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National Survey on Internal Quality Control for HbA(1c) Analytical Instruments in 331 Hospital Laboratories of China
Insights
Internal quality control for hemoglobin A1c (HbA1c) in China shows significant variability. Laboratories need to improve precision and adopt stricter quality specifications for accurate diabetes diagnosis.
Area of Science:
- Clinical Chemistry
- Laboratory Medicine
- Diabetes Diagnostics
Background:
- Accurate hemoglobin A1c (HbA1c) measurement is crucial for differentiating normal glucose levels from diabetes.
- Tight control of assay standardization, precision, and trueness is essential due to the narrow diagnostic gap.
- Internal quality control (IQC) practices for HbA1c in China were assessed to identify areas for improvement.
Purpose of the Study:
- To evaluate the current state of HbA1c IQC practices across Chinese clinical laboratories.
- To determine the most appropriate quality specifications for HbA1c control materials in China.
Main Methods:
- Data from 331 institutions participating in national proficiency testing (PT) programs were analyzed.
- Four levels of quality specifications were used to evaluate IQC data.
- Percentages of laboratories meeting quality requirements were calculated.
Main Results:
- Significant variability in HbA1c IQC data was observed among the 331 laboratories.
- Measurement of control materials ranged widely (4.52%–12.24% inter-quartile range).
- Capillary electrophoresis-high-performance liquid chromatography (CE-HPLC) and acid-alkali denaturation-high-performance liquid chromatography (AC-HPLC) demonstrated better precision compared to other methods.
Conclusions:
- Laboratory performance in HbA1c testing requires improvement in China.
- Stricter imprecision criteria are recommended for clinical laboratories to enhance diagnostic accuracy.
Background:
The narrow gap of HbA1 value of mass fraction between "normal" (< 6.0%) and "diabetes" (≥ 6.5%) necessitates tight control of inter-assay standardization, assay precision, and trueness. This survey was initiated to obtain knowledge of the current situation of internal quality control (IQC) practice for HbA(1c) in China and find out the most appropriate quality specifications.
Methods:
Data of IQC for HbA(1c) in 331 institutions participating in the national proficiency testing (PT) programs in China were evaluated using four levels of quality specifications, and the percentages of laboratories meeting the quality requirement were calculated to find out the most appropriate quality specifications for control materials of HbA(1c) in China.
Results:
The IQC data varied vastly among 331 clinical laboratories in China. The measurement of control materials covered a wide range from 4.52% to 12.24% (inter-quartile range) and there were significant differences among the CVs of different methods, including LPLC, CE-HPLC, AC-HPLC, immunoturbidimetry, and others. Among the four main methods, CE-HPLC and AC-HPLC achieved a better precision.
Conclusions:
As we can see, the performance of laboratories for HbA(1c) has yet to be improved. Clinical laboratories in China should improve their performance with a stricter imprecision criteria.
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