Sysmex CS5100全自动凝血分析仪性能评价

Performance evaluation of Sysmex CS5100 automatic blood coagulation analyzer

目的验证Sysmex CS5100全自动凝血分析仪的系统性能,确定该检测系统是否稳定、准确、可靠。方法对Sysmex CS5100全自动凝血分析仪上的准确度、不精密度、线性、检测限、携带污染率进行评价。测试20例健康体检者的凝血酶原时间(PT)、活化部分凝血活酶时间(APTT)、凝血酶时间(TT)、纤维蛋白原(FIB)验证厂家提供的参考区间。结果准确度试验测定结果全部合格;批内最大变异系数(CV)3.82%、批间最大CV值为6.24%;线性试验FIB相关系数(r)为0.998 9、D-二聚体(DD)r为0.996 7、纤维蛋白(原)降解产物(FDP)r为0.998 5;检测限最大CV为6.13%;携带污染率最大值为-6.45%,验证全部合格。结论 Sysmex CS5100全自动凝血分析仪是一个精密度好、准确度高、检测范围宽、携带污染率低的检测系统。

Objective To verify the systematic performance of the Sysmex CS5100 automatic coagulation analyzer for determining whether this detection system is stable, accurate, and reliable. Methods The accuracy, precision,linearity, limit of detection and the carrying-over contamination rate of the Sysmex CS5100 automatic coagulation analyzer were evaluated. Prothrombin time （PT）, activated partial thromboplastin time （APTT） ,thrombin time （TT） and fibrinogen （FIB） were detected by this analyzer in 20 cases of healthy physical examination were examined to verify the reference intervals provided by the manufacturer. Results The accura- cy examination results were all qualified;the maximum intra-assay coefficient of variation（CV） was 3.82 G, and maximum inter-day CV was 6.24 ~;the linear correlation coefficient （r） of FIB was 0. 998 9,which of D-dimer （D-D） was 0. 996 7 and which of fibrin （ogen） degradation products （FDP） was 0. 998 5the maximum CV of detection limit was 6.13 % ;carrying-over contamination rate was --6.45%. The verification results were all qualified. Conclusion The Sysmex CS5100 automatic blood coagulation analyzer is a detection system with good precision, high accuracy, wide detection range and low carrying-over contamination rate.