血小板聚集机能检测的新方法及仪器的性能评价

A new detection method for studying Platelet aggregation function and its performance evaluation

目的对血小板聚集机能检测的新方法及仪器的性能进行评价并报告。方法按照国际血液学标准华委员会（ICSH）制定的评价标准进行。用EDTA．K2及柠檬酸钠静脉抗凝血测试血小板分析仪的批内重复性、日间重复性、携带污染率、准确性及线性性能，并与MPG．3E多功能双通道血液凝聚仪测定结果进行相关分析。结果各参数皆符合ICSH的要求。血小板分析仪批内、日间精密度的CV均〈5％；携带污染率〈1％；测定定值全血质控物，准确性满意，线性良好；测定结果与光密度比浊法结果相关性分析，R^2=0．9439。结论新型血小板分析仪的批内重复性、日间重复性、携带污染率、准确性、线性及比较实验均较好，报告结果准确可靠。新型血小板分析仪是一种较理想的适用于血栓病早期预警和诊断的新型血小板聚集机能检测仪，值得推广应用。

Objective To function and its instrument evaluate and report the performance of the new detection method for studying Platelet aggregation Methods The evaluation was based on the guidelines of International Council for Standardization in Haematology （ICSH）. Intravenous blood samples anticoagulanted with EDTA-K2 and sodium citrate were detected by the new type platelet analyzer to evaluate the intra-assay and inter-assay coefficient of variation （CV）, carry-over rate, accuracy, linearity of the new type platelet analyzer. Platelet aggregation rate was detected by the new type platelet analyzer and MPG-3E multifunctional double channel blood coagulation analyzer, respectively. The correlation was detected between the new type platelet analyzer and MPG-3E multifunctional double channel blood coagulation analyzer. Results All the parameters were conformed to the standard of ICSH. Both of the intra-assay and inter-assay CV values were less than 5%; carry-over rate was less than 1%; the accuracy and the linearity was excellent （r 〉 0.99）. Conclusion The new type platelet analyzer is better in intra-assay and inter-assay coefficient of variation （CV）, carry-over rate, accuracy, linearity, and comparison test, and its analytical results are accurate and reliable. The new type platelet analyzer is a kind of new ideal platelet function detector for early warning and diagnosis of thromboembolic disease, it is worthy of popularization and application.