Evaluation of Hematocrit Influence on Self-Monitoring of Blood Glucose Based on ISO 15197:2013: Comparison of a Novel System With Five Systems With Different Hematocrit Ranges
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Introduction: ISO 15197:2013 recommends testing procedures and acceptance criteria for the evaluation of influence quantities such as hematocrit on measurement results with systems for self-monitoring of blood glucose (SMBG). In this study, hematocrit influence was evaluated for a novel SMBG system (system A) and five other systems with different hematocrit ranges based on ISO 15197:2013. Methods: Test procedures were performed with one test strip lot for each system. Each system was tested within the hematocrit range indicated in the manufacturer’s labeling (system A: 10-65%, B: 15-65%, C: 20-60%, D: 35-60%, E: 30-60%, F: 30-55%). According to ISO 15197:2013, clause 6.4.2, venous blood samples were used for the evaluation of hematocrit influence. The evaluation was performed for three glucose concentration categories (30-50 mg/dL, 96-144 mg/dL, and 280-420 mg/dL). For each glucose concentration category, at least five different hematocrit levels were investigated. Results: The novel system A and systems B, E, and F complied with the tested lot with the defined criteria and showed ≤10 mg/dL and ≤10% difference between the test sample and the respective control sample with a hematocrit value of 42% ± 2% for BG concentrations <100 mg/dL and ≥100 mg/dL, respectively. Two systems showed >10% difference at glucose concentrations ≥100 mg/dL. Conclusions: Remarkable hematocrit influence within the labeled hematocrit range was obtained in two systems with the tested reagent system lot. Adequate SMBG systems should be carefully chosen by patients and their health care professionals, particularly for patients with increased and decreased hematocrit values.
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Some SMBG systems may even miss their hematocrit claims.
“Many SMBG systems permit only a rather narrow specified HCT range of 30–55% [24], while HCT values are also quite prevalent outside of this range [30]; some SMBG systems may even miss their hematocrit claims [29].”
From Self-Monitoring of Blood Glucose as an Integral Part in the Management of People with Type 2 Diabetes Mellitus (2022) · cites this paper as [29]
Low hematocrit due to iron deficiency or chronic diseases, as well as high hematocrit, can markedly affect the measurement accuracy of SMBG systems.
“Low HCT due, for example, to iron deficiency or chronic diseases, as well as high HCT can markedly affect the measurement accuracy of SMBG systems [29, 30].”
From Self-Monitoring of Blood Glucose as an Integral Part in the Management of People with Type 2 Diabetes Mellitus (2022) · cites this paper as [29]
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- Authors
- Hattemer, A., & Wardat, S.
- Affiliations
- Roche Diabetes Care GmbH (Germany) (DE)
- Corresponding author
- Hattemer, Andrew
- Venue
- Journal of Diabetes Science and Technology
- Publisher
- SAGE Publications
- Published
- 2018-01-29
- Volume
- 12
- Issue
- 2
- Pages
- 333-340
- ISSN
- 1932-2968 (ISSN-L)
- PMC
- PMC5851235
- OpenAlex
- W2786868463
- Cited by
- 8
- References
- 20
- Citations by year
- 2023: 1 · 2022: 1 · 2021: 3 · 2020: 1 · 2019: 1 · 2018: 1
- FWCI
- 1.19
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of Diabetes Science and Technology (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Roche Diabetes Care
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hyperglycemia and glycemic control in critically ill and hospitalized patients
- Keywords
- self-monitoring of blood glucose, hematocrit, ISO 15197:2013, influence quantities, venous blood
- MeSH terms
- Blood Glucose, Diabetes Mellitus, Hematocrit, Humans, Blood Glucose Self-Monitoring
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