国产液体血凝试剂在Stago血凝仪上的性能评价

Evaluation of performance of domestic manufactured liquid coagulation reagents applied in Stago coagulation analyzer.

目的评价国产液体血凝试剂在法国Stago血凝仪上的性能。方法选择成人血浆样本285例,分别使用国产液体血凝试剂和法国Stago血凝仪原装试剂,在Stago血凝仪上进行凝血酶原时间、活化部分凝血活酶时间、纤维蛋白原和凝血酶时间4项凝血指标检测,检测结果参考美国临床实验室修正法规1988(CLIA'88)标准要求进行统计分析。结果国产液体血凝试剂的检测结果与Stago原装血凝试剂的检测结果相比,均符合美国CLIA'88标准要求,二者检测结果无显著性差异。结论国产液体血凝试剂可以代替进口原装试剂在Stago血凝仪上用于凝血4项临床实验检测。

Objective To evaluate the performance of domestic manufactured liquid coagulation reagentsapplied inStagocoagulation ana-lyzer.Methods Two hundred and eighty five plasma samples of adult patients were examined for 4 coagulation indices with both domestic liquid coagulation reagents and French original Stago coagulation reagents in Stago coagulometer.Four coagulation indices were prothrombin time,activa-ted partial thromboplastin time,fibrinogen and thrombin blood clotting time.Results of these examinations were compared and statistically analyzed according to the requirement and standard of the United States Clinical Laboratory Improvement Amendments of 1988（CLIA＇88）.Results Of ex-aminations with both domestic liquid coagulation reagents and French original Stago coagulation reagents compared with the standard requirements were in line with the United States CLIA＇88,both results of examinations showed no significant difference.Conclusion Domestic manufactured liq-uid coagulation reagents may replace French original Stago coagulation reagents and it can be applied in Stago coagulometer for clinical trials of blood coagulation.