[Point-of-Care Blood Glucose Testing: Post-Market Performance Assessment of the Accu-Chek Inform II Hospital-Use Glucose Meter].

IF 0.3 4区 医学 Q3 MEDICINE, GENERAL & INTERNAL
E E Petryaykina, N A Mayanskiy, E S Demina, I V Karamysheva, K A Gorst, A V Timofeev
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引用次数: 0

Abstract

Background: A point-of-care glucose testing (POCT) is an essential component of care in patients with hyperglycemia and hypoglycemia in inpatient and outpatient settings. In Russian medical facilities (MFs), conventional glucose meters designed for self-monitoring by patients with diabetes are commonly used for POCT. These home-use meters have two serious disadvantages: the first is large measurement bias and the second - they can't be integrated into laboratory information systems, so measurement data have to be recorded into patient charts manually. Both factors may lead to medical errors. It is reasonable to use in the MFs specialized POCT glucose meters, as they are superior to conventional ones in accuracy and may be easily connected to laboratory information systems. With this in mind, physicians at the Russian Children's Clinical Hospital decided to substitute conventional meters with the Accu-Chek Inform II POCT meter, however, after preliminary performance assessment of the model.

Aim: To test the Accu-Chek Inform II performance characteristics: accuracy, linearity, repeatability, and mean absolute relative difference (MARD).

Materials and methods: Performance of the Accu-Chek Inform II was tested by comparing the results of parallel CGL measurements with the meter and reference laboratory analyzer in capillary blood samples. Overall, 99 parallel CGL measurements were made in 45 samples. Accuracy was evaluated according to the ISO 15197-2013 and POCT12-A3 criteria.

Results: The Accu-Chek Inform II meter met the requirements of ISO 15197-2013 and POCT12-A3 and demonstrated high linearity (correlation coefficient, r=1,0), good repeatability (mean coefficient of variation, CV=1,38%) and acceptable MARD (4,9%).

Conclusion: The Accu-Chek Inform II POCT glucose meter may be efficiently and safely used in inpatient and outpatient MFs and particularly in pediatric clinics.

[护理点血糖检测:Accu-Chek Inform II 医院用血糖仪上市后性能评估"。]
背景:护理点葡萄糖检测(POCT)是住院和门诊高血糖和低血糖患者护理的重要组成部分。在俄罗斯的医疗机构(MFs)中,POCT 通常使用为糖尿病患者自我监测而设计的传统血糖仪。这些家用血糖仪有两个严重的缺点:一是测量偏差大,二是无法集成到实验室信息系统中,因此测量数据必须手动记录到病历中。这两个因素都可能导致医疗失误。在医疗设施中使用专用的 POCT 血糖仪是合理的,因为它们在准确性方面优于传统的血糖仪,而且可以很容易地与实验室信息系统连接。有鉴于此,俄罗斯儿童临床医院的医生们决定用 Accu-Chek Inform II POCT 血糖仪取代传统的血糖仪,但要先对该型号进行初步性能评估:对 Accu-Chek Inform II 的性能进行了测试,比较了毛细管血样中 CGL 测量结果与血糖仪和参考实验室分析仪的平行测定结果。总共对 45 份样本进行了 99 次平行 CGL 测量。准确度根据 ISO 15197-2013 和 POCT12-A3 标准进行评估:结果:Accu-Chek Inform II 血糖仪符合 ISO 15197-2013 和 POCT12-A3 的要求,线性度高(相关系数 r=1.0),重复性好(平均变异系数 CV=1.38%),MARD(4.9%)可接受:Accu-Chek Inform II POCT 血糖仪可高效、安全地用于产妇住院和门诊,尤其是儿科诊所。
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来源期刊
Terapevticheskii Arkhiv
Terapevticheskii Arkhiv 医学-医学:内科
CiteScore
1.40
自引率
33.30%
发文量
171
审稿时长
3-8 weeks
期刊介绍: Терапевтический архив The journal was founded by the prominent Russian therapists M.P. Konchalovsky and G.F. Lang in 1923. Then its editors-in-chief were Professors V.N. Vinogradov and A.G. Gukasyan. Since 1972, E.I. Chazov, Academician of the Russian Academy of Sciences, has been heading the editorial board of the journal. Over 90 years, there have been more than 1000 issues where the authors and editorial staff have done their best for readers to keep abreast of current advances in medical science and practice and for physicians to master the advanced principles of recognition and treatment of a wide spectrum of visceral diseases. The papers published in the journal (editorials, original articles, lectures, reviews, etc.) cover both current scientific achievements and practical experience in diagnosing, treating, and preventing visceral diseases. The authors of publications are not only Russian, but also foreign scientists and physicians. All papers are peer-reviewed by highly qualified Russian specialists. The journal is published monthly. Traditionally, each issue has predominantly certain thematic areas covering individual therapy specializations. Every year, one of the issues is devoted to related problems in practical medicine (allergology and immunology, neurology and psychiatry, obstetrics, oncology, etc.). This all draws the attention of the reading public to the journal. The journal is indexed in RSCI (Russian Science Citation Index), PubMed/Medline, Index Medicus, Scopus/EMBASE, Web of Science Core Collection (Science Citation Index Expanded), Web of Science (Russian Science Citation Index - RSCI, Current Contents Connect, BIOSIS Previews), Google Scholar, Ulrich''s Periodicals Directory. The journal is included in the list of periodicals recommended by the Higher Attestation Committee for publishing the papers containing the basic materials of doctoral and candidate dissertations. By the decision of the Presidium of the Russian Academy of Medical Sciences, the “Therapevticheskiy Arkhiv” was awarded the Botkin medal. It was admitted to the European Association of Sciences Editors (EASE). The journal was honored with the Golden Press Fund decoration at the 13th International Press Professional Exhibition.
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