ArticleJournal of diabetes science and technology2012
Lot-to-lot variability of test strips and accuracy assessment of systems for self-monitoring of blood glucose according to ISO 15197.
Article in Journal of diabetes science and technology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers.
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Who cites it
39 citing papers in PubMed.
- Evaluation of the accuracy, precision, and agreement of a glucometer compared to the standard laboratory test in diabetic and non-diabetic patients.Scientific reports · 2025Article
- Quality assessment of glucose measurement with regard to epidemiology and clinical management of diabetes mellitus in Germany.Frontiers in molecular biosciences · 2024Article
- Do We Need the Replacement of YSI 2300? A View from the Clinical Laboratory.Journal of diabetes science and technology · 2022Article
- What We Should Consider in Point of Care Blood Glucose Test; Current Quality Management Status of a Single Institution.Medicina (Kaunas, Lithuania) · 2021Article
- Performance of three different continuous glucose monitoring systems in children with type 1 diabetes during a diabetes summer camp.Pediatric diabetes · 2021Article
- Development and clinical trial of a smartphone-based colorimetric detection system for self-monitoring of blood glucose.Biomedical optics express · 2020Article
- System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015.BMJ open diabetes research & care · 2020Article
- System Accuracy Assessment of a Blood Glucose Meter With Wireless Internet Access Associated With Unusual Hypoglycemia Patterns in Clinical Trials.Journal of diabetes science and technology · 2019Article
- Laboratory Evaluation of Linearity, Repeatability, and Hematocrit Interference With an Internet-Enabled Blood Glucose Meter.Journal of diabetes science and technology · 2019Article
- Efficacy and Safety of Degludec Compared to Glargine 300 Units/mL in Insulin-Experienced Patients With Type 2 Diabetes: Trial Protocol Amendment (NCT03078478).Journal of diabetes science and technology · 2019Article
- Assessment of System Accuracy, Intermediate Measurement Precision, and Measurement Repeatability of a Blood Glucose Monitoring System Based on ISO 15197.Journal of diabetes science and technology · 2019Article
- Evaluation of Analytical Performance of Three Blood Glucose Monitoring Systems: System Accuracy, Measurement Repeatability, and Intermediate Measurement Precision.Journal of diabetes science and technology · 2019Article
- Seven-Year Clinical Surveillance Program Demonstrates Consistent MARD Accuracy Performance of a Blood Glucose Test Strip.Journal of diabetes science and technology · 2018Article
- User Performance Evaluation of Four Blood Glucose Monitoring Systems Applying ISO 15197:2013 Accuracy Criteria and Calculation of Insulin Dosing Errors.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2018Article
- The Financial Impact of Inaccurate Blood Glucose Monitoring Systems.Journal of diabetes science and technology · 2018Article
- Strengths and Limitations of New Approaches for Graphical Presentation of Blood Glucose Monitoring System Accuracy Data.Journal of diabetes science and technology · 2017Article
- Accuracy Evaluation of 19 Blood Glucose Monitoring Systems Manufactured in the Asia-Pacific Region: A Multicenter Study.Journal of diabetes science and technology · 2017Article
- If SMBG Accuracy Is Critical to Patient Safety, Why Are Inaccurate Meters Still on the Market?Journal of diabetes science and technology · 2017Article
- Comparative Accuracy of 17 Point-of-Care Glucose Meters.Journal of diabetes science and technology · 2017Article
- Interferences and Limitations in Blood Glucose Self-Testing: An Overview of the Current Knowledge.Journal of diabetes science and technology · 2016Review
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6 authors.
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No grant is acknowledged in the PubMed record.
Abstract
backgroundAccurate and reliable blood glucose (BG) measurements require that different test strip lots of the same BG monitoring system provide comparable measurement results. Only a small number of studies addressing this question have been published.
methodsIn this study, four test strip lots for each of five different BG systems [Accu-Chek® Aviva (system A), FreeStyle Lite® (system B), GlucoCheck XL (system C), Pura™/mylife™ Pura (system D), and OneTouch® Verio™ Pro (system E)] were evaluated with procedures according to DIN EN ISO 15197:2003. The BG system measurement results were compared with the manufacturer's measurement procedure (glucose oxidase or hexokinase method). Relative bias according to Bland and Altman and system accuracy according to ISO 15197 were analyzed. A BG system consists of the BG meter itself and the test strips.
resultsThe maximum lot-to-lot difference between any two of the four evaluated test strip lots per BG system was 1.0% for system E, 2.1% for system A, 3.1% for system C, 6.9% for system B, and 13.0% for system D. Only two systems (systems A and B) fulfill the criteria of DIN EN ISO 15197:2003 with each test strip lot.
conclusionsConsiderable lot-to-lot variability between test strip lots of the same BG system was found. These variations add to other sources of inaccuracy with the specific BG system. Manufacturers should regularly and effectively check the accuracy of their BG meters and test strips even between different test strip lots to minimize risk of false treatment decisions.
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