Recalibration of the point-of-care test for CARDIAC T Quantitative with Elecsys Troponin T 3rd generation

• Published in: Clinica chimica acta Vol. 307; no. 1-2; pp. 197 - 203
• Main Authors: Collinson, Paul O, Jørgensen, Bo, Sylvén, Christer, Haass, Markus, Chwallek, Frank, Katus, Hugo A, Müller-Bardorff, Margit, Derhaschnig, Ulla, Hirschl, Michael M, Zerback, Rainer
• Format: Journal Article Conference Proceeding
• Language: English
• Published: Shannon Elsevier B.V 01.05.2001; Elsevier
• Subjects: Acute myocardial infarction; Biological and medical sciences; Calibration; Cardiac troponin T; Clinical Chemistry Tests - standards; Humans; Investigative techniques, diagnostic techniques (general aspects); Medical sciences; Medicin och hälsovetenskap; Minor myocardial injury; Miscellaneous. Technology; Multicentre evaluation; Pathology. Cytology. Biochemistry. Spectrometry. Miscellaneous investigative techniques; Point-of-Care Systems - standards; Point-of-care testing; Quality Control; Reference Standards; Troponin T - blood; Troponin T - standards; Point-of-care testing; Minor myocardial injury; Calibration; Acute myocardial infarction; Cardiac troponin T; Multicentre evaluation; Human; Biochemical analysis; Infarct; Acute; Cardiovascular disease; Coronary heart disease; Myocardial disease; Troponin; Automatic analyzer; Point of care testing; Clinical biology; Calipering; Myocardium; Diagnosis; Technique; Quantitative analysis
• ISSN: 0009-8981; 1873-3492
• DOI: 10.1016/S0009-8981(01)00428-4

The rapid troponin T assay CARDIAC T Quantitative was recalibrated using Elecsys Troponin T 3rd Generation as a new reference method. This paper presents the method comparisons at six centres using the new reference method. Method comparison between CARDIAC T Quantitative versus Elecsys Troponin T 3rd Generation were performed using 319 samples from patients with acute coronary syndromes. The quality of the CARDIAC T Quantitative was controlled by a daily single determination of CARDIAC Control Troponin T, and for the Elecsys Troponin T 3rd Generation, the Elecsys controls were included in each run. The results for the control materials for the CARDIAC T Quantitative were between 93% and 107% of the target values. The CV ranged from 7% to 16%. From the regression analysis, according to Bablok and Passing (y=1.07x) and the Bland and Altman plot, the bias between CARDIAC T Quantitative and Elecsys Troponin T 3rd Generation is from +6% to +7%. The correlation coefficient is 0.93, and a 3×3 comparison of the clinical efficiency yielded 92% clinical concordance between CARDIAC T Quantitative and Elecsys Troponin T 3rd Generation. In conclusion, CARDIAC T Quantitative was in good agreement with the reference and calibration method Elecsys Troponin T 3rd Generation.