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: | , , , , , , , , , , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
8 January 2011
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| 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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| 245 | 1 | 0 | |a Multicenter analytical evaluation of a high-sensitivity troponin T assay |c 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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| 520 | |a 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. | ||
| 650 | 4 | |a 99th percentile | |
| 650 | 4 | |a Acute myocardial infarction | |
| 650 | 4 | |a Cardiac biomarkers | |
| 650 | 4 | |a High-sensitivity | |
| 650 | 4 | |a Troponin | |
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