血小板聚集功能的新检测方法和仪器的性能评价及临床应用

摘要

This study was purposed to evaluate a new method and instrument for detecting platelet aggregation function,establish the reference intervals for PL-11 platelet analyzer,and evaluate its clinical application.The evaluation was based on the guidelines of Clinical and Laboratory Standards Institute (CLSI or NCCLS) and Clinical Laboratory Improvement Amendment 88.Intravenous blood samples anticoagulanted with sodium citrate were detected by PL-11 platelet analyzer.The reference intervals were defined after statistic analysis.The clinical diagnostic significance of the PL-11 platelet analyzer was evaluated by testing the change rate of platelet maximum aggregation rate (MAR) of acute cerebral infarction (ACI) patients in the department of Neurology who took clopidogrel 7 d before and after.The result showed that all the parameters meet the standard of CLIA'88.The platelet MAR of 247 healthy volunteers which was induced by PLR-06,PLR-07,PLR-09 and PLR-10,was detected by the PL-11 platelet analyzer,respectively.The MAR is 58.8 ± 10.1 (％) 、61.2 ± 11.8 (％) 、51 ± 10.2(％) 、53.1 ± 9.2(％),respectively.The MAR of ACI patients is significantly lower than that after taking clopidogrel.It is concluded that the PL-11 platelet analyzer is an ideal platelet function detector for early warning and diagnosis of thromboembolic disease,which is worthy to be extended and applied.%本研究旨在评价对血小板聚集功能检测的新方法及仪器的性能,并建立其参考区间,探讨其临床应用价值.按照美国临床实验室标准化协会(Clinical and Laboratory Standards Institute,CLSI)制定的仪器性能验证标准和美国《临床实验室改进修正法案-88》(Clinical Laboratory Improvement Amendment 88,CLIA' 88法案)制定的评价标准,对PL-11血小板分析仪进行了分析性能评估.用PL-11血小板分析仪测试健康志愿者柠檬酸钠静脉抗凝血的聚集功能,并对测定结果进行统计分析,建立PL-11血小板分析仪本实验室的参考区间.同时收集本院神经内科急性脑梗死(ACI)患者服用氯吡格雷7d前后血小板最大聚集率(MAR)的变化来探讨PL-11血小板分析仪的临床诊断意义.结果表明,各参数皆符合CLIA'88法案的要求.测得PLR-06、PLR-07、PLR-09、PLR-10血小板诱聚剂诱导的247名健康正常人血小板MAR分别为58.8±10.1(％)、61.2±11.8(％)、51±10.2(％)、53.1±9.2(％).ACI患者MAR在服用氯吡格雷后明显降低.结论:PL-11血小板分析仪检测结果准确可靠,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功能检测仪,值得推广应用.