Evaluation of System Accuracy, Precision, Hematocrit Influence, and User Performance of Two Blood Glucose Monitoring Systems Based on ISO 15197:2013/EN ISO 15197:2015.
Blood glucose monitoring system
EN ISO 15197:2015
Hematocrit influence
ISO 15197:2013
Intermediate measurement repeatability
Measurement precision
System accuracy
User performance
Journal
Diabetes therapy : research, treatment and education of diabetes and related disorders
ISSN: 1869-6953
Titre abrégé: Diabetes Ther
Pays: United States
ID NLM: 101539025
Informations de publication
Date de publication:
15 Dec 2023
15 Dec 2023
Historique:
received:
18
10
2023
accepted:
29
11
2023
medline:
15
12
2023
pubmed:
15
12
2023
entrez:
15
12
2023
Statut:
aheadofprint
Résumé
Sufficiently high analytical quality of blood glucose monitoring systems (BGMS) is a prerequisite for efficient diabetes therapy. In this study we assessed system accuracy, measurement repeatability, intermediate measurement precision, user performance, and the influence of hematocrit on two CE-marked blood glucose monitoring systems. For one BGMS, measurement accuracy using venous samples was additionally investigated. Study procedures were based on the International Organization of Standardization (ISO) 15197:2013/EN ISO 15197:2015 ("ISO 15197"). User performance included data from 100 subjects who used one test strip lot, whereas for all other analyses three different reagent system lots were used. For system accuracy assessment, 100 capillary samples were measured in duplicate with each of three reagent system lots per system, resulting in 600 results per system. CareSens S Fit and CareSens H Beat both fulfilled the ISO 15197 accuracy criteria with 97.5-100% of each test strip lot's results falling within ± 15 mg/dL or ± 15% of the results of the comparison method and 100% of results in consensus error grid (CEG) zone A for all three lots. User performance evaluation revealed sufficient accuracy in the hands of lay users although some handling errors were documented by study staff. Assessment of measurement repeatability and intermediate measurement precision is given by standard deviation (SD) (glucose levels < 100 mg/dL) and by coefficient of variation (CV) (glucose concentrations ≥ 100 mg/dL). SD was ≤ 4.1 mg/dL and CV ≤ 4.2% for measurement repeatability and SD was ≤ 2.2 mg/dL and CV ≤ 2.6% for intermediate measurement precision. In case of hematocrit influence, both BGMS complied with all three tested lots with the defined criteria. Both BGMS analyzed in this study fulfilled the required accuracy criteria of ISO 15197. They showed high precision, good performance in the hands of lay users, and the influence of hematocrit was acceptable in the labeled range.
Identifiants
pubmed: 38100029
doi: 10.1007/s13300-023-01517-y
pii: 10.1007/s13300-023-01517-y
doi:
Types de publication
Journal Article
Langues
eng
Informations de copyright
© 2023. The Author(s).
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