TY - JOUR
AU1 - Goodall, Ian
AU2 - Colman, Peter G.
AU3 - Schneider, Hans G.
AU4 - McLean, Mark
AU5 - Barker, George
AB - Background : HbA 1c (glycohaemoglobin) is universally used in the ongoing monitoring of all patients with diabetes. There are many % HbA 1c target control rating recommendations by national, regional and international expert bodies for diabetes patients and these are variable around the world. General patient target control ratings are currently most often recommended as either <6.5% or <7.0% HbA 1c , with <6.0% HbA 1c stated for individual patients where clinically possible. This necessitates very precise HbA 1c assays and the same patient values, irrespective of HbA 1c method or area of the world. Methods : HbA 1c targets recommended by major expert groups and published HbA 1c assay precision (coefficient of variation, %CV) levels have been detailed. These have been compared with published biological variation levels and with calculated HbA 1c error ranges at various HbA 1c levels and %CV levels. In addition, these have been compared with the analytical precision necessary to differentiate between the upper limit of the normal range for HbA 1c and targets recommended by expert groups for diabetes control. Results : Intralaboratory analytical CVs of <2% are necessary and are achievable on automated HPLC analysers, and are supported on grounds of both clinical need and biological variation, as well as the need to differentiate the national, regional and international target recommendations from the upper limit of the normal range (<6.0% HbA 1c level). Conclusions : Routine methods with tight long-term imprecision with CVs of <2% are recommended. International HbA 1c targets essentially require that all HbA 1c methods be precise, and have minimal standardisation bias and minimal methodological interferences in individual patients. Clin Chem Lab Med 2007;45:1083–97.
TI - Desirable performance standards for HbA 1c analysis – precision, accuracy and standardisation Consensus statement of the Australasian Association of Clinical Biochemists (AACB), the Australian Diabetes Society (ADS), the Royal College of Pathologists of Australasia (RCPA), Endocrine Society of Australia (ESA), and the Australian Diabetes Educators Association (ADEA)
JF - Clinical Chemistry and Laboratory Medicine
DO - 10.1515/CCLM.2007.158
DA - 2007-08-01
UR - https://www.deepdyve.com/lp/de-gruyter/desirable-performance-standards-for-hba-1c-analysis-precision-accuracy-OFl7ewoZx0
SP - 1083
EP - 1097
VL - 45
IS - 8
DP - DeepDyve
ER -