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National Survey on Internal Quality Control for HbA1c Analytical Instruments in 331 Hospital Laboratories of China by Rong Zeng, Wei Wang, Haijian Zhao, Yang Fei, Zhiguo Wang

Background: The narrow gap of HbA1c 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 HbA1c in China and find out the most appropriate quality specifications.
Methods: Data of IQC for HbA1c 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 HbA1c 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 HbA1c has yet to be improved. Clinical laboratories in China should improve their performance with a stricter imprecision criteria.

DOI: 10.7754/Clin.Lab.2014.141123