• Sitemap
  • Contact us

pISSN 2950-9114 eISSN 2950-9122
Article View

Original Article

J Lab Med Qual Assur 2016; 38(4): 234-242

Published online December 31, 2016


Copyright © Korean Association of External Quality Assessment Service.

Performance Evaluation of B. Braun Omnitest 5 Blood Glucose Monitoring System for Self-Monitoring of Blood Glucose

Kyungso Jeon1 and Miseon Shin2

1Department of Laboratory Medicine and 2Division of Endocrinology and Metabolism, Hanil General Hospital, Seoul, Korea

Correspondence to:Kyungso Jeon
Department of Laboratory Medicine, Hanil General Hospital, 308 Uicheon-ro, Dobong-gu, Seoul 01450, Korea
Tel: +82-2-901-3720 Fax: +82-2-901-3606 E-mail: jks3393@hanmail.net

Received: April 12, 2016; Revised: August 22, 2016; Accepted: September 9, 2016

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Background: We evaluated the accuracy of the B. Braun Omnitest 5 blood glucose monitoring system (BGMS; Infopia Co. Ltd., Korea), which was recently developed for self-monitoring of blood glucose.
Methods: Precision was assessed according to Clinical and Laboratory Standards Institute guideline EP5-A3 with control materials containing low, normal, and high levels of glucose. Linearity was evaluated over the range of 52.5−548.0 mg/dL prepared from patient samples. For system accuracy, 100 capillary blood samples measured by the B. Braun Omnitest 5 BGMS were compared to plasma-equivalent blood glucose values of the fingertip blood samples measured by the YSI 2300 STAT PLUS glucose analyser (YSI Life Sciences, USA). Accuracy was evaluated according to the International Organization for Standardization (ISO) 15197: 2013 criteria.
Results: The range for the total coefficient of variation (%) was 1.5%−4.9% for three lots of strips. Both within-run precision and within-laboratory precision fulfilled the manufacturer’s claim. ISO 15197: 2013 states that more than 95% of blood glucose measurement values must be within ±15 mg/dL for ranges below 100 mg/dL and ±15% for ranges above 100 mg/ dL. Each of B. Braun Omnitest 5 lots satisfied ISO 15197: 2013, as 98.5% (197/200), 97.0% (194/200), and 99.5% (199/200) of values were within range. In consensus error grid analysis, respectively, 99.5%, 99.0%, and 100.0% of measurement values of each lot were within zone A, indicating that an average of over 99.0% of values were within zone A.
Conclusions: B. Braun Omnitest 5 provided reliable results and satisfied the ISO 15197: 2013 accuracy criteria. This test is an appropriate BGMS for the self-monitoring of blood glucose.

Keywords: Blood glucose monitoring system, Self-monitoring of blood glucose, Accuracy, Evaluation

  1. International Diabetes Federation. IDF diabetes atlas. 7th ed. Brussels: International Diabetes Federation, 2015.
  2. American Diabetes Association. Standards of medical care in diabetes 2015: glycemic targets. Diabetes Care 2015;38(Suppl 1):S33-S40.
  3. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993;329:977-86.
    Pubmed CrossRef
  4. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998;352:837-53.
  5. Virdi NS, Mahoney JJ. Importance of blood glucose meter and carbohydrate estimation accuracy. J Diabetes Sci Technol 2012;6:921-6.
  6. International Organization for Standardization. In vitro diagnostic test systems: requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus. Geneva: International Organization for Standardization, 2013.
  7. Clinical and Laboratory Standards Institute. Evaluation of precision of quantitative measurement procedures:approved guideline. 3rd ed. Wayne (PA): Clinical and Laboratory Standards Institute, 2014.
  8. Clinical and Laboratory Standards Institute. Evaluation of linearity of quantitative measurement procedures: a statistical approach: approved guideline. Wayne (PA):Clinical and Laboratory Standards Institute, 2003.
  9. Khan MI, Weinstock RS. Carbohydrates. In: Henry JB, editor. Clinical diagnosis and management by laboratory methods. 22nd ed. Philadelphia (PA): WB Saunders, 2011:210-25.
  10. Clinical and Laboratory Standards Institute. Method comparison and bias estimation using patient samples:approved guideline. 2nd ed. Wayne (PA): Clinical and Laboratory Standards Institute, 2010.
  11. 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.
    Pubmed CrossRef
  12. Thorpe GH. Assessing the quality of publications evaluating the accuracy of blood glucose monitoring systems. Diabetes Technol Ther 2013;15:253-9.
    Pubmed KoreaMed CrossRef
  13. Lee JH, Cha YJ. Performance evaluation of BAROZEN H, a networking blood glucose monitoring system for medical institutions. Lab Med Online 2015;5:69-76.
  14. Kim YB, Seo JY, Lee SY, Park HD. Performance evaluation of glucometer Barozen H based on ISO 15197 standards. Lab Med Online 2015;5:6-14.

Supplementary File

Share this article on :

Stats or metrics