PL-11血小板聚集仪检测全血血小板聚集功能方法学评价及临床意义

Evaluation of PL-11 instrument with the principles of electrical impedance method for assessment of platelet function and description its clinical significance

目的评价PLT-11血小板聚集仪电阻抗原理检测全血血小板聚集功能这一新方法的性能及临床价值。方法①参照美国临床和实验室标准协会,(Clinical and Laboratory Standards Institute,CLSI)相关文件,测试PL-11血小板聚集分析仪的日间、批内、批间的不精密度,准确性,携带污染率及线性性能。②选取2012年8月至2013年2月到解放军总医院就诊的患者100例,同时采用PL-11电阻抗法和临床比较公认的光学比浊法(light transmittance aggregometry,LTA)检测血小板聚集功能,对两种方法进行相关性分析;分析添加诱聚剂前两次检测的PLT的重复性,用散点图、相关系数表示。结果①PL-11电阻抗法和LTA法检测血小板聚集率相关性良好,r=0.62,P【0.01;②2个时间点的重复性较好,PLT(r=0.95,P【0.01);③各项检测的结果都符合CLIA’88的要求,其中检测的高值、低值质控品的PLT、RBC、MCV、MPV的日间、批内、批间不精密度的CV【5%,高值、低值的总变异系数(coefficient of varible,CV)分别为PLT(3.00&1.68),RBC(1.63&2.16),MCV(1.30&0.75),MPV(1.40&1.46);RBC、PLT的携带污染率分别为1.16%,1.02%,均【1.5%;PLT在40~800×109/L、RBC在0.3~6.0×1012/L的线性良好,r均】0.995;准确性实验,四大参数偏倚符合文件要求。结论 PL-11血小板聚集仪电阻抗原理检测全血血小板聚集功能的性能良好,是一种准确、可靠的检测血小板聚集功能的新方法。该仪器具有自动化程度高、操作简便、人为影响因素小等优点。

Objective The aim of this study is to evaluate the feasibility and clinical value of the PL-11 instrument with principles of electrical impedance,a new method for ADP-induced platelet aggregation detection.Methods This study performed on 400 samples,in which included 300 cases continuous selected from patients who came to People's Liberation Army General Hospital for treatment from August 2012 to February 2013 and had anti-platelet drugs used,and other 100 cases were from healthy persons.Intravenous blood samples anticoagulated with Sodium citrate were collected in the morning and detected within 4 hours after blood collection both by the PL-11 instrument and light transmission aggregometry(LTA) which is the gold standard methodology for assessing platelet function and make a comparison between them had been made.Using the scattergram and the correlation coefficient to analysis the repetitive of the first 2 time-points count of PLT that none ADP added.The methodology evaluation was accorded to the methods that recommended by CLSI.All statistical analysis was performed using SPSS17.0 statistical analysis software and excel and the results represented with a coefficient of variation(CV)to evaluate the intra-assay,the inter- assay,the carry-over rate,the accuracy of the PL-11 platelet analyzer instrument.Results ① Agreement between ADP-induced light transmission aggregometry(LTA) and PL-11 was good(r=0.62,P<0.01).② It had a good respective between the first 2 time-points count of PLT(r=0.95,P<0.01).③ Its performance evaluation results was well in line with the documentation requirements.The CV of intra–assay and inter-assay was less than 5%,and the carry-over rate was less than 1.5 %,the accuracy of the PL-11 platelet analyzer was filled with the acquirement of the document and its linearity was good.Conclusions In this study,the laboratory capability filled with the acquirement of operating specifications.It is possible for the new instrument PL-11 with principles of electrical impedance used as a new detection method for assessing platelet function.