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Multicenter analytical evaluation of a high-sensitivity troponin T assay

Background - High-sensitivity cardiac troponin assays are being introduced clinically for earlier diagnosis of acute myocardial infarction (AMI). We evaluated the analytical performance of a high-sensitivity cardiac troponin T assay (hscTnT, Roche Diagnostics) in a multicenter, international trial....

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Main Authors: Saenger, Amy (Author) , Beyrau, R. (Author) , Braun, S. (Author) , Cooray, R. (Author) , Dolci, A. (Author) , Freidank, H. (Author) , Giannitsis, Evangelos (Author) , Gustafson, S. (Author) , Handy, B. (Author) , Katus, Hugo (Author) , Melanson, S. E. (Author) , Panteghini, M. (Author) , Venge, P. (Author) , Zorn, Markus (Author) , Jarolim, P. (Author) , Bruton, D. (Author) , Jarausch, J. (Author) , Jaffe, A. S. (Author)
Format: Article (Journal)
Language:English
Published: 8 January 2011
In: Clinica chimica acta
Year: 2011, Volume: 412, Issue: 9, Pages: 748-754
ISSN:1873-3492
DOI:10.1016/j.cca.2010.12.034
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/j.cca.2010.12.034
Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S0009898111000052
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Author Notes:A.K. Saenger, R. Beyrau, S. Braun, R. Cooray, A. Dolci, H. Freidank, E. Giannitsis, S. Gustafson, B. Handy, H. Katus, S.E. Melanson, M. Panteghini, P. Venge, M. Zorn, P. Jarolim, D. Bruton, J. Jarausch, A.S. Jaffe
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Summary:Background - High-sensitivity cardiac troponin assays are being introduced clinically for earlier diagnosis of acute myocardial infarction (AMI). We evaluated the analytical performance of a high-sensitivity cardiac troponin T assay (hscTnT, Roche Diagnostics) in a multicenter, international trial. - Methods - Three US and 5 European sites evaluated hscTnT on the Modular® Analytics E170, cobas® 6000, Elecsys 2010, and cobas® e 411. Precision, accuracy, reportable range, an inter-laboratory comparison trial, and the 99th percentile of a reference population were assessed. - Results - Total imprecision (CVs) were 4.6-36.8% between 3.4 and 10.3ng/L hscTnT. Assay linearity was up to 10,000ng/L and the limit of blank and detection were 3 and 5ng/L, respectively. The 99th percentile reference limit was 14.2ng/L (n=533). No significant differences between specimen types, assay incubation time, or reagent lots existed. A substantial positive bias (76%) exists between the 4th generation and hscTnT assays at the low end of the measuring range (<50ng/L). hscTnT serum pool concentrations were within 2SD limits of the mean of means in the comparison trial, indicating comparable results across multiple platforms and laboratories. - Conclusion - The Roche hscTnT assay conforms to guideline precision requirements and will likely identify additional patients with myocardial injury suspicious for AMI.
Item Description:Gesehen am 30.09.2022
Physical Description:Online Resource
ISSN:1873-3492
DOI:10.1016/j.cca.2010.12.034

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