Laboratory Medicine ›› 2015, Vol. 30 ›› Issue (9): 948-952.DOI: 10.3969/j.issn.1673-8640.2015.09.019

• Orginal Article • Previous Articles     Next Articles

Research progress of Shanghai Glycohemoglobin Harmonization Program

SHAO Wenqi, SUN Lin, WANG Beili, WU Jiong, SONG Binbin, ZHANG Chunyan, GUO Wei, PAN Baishen   

  1. Department of Clinical Laboratory, Zhongshan Hospital, Fudan University, Shanghai 200032, China
  • Received:2014-11-11 Online:2015-09-30 Published:2015-09-29

Abstract: Objective

To improve the harmonization of hemoglobin A1c (HbA1c) results from laboratories participating in Shanghai Glycohemoglobin Harmonization Program(SHGHP)in order to improve the diagnosis of diabetes mellitus.

Methods

A total of 4 level Ⅰ laboratories certificated by the National Glycohemoglobin Standardization Program (NGSP) and a laboratory by the International Federation of Clinical Chemistry and Laboratory Medicine(IFCC)were comprised the proposed reference laboratory network. SHGHP website was established, and whole blood calibrators and comparative specimens were sent to all participating clinical laboratories. The harmonization of results before and after calibration was compared. The mean value, standard deviation and coefficient of variation(CV) of HbA1c detected by the laboratories before and after calibration were calculated and analyzed for difference statistically.

Results

The CV of low-level and high-level HbA1c by the 5 reference laboratories were 2.27% and 1.58%, respectively. The CV of HbA1c detected by the third-grade hospitals after calibration decreased significantly than that before calibration (P<0.001). The CV after calibration ranged from 0.94% to 4.22%. The percentages of passed laboratories in SHGHP from 2012 to 2013 were above 90% in which the third-grade hospitals all passed the evaluation.

Conclusions

SHGHP calibrates the different methods by fresh whole blood with no significant matrix effects and improves the harmonization of HbA1c significantly among the participating laboratories.

Key words: Hemoglobin A1c, Diabetes mellitus, Harmonization

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