摘要
目的:分析强生Vitros350全自动生化分析仪检测血清淀粉样蛋白A(SAA)的性能。方法:选择本院2020年10月~2020年12月健康体检中心进行体检者50例为研究对象,采集体检者晨起空腹外周静脉血3mL,常温下静置至血液凝固后以3000 r/m的速度离心后收集血清,立即送实验室检测。采用美国强生Vitros350全自动生化分析仪对血液样本中SAA进行检测,按照卫生行业标准要求,对Vitros350全自动生化分析仪的精密度、准确度做出评价。结果:SAA浓度的批内精密度结果:低值CV(1.43%)、高值CV(1.62%),均≤8.0%;批间精密度结果:质控1 CV(2.27%)、质控2 CV(2.34%),均≤8.3%,精密度测定结果均符合要求;以校准品为检验参照标准,线性回归方程为Y=0.979X+1.306,r^(2)=0.994>0.95,相关性良好;血液样本与便准品的检测结果比较,t=0.002,P=0.927,差异无统计学意义(P>0.05),准确度符合要求;对50例血液样本中SAA检测结果,均≤10mg/L,符合率为100.00%。结论:强生Vitros350全自动生化分析仪的精密度符合行业标准要求,检测SAA的准确度高,结果可靠,可以满足临床工作要求。
Objective:To evaluate the performance of Johnson Johnson Vitros350 automatic biochemical analyzer for the detection of serum amyloid A(SAA).Methods:50 patients who underwent physical examination in the health examination center of our hospital from October 2020 to December 2020 were selected as the research subjects.3mL of fasting peripheral venous blood was collected from the patients in the morning,and the serum was collected after standing at room temperature until the blood coagulated.After centrifugation at a speed of 3000 r/m,the serum was immediately sent to the laboratory for testing.SAA in blood samples was detected by Johnson&Johnson Vitros350 automatic biochemical analyzer,and the precision and accuracy of Vitros350 automatic biochemical analyzer were evaluated according to the requirements of health industry standards.Results:The results of intra batch precision of SAA concentration:low CV(1.43%),high CV(1.62%),all≤8.0%;Inter batch precision result:QC1 CV(2.27%,QC2 CV(2.34%),all≤8.3%.The results meet the requirements;The calibration product is taken as the inspection reference standard,and the linear regression equation is Y=0.979X+1.306,r^(2)=0.994>0.95,the correlation was good;Compared the test results of blood samples and stool samples,t=0.002,P=0.927,the difference was not statistically significant(P>0.05),and the accuracy met the requirements;the SAA test results in 50 blood samples were all≤10mg/L,the coincidence rate is 100.00%.Conclusion:The precision of Johnson Johnson Vitros350 automatic biochemical analyzer meets the requirements of industry standards,and the accuracy of SAA detection is high,the results are reliable and can meet the clinical requirements.
作者
李丹丹
LI Dan-dan(Laboratory Department,Branch of Tianjin Third Central Hospital,Tianjin 300250)
出处
《中国医疗器械信息》
2022年第8期52-54,共3页
China Medical Device Information
