SKML-Quality Mark for point-of-care test (POCT) glucose meters and glucose meters for home-use

Clinical Chemistry and Laboratory Medicine

Volumn 48, Issue 7, 2010, Pages 1021-1027

  Jansen, Rob T P ^a   Slingerland, Robbert J ^b  

^a SKML   (Netherlands)

^b ISALA HOSPITAL   (Netherlands)

Author keywords

bias; biological variation; point of care test (POCT); quality; total error

Indexed keywords

ARTICLE; BLOOD GLUCOSE METER; ERROR; EXTERNAL BIAS; HEMATOCRIT; POINT OF CARE TESTING; PRIORITY JOURNAL; QUALITY CONTROL; REFERENCE VALUE; SELF EVALUATION;

BLOOD GLUCOSE; BLOOD GLUCOSE SELF-MONITORING; HUMANS; POINT-OF-CARE SYSTEMS; QUALITY CONTROL; UNCERTAINTY;

EID: 77954236871     PISSN: 14346621     EISSN: 14374331     Source Type: Journal    
DOI: 10.1515/CCLM.2010.226     Document Type: Article

References (19)

1. Lex EU. Directive 98/79 EC on in vitro medical devices. Off J L 1998;331:1-37.
2. Staatstoezicht op de Volksgezondheid, Inspectie voor de Gezondheidszorg. Point-of-care bloedglucosemeters. Circulairenummer 2008-2102-IGZ. Apr 3, 2008.
3. ISO FDIS 22870. Point-of-care testing (POCT) - requirements for quality and competence. 2005.
4. Gezondheidsraad. Annual report on screening for disease 2007. Den Haag 2007/26E ISBN 978-90-5549-705-708
5. ISO 15197. In vitro diagnostic test systems - requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. 2003.
6. Post H, van Keulen GJ, Muller WJ, Miedema K. TNO Quality Guideline PG/TG/2001.045. Portable in-vitro blood monitor systems for (self)-monitoring - blood glucose monitors - particular requirements and test methods. Nov 2001.
7. Skeie S, Thue G, Nerhus K, Sandberg S. Instruments for selfmonitoring of blood glucose: comparisons of testing quality achieved by patients and a technician. Clin Chem 2002;48: 994-1003.
8. du Plessis M, Ubbink JB, Hayward Vermaak WJ. Analytical quality of near-patient blood cholesterol and glucose determinations. Clin Chem 2000;46:1085-1090
9. Boyd JC, Bruns D. Quality specifications for glucose meters: assessment by simulation modelling of errors in insulin dose. Clin Chem 2001;47:209-214
10. Tang Z, Du X, Louie RF, Kost GJ. Effects of drugs on glucose measurements with handheld glucose meters and a portable glucose analyzer. Am J Clin Pathol 2000;113:75-86. (Pubitemid 30217342)
11. Fraser CG, Petersen PH. Desirable standards for laboratory tests if they are to fulfill medical needs. Clin Chem 1993;39:1447- 53 wdiscussionx, 1453-1455 wreviewx.
12. Stöckl D, Baadenhuijsen H, Fraser CG, Libeer JC, Petersen PH, Ricos C. Desirable routine analytical goals for quantities assayed in serum. Eur J Clin Chem Clin Biochem 1995;33: 157-169
13. Ricós C, Alvares V, Cava F, García-Lario JV, Hernández A, Jiménez CV, et al. Current databases on biological variation: pros, cons and progress. Scand J Clin Lab Invest 1999;59:491-500.
14. Biological variation database specifications. http://www. westgard.com.
15. Baadenhuijsen H, Kuypers A, Weykamp C, Cobbaert C, Jansen R. External quality assessment in The Netherlands: time to introduce commutable survey specimens. Lessons from the Dutch "Calibration 2000" project. Clin Chem Lab Med 2005; 43:304-307
16. Baadenhuijsen H, Steigstra H, Cobbaert C, Kuypers A, Weykamp C, Jansen R. Commutability assessment of potential reference materials using a multicenter split-patient-sample between-field-methods (twin-study) design: study within the framework of the Dutch project "Calibration 2000". Clin Chem 2002;48:1520-1525 (Pubitemid 34925787)
17. Briedigkeit L, Müller-Plathe O, Schlebusch H, Ziems J. Recommendations of the German working group medical laboratory testing on the introduction and quality assurance of procedures for point-of-care testing (POCT) in hospitals. Clin Chem Lab Med 1999;37;919-925
18. Slingerland RJ, Muller W, Dollahmoersid R, Witteveen C, Meeues JTh, van Blerk I. Vier op de vijf bloedglucosemeters. DiabeteSpecialist 2006;20:28-30.
19. Vossen RC, Frings-Mioch IK, Boonen BA, Slobbe-van Drunen ME, van Acker BA, ten Kate J. Pre-analytisch handelen onontbeerlijk cruciaal bij glucosetesten wabstractx. NTKCL 2008; 33:75.