Einfluss der Messunsicherheit auf die Diagnose Diabetes mellitus verlässliche Minimal Difference von Plasma Glukose Messungen

Dissertation, Universitätsmedizin der Universität Greifswald, 2021

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1. Verfasser: Keutmann, Sandra (VerfasserIn)
Körperschaft: Universität Greifswald (Grad-verleihende Institution)
Weitere Verfasser: Petersmann, Astrid (AkademischeR BetreuerIn), Schleicher, Erwin (AkademischeR BetreuerIn)
Format: UnknownFormat
Sprache:ger
Veröffentlicht: Greifswald 2020
Schlagworte:
Hochschulschrift > Diabetes mellitus > Glucose > Blutzucker > Messunsicherheit > Standardabweichung > Variationskoeffizient > Qualitätskontrolle
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Zusammenfassung:Dissertation, Universitätsmedizin der Universität Greifswald, 2021
Diabetes mellitus, Messunsicherheit, Standardabweichung, Variationskoeffizient, Rili-BAEK, Assay performance, Coefficient of variation, Imprecision, Internal quality control, Minimal difference, Westgard rules
Introduction: The diagnosis of diabetes mellitus is based on suitable cut-off values of specific biomarkers, such as the concentration of glucose in plasma. The German Diabetes Association has very recently published a clinical practice guideline on the definition, classification and diagnosis of diabetes mellitus that recommends measurements of plasma glucose concentration have an imprecision defined as a minimal difference (MD) of at a fasting plasma glucose concentration of 7.0 mmol/L. To obtain reliable values for the MD, we investigated long-term and short-term measurement uncertainty. Methods: The imprecision was determined by two approaches: (1) a long-term dataset with imprecision based on the Guideline of the German Medical Association on Quality Assurance in Medical Laboratory Examinations (Rili-BAEK), in a medical laboratory operating 24/7, using internal quality control (IQC) data for four concentrations during a 10-year period; and (2) a detailed short-term dataset with imprecision assessed by hourly measurements of control materials. These datasets were used to calculate the MD cut-off (MDcut-off) as: MDcut-off= k x SD = 2 , where SD is the standard deviation and k = 2 represents a confidence level of 95%. Results: The MDcut-off of ≤ 0.7 mmol/L at a fasting plasma glucose concentration of 7.0 mmol/L (MDcut-off 7.0) for the long-term and the short-term approaches were 0.44 and 0.40 mmol/L, respectively. The MDcut-off 7.0 from both approaches was therefore below ...
Beschreibung:Literaturverzeichnis: Blatt 29-30
Beschreibung:46 Blätter
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