Analytical validation of a high-sensitivity cardiac troponin T assay

• Verfasst von: Giannitsis, Evangelos [VerfasserIn]
• Verfasst von: Kurz, Kerstin [VerfasserIn]
• Verfasst von: Hallermayer, Klaus [VerfasserIn]
• Verfasst von: Jarausch, Jochen [VerfasserIn]
• Verfasst von: Jaffe, Allan S. [VerfasserIn]
• Verfasst von: Katus, Hugo [VerfasserIn]
• Titel: Analytical validation of a high-sensitivity cardiac troponin T assay
• Verf.angabe: Evangelos Giannitsis, Kerstin Kurz, Klaus Hallermayer, Jochen Jarausch, Allan S. Jaffe, and Hugo A. Katus
• E-Jahr: 2010
• Jahr: 01 February 2010
• Umfang: 8 S.
• Fussnoten: Gesehen am 10.03.2023
• Titel Quelle: Enthalten in: Clinical chemistry
• Ort Quelle: Washington, DC : American Association for Clinical Chemistry, 1955
• Jahr Quelle: 2010
• Band/Heft Quelle: 56(2010), 2, Seite 254-261
• ISSN Quelle: 1530-8561
• DOI: doi:10.1373/clinchem.2009.132654
• Datenträger: Online-Ressource
• Sprache: eng
• K10plus-PPN: 1838868569

Abstract

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.