Report on HbA(1c) Proficiency Testing in Asia in 2012.
10.3343/alm.2015.35.3.352
- Author:
Masao UMEMOTO
1
;
Tadao HOSHINO
;
Tetsuo MIYASHITA
;
Wataru TANI
;
Katsuhiko KUWA
Author Information
1. Reference Material Institute for Clinical Chemistry Standards, Kanagawa, Japan.
- Publication Type:Brief Communication
- Keywords:
HbA(1c);
National Glycohemoglobin Standardization Program;
Proficiency testing;
Asian Secondary Reference Laboratory
- MeSH:
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
- From:Annals of Laboratory Medicine
2015;35(3):352-355
- CountryRepublic of Korea
- Language:English
-
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.
