Ann Lab Med.  2015 May;35(3):352-355. 10.3343/alm.2015.35.3.352.

Report on HbA(1c) Proficiency Testing in Asia in 2012

• Umemoto M
• Hoshino T
• Miyashita
• Tani W
• Kuwa K

• KMID: 2363209
• DOI: http://doi.org/10.3343/alm.2015.35.3.352

Abstract

In 2010, the Japan Diabetes Society decided to introduce the National Glycohemoglobin Standardization Program (NGSP) values into clinical practice. Accordingly, NGSP Certification of Japanese manufacturers of HbA(1c)-related diagnostic reagents and instruments was initiated in February, 2012, through an NGSP network laboratory, the Asian Secondary Reference Laboratory (ASRL) #1. Traceability to the NGSP reference system can be endorsed by manufacturer certification, as well as by the College of American Pathologists (CAP) survey. Nevertheless, only a few manufacturers participate in the CAP survey in Japan. Thus, proficiency testing (PT) was proposed and executed by ASRL #1. Single-donor whole-blood samples were used for the PT. The participated measurement systems were NGSP certified. Twenty-two laboratories obtained certification through ASRL #1; 2 through the Secondary Reference Laboratory (SRL) #8; and 9 through the SRL #9. The combination plots of the bias data in this PT and in the NGSP certification performed in March and May in 2012 were consistent with each other: mean NGSP values at each level agreed well with the target value. In conclusion, PT using whole blood is useful in endorsing NGSP certification.

Keyword

HbA(1c); National Glycohemoglobin Standardization Program; Proficiency testing; Asian Secondary Reference Laboratory

MeSH Terms

Asia
Chromatography, High Pressure Liquid
Enzyme Assays
Hemoglobin A, Glycosylated/*analysis/standards
Humans
Immunoassay
Japan
Laboratory Proficiency Testing/*standards
Quality Control
Reference Standards
Republic of Korea
Societies, Scientific
Hemoglobin A, Glycosylated

Figure

• 

  Fig. 1 Observed HbA1c values of each participating laboratory compared to the NGSP/ASRL target (dashed line) in 2012 based on ASRL PT data. Closed circles show within ±5% (dotted line) of relative bias. Open circles show within ±7% (dashed line) of relative bias. Open squares show biases of all manufacturers versus ASRL target PT samples.Abbreviations: NGSP, National Glycohemoglobin Standardization Program; ASRL, Asian Secondary Reference Laboratory; PT, proficiency testing.

Reference

1. Committee of the Japan Diabetes Society on the Diagnostic Criteria of Diabetes Mellitus. Seino Y, Nanjo K, Tajima N, Kadowaki T, Kashiwagi A, et al. Report of the Committee on the classification and diagnostic criteria of diabetes mellitus. J Diabetes Investig. 2010; 1:212–228.

2. NGSP Network Laboratory Members. Updated in 2010. http://www.ngsp.org/network.asp.