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System accuracy assessments with a blood glucose meter with combined glucose and ß-hydroxybutyrate measurement capabilities

  • Background: We evaluated the Wellion Galileo GLU/KET blood and ketone (ß-Hydroxybutyrate, ß-OHB) meter to demonstrate that it meets ISO15107:2015 regulatory approval criteria. Research Design and Methods: A total of 100 subjects (52 female, age: 30 to 84 years, diabetes: 10 type 1/90 type 2) with blood glucose levels distributed over the entire measurement range as required by the ISO15197 protocol were tested (double determinations with 3 strip lots and two devices). A similar test protocol was followed to test ß-OHB strip performance (reference devices: YSI 2300plus for glucose and STANBIO ß-HOB LiquiColor TestKit for ß-OHB). Precision was tested for glucose with 3 blood glucose concentrations (ß-OHB: 2 control solutions). Results: All glucose test-strip lots met the strict ISO acceptance criteria. Mean absolute relative difference (MARD) was 4.9% and all data pairs were in zone A of the consensus error grid. The ß-OHB test-strips also met the pre-defined acceptance criteria. Within-run and between-run precision was calculated to be 2.3% and 0.7% for the glucose strips (3.7%/0.8% for the ketone strips). Conclusions: When tested according to the ISO15197:2015 guideline, the device showed very accurate measurement performance for glucose and ß-OHB testing and fully met regulatory accuracy approval criteria.

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Metadaten
Document Type:Article
Language:English
Author:Sylvia Weissenbacher, Chen-Yu Yang, Tang-Chin Kuan, Filiz Demircik, Mina Hanna, Andreas Pfützner
Parent Title (English):Expert Review of Molecular Diagnostics
First Page:1
Last Page:6
ISSN:1473-7159
DOI:https://doi.org/10.1080/14737159.2019.1662300
Pubmed Id:http://www.ncbi.nlm.nih.gov/pubmed?term=31482753
Publisher:Taylor & Francis
Date of first publication:2019/09/04
Tag:Accuracy; Blood glucose meter; precision; ß-OHB; ß-hydroxybutyrate
Departments, institutes and facilities:Fachbereich Angewandte Naturwissenschaften
Dewey Decimal Classification (DDC):6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Entry in this database:2019/09/18