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首页> 外文期刊>Clinical Chemistry >Analytic and Clinical Utility of a Next-Generation, Highly Sensitive Cardiac Troponin I Assay for Early Detection of Myocardial Injury
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Analytic and Clinical Utility of a Next-Generation, Highly Sensitive Cardiac Troponin I Assay for Early Detection of Myocardial Injury

机译：新一代高敏感性心肌肌钙蛋白I测定法在心肌损伤早期检测中的分析和临床应用

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摘要

Improvements in cardiac troponin (cTn) assays have increased the rapidity with which clinicians can identify patients with changing cTn concentrations (rise or fall) indicative of acute myocardial injury. The aim of the present study was to characterize a new, high-sensitivity cTnI (hs-cTnI) assay and examine whether increased sensitivity can result in still earlier detection of evolving injury. We determined the limit of detection, precision profiles, and preliminary estimates of the 99th percentile for the Beckman Coulter hs-cTnI assay in 125 healthy individuals (age 0.10 µg/L) were exceeded in the first 2 specimens (median time between specimens, 1 h; 25th-75th percentile, 1-3 h) from subjects with symptoms suggestive of cardiac ischemia (n = 290). The limit of detection for the hs-cTnI assay was 2.06 ng/L, and the 20% CV and 10% CV concentrations were 2.95 and 8.66 ng/L, respectively. The preliminary 99th percentile estimates in lithium heparin, serum, and EDTA plasma were 9.20, 8.00, and 8.60 ng/L, respectively. In 108 patients with myocardial injury based on the peak AccuTnI concentration, applying the change criteria on the 2 earliest specimens identified 81% (95% CI 73%-88%) of patients using the hs-cTnI assay compared to 62% (53%-71%) using the AccuTnI assay (P < 0.001). Although more extensive validation studies are required, this Beckman Coulter hs-cTnI assay appears to detect patients with evolving myocardial injury earlier.
机译：心肌肌钙蛋白（cTn）测定方法的改进提高了临床医生能够快速识别出指示急性心肌损伤的cTn浓度变化（上升或下降）的患者的速度。本研究的目的是表征一种新的高灵敏度cTnI（hs-cTnI）检测方法，并检查灵敏度的提高是否可以导致更早地检测到发展中的损伤。我们确定了前2个样本中超过125个健康个体（年龄0.10 µg / L）的贝克曼库尔特hs-cTnI测定的99％的检出限，精密度和初步估计（样本之间的中位数时间为1 h；第25-75％百分数，1-3小时）来自具有心脏缺血症状的受试者（n = 290）。 hs-cTnI分析的检出限为2.06 ng / L，20％CV和10％CV浓度分别为2.95和8.66 ng / L。肝素锂，血清和EDTA血浆中第99个百分点的初步估计分别为9.20、8.00和8.60 ng / L。根据AccuTnI峰值浓度，在108例心肌损伤患者中，应用hs-cTnI分析在2个最早的标本上应用变化标准确定了81％（95％CI 73％-88％）的患者，而62％（53％） -71％）使用AccuTnI分析（P <0.001）。尽管需要进行更广泛的验证研究，但这种Beckman Coulter hs-cTnI分析似乎可以更早地检测出发展中的心肌损伤患者。

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    《Clinical Chemistry》 |2009年第3期|p.573-577|共5页
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    Peter A Kavsak Andrew R MacRae Marie-Jeanne Yerna Allan S Jaffe;

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    Peter A. Kavsak,1* Andrew R. MacRae,2 Marie- Jeanne Yerna,3 and Allan S. Jaffe41 Department of Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada, 2 Department of Biochemistry and Medical Genetics, University of Manitoba, MB, Canada, 3 Beckman Coulter, Inc., Chaska, MN, 4 Cardiovascular Division and Division of Laboratory Medicine, Mayo Clinic, Rochester, MN, * address correspondence to this author at: Hamilton Regional Laboratory Medicine Program, Henderson General Hospital (Core Lab Section), 711 Concession St., Hamilton, ON Canada. Fax 905.575.2581, e-mail kavsakp@mcmaster.ca.Author Contributions: All authors confirmed they have contributed to the intellectual content of this paper and have met the following 3 requirements: (a) significant contributions to the conception and design, acquisition of data, or analysis and interpretation of data, (b) drafting or revising the article for intellectual content, and (c) final approval of the published article.Authors' Disclosures of Potential Conflicts of Interest: Upon manuscript submission, all authors completed the Disclosures of Potential Conflict of Interest form. Potential conflicts of interest:Employment or Leadership: M.-J. Yerna is employed by Beckman- Coulter.Consultant or Advisory Role: A.R. MacRae, Beckman-Coulter, A.S. Jaffe, Siemens, Beckman-Coulter, Singulex, Nanosphere, Ortho Diagnostics, Critical Diagnostics, Novartis, and Hoffman-LaRoche.Stock Ownership: None declared.Honoraria: P. Kavsak, Beckman-Coulter.Research Funding: This work was supported by an unrestricted grant from Beckman Coulter. P. Kavsak, Beckman-Coulter, A.S. Jaffe, Siemens and Beckman-Coulter.Expert Testimony: None declared.Role of Sponsor: The funding organizations played a direct role in the design of study, choice of enrolled patients, review and interpretation of data, and final approval of manuscript.Acknowledgments: The hs-cTnI assay is for research use only and not for use in diagnostic procedures.,;

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