Department of Laboratory Medicine, Pusan National University School of Medicine, Biomedical Research Institute, Pusan National University Hospital, Busan.
Department of Laboratory Medicine, Pusan National University School of Medicine.
Blood Coagul Fibrinolysis. 2023 Mar 1;34(2):93-98. doi: 10.1097/MBC.0000000000001184. Epub 2022 Dec 22.
The Sysmex CN-6000 is a novel automated multiparameter coagulometer that performs clotting, chromogenic and immunological assays, and platelet aggregation tests in a single system. Here we evaluated its performance of routine coagulation assays. The precision, linearity, carryover and establishment of reference ranges of the CN-6000, as well as correlations between it and the currently used Diagnostica Stago STA-R Max were determined according to Clinical and Laboratory Standards Institute guidelines. The evaluated parameters included prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (FBG), antithrombin (AT), d-dimers (DDi), and fibrin and FBG degradation products (FDP). The intra-run and inter-run precisions of the six tests were determined using normal and pathological control materials; all coefficients of variation were acceptable and within the allowable ranges. The CN-6000 showed excellent linearity for FBG, AT, DDi, and FDP (R = 0.999-1.00). Passing-Bablok regression (R2 > 0.95) demonstrated good agreement between the analyzers. In the carryover study, APTT, PT, FBG, AT, DDi, and FDP values were all acceptable. The establishing reference intervals revealed that each manufacturer's range was acceptable. Significant differences were observed in the APTT reference range because of using different detection systems and reagents. The CN-6000 analyzer showed reliable performance and good correlation with the currently used STA-R Max automated hemostatic analyzer. As CN-6000 uses an optical clot-detection method, its reference ranges for PT and APTT are lower than those of the STA-R Max; thus, the difference should be considered before its use.
Sysmex CN-6000 是一种新型的自动化多参数凝血仪，可在单个系统中进行凝血、显色和免疫测定以及血小板聚集试验。在此，我们评估了其常规凝血检测的性能。根据临床和实验室标准协会的指南，评估了 CN-6000 的精密度、线性、携带污染和参考范围的建立，以及与当前使用的 Diagnostica Stago STA-R Max 的相关性。评估的参数包括凝血酶原时间（PT）、活化部分凝血活酶时间（APTT）、纤维蛋白原（FBG）、抗凝血酶（AT）、D-二聚体（DDi）以及纤维蛋白和 FBG 降解产物（FDP）。使用正常和病理对照材料确定了六个测试的内运行和外运行精密度；所有变异系数均在可接受范围内。CN-6000 对 FBG、AT、DDi 和 FDP 显示出优异的线性（R = 0.999-1.00）。通过传递-巴布洛克回归（R2＞0.95）表明两个分析仪之间具有良好的一致性。在携带污染研究中，APTT、PT、FBG、AT、DDi 和 FDP 值均在可接受范围内。建立参考区间表明每个制造商的范围都是可接受的。由于使用不同的检测系统和试剂，APTT 参考范围存在显著差异。CN-6000 分析仪具有可靠的性能，与当前使用的 STA-R Max 自动化止血分析仪具有良好的相关性。由于 CN-6000 使用光学凝块检测方法，其 PT 和 APTT 的参考范围低于 STA-R Max；因此，在使用之前应考虑到这种差异。
