Analytical performance of publicly dispensed glucometers in primary health care in a southern Brazilian city

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY Practical Laboratory Medicine Pub Date : 2024-08-01 DOI:10.1016/j.plabm.2024.e00421

Isabelle L. Silva, Flávia Martinello

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Abstract

Aims

This study aimed to assess the use of glucometers by patients and the analytical performance of glucometers provided by the primary care services.

Methods

The analytical performance of 48 glucometers Accu-Chek® Active, was assessed through quintuplicate analyses of one Roche and one PNCQ (National Quality Control Program) control sample at different concentrations; 31 were also evaluated by a single proficiency testing sample. The evaluation metrics included imprecision, bias, and total error and were measured according to quality specifications based on biological variation (QSBV). Glucometer users answered a questionnaire regarding their experience.

Results

Among the 48 glucometers evaluated with internal control samples, 17 met precision criteria at both control levels according to QSBV, while 24 met the criteria at only one control level. Of the 31 glucometers further evaluated through proficiency test, 11 met accuracy criteria according to QSBV, and only one device showed an unacceptable result. Out of these 31, only 15 demonstrated a total error within the acceptable maximum limits based on QSBV.

Conclusions

Overall, our findings showed that patients had a good understanding of glucometer usage and suggested that some glucometers should be replaced, as they sometimes failed to meet even the manufacturer’s acceptable variation limits, and/or did not meet QSBV.

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巴西南部城市初级卫生保健中公共配发血糖仪的分析性能

本研究旨在评估患者使用血糖仪的情况以及基层医疗服务机构提供的血糖仪的分析性能。方法通过对不同浓度的一个罗氏和一个 PNCQ（国家质量控制计划）对照样本进行五次重复分析，评估了 48 台 Accu-Chek® Active 血糖仪的分析性能；还通过一个能力测试样本评估了 31 台血糖仪的分析性能。评估指标包括不精确度、偏差和总误差，并根据基于生物变异（QSBV）的质量规范进行测量。结果在使用内部对照样本进行评估的 48 台血糖仪中，17 台在两个对照水平上都符合 QSBV 的精度标准，24 台仅在一个对照水平上符合标准。通过能力验证进一步评估的 31 台血糖仪中，有 11 台符合 QSBV 的准确度标准，只有一台的结果不可接受。结论总体而言，我们的研究结果表明，患者对血糖仪的使用方法非常了解，但也建议更换一些血糖仪，因为这些血糖仪有时甚至达不到生产商规定的可接受误差范围，和/或不符合 QSBV 标准。

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来源期刊

Practical Laboratory Medicine Health Professions-Radiological and Ultrasound Technology

CiteScore

3.50

自引率

0.00%

发文量

审稿时长

7 weeks

期刊介绍： Practical Laboratory Medicine is a high-quality, peer-reviewed, international open-access journal publishing original research, new methods and critical evaluations, case reports and short papers in the fields of clinical chemistry and laboratory medicine. The objective of the journal is to provide practical information of immediate relevance to workers in clinical laboratories. The primary scope of the journal covers clinical chemistry, hematology, molecular biology and genetics relevant to laboratory medicine, microbiology, immunology, therapeutic drug monitoring and toxicology, laboratory management and informatics. We welcome papers which describe critical evaluations of biomarkers and their role in the diagnosis and treatment of clinically significant disease, validation of commercial and in-house IVD methods, method comparisons, interference reports, the development of new reagents and reference materials, reference range studies and regulatory compliance reports. Manuscripts describing the development of new methods applicable to laboratory medicine (including point-of-care testing) are particularly encouraged, even if preliminary or small scale.