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血糖仪——适用于临床用途。

Glucose meters - fit for clinical purpose.

机构信息

Roche Diagnostics, Sydney, New South Wales, Australia.

出版信息

Clin Chem Lab Med. 2013 May;51(5):943-52. doi: 10.1515/cclm-2013-0011.

DOI:10.1515/cclm-2013-0011
PMID:23399591
Abstract

Glucose meters have improved considerably since they were first introduced in 1960, but many questions are being asked about their accuracy and reliability in certain clinical situations. These questions have arisen because of the widespread use of these meters into clinical areas they have not been designed for such as critical care. The lack of understanding by some health professionals on factors that affect glucose results, such as sample type, glucose test strip methodologic limitations, calibration to recognized reference methods, and interferences, leads to misleading results that may affect patient care. Much debate continues on the quality specifications for glucose meters. Because there is an extensive use of these meters in different clinical scenarios, the setting of quality specifications will remain a challenge for regulatory and professional organizations. In this article, we have attempted to collect and provide relevant information addressing the limitations above. Pivotal to obtaining the best quality of results is education, particularly for diabetic patients monitoring their glucose. The International Federation of Clinical Chemistry and Laboratory Medicine through its Point-of-Care Testing Task Force and its Working Group on Glucose Point-of-Care Testing is actively working toward improving the quality of glucose results by improving education and working with the industry to improve strip performance and work toward the better standardization of strips.

摘要

血糖仪自 1960 年问世以来已经有了很大的改进,但在某些临床情况下,人们对其准确性和可靠性提出了许多质疑。这些质疑的出现是由于这些血糖仪在设计范围之外的临床领域得到了广泛应用,如重症监护。一些卫生专业人员对影响血糖结果的因素缺乏了解,例如样本类型、血糖测试条方法学限制、与公认参考方法的校准以及干扰,这导致了可能影响患者治疗的误导性结果。关于血糖仪的质量规格仍存在许多争议。由于这些血糖仪在不同的临床场景中得到了广泛应用,因此为监管和专业组织设定质量规格仍然是一项挑战。在本文中,我们试图收集并提供有关上述限制的相关信息。获得最佳结果质量的关键是教育,特别是对于监测血糖的糖尿病患者。国际临床化学和实验室医学联合会通过其即时检验工作组及其即时血糖检测工作组,正在积极努力通过提高教育质量来改善血糖检测结果,并与行业合作,改善测试条性能,努力实现更好的测试条标准化。

相似文献

1
Glucose meters - fit for clinical purpose.血糖仪——适用于临床用途。
Clin Chem Lab Med. 2013 May;51(5):943-52. doi: 10.1515/cclm-2013-0011.
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Performance evaluation of blood glucose monitoring devices.血糖监测设备的性能评估
Diabetes Technol Ther. 2003;5(5):749-68. doi: 10.1089/152091503322526969.
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Quality of glucose measurement with blood glucose meters at the point-of-care: relevance of interfering factors.即时检测血糖仪的血糖测量质量:干扰因素的相关性。
Diabetes Technol Ther. 2010 Nov;12(11):847-57. doi: 10.1089/dia.2010.0076. Epub 2010 Sep 30.
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Capillary glucose meter accuracy and sources of error in the ambulatory setting.动态环境下便携式血糖仪的准确性及误差来源。
N Z Med J. 2010 Mar 5;123(1310):74-85.
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Glucose meter inaccuracy and the impact on the care of patients.血糖仪不准确对患者护理的影响。
Diabetes Metab Res Rev. 2012 Mar;28(3):207-9. doi: 10.1002/dmrr.2271.
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Approved IFCC recommendation on reporting results for blood glucose: International Federation of Clinical Chemistry and Laboratory Medicine Scientific Division, Working Group on Selective Electrodes and Point-of-Care Testing (IFCC-SD-WG-SEPOCT).国际临床化学和检验医学联合会科学部选择性电极与即时检验工作组(IFCC-SD-WG-SEPOCT)批准的血糖检测结果报告建议。
Clin Chem Lab Med. 2006;44(12):1486-90. doi: 10.1515/CCLM.2006.275.
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Diabetic home blood glucose monitoring using a direct reading glucose sensitive test strip.使用直读式葡萄糖敏感测试条进行糖尿病患者家庭血糖监测。
N Z Med J. 1981 Oct 14;94(693):252-4.
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Maltose interference-free test strips for blood glucose testing at point-of-care: a laboratory performance evaluation.即时检测用无麦芽糖干扰血糖测试条:实验室性能评估。
Diabetes Technol Ther. 2010 Nov;12(11):889-93. doi: 10.1089/dia.2010.0095. Epub 2010 Sep 30.
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Educational intervention together with an on-line quality control program achieve recommended analytical goals for bedside blood glucose monitoring in a 1200-bed university hospital.在一家拥有1200张床位的大学医院中,教育干预与在线质量控制程序相结合,实现了床边血糖监测的推荐分析目标。
Clin Chem Lab Med. 2005;43(8):876-9. doi: 10.1515/CCLM.2005.147.
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Glucose meters: evaluation of the new formulation measuring strips from Roche (Accu-Chek) and Abbott (MediSense).血糖仪:罗氏(Accu-Chek)和雅培(MediSense)新款测量条的评估。
Ann Clin Biochem. 2010 Jul;47(Pt 4):358-65. doi: 10.1258/acb.2010.009291.

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