Verification of accuracy of 3 glucose point-of-care testing (POCT) devices for their use in a hospital setting;Verifica dell'accuratezza di tre glucometri "point-of-care" per l'utilizzo in ambito ospedaliero

Biochimica Clinica

Volumn 41, Issue 1, 2017, Pages 79-84

  Aloisio, Elena ^a   Frusciante, Erika ^a   Dolci, Alberto ^b   Panteghini, Mauro ^a,b  

^a UNIVERSITY OF MILAN   (Italy)

^b ASST FATEBENEFRATELLI SACCO UNIVERSITY HOSPITAL   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

GLUCOSE; HEXOKINASE;

ARTICLE; ASSAY; AUTOMATION; BLOOD GLUCOSE METER; CALIBRATION; CLINICAL LABORATORY; CONTROLLED STUDY; CRITERION VARIABLE; ENZYME ASSAY; GLUCOSE BLOOD LEVEL; HEXOKINASE ASSAY; HOSPITAL; HUMAN; INTERMETHOD COMPARISON; MEASUREMENT ACCURACY; PERFORMANCE MEASUREMENT SYSTEM; PLASMA; POINT OF CARE TESTING; STANDARD; STANDARDIZATION; VENOUS BLOOD;

EID: 85018649565     PISSN: 03930564     EISSN: None     Source Type: Journal    
DOI: 10.19186/BC-2017.006     Document Type: Article

References (28)

1. Rajendran R, Rayman G. Point-of-care blood glucose testing for diabetes care in hospitalized patients: An evidence-based review. J Diabetes Sci Technol 2014;8:1081-90.
2. Hofmans M, Oyaert M, De Schrijver P, et al. Clinical laboratories have a critical role in test strip lot management in glucose point-of-care testing. Clin Chem Lab Med 2016;54:e155-9.
3. Raine CH, Pardo S, Parkes JL. Predicted blood glucose from insulin administration based on values from miscoded glucose meters. J Diabetes Sci Technol 2008;2:557-62.
4. Ehrmeyer SS, Laessig RH. Point-of-care testing, medical error, and patient safety: A 2007 assessment. Clin Chem Lab Med 2007;45:766-73.
5. Bedini JL, Wallace JF, Pardo S, et al. Performance evaluation of three blood glucose monitoring systems using ISO 15197: 2013 accuracy criteria, consensus and surveillance error grid analyses, and insulin dosing error modelling in a hospital setting. J Diabetes Sci Technol 2016;10:85-92.
6. CLSI. Point-of-care blood glucose testing in acute and chronic care facilities; Approved guideline - 3rd ed. CLSI document POCT12-A3. Wayne, PA: Clinical and Laboratory Standards Institute, 2013.
7. Simmons DA. How should blood glucose meter system analytical performance be assessed? J Diabetes Sci Technol 2016;10:178-84.
8. Parkes JL, Slatin SL, Pardo S, et al. A new consensus error grid to evaluate the clinical significance of inaccuracy in the measurement of blood glucose. Diabetes Care 2000;23:1143-8.
9. Pfutzner A, Klonoff DC, Pardo S, et al. Technical aspects of the Parkes error grid. J Diabetes Sci Technol 2013;7:1275-81.
10. Dungan K, Chapman J, Braithwaite SS, et al. Glucose measurement: confounding issues in setting target for inpatient management. Diabetes Care 2007;30:403-9.
11. D'Orazio P, Burnett RW, Fogh-Andersen N, et al. The International Federation of Clinical Chemistry Scientific Division working group on selective electrodes and point of care testing. Approved IFCC recommendation on reporting results for blood glucose (abbreviated). Clin Chem 2005;51:1573-6.
12. Pasqualetti S, Szoke D, Birindelli S, et al. Optimal collection tubes for plasma glucose determination: confusion reigns supreme. Clin Chem Lab Med 2016;54:e281-3.
13. Birindelli S, Carnevale A, Aloisio E, et al. Valutazione dell'imprecisione dell'esame emocromocitometrico eseguito con analizzatore Sysmex XN-9000. Biochim Clin 2016;40:282-4.
14. Neese JW, Duncan P, Bayse D, et al. Development and evaluation of a hexokinase/glucose-6-phosphate dehydrogenase procedure for use as a National Glucose Reference Method. U.S. Public Health Service, Center for Disease Control, Bureau of Laboratories, Clinical Chemistry Division, 1976.
15. Infusino I, Braga F, Paleari R, et al. Il "Joint Committee for Traceability in Laboratory Medicine" (JCTLM): una cooperazione internazionale per promuovere la standardizzazione dei risultati in Medicina di Laboratorio. Biochim Clin 2011;35:377-81.
16. Desirable specifications for total error, imprecision, and bias, derived from intra-And inter-individual biologic variation. Disponibile su www.westgard.com/biodatabase1.htm.
17. Synek V. Evaluation of the standard deviation from duplicate results. Accred Qual Assur 2008;13:335-7.
18. Rebel A, Rice MA, Fahy BG. The accuracy of point-of-care glucose measurements. J Diabetes Sci Technol 2012;6:396-411.
19. Hasslacher C, Kulozik F, Platten I. Analytical performance of glucose monitoring systems at different blood glucose ranges and analysis of outliers in a clinical setting. J Diabetes Sci Technol 2014;8:466-72.
20. Ceriotti F, Kaczmarek E, Guerra E, et al. Comparative performance assessment of point-of-care testing devices for measuring glucose and ketones at the patient bedside. J Diabetes Sci Technol 2015;9:268-77.
21. Carraro P, Plebani M. Post-Analytical errors with portable glucose meters in the hospital setting. Clin Chim Acta 2009;404:65-7.
22. ISO 15197:2003(E): In vitro diagnostic test systems - Requirements for blood glucose monitoring systems for self-Testing in managing diabetes mellitus. Geneva, Switzerland: International Organization for Standardization, 2003.
23. Clarke WL, Cox D, Gonder-Frederick LA, et al. Evaluating clinical accuracy of systems for self-monitoring of blood glucose. Diabetes Care 1987;10:622-8.
24. ISO 15197:2013(E): 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.
25. Krouwer JS. The new glucose standard POCT12-A3 misses the mark. J Diabetes Sci Technol 2013;7:1400-2.
26. Krouwer JS. Why specifications for allowable glucose meter errors should include 100% of the data. Clin Chem Lab Med 2013;51:1543-4.
27. Blood glucose monitoring test systems for prescription point-of-care use, Draft guidance for industry and Food and Drug Administration staff. www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm380325.pdf.
28. Krouwer JS, Cembrowski GS. A review of standards and statistics used to describe blood glucose monitor performance. J Diabetes Sci Technol 2010;4:75-83.