Clin Lab. 2022 Feb 1;68(2). doi: 10.7754/Clin.Lab.2021.210501.
In this study, our purpose was to evaluate the analytical performances of the STA R Max and CN-3000, and compare the results of both for PT, aPTT, fibrinogen, D-dimer, and factor VIII, and also to show the influence of hemolysis on PT, aPTT, and fibrinogen assays.
Three hundred ninety-five randomly-selected blood samples from residual material from Istanbul Faculty of Medicine, Central Laboratory workflow comprised the study group. PT, aPTT, fibrinogen, D-dimer, and factor VIII activity were done using both analyzers. Analytical performances were determined through precision, linearity, and comparability studies. Artificial hemolysis was performed through freezing-thawing and mechanical-sheer methods.
Intra-assay and between-day CVs% of PT and aPTT were lower than 5% for STA R Max and CN-3000. Only the within-run and between-day CVs% of fibrinogen and the between-day CVs% of D-dimer were higher than 5%, but in acceptable targets. Intra-assay and between-day CVs% of FVIII on the CN-3000 were 3.5% and 12.3% at the low and 2.5% and 5.3% at high level, and 1.8% and 3.7% at the low and 6.3% and 5.9% at high level on the STA R Max. The comparison results of PT, aPTT, fibrinogen, and D-dimer were good (r > 0.91), also good correlations were obtained for FVIII activity > 40 IU/dL and FVIII between 5 - 40 IU/dL (r = 0.89). The results of the hemolysis study were within acceptable limits of the recommended criteria of Fraser and the manufacturer.
CN-3000 and STA R Max coagulation analyzers are accurate and highly precise systems for safe use in clinical diagnostic applications. The interferences obtained for both analyzers were found to be within accepted targets.
本研究旨在评估 STA R Max 和 CN-3000 的分析性能，并比较这两种仪器在 PT、APTT、纤维蛋白原、D-二聚体和因子 VIII 检测中的结果，同时还展示溶血对 PT、APTT 和纤维蛋白原检测的影响。
本研究纳入了来自伊斯坦布尔医学院中心实验室工作流程中剩余材料的 395 份随机血液样本。使用这两种分析仪检测 PT、APTT、纤维蛋白原、D-二聚体和因子 VIII 的活性。通过精密度、线性和可比性研究来确定分析性能。通过冻融和机械剪切方法进行人工溶血。
STA R Max 和 CN-3000 的 PT 和 APTT 的日内和日间 CV%均低于 5%。只有纤维蛋白原的批内和日间 CV%以及 D-二聚体的日间 CV%高于 5%，但处于可接受的范围内。CN-3000 上 FVIII 的日内和日间 CV%低值分别为 3.5%和 12.3%，高值分别为 2.5%和 5.3%，STA R Max 上低值分别为 1.8%和 3.7%，高值分别为 6.3%和 5.9%。PT、APTT、纤维蛋白原和 D-二聚体的比较结果良好（r > 0.91），FVIII 活性>40 IU/dL 和 5-40 IU/dL 之间的 FVIII 相关性也很好（r = 0.89）。溶血研究的结果在 Fraser 和制造商推荐标准的可接受范围内。
CN-3000 和 STA R Max 凝血分析仪是安全用于临床诊断应用的准确且高度精确的系统。两种分析仪的干扰均在可接受范围内。
