Cook and Chill

Deakin, Sherine; Steele, D Feldman; Clarke, Sarah; Gribben, Cathryn; Bexley, Anne-Marie; Laan, Remmert; Kerr, David

doi:10.1177/1932296815598775

Cited by 9 publications

(3 citation statements)

References 11 publications

(12 reference statements)

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“…All measurements were performed in a controlled environment with a certain temperature and humidity as required in ISO 15197. These conditions do not reflect real-world usage and it is well known that environmental conditions can affect analytical performance [ 22 , 23 ]. Regarding user performance evaluation, it would be valuable to see whether training of the subjects would lead to a significant reduction of handling errors.…”

Section: Discussionmentioning

confidence: 99%

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

Pleus,

Jendrike,

Baumstark

et al. 2023

Diabetes Ther

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Introduction 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. Methods 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. Results 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. Conclusion 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. Supplementary Information The online version contains supplementary material available at 10.1007/s13300-023-01517-y.

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Section: Discussionmentioning

confidence: 99%

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

Pleus,

Jendrike,

Baumstark

et al. 2023

Diabetes Ther

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“…Differences in sensitivity and specificity may be attributed to different temperatures in our and other studies. It has been shown that when POC devices and strips are exposed to temperatures out of the range specified by the manufacturer, erroneous measurements might result (Nerhus et al, 2011;Deakin et al, 2015).…”

Section: Technical Notementioning

confidence: 99%

Technical note: Evaluation of the diagnostic accuracy of 2 point-of-care β-hydroxybutyrate devices in stored bovine plasma at room temperature and at 37°C

Yepes

Nydam

Heuwieser

et al. 2018

Journal of Dairy Science

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The use of point-of-care (POC) devices to measure blood metabolites, such as β-hydroxybutyrate (BHB), on farm have become an important diagnostic and screening tool in the modern dairy industry. The POC devices allow for immediate decision making and are often more economical than the use of laboratory-based methods; however, precision and accuracy may be lower when measurements are performed in an uncontrolled environment. Ideally, the advantages of the POC devices and the standardized laboratory environment could be combined when measuring samples that do not require an immediate result-for example, in research applications or when immediate intervention is not the goal. The objective of this study was to compare the capability of 2 POC devices (TaiDoc, Pharmadoc, Lübeck, Germany; Precision Xtra, Abbott Diabetes Care, Abingdon, UK) to measure BHB concentrations either at room temperature (RT; 20-22°C) or at 37°C compared with the gold standard test in stored plasma samples. Whole blood from multiparous Holstein dairy cows (n = 113) was sampled from the coccygeal vessels between 28 d before expected calving and 42 DIM. Whole-blood BHB concentrations were determined cow-side using the TaiDoc POC device. Plasma was separated within 1 h of collection and stored until analysis. A subset of stored plasma samples (n = 100) consisting of 1 sample per animal was chosen retrospectively based on the BHB concentrations in whole blood within the range of 0.2 to 4.0 mmol/L. The samples were analyzed for BHB plasma concentration using an automated chemistry analyzer (Hitachi 917, Hitachi, Tokyo, Japan), which was considered the gold standard. On the same day, the samples were also measured with the 2 POC devices, with samples either at RT or heated up to 37°C. Our study showed high Spearman correlation coefficients (>0.99) using either device and with samples at both temperatures compared with the gold standard. Passing-Bablok regression revealed a very strong correlation (>0.99), indicating good agreement between both POC devices and the gold standard method. For hyperketonemia detection, defined as BHB concentration ≥1.2 mmol/L, the sensitivity for both POC devices at RT and 37°C was equally high at 100%. Specificity was lowest (67.4%) for the TaiDoc used with plasma at RT and was highest (86.5%) when plasma was measured at 37°C with the Precision Xtra meter. Bland-Altman plots revealed a mean bias of 0.25 and 0.4 mmol/L for the Precision Xtra meter and TaiDoc, respectively, when tested on plasma at 37°C. Our data showed that both POC devices are suitable for measuring BHB concentration in stored bovine plasma, and accuracy was highest when samples were heated to 37°C compared with RT.

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“…10 Glucose test strips of 5 test systems were kept at −5°C or at 50°C within 30 minutes had little effect on the glucose measurements when compared to those kept at room temperature. 11 Therefore, the performance of BG testing by glucose meter should be investigated under stressed environmental conditions to prevent potential adverse effects influencing clinical decisions making.…”

mentioning

confidence: 99%

Effects of Simulated Adverse Environmental Conditions Related to Actual Conditions at Health Promoting Hospitals on the Performance of Blood Glucose Testing by Glucose Meters

Apiratmateekul

Duanginta

Phetree

et al. 2021

J Diabetes Sci Technol

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Background: Annual peaks in temperature and humidity exceed manufacturers’ specifications for blood glucose test strip storage in Thailand. Health Promoting Hospitals (HPH) do not always provide the same level of health services that hospitals do since they often only turn on air-conditioning units during working hours. Methods: The blood glucose testing performance of 4 glucose meters were investigated for short and long terms stress at 5 simulated conditions. Temperature and relative humidity (RH) at 5 HPHs in different regions of Thailand were monitored for 9 weeks during April to July 2019. The use of air conditioning in storage rooms for storing test strips was surveyed at 131 HPHs using questionnaires. Results: Median-paired differences of glucose measurements with stressed test strips in 5 simulated conditions significantly differed ( P < 0.05) both in the short term (3 days) and in the long term (30 days) with 4 glucose meters when compared to unstressed test strips. The average temperature of all HPHs exceeded 30°C (86°F). The average RH was 84%. There was only one HPH that occasionally turned on its air conditioners. Most HPHs kept both opened and unopened vials of test strips in rooms without air conditioners. Further, 21.4-32.0% of HPHs kept test strips at room with air conditioners. Conclusions: This study provides evidence for poor performance of blood glucose testing by glucose meters that are affected by adverse environmental conditions. The environmental for test strips storage at HPHs should be considered to prevent analytical errors of glucose measurement.

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Cook and Chill

Cited by 9 publications

References 11 publications

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

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

Technical note: Evaluation of the diagnostic accuracy of 2 point-of-care β-hydroxybutyrate devices in stored bovine plasma at room temperature and at 37°C

Effects of Simulated Adverse Environmental Conditions Related to Actual Conditions at Health Promoting Hospitals on the Performance of Blood Glucose Testing by Glucose Meters

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