Estimation of values below the LoD of a cs-cTnI assay with this new approach improves the diagnostic performance in evaluation of patients with suspected AMI.",
keywords = "Acute Disease, Aged, Aged, 80 and over, Area Under Curve, Cohort Studies, Female, Humans, Limit of Detection, Male, Middle Aged, Myocardial Infarction/blood, Prognosis, ROC Curve, Regression Analysis, Troponin I/blood",
author = "Jes-Niels Boeckel and Lars Palapies and Tanja Zeller and Reis, {Sophia M} and {von Jeinsen}, Beatrice and Stergios Tzikas and Christoph Bickel and Stephan Baldus and Stefan Blankenberg and Thomas M{\"u}nzel and Zeiher, {Andreas M} and Lackner, {Karl J} and Till Keller",
note = "{\textcopyright} 2015 American Association for Clinical Chemistry.",
year = "2015",
month = sep,
doi = "10.1373/clinchem.2015.238949",
language = "English",
volume = "61",
pages = "1197--1206",
journal = "CLIN CHEM",
issn = "0009-9147",
publisher = "American Association for Clinical Chemistry Inc.",
number = "9",

}

RIS

TY - JOUR

T1 - Estimation of Values below the Limit of Detection of a Contemporary Sensitive Troponin I Assay Improves Diagnosis of Acute Myocardial Infarction

AU - Boeckel, Jes-Niels

AU - Palapies, Lars

AU - Zeller, Tanja

AU - Reis, Sophia M

AU - von Jeinsen, Beatrice

AU - Tzikas, Stergios

AU - Bickel, Christoph

AU - Baldus, Stephan

AU - Blankenberg, Stefan

AU - Münzel, Thomas

AU - Zeiher, Andreas M

AU - Lackner, Karl J

AU - Keller, Till

N1 - © 2015 American Association for Clinical Chemistry.

PY - 2015/9

Y1 - 2015/9

N2 - BACKGROUND: The limit of detection (LoD) is the minimal amount of a substance that can be consistently detected. In the diagnosis of acute myocardial infarction (AMI) many patients present with troponin concentrations below the LoD of contemporary sensitive cardiac troponin I (cs-cTnI) assays. These censored values below the LoD influence the diagnostic performance of these assays compared to highly sensitive cTnI (hs-cTnI) assays. Therefore we assessed the impact of a new approach for interpolation of the left-censored data of a cs-cTnI assay in the evaluation of patients with suspected AMI.METHODS: Our posthoc analysis used a real world cohort of 1818 patients with suspected MI. Data on cs-cTnI was available in 1786 patients. As a comparator the hs-cTnI version of the assay was used. To reconstruct quantities below the LoD of the cs-cTnI assay, a gamma regression approach incorporating the GRACE (Global Registry of Acute Coronary Events) score variables was used.RESULTS: Censoring of cs-cTnI data below the LoD yielded weaker diagnostic information [area under the curve (AUC), 0.781; 95% CI, 0.731-0.831] regarding AMI compared to the hs-cTnI assay (AUC, 0.949; CI, 0.936-0.961). Use of our model to estimate cs-cTnI values below the LoD showed an AUC improvement to 0.921 (CI, 0.902-0.940). The cs-cTnI LoD concentration had a negative predictive value (NPV) of 0.950. An estimated concentration that was to be undercut by 25% of patients presenting with suspected AMI was associated with an improvement of the NPV to 0.979.CONCLUSIONS: Estimation of values below the LoD of a cs-cTnI assay with this new approach improves the diagnostic performance in evaluation of patients with suspected AMI.

AB - BACKGROUND: The limit of detection (LoD) is the minimal amount of a substance that can be consistently detected. In the diagnosis of acute myocardial infarction (AMI) many patients present with troponin concentrations below the LoD of contemporary sensitive cardiac troponin I (cs-cTnI) assays. These censored values below the LoD influence the diagnostic performance of these assays compared to highly sensitive cTnI (hs-cTnI) assays. Therefore we assessed the impact of a new approach for interpolation of the left-censored data of a cs-cTnI assay in the evaluation of patients with suspected AMI.METHODS: Our posthoc analysis used a real world cohort of 1818 patients with suspected MI. Data on cs-cTnI was available in 1786 patients. As a comparator the hs-cTnI version of the assay was used. To reconstruct quantities below the LoD of the cs-cTnI assay, a gamma regression approach incorporating the GRACE (Global Registry of Acute Coronary Events) score variables was used.RESULTS: Censoring of cs-cTnI data below the LoD yielded weaker diagnostic information [area under the curve (AUC), 0.781; 95% CI, 0.731-0.831] regarding AMI compared to the hs-cTnI assay (AUC, 0.949; CI, 0.936-0.961). Use of our model to estimate cs-cTnI values below the LoD showed an AUC improvement to 0.921 (CI, 0.902-0.940). The cs-cTnI LoD concentration had a negative predictive value (NPV) of 0.950. An estimated concentration that was to be undercut by 25% of patients presenting with suspected AMI was associated with an improvement of the NPV to 0.979.CONCLUSIONS: Estimation of values below the LoD of a cs-cTnI assay with this new approach improves the diagnostic performance in evaluation of patients with suspected AMI.

KW - Acute Disease

KW - Aged

KW - Aged, 80 and over

KW - Area Under Curve

KW - Cohort Studies

KW - Female

KW - Humans

KW - Limit of Detection

KW - Male

KW - Middle Aged

KW - Myocardial Infarction/blood

KW - Prognosis

KW - ROC Curve

KW - Regression Analysis

KW - Troponin I/blood

U2 - 10.1373/clinchem.2015.238949

DO - 10.1373/clinchem.2015.238949

M3 - SCORING: Journal article

C2 - 26220065

VL - 61

SP - 1197

EP - 1206

JO - CLIN CHEM

JF - CLIN CHEM

SN - 0009-9147

IS - 9

ER -