Boeckel, Jes-Niels, Palapies, Lars, Zeller, Tanja ORCID: 0000-0003-3379-2641, Reis, Sophia M., von Jeinsen, Beatrice, Tzikas, Stergios ORCID: 0000-0002-7811-5620, Bickel, Christoph, Baldus, Stephan, Blankenberg, Stefan, Muenzel, Thomas ORCID: 0000-0001-5503-4150, Zeiher, Andreas M., Lackner, Karl J. and Keller, Till ORCID: 0000-0002-0895-6491 (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). S. 1197 - 1207. WASHINGTON: AMER ASSOC CLINICAL CHEMISTRY. ISSN 1530-8561

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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. (C) 2015 American Association for Clinical Chemistry

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Boeckel, Jes-NielsUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Palapies, LarsUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zeller, TanjaUNSPECIFIEDorcid.org/0000-0003-3379-2641UNSPECIFIED
Reis, Sophia M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
von Jeinsen, BeatriceUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tzikas, StergiosUNSPECIFIEDorcid.org/0000-0002-7811-5620UNSPECIFIED
Bickel, ChristophUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Baldus, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Blankenberg, StefanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Muenzel, ThomasUNSPECIFIEDorcid.org/0000-0001-5503-4150UNSPECIFIED
Zeiher, Andreas M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lackner, Karl J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Keller, TillUNSPECIFIEDorcid.org/0000-0002-0895-6491UNSPECIFIED
URN: urn:nbn:de:hbz:38-395274
DOI: 10.1373/clinchem.2015.238949
Journal or Publication Title: Clin. Chem.
Volume: 61
Number: 9
Page Range: S. 1197 - 1207
Date: 2015
Publisher: AMER ASSOC CLINICAL CHEMISTRY
Place of Publication: WASHINGTON
ISSN: 1530-8561
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
RISK; TIMEMultiple languages
Medical Laboratory TechnologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/39527

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