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Statistical methods for monitoring the relationship between the IFCC reference measurement procedure for hemoglobin A(1c) and the designated comparison methods in the United States, Japan, and Sweden

In English

Författare

  • Andrea Geistanger
  • Sabine Arends
  • Christoph Berding
  • Tadao Hoshino
  • Jan-Olof Jeppsson
  • Randie Little
  • Carla Siebelder
  • Cas Weykamp

Summary, in English

BACKGROUND: The American Diabetes Association (ADA)/European Association for the Study of Diabetes (EASD)/International Diabetes Federation GDFAFCC Consensus Statement on the worldwide standardization of HbA(1c) states that"...[HbA(1c)] results are to be reported world-wide in IFCC units...and derived NGSP units...,using the IFCC-NGSP master equation." METHODS: We describe statistical methods to evaluate and monitor the relationships as expressed in master equations (MEs) between the IFCC Reference Measurement procedure (IFCC-RM) and designated comparison methods (DCMs) [US National Glycohemoglobin Standardization Program (NGSP), Japanese Diabetes Society/Japanese Society for Clinical Chemistry (JDS/JSCC), and Mono-S in Sweden]. We applied these statistics, including uncertainty calculations, to 12 studies in which networks of reference laboratories participated, operating the IFCC-RM and DCMs. RESULTS: For NGSP and Mono-S, slope, intercept, and derived percentage HbA(1c) at the therapeutic target show compliance with the respective MEs in all 12 studies. For JDS/JSCC, a slight deviation is seen in slope and derived percentage HbA(1c) in 2 of the 12 studies. Using the MEs, the uncertainty in an assigned value increases from 0.42 mmol/mol HbA(1c) (IFCC-RM) to 0.47 (NGSP), 0.49 (JDS/JSCC), and 0.51 (Mono-S). CONCLUSIONS: We describe sound statistical methods for the investigation of relations between networks of reference laboratories. Application of these statistical methods to the relationship between the JFCC-RM and DCMs in the US, Japan, and Sweden shows that they are suitable for the purpose, and the results support the applicability of the ADA/EASD/lDF/lFCC Consensus Statement on HbA1c measurement. (C) 2008 American Association for Clinical Chemistry.

Publiceringsår

2008

Språk

Engelska

Sidor

1379-1385

Publikation/Tidskrift/Serie

Clinical Chemistry

Volym

54

Issue

8

Dokumenttyp

Artikel i tidskrift

Förlag

American Association for Clinical Chemistry

Ämne

  • Biochemistry and Molecular Biology

Status

Published

Forskningsgrupp

  • Clinical Chemistry, Malmö

ISBN/ISSN/Övrigt

  • ISSN: 0009-9147