The Need for Accuracy in Hemoglobin A1c Proficiency Testing: Why the Proposed CLIA Rule of 2019 Is a Step Backward.
作者信息
Klonoff David C, Aron David, Cohen Robert M, Home Philip, John W Garry, Little Randie R, Nathan David M, Sacks David B
机构信息
1 Diabetes Research Institute, Mills-Peninsula Medical Center, San Mateo, CA, USA.
2 Louis Stokes Cleveland VA Medical Center, Cleveland, OH, USA.
出版信息
J Diabetes Sci Technol. 2019 May;13(3):424-427. doi: 10.1177/1932296819841699. Epub 2019 Mar 22.
Abstract
摘要
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本文引用的文献
1
Introduction: .引言：.
Diabetes Care. 2019 Jan;42(Suppl 1):S1-S2. doi: 10.2337/dc19-Sint01.
2
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Clin Chem. 2019 Jul;65(7):839-848. doi: 10.1373/clinchem.2018.296962. Epub 2018 Dec 5.
3
Status of hemoglobin A1c measurement and goals for improvement: from chaos to order for improving diabetes care.糖化血红蛋白测量的现状和改进目标：为改善糖尿病护理而从混乱走向有序。
Clin Chem. 2011 Feb;57(2):205-14. doi: 10.1373/clinchem.2010.148841. Epub 2010 Dec 9.
4
Standards of medical care in diabetes--2010.《糖尿病医疗护理标准——2010》
Diabetes Care. 2010 Jan;33 Suppl 1(Suppl 1):S11-61. doi: 10.2337/dc10-S011.
5
International Expert Committee report on the role of the A1C assay in the diagnosis of diabetes.国际专家委员会关于糖化血红蛋白检测在糖尿病诊断中作用的报告。
Diabetes Care. 2009 Jul;32(7):1327-34. doi: 10.2337/dc09-9033. Epub 2009 Jun 5.
6
The national glycohemoglobin standardization program: a five-year progress report.国家糖化血红蛋白标准化项目：五年进展报告。
Clin Chem. 2001 Nov;47(11):1985-92.
7
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