The Nanjing Glycated Hemoglobin Standardization Program: 2012 to 2015

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• 作者：Kui Zhang ; MM¹ ; ^⁎ ; ^{13505151066@163.com} ; Yan Wang ; MM² ; ^⁎ ; Hongxia Wei ; MM¹ ; Zhiye Xu ; MD¹
• 关键词：between-laboratory imprecision ; EQA ; glycated hemoglobin ; proficiency testing ; quality control ; standardization
• 刊名：Clinical Therapeutics
• 出版年：2017
• 出版时间：January 2017
• 年：2017
• 卷：39
• 期：1
• 页码：220-229
• 全文大小：203 K
• 卷排序：39

文摘

This study aims to investigate glycosylated hemoglobin (HbA1c), between-laboratory imprecision (%CV), and pass rates from 2012 to 2015 in Nanjing to provide evidence for improving the HbA1c measurement.MethodsThis was a retrospective, descriptive analysis of HbA1c levels obtained from participating hospitals in Nanjing from 2012 to 2015. The HbA1c levels of fresh whole blood samples taken from healthy and diabetic adults were determined within 24 hours. HbA1c levels (low level: 4.0%−6.0% HbA1c; medium level: 6.1%−8.0% HbA1c; and high level: 8.1%−10.0%) were grouped. Meanwhile, the target values were determined and assigned by a Level I−certified laboratory to assess the accuracy. Results as %HbA1c and related detection information, such as methods, were collected from all participants, then evaluated after each survey part of the program.FindingsOverall, the %CVs acquired by HPLC methods were lower than those determined by other methods. Pass rates ranged from 62.9% to 100%, depending on the HbA1c level, and overall pass rates increased from 54.3% to 94.4% for those laboratories passing the 3 HbA1c levels. In addition, the top-grade hospital-based laboratories had better performances than the secondary hospital-based laboratories in 2012 to 2015.ImplicationsThe use of accuracy-based proficiency testing with stringent quality-control management has greatly improved the performance of HbA1c testing. The Nanjing Glycated Hemoglobin Standardization Program (NJGHSP) played an important role in this improvement by encouraging use of more rigorous quality control, participation in external proficiency testing programs, and providing education.