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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. -
Key words:
- point-of-care testing /
- imprecision /
- accuracy /
- comparison test
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表 1 受试者血脂分布情况
血脂项目 分布 TC 浓度(mmol/L) 2.60 ~4.15 4.16 ~5.19 5.20 ~6.23 6.24 ~7.27 >7.27 例数 9 20 19 5 1 TG 浓度(mmol/L) 0.55~1.10 1.11~1.65 1.66~2.20 2.21~3.30 >3.30 例数 25 12 7 5 5 HDL-C 浓度(mmol/L) 0.39~0.91 0.92~1.17 1.18~1.42 1.43~1.82 >1.82 例数 3 16 11 20 4 TC:总胆固醇;TG:甘油三酯;HDL-C:高密度脂蛋白胆固醇 表 2 3台CardioChek PA的批内不精密度及不同仪器间总不精密度
血脂
项目仪器序列号 L M H MEAN
(mmol/L)CV
(%)CV
(%)MEAN
(mmol/L)MEAN
(mmol/L)CV
(%)TC SN 3017711 3.79 3.60 4.07 3.99 4.91 3.39 SN 3015966 3.73 2.78 4.06 4.69 5.04 3.36 SN 3017755 3.72 2.71 4.06 5.10 4.97 3.57 总计 3.72 2.69 4.06 4.88 5.00 3.51 TG SN 3017711 0.74 4.18 1.87 2.95 3.35 4.03 SN 3015966 0.76 6.99 1.88 4.39 3.45 5.52 SN 3017755 0.75 4.64 1.86 5.75 3.39 4.66 总计 0.75 5.51 1.87 5.27 3.41 4.96 HDL-C SN 3017711 1.05 6.14 1.12 6.38 1.46 5.72 SN 3015966 1.10 7.24 1.16 7.89 1.49 7.69 SN 3017755 1.09 7.43 1.14 6.34 1.48 6.44 总计 1.09 7.27 1.15 6.84 1.49 6.79 TC、TG、HDL-C:同表 1;L:血脂低水平;M:血脂中间水平;H:血脂高水平;MEAN:平均值;CV:不精密度 表 3 不同批号试纸条批内不精密度和批间总不精密度
血脂
项目试纸条
批号MEAN
(mmol/L)CV
(%)diffmean
(mmol/L)diff%mean
(%)TC 221 4.21 1.51 0.223 5.78 219 3.94 3.31 -0.036 -0.91 215 3.97 5.49 - - 总计 4.04 4.70 - - TG 221 0.67 8.18 0.015 2.30 219 0.72 6.61 -0.068 10.43 215 0.65 3.95 - - 总计 0.68 7.66 - - HDL-C 221 1.53 5.62 -0.236 -13.36 219 1.59 7.02 -0.180 -4.53 215 1.77 5.58 - - 总计 1.63 8.61 - - TC、TG、HDL-C:同表 1;MEAN、CV:同表 2;diffmean:平均偏差;diff%mean:平均百分偏差 表 4 CardioChek PA检测系统与4种常规生化检测系统医学决定水平偏差判定
常规生化检测系统 TC TG HDL-C 水平 医学决定水平
(mmol/L)偏差
(mmol/L)百分偏差
(%)医学决定水平
(mmol/L)偏差
(mmol/L)百分偏差
(%)医学决定水平
(mmol/L)偏差
(mmol/L)百分偏差
(%)Beckman AU5400 高 5.17 0.03 0.61 1.69 -0.11 -6.49 1.03 -0.06 -5.86 中 6.24 -0.09 -1.38 2.26 -0.18 -8.13 1.56 0.11 7.00 低 5.65 -0.62 -11.05 Roche P Modular 高 5.17 -0.07 -1.36 1.69 0.13 7.65 1.03 -0.04 -3.62 中 6.24 -0.20 -3.19 2.26 0.11 4.96 1.56 0.01 0.67 低 5.65 0.01 0.19 Hitach 7180 高 5.17 0.08 1.51 1.69 0.04 2.57 1.03 -0.05 -4.45 中 6.24 0.00 0.05 2.26 -0.04 -1.61 1.56 0.03 1.82 低 5.65 -0.51 -9.04 BeckmanDxC 800 高 5.17 -0.06 -1.07 1.69 0.22 13.16 1.03 0.00 0.02 中 6.24 -0.15 -2.43 2.26 0.20 8.83 1.56 0.18 11.56 低 5.65 0.06 1.13 参考方法 高 5.17 0.10 1.96 1.69 1.03 0.02 2.23 中 6.24 0.05 0.77 2.26 1.56 0.08 4.87 低 5.65 TC、TG、HDL-C:同表 1 -
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