Evaluation and quality assessment of glucose concentration measurement in blood by point-of-care testing devices. 2006

Michael Wehmeier, and Burkhard T Arndt, and Gerhard Schumann, and Wolf R Külpmann
Medical School Hannover, Department of Clinical Chemistry, Hannover, Germany. wehmeier.michael@mh-hannover.de

BACKGROUND In this study the analytical performance of eight glucose point-of-care testing (POCT) devices was evaluated. For this purpose, POCT measurement of glucose in heparinized blood collected from patients was paralleled by determination of the glucose concentration in the respective plasma by an analyzer (Hitachi 917) in the central laboratory, providing traceable results. METHODS Trueness of POCT measurements was studied by comparing the plasma POCT values (mean of five measurements) with the results from the traceable measurement procedure (TMP). RESULTS The percentage of POCT results within +/-6% of the TMP mean value ranged from 24% to 50%, depending on the POCT device. Within the reference interval of plasma glucose (4.4-6.0 mmol/L), up to 67% of the POCT values were lower than 4.4 mmol/L, leading to a false diagnosis of hypoglycemia. In the hypoglycemic range (<4.4 mmol/L) up to 29% of the POCT analyses were false normoglycemic. CONCLUSIONS In conclusion, this study shows an insufficient trueness of glucose measurements by POCT devices in the normo- and hypoglycemic range. To improve quality assessment, sample splitting and simultaneous measurement of blood glucose concentration every 4 weeks by POCT devices and of plasma glucose concentration by a reliable TMP is recommended.

UI MeSH Term Description Entries
D001786 Blood Glucose Glucose in blood. Blood Sugar,Glucose, Blood,Sugar, Blood
D003951 Diagnostic Errors Incorrect or incomplete diagnoses following clinical or technical diagnostic procedures. Diagnostic Blind Spots,Errors, Diagnostic,Misdiagnosis,Blind Spot, Diagnostic,Blind Spots, Diagnostic,Diagnostic Blind Spot,Diagnostic Error,Error, Diagnostic,Misdiagnoses
D006403 Hematologic Tests Tests used in the analysis of the hemic system. Blood Tests,Hematologic Test,Hematological Tests,Test, Hematologic,Tests, Hematologic,Blood Test,Hematological Test,Test, Blood,Test, Hematological,Tests, Blood,Tests, Hematological
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D006943 Hyperglycemia Abnormally high BLOOD GLUCOSE level. Postprandial Hyperglycemia,Hyperglycemia, Postprandial,Hyperglycemias,Hyperglycemias, Postprandial,Postprandial Hyperglycemias
D019095 Point-of-Care Systems Laboratory and other services provided to patients at the bedside. These include diagnostic and laboratory testing using automated information entry. Bedside Computing,Point of Care Technology,Bedside Technology,Point-of-Care,Bedside Technologies,Computing, Bedside,Point of Care,Point of Care Systems,Point-of-Care System,Systems, Point-of-Care,Technologies, Bedside,Technology, Bedside

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