Report on HbA1c Proficiency Testing in Asia in 2012.
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.
Reference Material Institute for Clinical Chemistry Standards, Kanagawa, Japan.
Masao
M
Umemoto
Reference Laboratory Institute of Biopathological Medicine, Kanagawa, Japan.
Tadao
T
Hoshino
Nihon University Itabashi Hospital, Tokyo, Japan.
Tetsuo
T
Miyashita
Reference Material Institute for Clinical Chemistry Standards, Kanagawa, Japan.
Wataru
W
Tani
National Metrology Institute of Japan, Ibaraki, Japan.
Katsuhiko
K
Kuwa
D001208:Asia; D002851:Chromatography, High Pressure Liquid; D057075:Enzyme Assays; D006442:Glycated Hemoglobin / Q000032:analysis* / Q000592:standards; D006801:Humans; D007118:Immunoassay; D007564:Japan; D059021:Laboratory Proficiency Testing / Q000592:standards*; D011786:Quality Control; D012015:Reference Standards; D056910:Republic of Korea; D012958:Societies, Scientific
D006442:Glycated Hemoglobin
Asian Secondary Reference Laboratory; HbA1c; National Glycohemoglobin Standardization Program; Proficiency testing