Clin Lab. 2023 Aug 1;69(8). doi: 10.7754/Clin.Lab.2023.221131.
The aim of the study was to conduct a comprehensive performance evaluation of the Mindray CX-9000 fully automated coagulation analyzer for the detection of the seven coagulation items.
The performance of activated partial thromboplastin time (APTT), prothrombin time (PT), fibrinogen (FIB), thrombin time (TT), D-dimer (D-D), fibrinogen degradation product (FDP), and antithrombin Ⅲ (AT) was validated for precision, linear range, carryover contamination rate, reference interval validation, inter-method agreement, and anti-interference ability.
The intra- and inter-precision (coefficient of variation, CV%) of all seven items was less than the target CV%; the carryover contamination rates for different concentrations and between items were < 10%. The slope of the linear regression equation for the theoretical and measured values of the linear range was within 1 ± 0.05 and R ≥ 0.975. The reference interval quoted from the manufacturer's reference interval passed ≥ 95%. The CX-9000 was compared with the results of the reference instrument STAGO R MAX (STA-R MAX) and the p-values for all items ranged from 0.822 to 0.987. Within the concentration range claimed by the manufacturer, the interference errors produced by all items met the manufacturer's claimed criteria, except for triglycerides which produced interference errors > 10% for the FIB, D-D, FDP, and bilirubin which produced interference errors for the FIB and D-D assays.
The CX-9000 automatic coagulation analyzer has good stability and repeatability, a wide linear range of detection, low carryover contamination rate, and high resistance to interference, making it suitable for the testing of clinical specimens.
本研究旨在对迈瑞 CX-9000 全自动凝血分析仪检测七种凝血项目的性能进行全面评估。
对活化部分凝血活酶时间（APTT）、凝血酶原时间（PT）、纤维蛋白原（FIB）、凝血酶时间（TT）、D-二聚体（D-D）、纤维蛋白（原）降解产物（FDP）和抗凝血酶Ⅲ（AT）的精密度、线性范围、携带污染率、参考区间验证、方法间一致性和抗干扰能力进行验证。
所有七种项目的批内和批间精密度（变异系数，CV%）均小于目标 CV%；不同浓度和不同项目之间的携带污染率均<10%。线性范围内理论值和实测值的线性回归方程斜率在 1±0.05 范围内，R≥0.975。制造商参考区间引用的参考区间通过率≥95%。将 CX-9000 与参考仪器 STAGO R MAX（STA-R MAX）的结果进行比较，所有项目的 p 值均在 0.822 至 0.987 之间。在制造商声称的浓度范围内，除了甘油三酯对 FIB、D-D、FDP 产生的干扰误差>10%以及胆红素对 FIB 和 D-D 检测产生的干扰误差外，所有项目产生的干扰误差均符合制造商的声称标准。
CX-9000 全自动凝血分析仪具有良好的稳定性和重复性、较宽的检测线性范围、较低的携带污染率和较高的抗干扰能力，适用于临床标本的检测。
