HbA1c

Landgraf, R.; Kowall, Bernd; Rathmann, Wolfgang

doi:10.1007/s11428-011-0739-3

Cited by 5 publications

(2 citation statements)

References 48 publications

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“…A significantly higher degree of analytical accuracy and precision is necessary when it is used for the diagnosis of diabetes. The use of HbA1c as an instrument for the diagnosis of diabetes was introduced by the American Diabetes Association, and other associations, like the IDF and the WHO, and a HbA1c limit value of ≥ 48 mmol/mol for the diagnosis of diabetes [7][8][9][10][11]: ▪ Is the degree of biological variation of the HbA1c concentration too broad for a confident diagnosis, even when the actual measurement takes place under ideal conditions (i. e., only a small measurement error occurs, etc.)? ▪ Is the analytical reliability of the different available HbA1c measuring systems sufficient and adequately standardized for its use?…”

Section: Introductionmentioning

confidence: 99%

Higher HbA1c Measurement Quality Standards are Needed for Follow-Up and Diagnosis: Experience and Analyses from Germany

Heinemann¹,

Kaiser

Freckmann³

et al. 2018

Horm Metab Res

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Measurement of HbA1c is an essential laboratory measure for the follow-up and therapy decision-making in patients with diabetes. HbA1c is one of the measurands in laboratory medicine that have to be successfully checked according to the criteria of the guidelines of the German Medical Association (Rili-BAEK) in external quality assurance using the reference method value concept, when applied in patient care. The allowed deviation of ±18% in external quality assessment (EQA) and ± 10% in internal quality control has been ultimately met by virtually all the different manufacturers and methods. However, such broad limits for permissible deviations are not suitable in view of medical requirements in patient care. The low-level acceptance criteria also depends on the previously used EQA materials used in Germany. In fact, HbA1c measurement results that are imprecisely measured or come from incorrectly calibrated devices are difficult to identify. With implementation of unprocessed fresh EDTA blood, the situation has changed. Until now systems with unit use reagents for point-of-care testing (POCT) of HbA1c are not mandatory to participate in EQA schemes in Germany. This paper outlines why there was a need to narrow the acceptance limits listed within the Rili-BAEK for HbA1c's internal (to ± 3%) and external (to ± 8%) quality controls in EQA schemes for Germany, which will take place after a transition period in the next years. Higher quality in HbA1c measurements will help to avoid misdiagnosis of diabetes as well as potential over- or undertreatment of patients at risk for diabetes.

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Section: Introductionmentioning

confidence: 99%

Higher HbA1c Measurement Quality Standards are Needed for Follow-Up and Diagnosis: Experience and Analyses from Germany

Heinemann¹,

Kaiser

Freckmann³

et al. 2018

Horm Metab Res

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“…Der Test ist vom Zeitpunkt der letzten Nahrungsaufnahme unabhängig und wird kurzfristig durch Operation, Stress oder Medikamente kaum beeinflusst. In der Beurteilung muss allerdings bedacht werden, dass beispielsweise Niereninsuffizienz, Schwangerschaft, Hä-moglobinopathien, Blutverlust und Anä-mien den HbA 1c -Wert beeinflussen kön-nen [2].…”

Section: Testung Und Aussagekraftunclassified

Schröder¹,

Siegel²

2011

Diabetologe

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