AG800全自动血小板聚集仪血小板聚集功能检测方法学评价及仪器性能评估

Evaluation of Platelet Aggregation Test Methodology and Instrument Performance of AG800 Automatic Platelet Aggregation Instrument

目的对AG800全自动血小板聚集仪光学比浊法检测血小板聚集功能进行评价,并测试仪器的检测性能。方法参照美国临床实验室标准化委员会(Clinical and Laboratory Standards Institute,CLSI)及《光学比浊法检测血小板聚集标准化专家共识》等相关文件,使用AG800全自动血小板聚集仪和美国Chrono-log700型血小板聚集仪,从样本精密度检验、二磷酸腺苷(adenosine diphosphate,ADP)和花生四烯酸(arachidonic acid,AA)相关性及一致性检验评估两台仪器对血小板聚集功能的检测。对AG800全自动血小板聚集仪进行了性能评估,包括加样、温控及光学检测精密度检验。结果通过7 d的连续跟踪结果显示,Chrono-log700血小板聚集仪低水平样本总体检测精密度CV值为10.99%,AG800自动血小板聚集仪的低水平总体精密度为4.95%,Chrono-log700血小板聚集仪的高水平样本总体检测精密度CV值为9.00%,而AG800全自动血小板聚集仪的高水平总体精密度为4.91%。ADP检测结果统计分析,Pearson相关系数r=0.9915,相关程度高。P<0.0001,表示存在显著性,Bland-Altman一致性检验统计结果显示0个点在95%一致性界限以外,符合一致性分析原则,说明两机检测ADP结果一致性好;AA检测结果统计分析,Pearson相关系数r=0.9832,相关程度高。P<0.0001,表示存在显著性;Bland-Altman一致性检验统计结果显示1个点(2.86%)在95%一致性界限以外,符合一致性分析原则,说明两机检测AA结果一致性好。性能评估结果分析,AG800全自动血小板聚集仪的加样均数(Mean)=9.99μL,均数标准误(Standard error of mean)=0.006,偏度系数(Skewness)=0.119,加样精密度CV为0.48%,离散度(平均绝对偏差,AVEDEV)为0.038μL;AG800全自动血小板聚集仪的温度均数=36.98℃,均数标准误=0.041,偏度系数=-0.293,加样精密度CV为0.93%,离散度为0.284℃;AG800全自动血小板聚集仪对低水平标本的检测均数=20.02%,均数标准误=0.099,偏度系数=0.733,加样精密度CV为4.94%,离散度为0.74%。对高水平标本检测的均数=44.13%,均数标准误=0.184,偏度系数=0.416,加样精密度CV为4.14%,离散度为1.49%。结论AG800全自动血小板聚集仪和Chrono-log700血小板聚集仪检测的ADP和AA值之间存在强线性相关性,说明两机检测结果一致性好;AG800全自动血小板聚集仪在对临床样本低水平和高水平标本的检测CV不超过5%,加样、温控及对样本的浊度变化检测精密度高,可满足临床检测的精密度要求,临床适应性好,具有自动化程度高、操作简便、人为影响因素小等优点。

Objective To evaluate the AG800 automatic platelet aggregator's ability to detect platelet aggregation using optical turbidimetry and to test the device's detection capabilities.Methods AG800 automatic platelet aggregator and the Chrono-log700 platelet aggregator were evaluated for the platelet aggregation function with sample precision,adenosine diphosphate(ADP),and arachidonic acid(AA)correlation and consistency tests,according to the Clinical and Laboratory Standards Institute(CLSI)and Expert Consensus on Standardization of Platelet Aggregation by optical turbidimetry and other pertinent documents.AG800 automatic platelet aggregator's functionality was tested and evaluated including sample addition,temperature control,and optical accuracy testing.Results Following seven days of nonstop monitoring,the overall detection precision CV value of low-level samples with Chrono-log700 platelet aggregator was 10.99%,and the low-level overall precision of the AG800 automatic platelet aggregator was 4.95%.The overall precision CV value of the high-level sample detection of the Chrono-log700 platelet aggregator was 9.00%,and the high-level overall precision of the AG800 automatic platelet aggregator was 4.91%.The statistical analysis of the ADP test results revealed a high degree of connection,with a Pearson correlation coefficient of r=0.9915.P<0.0001 suggested that the data were significant.According to the statistical results of the Bland-Altman consistency test,the ADP values found by the two machines were consistent,which reveals that 0 points were beyond the 95%consistency limit.This finding complies with the consistency analysis principle.The findings of the statistical analysis of the AA detection showed a high degree of correlation,with a Pearson correlation coefficient of r=0.9832.Significance was indicated by P<0.0001.According to the consistency analysis concept,the statistical findings of the Bland-Altman consistency test revealed that 1 point(2.86%)was outside the 95%consistency limit,demonstrating the consistency of the AA values found by the two machines.Performance evaluation results analysis of the AG800 fully automated platelet aggregometer had a spiked mean(Mean)=9.99μL,standard error of the Mean(Standard error of mean)=0.006,skewness coefficient(Skewness)=0.119,spiked precision CV of 0.48%,and dispersion(average absolute deviation,AVEDEV)of 0.038μL.The temperature mean was 36.98℃,the standard error of the mean was 0.041,the skewness coefficient was-0.293,the sampling precision CV was 0.93%,the AVEDEV was 0.284℃.For low-level specimens,the AG800 fully automated platelet aggregometer had a Mean=20.02%,Standard error of mean=0.099,Skewness=0.733,spiking precision CV of 4.94%,and AVEDEV of 0.74%.For high-level specimens,Mean=44.13%,Standard error of mean=0.184,Skewness=0.416,CV of spiking precision 4.14%,and AVEDEV was 1.49%.Conclusion The ADP and AA values obtained from the AG800 automatic platelet aggregator and the Chrono-log700 platelet aggregator show a strong linear correlation,indicating that the detection results of the two machines are consistent.The AG800 automatic platelet aggregator has a CV of no more than 5%in detecting low and high-level specimens in clinical samples and has high precision in sample addition,temperature control,and turbidity change detection of samples.It can meet the precision requirements of clinical detection and has good clinical adaptability,high automation,easy operation,and low human influence elements.