[1]刁志宏 黄海霞 唐连顺 孙 亮 雷 达 劳炜东.快速血糖仪与生化分析仪血糖检测结果的比对分析[J].大众科技,2021,23(11):64-66.
 Comparison and Analysis of Blood Glucose Detection Results between Rapid Blood Glucose Meter and Biochemical Analyzer[J].Popular Science & Technology,2021,23(11):64-66.
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快速血糖仪与生化分析仪血糖检测结果的 比对分析()
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《大众科技》[ISSN:1008-1151/CN:45-1235/N]

卷:
23
期数:
2021年11
页码:
64-66
栏目:
医药与卫生
出版日期:
2021-11-20

文章信息/Info

Title:
Comparison and Analysis of Blood Glucose Detection Results between Rapid Blood Glucose Meter and Biochemical Analyzer
作者:
刁志宏12 黄海霞1 唐连顺1 孙 亮2 雷 达2 劳炜东2
(1.广西中医药大学附属瑞康医院,广西 南宁 530011; 2.广东省第二人民医院,广东 广州 510317)
关键词:
血糖快速血糖仪生化分析仪比对EP9-A2
Keywords:
blood glucose rapid blood glucose meter biochemical analyzer comparison EP9-A2
文献标志码:
A
摘要:
目的:探讨A、B、C三种型号快速血糖仪和罗氏P-800生化分析仪的血糖测定结果的可比性和临床可接受性。方法:参照美国临床和实验室标准化协会(CLSI)EP9-A2文件,每天选择8份肝素锂抗凝的新鲜血标本,分别用A、B、C三种型号的快速血糖仪和罗氏P-800生化分析仪测定血糖,连续检测5天,计算线性回归方程和方法间的相对偏差,以美国临床实验室修正法规(CLIA88)允许总误差的1/2作标准,判断不同检测系统间的可比性。结果:三种快速血糖仪分别与罗氏P-800生化分析仪之间的相关系数均大于0.975,表明回归统计的斜率和截距可靠。除A型快速血糖仪与罗氏P-800生化分析仪在高值危急值处的相对偏差大于1/2 CLIA88的允许误差外,其余测定结果的系统误差均小于1/2 CLIA88的允许误差。结论:A、B、C三种型号的快速血糖仪与罗氏P-800生化分析仪在医学决定水平处之间检测血糖的结果具有良好的可比性,A型快速血糖仪在高值危急值处的血糖检测结果与生化分析仪差异较大。
Abstract:
Objective: To explore the comparability and clinical acceptability of the blood glucose measurement results of A, B and C rapid blood glucose meter and Roche P-800 biochemical analyzer. Methods: According to the American Society for Clinical and Laboratory Standardization (CLSI) EP9-A2 document, 8 fresh blood samples anticoagulated with heparin lithium were selected every day. Blood glucose was measured by three types of rapid blood glucose meter A, B and C and Roche P-800 biochemical analyzer for 5 consecutive days. The relative deviation between linear regression equation and method was calculated, and the American Clinical Laboratory Amendment Regulation (CLIA 88) was used allow 1/2 of the total error as the standard to judge the comparability between different detection systems. Results: The correlation coefficients between the three rapid blood glucose meters and the Roche P-800 biochemical analyzer were greater than 0.975, indicating that the slope and intercept of the regression statistics were reliable. Except the relative deviation between type A rapid blood glucose meter and Roche P-800 biochemical analyzer at high critical value is greater than the allowable error of 1/2 CLIA88, the systematic error of other measurement results is less than the allowable error of 1/2 CLIA88. Conclusion: The blood glucose detection results of three types of rapid blood glucose meter A, B and C and Roche P-800 biochemical analyzer at the medical decision level are well comparable. The blood glucose detection results of type A rapid blood glucose meter at the high critical value are quite different from those of biochemical analyzer.

参考文献/References:

[1] 王淼,周染云,杨兴龙,等. 医院POCT血糖仪应用现状分析[J]. 中华检验医学杂志,2016(8): 643-645. [2] Mancini A, Esposto G, Manfrini S, et al. A real-world setting study: which glucose meter could be the best for POCT use? An easy and applicable protocol during the hospital routine[J]. Journal of Diabetes Science and Technology, 2018, 12(5): 1053-1060. [3] Krouwer J S, Tholen D W, Garber C C, et al. Method comparison and bias estimation using patient samples approved guideline-second edition[J]. EP9-A2, 2002, 22(19): 1-52. [4] U.S. Department of Health and human Services. Medicare, medicaid and CLIA program: regulations implementing the clinical laboratory improvement amendment of 1988 (CLIA)--HCFA. Final rule with comment period[J]. Federal Register, 1992, 57(40): 7002-7186. [5] Jingi A M, Tankeu A T, Ateba N A , et al. Mechanism of worsening diabetic retinopathy with rapid lowering of blood glucose: the synergistic hypothesis[J]. BMC Endocrine Disorders, 2017, 17(1): 63. [6] Shohat N, Foltz C, Restrepo C, et al. Increased postoperative glucose variability is associated with adverse outcomes following orthopaedic surgery [J]. The Bone and Joint Journal, 2018, 100(8): 1125-1132. [7] 王尉,郑华荣,周睿,等. 两款糖化血红蛋白床旁分析仪的正确性评价[J]. 标记免疫分析与临床,2019(5): 871-873. [8] Shaw J L V. Practical challenges related to point of care testing [J]. Practical Laboratory Medicine, 2016, 4: 22-29. [9] 刘建华,钟白云,梁运来,等. 3种品牌POCT血糖仪与生化分析仪己糖激酶法检测血糖的比对[J]. 临床检验杂志,2018, 36(6): 411-414. [10] Fu H, Yan S, Wang Y, et al. Methods comparison and bias estimation of three distinct biochemistry analytical systems in one clinical laboratory using patient samples [J]. Clinical Laboratory, 2016, 62(1-2): 187-194. [11] 刘颖,张军,李振. 三诺金准血糖仪测定末梢毛细血管、静脉血糖水平准确性的研究[J]. 国际检验医学杂志,2016,37(22): 3207-3208.

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备注/Memo

备注/Memo:
【收稿日期】2021-08-11 【基金项目】利用POCT技术建立平急兼备的检验医学应急平台、广东省医学科学技术研究基金指令性课题(C2015005)。 【作者简介】刁志宏(1970-),男,广西中医药大学附属瑞康医院检验科副主任技师,博士后,研究方向为抗感染、免疫机制。
更新日期/Last Update: 2022-02-14