Geens T, Vertessen F, Malfait R, Deiteren K, Maes M B
Laboratory of Hematology, University Hospital of Antwerp, Edegem, Belgium.
Int J Lab Hematol. 2015 Jun;37(3):372-81. doi: 10.1111/ijlh.12295. Epub 2014 Sep 18.
The CS5100 analyzer (Sysmex) was validated for the determination of routine coagulation parameters. This fully automated coagulation analyzer uses multiple wavelength technology to perform coagulation (e.g., activated partial thromboplastin time - APTT, prothrombin time - PT, fibrinogen - FBG), chromogenic (e.g., antithrombin - AT) and immunological (e.g., D-dimers - DDi) assays.
A comparison with the currently used STA-R Evolution (Stago) was performed. Validation and verification of reference values of the CS5100 was performed in accordance to CLSI guidelines (H57-A, H47-A2, and C28-A3).
As a different detection system and reagents were used, significant differences were observed (e.g. APTT). The within-day and between-day imprecision, accuracy and total error were all acceptable. The reference values defined by the manufacturer could be used except for APTT. In our settings, the therapeutic anti-Xa range of 0.3-0.7 IU/mL corresponded to an APTT range of 60-100 s (Dade actin FS reagent). The APTT reagent showed factor sensitivities between 46 and 72% for FVIII, IX, XI and XII while the PT reagent showed sensitivities between 34 and 52% for FII, FV, FXII, and FX.
In conclusion, the CS5100 instrument is suitable for the determination of the APTT, PT, FBG, DDi and AT in routine analysis.
CS5100分析仪（希森美康公司）已通过常规凝血参数测定的验证。这款全自动凝血分析仪采用多波长技术进行凝血检测（如活化部分凝血活酶时间 - APTT、凝血酶原时间 - PT、纤维蛋白原 - FBG）、发色底物法检测（如抗凝血酶 - AT）和免疫检测（如D - 二聚体 - DDi）。
与当前使用的STA - R Evolution（思塔高公司）进行了比较。按照CLSI指南（H57 - A、H47 - A2和C28 - A3）对CS5100的参考值进行了验证和核查。
由于使用了不同的检测系统和试剂，观察到显著差异（如APTT）。日内和日间不精密度、准确性和总误差均可接受。除APTT外，制造商定义的参考值均可使用。在我们的实验条件下，治疗性抗Xa范围为0.3 - 0.7 IU/mL对应APTT范围为60 - 100秒（达德肌动蛋白FS试剂）。APTT试剂对FVIII、IX、XI和XII的因子敏感性在46%至72%之间，而PT试剂对FII、FV、FXII和FX的敏感性在34%至52%之间。
总之，CS5100仪器适用于常规分析中APTT、PT、FBG、DDi和AT的测定。
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