System accuracy evaluation for blood glucose measurements should be performed in accordance with ISO 15197:2003 and CLSI-approved guideline EP7-A2

Diabetes Technology and Therapeutics

Volumn 14, Issue 4, 2012, Pages 379-380

  Hinzmann, Rolf ^a   Tran, Cam Tuan ^a  

^a ROCHE DIAGNOSTICS GMBH   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

GLUCOSE; MALTOSE;

ACCURACY; BLOOD GLUCOSE METER; BLOOD GLUCOSE MONITORING; GLUCOSE BLOOD LEVEL; HEMATOCRIT; HUMAN; INTERMETHOD COMPARISON; LETTER; PRACTICE GUIDELINE; PRIORITY JOURNAL; REFERENCE VALUE;

BLOOD GLUCOSE; DIAGNOSTIC EQUIPMENT; HUMANS; POINT-OF-CARE SYSTEMS;

EID: 84859316447     PISSN: 15209156     EISSN: 15578593     Source Type: Journal    
DOI: 10.1089/dia.2011.0240     Document Type: Letter

References (7)

1. Warner JV, Wu JY, Buckingham N, McLeod DS, Mottram B, Carter AC: Can one point-of-care glucose meter be used for all pediatric and adult hospital patients? Evaluation of three meters, including recently modified test strips. Diabetes Technol Ther 2011;13:55-62.
2. ReferenceMeasurementMethods/Procedures.www.bipm.org/jctlm/viewResults.do? type = isRMP&searchString = glucose& searchStringIUPAC= &searchStringMixed = &analyteCategory = Metabolites + and + substrates&matrixCategory = Whole + blood&sortBy = Analyte- Name&status = P&id = C3RMMP19 610&x = 39&y = 9 (accessed December 14, 2011).
3. ISO 15297:2003. In Vitro Diagnostic Test Systems Requirements for Blood-Glucose Monitoring Systems for Self-Testing in Managing Diabetes Mellitus. www.iso.org/iso/iso-catalogue/catalogue-tc/catalogue-detail.htm?csnumber = 26309 (accessed December 14, 2011).
4. Youdendiagramme KS4/11. www.dgkl-rfb.de/4daction/g-send-pdfGET/ Youdenplots-KS4/11.pdf?rvID =KS114&year=2011& type =plot&split =1&lang=d (accessed December 14, 2011).
5. Schleis T: Interference of maltose, icodextrin, galactose, or xylose with some blood glucose monitoring systems. Pharmacotherapy 2007;27:1313-1321. (Pubitemid 47339129)
6. Warner JV, Wu JY, Buckingham N, McLeod DSA, Carter AC: P91 Evaluation of Hemocue, Accu-Chek and Optium blood glucose meters for point-of-care use in paediatric and adult hospital patients [sub-article 114]. Clin Biochem Rev 2009;30:S7-S47.
7. Clinical and Laboratory Standards Institute: Interference Testing in Clinical Chemistry: Approved Guidelines, 2nd ed. CLSI document EP7-A2, Clinical and Laboratory Standards Institute, Wayne, PA, 2005.