PL-11血小板分析仪检测血小板计数及聚集功能的性能评价

Performance evaluation of PL-11 platelet analyzer in the detection of platelet count and platelet aggregation

目的：探讨PL-11血小板分析仪在检测血小板数量及聚集功能方面的性能。方法按照美国临床实验室标准化协会（ CLSI）制定的仪器性能验证标准及我国卫生行业标准 WS／T 406-2012《临床血液学检验常规项目分析质量要求》对PL-11血小板分析仪进行血小板计数及聚集功能的性能评价。采用PL-11血小板分析仪、LBY-NJ4血小板聚集仪及TEG-5000血栓弹力图仪检测健康人群血小板聚集率，分析各仪器检测结果间的相关性。结果 PL-11血小板分析仪的批内及日间精密度均＜1／3总误差（7％）；携带污染率为0．32％；在（4．12～1380．4）×109／L线性范围内回归方程斜率为1．03，R2＝0．993；血小板计数结果与血小板参考方法的结果符合率为84％，均符合行业标准要求。分别采用PL-11血小板分析仪、LBY-NJ4血小板聚集仪及TEG-5000血栓弹力图仪检测79例2型糖尿病患者单服用氯匹格雷前、后血小板聚集率，3种仪器之间差异均无统计学意义（ P＞0．05），患者服药前、后血小板聚集率差异有统计学意义（P＜0．01）。结论 PL-11血小板分析仪可为临床提供准确、可靠的血小板计数及聚集功能的检测结果。

Objective To investigate the performance of PL-11 platelet analyzer in the detection of platelet count and platelet aggregation.Methods According to the instrument performance verification standards in the Clinical and Laboratory Standards Institute （ CLSI） and the Health Industry Standard of the People′s Republic of China, WS/T 406-2012：the Quality Standard of Routine Tests in Clinical Hematology, the performance of PL-11 platelet analyzer in the detection of platelet count and platelet aggregation were evaluated.Platelet aggregation rate in healthy subjects was compared for correlation, which was detected by PL-11 platelet analyzer, LBY-NJ4 platelet tester and TEG-5000 thromboelastogram.Results The within-run and inter-day precisions of PL-11 platelet analyzer were〈1/3 of total error （7%）, and the carry-over rate was 0.32%.In （4.12-1 380.4） ×109/L linear range, the regression equation slope was 1.03 （R2 =0.993）.The coincidence rate for platelet count by PL-11 platelet analyzer with reference method was 84%.There was no statistical significance of platelet aggregation rate among PL-11 platelet analyzer, LBY-NJ4 platelet tester and TEG-5000 thromboelastogram in 79 patients with type 2 diabetes mellitus （P〉0.05）.However, there was statistical significance in platelet aggregation rates before and after taking clopidogrel hydrogen（P〈0.01）.Conclusions PL-11 platelet analyzer can provide accurate and reliable results for platelet count and aggregation.