Analytical Validation of a High-Sensitivity Cardiac Troponin T Assay
ABSTRACT We report the development of a novel high-sensitivity cardiac troponin T (hs-cTnT) assay, a modification of the Roche fourth-generation cTnT assay, and validation of the analytical performance of this assay.
Validation included testing of analytical sensitivity, specificity, interferences, and precision. We established the 99th percentile cutoff from healthy reference populations (n = 616). In addition, we studied differences in time to a positive result when using serial measurements of hs-cTnT vs cTnT in patients with a confirmed diagnosis of non-ST elevation myocardial infarction (non-STEMI).
The hs-cTnT assay had an analytical range from 3 to 10 000 ng/L. At the 99th percentile value of 13.5 ng/L, the CV was 9% using the Elecsys 2010 analyzer. The assay was specific for cTnT without interferences from human cTnI or cTnC, skeletal muscle TnT, or hemoglobin concentrations up to 1000 mg/L, above which falsely lower values would be expected. When the assay was evaluated clinically, a hs-cTnT higher than the 99th percentile concentration identified a significantly higher number of patients with non-STEMI on presentation (45 vs 20 patients, P = 0.0004) compared with cTnT, and a final diagnosis of non-STEMI was made in 9 additional patients (55 vs 46 patients, P = 0.23) after serial sampling. Time to diagnosis was significantly shorter using hs-cTnT compared with cTnT [mean 71.5 (SD 108.7) min vs 246.9 (82.0) min, respectively; P < 0.01].
The analytical performance of hs-cTnT complies with the ESC-ACCF-AHA-WHF Global Task Force recommendations for use in the diagnosis of MI.
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ABSTRACT: Despite several publications on the analytical performance of high-sensitivity cardiac troponin (hs-cTn) assays, there has been little information on how laboratories should validate and implement these assays into clinical service. Our study provides a practical approach for the validation and implementation of a hs-cTn assay across a large North American City.04/2015; 1:28-34. DOI:10.1016/j.plabm.2015.02.001
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ABSTRACT: Since natriuretic peptides were successfully integrated into the clinical practice of heart failure (HF), the possibility of using new biomarkers to advance the management of affected patients has been explored. While a huge number of candidate HF biomarkers have been described recently, very few have made the difficult translation from initial promise to clinical application. These markers mirror the complex pathophysiology of heart failure at various levels: cell loss (troponin), fibrosis (ST2 and galectin-3), infection (procalcitonin), and renal disease (several renal markers). In this review, we examine the best emerging candidates for clinical assessment and management of patients with HF. © 2015 The Authors European Journal of Heart Failure © 2015 European Society of Cardiology.European Journal of Heart Failure 04/2015; DOI:10.1002/ejhf.273 · 6.58 Impact Factor
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ABSTRACT: Cardiac troponin is used as a marker for all types of myocardial infarction. Assays for high-sensitivity troponin T and I were performed before, immediately and 24hours after a 40km bicycle ride in two middle aged individuals. There was a significant increase in cardiac troponin immediately after exercise in both individuals. This was accompanied by a return to baseline levels within 24hours. A CT angiogram was normal in one while the other had a significant occlusion in the mid right coronary artery. After a stent placement, in this latter individual, there was no major increase in troponin after a second bicycle ride. Using high sensitivity assays, at least one of these two subjects may have suffered a type 2 myocardial infarction had the increases in hs-cTnI were accompanied by other acceptable evidence of myocardial ischemia (symptoms, ECG, etc.).. Copyright © 2015. Published by Elsevier B.V.Clinica chimica acta; international journal of clinical chemistry 04/2015; 446. DOI:10.1016/j.cca.2015.04.002 · 2.76 Impact Factor