Clinical Chemistry 56: 254-261, 2010. First published December 3, 2009; 10.1373/clinchem.2009.132654
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Right arrow Proteomics and Protein Markers
(Clinical Chemistry. 2010;56:254-261.)
© 2010 American Association for Clinical Chemistry, Inc.

Proteomics and Protein Markers

Analytical Validation of a High-Sensitivity Cardiac Troponin T Assay

Evangelos Giannitsis1, Kerstin Kurz1, Klaus Hallermayer2, Jochen Jarausch2, Allan S. Jaffe3 and Hugo A. Katus1,a

1 Medizinische Klinik, Abteilung für Innere Medizin III, Universitätsklinikum Heidelberg, Germany; 2 Roche Diagnostics GmbH, Nonnenwald 2, Penzberg, Germany; 3 Mayo Clinic and Mayo College of Medicine, Rochester, MN.

aAddress correspondence to this author at: Medizinische Klinik III, Im Neuenheimer Feld 410, 69120 Heidelberg, Germany. Fax +49-6221-56-5516; e-mail evangelos_giannitsis{at}med.uni-heidelberg.de.

Background: 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.

Methods: 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).

Results: 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].

Conclusions: 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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E. Giannitsis, M. Becker, K. Kurz, G. Hess, D. Zdunek, and H. A. Katus
High-Sensitivity Cardiac Troponin T for Early Prediction of Evolving Non-ST-Segment Elevation Myocardial Infarction in Patients with Suspected Acute Coronary Syndrome and Negative Troponin Results on Admission
Clin. Chem., April 1, 2010; 56(4): 642 - 650.
[Abstract] [Full Text] [PDF]