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目的:评价Sysmex-CA7000全自动凝血仪的性能。方法:选择活化部分凝血活酶时间(APTT)、凝血酶时间(TT)、纤维蛋白原(FIB)、凝血酶原时间(PT)四个常用凝血检测项目分别从仪器检测准确性、精密度,抗干扰性及参考范围几方面对SysmexCA7000凝血仪进行性能验证。结果:四个项目准确性验证结果均符合厂家要求(CV%<5%),但低值样本PT(CV3.13%)和TT(CV3.36%)准确性不及其他几个项目;批内和批间精密度检测均满足厂家要求,且除PT外其余三个项目远低于厂家要求CV%;参考范围验证和抗干扰能力结果显示四个检测项目均较理想。结论:Sysmex CA7000凝血仪具有检测准确性好、精密度高、检测范围宽、抗干扰能力强等特点,值得临床推广应用。
Objective: To evaluate the performance of Sysmex-CA7000 automatic coagulation analyzer. Methods: Four commonly used blood coagulation test items including activated partial thromboplastin time (APTT), thrombin time (TT), fibrinogen (FIB) and prothrombin time (PT) were selected respectively from accuracy, precision, Anti-jamming and reference range of several aspects of SysmexCA7000 coagulation performance verification. Results: The validation results of the four projects met the manufacturers’ requirements (CV% <5%), but the accuracy of the low-value samples PT (CV3.13%) and TT (CV3.36%) was less than those of other projects. And inter-batch precision testing all meet the manufacturers’ requirements. Besides the PT, the remaining three items are much lower than the manufacturer’s requirement of CV%; the reference range verification and anti-interference ability results show that the four test items are ideal. Conclusion: Sysmex CA7000 coagulation analyzer has the advantages of good detection accuracy, high precision, wide detection range and strong anti-interference ability, which is worthy of clinical application.