Analytical verification of the Dymind D7-CRP automated analyser.

IF 3.8 3区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Biochemia Medica Pub Date : 2023-06-15 DOI:10.11613/BM.2023.020703
Merima Čolić, Bojana Magdić, Monika Kolundžić, Jasna Leniček Krleža
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Abstract

Introduction: The aim of this study was to perform a verification of the Dymind D7-CRP automated analyser and compare it with established analysers.

Materials and methods: Analytical verification included estimation of repeatability, between run precision, within-laboratory precision, and bias in control samples with low, normal and high levels. The acceptance criteria for analytical verification were defined using the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) 2019 Biological Variation Database. Method comparison between the Dymind D7-CRP and the Sysmex XN1000 for haematological parameters and the Dymind D7-CRP and the Beckman Coulter AU680 for CRP values was performed on 40 patient samples.

Results: Analytical verification criteria were adequately met with the exception of monocyte count for repeatability and within-laboratory precision (13.4% and 11.5%, respectively, acceptance criteria 10.1%) and measurement uncertainty (23.0, acceptance criteria 20.0%) at low level, eosinophil count for BIAS at the low level (37.7%, acceptance criteria 25.2%), basophil count (BAS) for BIAS at the high level (14.2%, acceptance criteria 10.9%), and mean platelet volume (MPV) for repeatability (4.2% and 6.8%), between run precision (2.2% and 4.7%), within-laboratory precision (4.0% and 7.3%) (acceptance criteria 1.7%), and measurement uncertainty (8.0 and 14.6%, acceptance criteria 3.4%) at both the low and high concentrations. Method comparison showed no clinically significant constant or proportional differences for all parameters except BAS and MPV.

Conclusion: The analytical verification of the Dymind D7-CRP showed adequate analytical characteristics. The Dymind D7-CRP can be used interchangeably with the Sysmex XN-1000 for all parameters tested, except BAS and MPV, and with the Beckman Coulter AU-680 for the determination of CRP.

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Dymind D7-CRP 自动分析仪的分析验证。
简介本研究旨在对Dymind D7-CRP自动分析仪进行验证,并将其与现有分析仪进行比较:分析验证包括对重复性、运行间精密度、实验室内精密度以及低、正常和高水平对照样本的偏差进行估计。利用欧洲临床化学和实验室医学联合会(EFLM)2019 年生物变异数据库确定了分析验证的接受标准。对40份患者样本进行了Dymind D7-CRP与Sysmex XN1000血液学参数的方法比较,以及Dymind D7-CRP与贝克曼库尔特AU680 CRP值的方法比较:重复性(4.2% 和 6.8%)、运行间精密度(2.2% 和 4.7%)、实验室内精密度(4.0% 和 7.3%)(接受标准为 1.7%)和测量不确定性(8.0% 和 14.6%,接受标准为 3.4%)在低浓度和高浓度时均相同。方法比较显示,除BAS和MPV外,所有参数的常数或比例差异均无临床意义:结论:Dymind D7-CRP的分析验证显示出足够的分析特性。除BAS和MPV外,Dymind D7-CRP可与Sysmex XN-1000互换使用,也可与Beckman Coulter AU-680互换使用。
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来源期刊
Biochemia Medica
Biochemia Medica 医学-医学实验技术
CiteScore
5.50
自引率
3.00%
发文量
70
审稿时长
>12 weeks
期刊介绍: Biochemia Medica is the official peer-reviewed journal of the Croatian Society of Medical Biochemistry and Laboratory Medicine. Journal provides a wide coverage of research in all aspects of clinical chemistry and laboratory medicine. Following categories fit into the scope of the Journal: general clinical chemistry, haematology and haemostasis, molecular diagnostics and endocrinology. Development, validation and verification of analytical techniques and methods applicable to clinical chemistry and laboratory medicine are welcome as well as studies dealing with laboratory organization, automation and quality control. Journal publishes on a regular basis educative preanalytical case reports (Preanalytical mysteries), articles dealing with applied biostatistics (Lessons in biostatistics) and research integrity (Research integrity corner).
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