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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

    摘要
  • 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。

     

    Abstract:
      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 number 20 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 were 7.27%, 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.

     

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