Mindray BC-6800全自动血液细胞分析仪低值血小板临床性能评价

Clinical performance evaluation of low-count platelet samples for Mindray BC-6800 automatic hematology analyzer

目的:评估Mindray BC-6800全自动血液细胞分析仪低值血小板(PLT)临床性能,对比评价自动及手动进样两种模式低值PLT的检测结果。方法:参照国际血液学标准化委员会(ICSH)、美国临床实验室标准化协会(CLSI)等标准,评估BC-6800低值PLT重复性及携带污染率;选取108份PLT减少患者抗凝全血,采用自动和手动两种模式进行检测,评估两种模式对低值PLT检测结果的一致性。结果:自动及手动模式低值PLT均有较好重复性,20×10~9/L以上样本两种模式变异系数(CV)均能保证在5%以内。20×10~9/L以内样本两种模式重复测试标准差(SD)和极差(R)均非常小,标准差(SD)分别为0.5和0.8,极差(R)分别为1和2,结果波动均非常小。自动及手动模式PLT携带污染率均<1%,高值PLT对低值PLT均无携带干扰。108份低值PLT样本两个模式相关系数达到0.9910。对临床医学决定水平浓度点进行分析,两种模式偏差较小。结论:Mindray BC-6800全自动血液细胞分析仪对低值PLT具有良好临床性能,自动与手动模式对低值PLT检测一致性较好,可根据实际情况选择合适的模式进行测试。

Objective: To evaluate the clinical performance of low-count platelet(PLT) samples for Mindray BC-6800 automatic hematology analyzer and compare the detection results between two sampling mode(automatic injection, manual injection).Methods: To evaluate the repeatability and contamination rate of low-count platelet samples depend on ICHC, CLSI and other standards; to choose 108blood samples with thrombocyt openia and detect them in two kinds of detection mode (automatic and manualoperation), and then evaluate the consistency of low-count PLT samples between the two modes. Results: The results of two detection modes for low-count platelet samples showed there were well repeatability between them.The CV% of those samples which PLT were upon 20×109/L can be assurance within 5% in two modes. The value and fluctuation of SD and range of those samples which PLT were under 20×109/L were smaller; the SD of two modes were 0.5 and 0.8, respectively; and the Range were 1 and 2, respectively. Both of the two modes were lessthan 1% in carryover rates, high PLT accounts has no influence on low accounts. The correlation coefficient wasup to 0.9910 between the two modes by analyzing the 108 blood samples. The results demonstrate there were lowdeviation and well consistency between the two modes by analyzing medical decision level concentration point forthem. Conclusion: Mindray BC-6800 has good clinical performance to detect low-count PLT samples and the reare well consistency between automatic and manual operation. Clinical Laboratory chooses which suitable mode to detect samples may depend on self-situation.