协和医学杂志

2014, v.5(03) 283-289

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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

侯立安;邱玲;邸茜;国秀芝;解宏杰;李鹏昌;王凯;程歆琦;刘荔;
HOU Li-an;QIU Ling;DI Qian;GUO Xiu-zhi;XIE Hong-jie;LI Peng-chang;WANG Kai;CHENG Xin-qi;LIU Li;Department of Clinical Laboratory,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences &Peking Union Medical College;

摘要(Abstract):

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为1.96%和0.77%;HDL-C分别为2.34%和4.87%。结论 CardioChek PA床旁血脂检测仪准确度满足临床需求,适用于临床血脂异常筛查及治疗检测。
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 other 3 systems were- 4. 55%-13. 34%. Deviation of TC,TG,and HDL-C in different medical decision levels were- 3. 27%-1. 96%,- 11. 05%-13. 06%,and- 5. 86%-11. 56%,respectively,all of which could satisfy the requirements of the National Cholesterol Education Program( NCEP).Compared with reference methods,the biases of TC in medical decision levels were 1. 96% and 0. 77%; for HDL-C,they were 2. 34% and 4. 87%. Conclusion The accuracy of CardioChek PA lipid point-of-care device can satisfy the clinical requirements,and the device can be used in the screening and monitoring of dyslipidemia.

关键词(KeyWords): 床旁检验;不精密度;准确度;比对实验
point-of-care testing;imprecision;accuracy;comparison test

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作者(Author): 侯立安;邱玲;邸茜;国秀芝;解宏杰;李鹏昌;王凯;程歆琦;刘荔;
HOU Li-an;QIU Ling;DI Qian;GUO Xiu-zhi;XIE Hong-jie;LI Peng-chang;WANG Kai;CHENG Xin-qi;LIU Li;Department of Clinical Laboratory,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences &Peking Union Medical College;

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