Why specifications for allowable glucose meter errors should include 100% of the data

Clinical Chemistry and Laboratory Medicine

Volumn 51, Issue 8, 2013, Pages 1543-1544

  Krouwer, Jan S ^a  

^a Krouwer Consulting   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GLUCOSE;

BLOOD GLUCOSE METER; CLINICAL CHEMISTRY; EDITORIAL; HUMAN; INTERMETHOD COMPARISON; MARKET; MEASUREMENT ACCURACY; MEASUREMENT ERROR; PRACTICE GUIDELINE; PRIORITY JOURNAL; UNITED STATES;

BLOOD GLUCOSE; BLOOD GLUCOSE SELF-MONITORING; EQUIPMENT FAILURE; HUMANS;

EID: 84883029556     PISSN: 14346621     EISSN: 14374331     Source Type: Journal    
DOI: 10.1515/cclm-2013-0387     Document Type: Editorial

References (6)

1. ISO 15197:2013 In vitro diagnostic test systems-Requirements for blood-glucose monitoring systems for self-Testing in managing diabetes mellitus. Geneva, Switzerland: International Organization for Standardization, 2013
2. CLSI POCT12-A3 point-of-care blood glucose testing in acute and chronic care facilities; approved guideline, 3rd ed. Wayne, PA: CLSI, 2013
3. Krouwer JS. Recommendation to treat continuous variable errors like attribute errors. Clin Chem Lab Med 2006;44:797-8
4. Parkes JL, Slatin SL, Pardo S, Ginsberg BH. A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. Diabetes Care 2000;23:1143-8 (Pubitemid 30616803)
5. Assumes that patients who take insulin test 3 times per day-FDA public meeting clinical accuracy requirements for point of care blood glucose meters March 16, 2010. Available from: Http://www.fda.gov/downloads/MedicalDevices/ NewsEvents/ WorkshopsConferences/UCM208598.pdf. Accessed on 23 May, 2013
6. Hahn GJ, Meeker WQ. Statistical intervals. A guide for practitioners. New York: Wiley, 1991:104