Tomassetti Flaminia, Fiorelli Denise, Cappa Edoardo, Giovannelli Alfredo, Pelagalli Martina, Velocci Silvia, Nicolai Eleonora, Minieri Marilena, Perrone Marco Alfonso, Bernardini Sergio, Pieri Massimo
Department of Experimental Medicine, University of Rome Tor Vergata, Via Montpellier 1, 00133 Rome, Italy.
Department of Laboratory Medicine, Tor Vergata University Hospital, Viale Oxford 81, 00133 Rome, Italy.
Diagnostics (Basel). 2025 Apr 18;15(8):1031. doi: 10.3390/diagnostics15081031.
: International guidelines recommend the use of high-sensitivity cardiac troponin (hs-cTn) I and T methods for the detection of myocardial injury as a pre-requisite for the diagnosis of acute myocardial infarction (AMI) in patients admitted to the emergency department. Recently, Mindray (Mindray Bio-Medical Electronics Co., Ltd., Shenzhen, China) has introduced a new chemiluminescence immunoassay (CLIA) for the detection of the cTn complex. The present study aims to verify and validate the hs-cTnI Mindray assay on the new automated CL2600i analyzer compared to the routine Alinity-i series instrument by Abbott (Abbott, Chicago, IL, USA). : This study evaluated linearity, precision through the 5 × 5 protocol, methodological comparison on plasma and serum matrices, hs-cTnI 99th percentile imprecision, and the hs-cTnI detection rate in a healthy population. : The results obtained proved that the performance of the Mindray hs-cTnI test on the CL2600i platform was closely comparable to the Abbott Alinity-i system (plasma R: 0.974; serum R: 0.995). The CVs were consistently low, and no significant differences were reported. Excellent analytical performance, with high sensitivity, was also observed in the healthy population (overall detection rate: 79%), as well as good linearity within the measuring range (R: 0.994). : The Mindray hs-cTnI test confirms its robustness and utility in routine practice as an advanced assay. The new technology, with more sensitive detection methods, may improve the accuracy and reliability of cardiac biomarker testing, ultimately leading to better outcomes in the management of patients with AMI and other cardiac conditions.
国际指南推荐使用高敏心肌肌钙蛋白（hs-cTn）I和T检测方法来检测心肌损伤，这是急诊科收治患者诊断急性心肌梗死（AMI）的前提条件。最近，迈瑞（深圳迈瑞生物医疗电子股份有限公司，中国深圳）推出了一种用于检测肌钙蛋白复合物的新型化学发光免疫分析法（CLIA）。本研究旨在将迈瑞hs-cTnI检测方法在新型自动化CL2600i分析仪上与美国雅培公司（雅培，伊利诺伊州芝加哥）的常规Alinity-i系列仪器进行比较，以验证和确认该检测方法。：本研究评估了线性、通过5×5方案的精密度、血浆和血清基质的方法学比较、hs-cTnI第99百分位数的不精密度以及健康人群中的hs-cTnI检测率。：所获得的结果证明，迈瑞hs-cTnI检测方法在CL2600i平台上的性能与雅培Alinity-i系统密切可比（血浆R：0.974；血清R：0.995）。变异系数始终较低，且未报告显著差异。在健康人群中也观察到了具有高灵敏度的出色分析性能（总体检测率：79%），以及在测量范围内良好的线性（R：0.994）。：迈瑞hs-cTnI检测方法证实了其作为一种先进检测方法在常规实践中的稳健性和实用性。这种具有更灵敏检测方法的新技术可能会提高心脏生物标志物检测的准确性和可靠性，最终在AMI和其他心脏疾病患者的管理中带来更好的结果。
