BACKGROUND: The accuracy and trueness of results from a laboratory test, such as the HbA1c test, should not be taken for granted but must be checked continuously. A tool for this is the participation in external quality assessment (EQA) for all laboratories performing the HbA1c-test. An additional possibility to detect changes in trueness is to monitor variations in patient cohort mean or median values that is not explained by changes in treatment or selection of patients. METHODS: Results reported to an EQA scheme for HbA1c during 20 years have been extracted from Equalis database. The results are compared to current analytical performance specifications (APS) and to the mean HbA1c levels for the Swedish population of persons with type 2 diabetes. RESULTS: The accuracy of the HbA1c test has improved during the period. The hospital lab methods used in Sweden now fulfil APS agreed by professional organizations in Sweden. The accuracy for point-of-care tests (POCT) methods vary over time and fulfil APS for some periods. The bias found for some of the methods might explain changes seen in patient mean values for HbA1c in Sweden during the period 2007-2017. CONCLUSIONS: The global standardization of HbA1c has resulted in an improved comparability for HbA1c-results worldwide. But even small variation in trueness for the methods in use might have important impact on mean HbA1c values for cohorts of patients. When a systematic error is observed for a specific method it is therefore essential that manufacturers correct the method without delay.
BACKGROUND: The accuracy and trueness of results from a laboratory test, such as the HbA1c test, should not be taken for granted but must be checked continuously. A tool for this is the participation in external quality assessment (EQA) for all laboratories performing the HbA1c-test. An additional possibility to detect changes in trueness is to monitor variations in patient cohort mean or median values that is not explained by changes in treatment or selection of patients. METHODS: Results reported to an EQA scheme for HbA1c during 20 years have been extracted from Equalis database. The results are compared to current analytical performance specifications (APS) and to the mean HbA1c levels for the Swedish population of persons with type 2 diabetes. RESULTS: The accuracy of the HbA1c test has improved during the period. The hospital lab methods used in Sweden now fulfil APS agreed by professional organizations in Sweden. The accuracy for point-of-care tests (POCT) methods vary over time and fulfil APS for some periods. The bias found for some of the methods might explain changes seen in patient mean values for HbA1c in Sweden during the period 2007-2017. CONCLUSIONS: The global standardization of HbA1c has resulted in an improved comparability for HbA1c-results worldwide. But even small variation in trueness for the methods in use might have important impact on mean HbA1c values for cohorts of patients. When a systematic error is observed for a specific method it is therefore essential that manufacturers correct the method without delay.
Authors: Susan E Manley; Laura J Hikin; Rachel A Round; Peter W Manning; Stephen D Luzio; Gareth J Dunseath; Peter G Nightingale; Irene M Stratton; Robert Cramb; Kenneth A Sikaris; Stephen C L Gough; Jonathan Webber Journal: Diabetes Res Clin Pract Date: 2014-05-23 Impact factor: 5.602
Authors: Colette Mair; Wahyu Wulaningsih; Anita Jeyam; Stuart McGurnaghan; Luke Blackbourn; Brian Kennon; Graham Leese; Robert Lindsay; Rory J McCrimmon; John McKnight; John R Petrie; Naveed Sattar; Sarah H Wild; Nicholas Conway; Ian Craigie; Kenneth Robertson; Louise Bath; Paul M McKeigue; Helen M Colhoun Journal: Diabetologia Date: 2019-05-18 Impact factor: 10.122
Authors: Shengxin Liu; Ralf Kuja-Halkola; Henrik Larsson; Paul Lichtenstein; Jonas F Ludvigsson; Ann-Marie Svensson; Soffia Gudbjörnsdottir; Magnus Tideman; Eva Serlachius; Agnieszka Butwicka Journal: Diabetologia Date: 2021-01-16 Impact factor: 10.122
Authors: An Tran-Duy; Josh Knight; Andrew J Palmer; Dennis Petrie; Tom W C Lung; William H Herman; Björn Eliasson; Ann-Marie Svensson; Philip M Clarke Journal: Diabetes Care Date: 2020-06-12 Impact factor: 19.112