Japanese standard reference material JDS Lot 2 for haemoglobin A1c. II: Present state of standardization of haemoglobin A1c in Japan using the new reference material in routine clinical assays

Ann Clin Biochem 2005;42:47-50
doi:10.1258/0004563053026844
© 2005 Association for Clinical Biochemistry

 

This Article
Right arrow

Full Text (PDF)

Right arrow
Alert me when this article is cited
Right arrow
Alert me if a correction is posted
Services
Right arrow
Email this article to a friend
Right arrow

Similar articles in this journal

Right arrow
Similar articles in PubMed
Right arrow
Alert me to new issues of the journal
Right arrow
Download to citation manager
Right arrow
Citing Articles
Right arrow
Citing Articles via HighWire
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow
Articles by Tominaga, M.
Right arrow
Articles by Ono, J.
Right arrow Search for Related Content
PubMed
Right arrow
PubMed Citation
Social Bookmarking

What’s this?

Original Articles


Makoto Tominaga,
Hideichi Makino,
Gen Yoshino,
Katsuhiko Kuwa,
Izumi Takei,
Yukuko Aono,
Tadao Hoshino,
Masao Umemoto,
Akira Shimatsu,
Tokio Sanke,
Masamichi Kuwashima,
Tomohiko Taminato and
Junko Ono


Department of Laboratory Medicine, Yamagata University School of Medicine, 2-2-2 Iida-Nishi, Yamagata 990-9585, Japan and Chairman of the Committee on Standardization of Laboratory Testing Related to Diabetes Mellitus of Japan Diabetes Society;
Department of Laboratory Medicine, Ehime University School of Medicine, Japan;
Department of Laboratory Medicine, Toho University School of Medicine, Japan;
Institute of Clinical Medicine, University of Tsukuba, Japan;
Department of Laboratory Medicine, Keio University School of Medicine, Japan;
Clinical Laboratory, Tokyo University Hospital, Japan;
Institute of Biopathological Medicine, Japan;
Health Care Technology Foundation Standard Reference Center, Japan;
Clinical Research Institute, Kyoto National Hospital, Japan;
Department of Clinical Laboratory Medicine, Wakayama Medical University, Japan;
Department of Laboratory Medicine, University of Tokushima School of Medicine, Japan;
Department of Laboratory Medicine, Kagawa University School of Medicine, Japan;
Department of Laboratory Medicine, Fukuoka University School of Medicine, Japan


Background: In 2001, the Committee on Standardization of LaboratoryTesting Related to Diabetes Mellitus of the Japan Diabetes Society(JDS) prepared and certified a new reference material for haemoglobinA1c (HbA1c), Lot 2. The standardization programme for HbA1cmeasurement in Japan is currently based on Lot 2, although somelaboratories still use the previous material (Lot 1). The valuesassigned to Lot 2 were based on the consensus values for Lot1 and should give the same results. Therefore, there shouldbe no difference in the measured values no matter which calibratorsare used. The Committee conducted a domestic survey in orderto confirm this relationship.

Method: In November 2002, four samples for HbA1c assay weresent to 795 laboratories as part of a national survey in Japan.Assays were performed using the laboratories’ routine clinicalmethods. The coefficients of variation (CVs) of the reportedvalues from all laboratories for the samples were calculatedin order to determine the current level of standardization inJapan.

Results: The overall CVs in the measured values for the foursamples ranged from 2.7% to 4.0%. Values from laboratories usingcalibrators based on Lots 1 and 2 were similar.

Conclusion: The present state of standardization for the routinemeasurement of HbA1c in Japan, as indicated by the 2002 survey,is excellent. This should aid in the eventual conversion ofLot 2 to IFCC-based values from the results of the 2002 nationalHbA1c survey.


CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    What’s this?






This article has been cited by other articles:


R. R. Little and C. L. Rohlfing
HbA1c Standardization: Background, Progress and Current Issues
Lab Med,

June 1, 2009;
40(6):
368 – 373.

[Abstract]
[Full Text]
[PDF]


Home page J. Clin. Pathol.Home page

A H Berg and D B Sacks
Haemoglobin A1c analysis in the management of patients with diabetes: from chaos to harmony
J. Clin. Pathol.,

September 1, 2008;
61(9):
983 – 987.

[Abstract]
[Full Text]
[PDF]