摘要
目的评价PL-11血小板功能分析仪(电阻抗法)检测二磷酸腺苷(ADP)诱导的血小板聚集率的性能并初步调查其参考区间。方法参照临床和实验室标准化协会(CLSI)相关文件,评价PL-11血小板功能分析仪检测PLT的精密度、正确度、携带污染率及线性范围,与比浊法检测100例心内科患者ADP诱导的血小板聚集率结果进行对比。用PL-11血小板功能分析仪检测544例体检健康者ADP诱导的血小板聚集率水平,初步建立健康成人ADP诱导的血小板聚率的参考区间。结果PL-11血小板功能分析仪检测PLT的变异系数(CV)<4.0%,偏移<4.0%,在(40～800)×109/L范围内线性良好(R2=0.995 3),携带污染率<1.5%,符合CLSI相关文件要求;电阻抗法和比浊法检测ADP诱导的血小板聚集率结果分别为(67.58±15.14)%、(41.28±15.45)%,相关系数(r)=0.62(P<0.05)。健康成人ADP诱导的血小板聚集率(电阻抗法)的参考区间为49.66%～86.62%。结论 PL-11血小板功能分析仪检测ADP诱导的血小板聚集率性能良好,初步建立了其参考区间。
Objective To evaluate the performance of PL-11 platelet function analyzer based on electrical impedance technology and establish a preliminary reference interval for adenosine diphosphate （ADP）-induced platelet aggregation rate. Methods According to the document of Clinical and Laboratory Standards Institute （CLSI）, the precision, accuracy, carry-over rate and linearity of the PL-11 platelet function analyzer were evaluated. The test results of 100 patients with cardiovascular diseases were compared with those tested by light transmission aggregometry （LTA）. The preliminary reference interval of ADP-induced platelet aggregation rate of PL-11 plate-let function analyzer was defined by testing 544 samples from healthy volunteers. Results The total coefficient of variation values （CV） of precision at different levels was less than 4% and the bias of all levels was less than 4%. The assay displayed a fine linearity for platelet test （R^2 = 0.995 3） over the studied range （40-800） × 10^9/L, and the carry-over rate was less than 1.5%. The ADP-in-duced platelet aggregation rates tested by PL-11 platelet function analyzer with electrical impedance and LTA with turbidimetry method were （67.58±15.14）% and （41.28 ±15.45 ）% respectively, and the correlation coefficient between the two methods was 0.62 （P 〈 0.05 ）. The biological reference interval of ADP-induced platelet aggregation rate in healthy subjects was from 49.66% to 86.62%. Conclusions PL-11 platelet function analyzer has been verified to be a reliable assay with convenient performance characteristics, en-abling for routine testing in clinical laboratory. The biological reference interval of PL-11 platelet function analyzer for ADP-induced platelet aggregation rate was preliminary defined.
出处
《临床检验杂志》
CAS
CSCD
北大核心
2013年第9期715-717,共3页
Chinese Journal of Clinical Laboratory Science
作者简介
吴小利，1986年生，女，硕士研究生，主要研究方向：免疫与血栓止血。
通信作者：王成彬，教授，博士研究生导师，E—mail：wangcb301@126．com。
