Wlazeł Rafał Nikodem, Kasprzak Jarosław, Paradowski Marek
Department of Laboratory Diagnostics and Clinical Biochemistry, Medical University of Łódź, Łódź, Poland.
Chair and Department of Cardiology, Medical University of Łódź, Łódź, Poland.
Med Sci Monit. 2015 Jan 28;21:338-44. doi: 10.12659/MSM.892033.
Recent 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/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.
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).
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.
欧洲心脏病学会（ESC）、美国心脏病学会（ACC）、美国心脏协会（AHA）和世界心脏联盟（WHF）近期推荐的关于心肌坏死生物标志物的指南也适用于临床实验室工作。用于测定心脏生物标志物的检测方法的改进将分析过程时间缩短至9分钟（检测的即时检验版本）。我们决定测定并比较标准版本和即时检验版本检测血清肌钙蛋白T、肌酸激酶MB同工酶和肌红蛋白水平的分析质量，并验证肌钙蛋白T即时检验检测是否满足以下要求：在接近诊断水平（等于参考人群第99百分位数）时变异系数（CV）<10%，且周转时间<60分钟。
材料/方法：我们评估了检测标准版本和即时检验版本的实际精密度和准确性，以及生理和病理水平结果的相关性。此外，还对周转时间进行了观察。
计算得出的总误差值未超过推荐的可接受总误差（<20%）。两种测量方法的精密度相当（CV=3.07%）。证实了所有参数的两种检测变体之间具有强相关性（R>0.99）。由于应用了新试剂盒，周转时间<60分钟的结果百分比从40%提高到了75%（n=115；p=0.000008）。
新一代即时检验心脏生物标志物具有较高的分析质量，符合国际精密度要求。它保证了结果具有较高的分析和临床可靠性。使用生物标志物的即时检验版本有助于显著缩短周转时间，并能获得良好的分析结果。
