凝血3项生物参考区间验证的实验探讨

Study on the validation for biology reference interval of PT APTT,and FBG

目的对实验室凝血检测项目血浆凝血酶原时间(PT)、活化部分凝血活酶时间(APTT)、纤维蛋白原(FBG)现用的生物参考区间进行验证,确保其适用于临床。方法根据纳入标准选择健康参考个体20名,采集符合要求对象标本,按实验室标准操作手册(SOP)要求进行规范检测,采用性能评价符合要求的Sysmex CA7000血凝仪检测标本。结果参与验证的3个项目中,20名健康参考个体100%结果落在现用参考区间内。结论本次验证项目现用的生物参考区间适用于本实验室,可以继续使用。实验室应建立完善、规范的验证制度、程序,保证生物参考区间的适用性。

Objective To validate the biology reference interval of prothrombin time（PT） ,activated partial thromboplastin time （APTT）, fibrinogen（FBG） ,and ensure their clinical application. Methods According to selective standard, 20 health reference individuals were chosen. The blood samples were detected by the automatic blood coagulation analyzer Sysmex CA7000 according to the laboratory SOP operation document requiring. Results In 3 verified projects,all results of 20 reference individuals samples were within the biology reference interval being used. Conclusion The biology reference interval being used is suitable for our laboratory and can continue to be used. To maintain clinical application, a standard and consummate verification system and program should be established in laboratory.