CardioChek PA床旁血脂检测仪的准确性验证  

Performance Verification of CardioChek PA Lipid Point-of-care Devices

作　　者：侯立安[1] 邱玲[1] 邸茜[1] 国秀芝[1] 解宏杰[1] 李鹏昌[1] 王凯[1] 程歆琦[1] 刘荔[1] 

机构地区：[1]中国医学科学院北京协和医学院北京协和医院检验科,北京100730

出　　处：《协和医学杂志》2014年第3期283-289,共7页Medical Journal of Peking Union Medical College Hospital

摘　　要：目的验证CardioChek PA床旁血脂检测仪测定全血总胆固醇（total cholesterol,TC）、甘油三酯（triglyceride,TG）和高密度脂蛋白胆固醇（high-density lipoprotein cholesterol,HDL-C）的准确度及其与全自动生化分析仪结果的可比性。方法使用同一批号试纸条分别在3台CardioChek PA血脂检测仪上连续检测低、中、高三个浓度水平全血20次,评价TC、TG和HDL-C各项目的批内不精密度和仪器间总不精密度;在同一台仪器上使用三个批号的试纸条检测全血各10次,计算批内不精密度和总不精密度。筛选血脂浓度覆盖高、中、低三个水平的54名志愿者,清晨空腹采集末梢全血,在3台床旁血脂仪上测定血脂;同时采集静脉血,在4种不同的全自动生化分析仪检测血清TC、TG及HDL-C。绘制Bland-Altman图,比较CardioChek PA与各生化分析仪测定结果的离散趋势;将CardioChek PA检测结果与不同生化分析系统及参考方法检测结果进行线性回归;计算CardioChek PA与不同生化分析系统的偏差及百分偏差,同时判定在医学决定水平处偏差是否符合相关要求。结果 3台CardioChek PA仪器低、中、高水平的总不精密度TC分别为：2.69%、4.88%、3.51%,TG分别为5.51%、5.27%、4.96%,HDL-C分别为7.27%、6.84%、6.79%;相同仪器、不同批号试纸间总不精密度TC为4.70%,TG为7.66%,HDL-C为8.61%。CardioChek PA检测系统与4种全自动生化仪分析比对结果显示：TC与各系统的偏差最小,在-2.21%～2.56%之间,HDL-C在-1.12%～5.57%之间,TG除与BeckmanDxC 800偏差较大外（25.85%）,与其他3个系统的平均百分偏差在-4.55%～13.34%之间。医学决定水平偏差分析显示：TC在不同医学决定水平处的偏差在-3.27%～1.96%之间,TG在-11.05%～13.06%之间,HDL-C在-5.86%～11.56%之间,均满足美国国家胆固醇教育计划总允许误差标准（15%）。进一步的正确度验证结果显示：与参考方法比对,TC在医学决定水平处偏倚分别�Objective To validate the accuracy of CardioChek PA lipid point-of-care devices in determining total cholesterol（ TC）,triglyceride（ TG）,and high-density lipoprotein cholesterol（ HDL-C） in whole blood and the comparability with results determined by full-automatic biochemical analyzer. Methods We determined the low,medium,and high levels of TG,TC,and HDL-C in whole blood with single reagent lot number20 times using 3 different CardioChek PA devices to evaluate inter-run and devices＇ coefficient of variations（ CVs）,and used single CardioChek PA device with 3 reagent lot number to determine the whole blood 10 times for evaluating inter-run and total CVs. Fifty-four volunteers whose lipid profiles covered up high,medium,and low levels were recruited. Lipids in fasting periphery whole blood and venous serum were collected and determined using 3 different CardioChek PA devices and 4 kinds of full-automatic biochemical analyzers,respectively.Bland-Altman plot was made to analyze the comparability of results from CardioChek PA and the full-automatic biochemical analyzers. Linear regression was analyzed using results of CardioChek PA and full-automatic biochemical analyzers. Bias and percentage bias were determined between CardioChek PA and different automatic biochemical analyzers; meanwhile,whether they satisfied the requirements of medical decision levels was determined. Results The total CVs of TC in low,medium,and high levels in 3 different devices were 2. 69%,4. 88%,and 3. 51%,respectively; for TG,they were 5. 51%,5. 27% and 4. 96%; and for HDL-C,they were7. 27%,6. 84% and 6. 79%. The total CVs of TC,TG,and HDL-C determined with the same device but different reagent lot number were 4. 70%,7. 66%,and 8. 61%,respectively. Comparison of the results from CardioChek PA devices and the 4 kinds of full-automatic biochemical analyzers showed lowest deviation for TC with- 2. 21%-2. 56%,and for HDL-C with- 1. 12%-5. 57%; the deviation of TG results of BeckmanDxC800 was relatively high with 25. 85%,but in oth

关 键 词：床旁检验 不精密度 准确度 比对实验 

分 类 号：R446[医药卫生—诊断学]