External quality assessment schemes for glucose measurements in Germany: factors for successful participation, analytical performance and medical impact.

摘要: Background: Determination of blood glucose concentration is one the most important measurements in clinical chemistry worldwide. Analyzers central laboratories (CL) and point-of-care tests (POCT) are both frequently used. In Germany, regular participation external quality assessment (EQA) schemes mandatory for performing testing. Methods: Glucose testing data from two German EQAs "Reference Institute Bioanalytics" (RfB) "INSTAND - Gesellschaft zur Forderung der Qualitatssi-cherung medizinischen Laboratorien" (Instand) were analyzed 2012 to 2016. Multivariable odds ratios (OR) probability reach a "good" result calculated. Imprecision bias determined risk measurement errors estimated. Results: The device employed was variable required performance all EQAs. Additional an EQA CL automated analyzers improved POCT reciprocal effect less pronounced. New participants performed worse than experienced especially generally smaller CL, but some devices reached comparable performance. Large lot-to-lot differences occurred over 10% cases. We propose "bias budget" as new metric express maximum allowable that still carries acceptable medical risk. Bias budgets smallest risks greatest low range 60-115 mg/dL (3.3-6.4 mmol/L) devices. Conclusions: help maintain high analytical performances. They generate serve foundation learning improvement laboratory healthcare system.