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KMID : 1100720150350030352
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Annals of Laboratory Medicine
2015 Volume.35 No. 3 p.352 ~ p.355
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Report on HbA1c Proficiency Testing in Asia in 2012
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Umemoto Masao
Hoshino Tadao
Miyashita Tetsuo
Tani Wataru
Kuwa Katsuhiko
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Abstract
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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 HbA1c-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.
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KEYWORD
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HbA1c, National Glycohemoglobin Standardization Program, Proficiency testing, Asian Secondary Reference Laboratory
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