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28 January 2015 : Clinical Research

A New Generation of Biomarkers Tests of Myocardial Necrosis: The Real Quality a Physician can get from the Laboratory

Rafał Nikodem WlazełABCDEFG, Jarosław KasprzakCDE, Marek ParadowskiADFG

Med Sci Monit 2015; 21:338-344

Abstract

BACKGROUND: ecent guidelines recommended by ESC, ACC, AHA, and WHF concerning biomarkers of myocardial necrosis also apply to the work of clinical laboratories. Methodological modification for tests used in determining cardiac biomarkers reduced the time of the analytical procedure to 9 min (STAT version of the tests). We decided to determine and compare analytical quality of the tests in standard and STAT versions for determining serum level: troponin T, MB isoenzyme of creatine kinase, and myoglobin, as well as to verify whether the TnThs STAT test meets the following requirements: CV <10% at the level close to diagnostic, equal to the 99th percentile of reference population, and turnaround time <60 min.

MATERIAL AND METHODS: We evaluated real precision and accuracy for both standard and STAT versions of tests as well as the correlation of results of physiological and pathological levels. Additionally, observations of turnaround time were made.

RESULTS: Calculated values of total errors did not exceed the recommended acceptable total error (<20%). Comparable precision of the 2 measurement methods (CV=3.07%) was obtained. A strong correlation (R>0.99) between both variants of tests for all the parameters was confirmed. Thanks to the application of new reagent kit, the percentage of results with turnaround time <60 min increased from 40% to 75% (n=115; p=0.000008).

CONCLUSIONS: The new generation of STAT cardiac biomarkers has high analytical quality and meets international precision requirements. It guarantees high analytical and clinical reliability of results. Use of the STAT version of biomarkers contributes to a significant decrease in turnaround time and allows obtaining a good result of an analysis.

Keywords: Acute Coronary Syndrome - diagnosis, Biological Markers - metabolism, Clinical Laboratory Techniques, Creatine Kinase, MB Form - chemistry, Isoenzymes - chemistry, Myocardium - pathology, Myoglobin - chemistry, Necrosis - pathology, Reproducibility of Results, Time Factors, Troponin T - chemistry

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Medical Science Monitor eISSN: 1643-3750