APTT、PT、FIB生物参考区间适用性验证探讨

目的对实验室检测项目血浆激活部分凝血活酶时间（AVTT）、血浆凝血酶原时间（明）、纤维蛋白原（FIB）现用的生物参考区间进行验证，确保其适用于临床。方法按美国临床实验室标准化委员会（NCCLS）C28-A2推荐方法，各验证项目选择健康参考个体20名，采集符合要求对象标本，按实验室操作手册（SOP）要求进行规范检测，采用性能评价符合要求的ACL FUTURA PLUS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％结果落在现用的生物区间内。讨论本次验证的项目现用的生物参考区间适用于本实验室，可以继续使用；实验的验证具有科学的说服力，容易发现生物参考区间的偏离，值得建立完善的验证制度、程序，并推广应用。

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

Objective To validate the biology reference interval of activated partial thromboplastin time （APTT）, prothrombin time（PT）, fibrinogen（FIB）, and ensure their clinical application. Methods According to NCCLS C28- A2 recommendation method, 20 reference individuals were chosen. The whole blood samples were detected by the automated blood coagulation analyzer ACL FUTURA PLUS 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. Conclusions The biology reference intervel being used is suitable for our laboratory and can continue to be used; the experiment verification has the scientific stringency. It is easy to discover the deviation of the biology reference interval and is worth establishing a perfect verification system, and promoting the application.