Time-related performance characteristics of high-sensitivity troponin I assay using manufacturer’s controls and reagents
作者： Sebastian Vencken , Peter Doran , Rosanna Inzitari , Marie Galligan , Karl McAuley
DOI: 10.1016/J.PLABM.2021.E00217
关键词:
摘要: Abstract Background Troponin is a widely used cardiac protein biomarker for acute coronary syndrome. Its increasing importance drives an need to assess, in real-world conditions, the performance of tests measure it. We evaluated characteristics high-sensitivity troponin I assay reagents and ancillary agents on Abbott ARCHITECT ci4100, i2000SR Alinity ci using historical quality control data spanning 5 years. Design method Retrospective diagnostic hs-TnI were collected between 2015 2019 from located University College Dublin Clinical Research Centre Core Lab facility. Descriptive statistics bias variability generated. Linear regression models calculate mean concentrations over or reagent lot age time last calibration analysers. Results Measurement all three systems ranged -2.49% 3.98%. The total CV was ≤8.80%, with within-lot controls ≤5.45% ≤7.13%, respectively. between-lot CVs ≤7.16% 6.19%, effect did not greatly affect stability time. also stable different times Conclusion results this study show that i2000sr ci4000 quite core laboratory environment. system exhibits similar characteristics.
sci-hub.st 参考文章(19)
Till Keller, Tanja Zeller, Francisco Ojeda, Stergios Tzikas, Lars Lillpopp, Christoph Sinning, Philipp Wild, Sabine Genth-Zotz, Ascan Warnholtz, Evangelos Giannitsis, Martin Möckel, Christoph Bickel, Dirk Peetz, Karl Lackner, Stephan Baldus, Thomas Münzel, Stefan Blankenberg, Serial changes in highly sensitive troponin I assay and early diagnosis of myocardial infarction. JAMA. ,vol. 306, pp. 2684- 2693 ,(2011) , 10.1001/JAMA.2011.1896
Alan H B Wu, Quynh Anh Lu, John Todd, Joachim Moecks, Frank Wians, Short- and Long-Term Biological Variation in Cardiac Troponin I Measured with a High-Sensitivity Assay: Implications for Clinical Practice Clinical Chemistry. ,vol. 55, pp. 52- 58 ,(2009) , 10.1373/CLINCHEM.2008.107391
Maria Rubini Giménez, Rebeca Hoeller, Tobias Reichlin, Christa Zellweger, Raphael Twerenbold, Miriam Reiter, Berit Moehring, Karin Wildi, Tamina Mosimann, Mira Mueller, Bernadette Meller, Thomas Hochgruber, Ronny Ziller, Seoung Mann Sou, Karsten Murray, Konstantin Sakarikos, Susanne Ernst, Joaquim Gea, Isabel Campodarve, Carles Vilaplana, Philip Haaf, Stephan Steuer, Jan Minners, Stefan Osswald, Christian Mueller, Rapid rule out of acute myocardial infarction using undetectable levels of high-sensitivity cardiac troponin☆ International Journal of Cardiology. ,vol. 168, pp. 3896- 3901 ,(2013) , 10.1016/J.IJCARD.2013.06.049
Vlad C Vasile, Amy K Saenger, Jean M Kroning, Allan S Jaffe, Biological and Analytical Variability of a Novel High-Sensitivity Cardiac Troponin T Assay Clinical Chemistry. ,vol. 56, pp. 1086- 1090 ,(2010) , 10.1373/CLINCHEM.2009.140616
Association between postoperative troponin levels and 30-day mortality among patients undergoing noncardiac surgery JAMA. ,vol. 307, pp. 2295- 2304 ,(2012) , 10.1001/JAMA.2012.5502
Anoop S V Shah, Megan Griffiths, Kuan Ken Lee, David A McAllister, Amanda L Hunter, Amy V Ferry, Anne Cruikshank, Alan Reid, Mary Stoddart, Fiona Strachan, Simon Walker, Paul O Collinson, Fred S Apple, Alasdair J Gray, Keith A A Fox, David E Newby, Nicholas L Mills, High sensitivity cardiac troponin and the under-diagnosis of myocardial infarction in women: prospective cohort study BMJ. ,vol. 350, ,(2015) , 10.1136/BMJ.G7873
W. Frank Peacock, Teresa De Marco, Gregg C. Fonarow, Deborah Diercks, Janet Wynne, Fred S. Apple, Alan H.B. Wu, Cardiac Troponin and Outcome in Acute Heart Failure The New England Journal of Medicine. ,vol. 358, pp. 2117- 2126 ,(2008) , 10.1056/NEJMOA0706824
Marco Roffi, Carlo Patrono, Jean-Philippe Collet, Christian Mueller, Marco Valgimigli, Felicita Andreotti, Jeroen J. Bax, Michael A. Borger, Carlos Brotons, Derek P. Chew, Baris Gencer, Gerd Hasenfuss, Keld Kjeldsen, Patrizio Lancellotti, Ulf Landmesser, Julinda Mehilli, Debabrata Mukherjee, Robert F. Storey, Stephan Windecker, 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC) European Heart Journal. ,vol. 37, pp. 267- 315 ,(2011) , 10.1093/EURHEARTJ/EHV320
Heloisa Sawaya, Igal A. Sebag, Juan Carlos Plana, James L. Januzzi, Bonnie Ky, Timothy C. Tan, Victor Cohen, Jose Banchs, Joseph R. Carver, Susan E. Wiegers, Randolph P. Martin, Michael H. Picard, Robert E. Gerszten, Elkan F. Halpern, Jonathan Passeri, Irene Kuter, Marielle Scherrer-Crosbie, Assessment of Echocardiography and Biomarkers for the Extended Prediction of Cardiotoxicity in Patients Treated With Anthracyclines, Taxanes, and Trastuzumab Circulation-cardiovascular Imaging. ,vol. 5, pp. 596- 603 ,(2012) , 10.1161/CIRCIMAGING.112.973321
Anoop SV Shah, Atul Anand, Yader Sandoval, Kuan Ken Lee, Stephen W Smith, Philip D Adamson, Andrew R Chapman, Timothy Langdon, Dennis Sandeman, Amar Vaswani, Fiona E Strachan, Amy Ferry, Alexandra G Stirzaker, Alan Reid, Alasdair J Gray, Paul O Collinson, David A McAllister, Fred S Apple, David E Newby, Nicholas L Mills, None, High-sensitivity cardiac troponin I at presentation in patients with suspected acute coronary syndrome: a cohort study The Lancet. ,vol. 386, pp. 2481- 2488 ,(2015) , 10.1016/S0140-6736(15)00391-8