CardioChek PA床旁血脂检测仪的准确性验证

  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。

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

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