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The Nanjing Glycated Hemoglobin Standardization Program: 2012 to 2015
Kui Zhang1, Yan Wang2, Hongxia Wei1
1Department of Laboratory Medicine, the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing University, Nanjing, PR China.
Clinical Therapeutics
|December 7, 2016
Summary
Glycosylated hemoglobin (HbA1c) testing quality improved significantly in Nanjing from 2012-2015. Enhanced quality control and proficiency testing led to higher pass rates and better accuracy in HbA1c measurements.
Area of Science:
- Clinical Chemistry
- Laboratory Medicine
- Diabetes Diagnostics
Background:
- Glycosylated hemoglobin (HbA1c) is a critical biomarker for diabetes management.
- Ensuring accurate and precise HbA1c measurements is essential for effective patient care.
- Variability in laboratory performance can impact clinical decision-making.
Purpose of the Study:
- To evaluate the trends in between-laboratory imprecision (%CV) and pass rates for HbA1c testing in Nanjing from 2012 to 2015.
- To provide data supporting the improvement of HbA1c measurement quality.
- To assess the impact of standardization programs on laboratory performance.
Main Methods:
- A retrospective analysis of HbA1c data from Nanjing hospitals (2012-2015).
- Collected HbA1c levels from fresh whole blood samples of healthy and diabetic adults.
- Grouped HbA1c levels into low, medium, and high categories for analysis and assessed accuracy against a Level I-certified laboratory.
Main Results:
- High-performance liquid chromatography (HPLC) methods demonstrated lower %CV compared to other techniques.
- Overall laboratory pass rates for HbA1c testing increased from 54.3% to 94.4% during the study period.
- Top-grade hospitals exhibited superior performance in HbA1c testing compared to secondary hospitals.
Conclusions:
- Accuracy-based proficiency testing and stringent quality control significantly enhance HbA1c testing performance.
- The Nanjing Glycated Hemoglobin Standardization Program (NJGHSP) was instrumental in driving these improvements through quality control, proficiency testing, and education.
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