Evaluation of the clinical chemistry tests analytical performance with Sigma Metric by using different quality specifications - Comparison of analyser actual performance with manufacturer data.

IF 3.8 3区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY
Biochemia Medica Pub Date : 2022-02-15 Epub Date: 2021-12-15 DOI:10.11613/BM.2022.010703
Murat Keleş
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引用次数: 0

Abstract

Introduction: The interest in quality management tools/methodologies is gradually increasing to ensure quality and accurate results in line with international standards in clinical laboratories. Six Sigma stands apart from other methodologies with its total quality management system approach. However, the lack of standardization in tolerance limits restricts the advantages for the process. Our study aimed both to evaluate the applicability of analytical quality goals with Roche Cobas c 702 analyser and to determine achievable goals specific to the analyser used.

Materials and methods: The study examined under two main headings as Sigmalaboratory and Sigmaanalyser. Sigmalaboratory was calculated using internal and external quality control data by using Roche Cobas c 702 analyser for 21 routine biochemistry parameters and, Sigmaanalyser calculation was based on the manufacturer data presented in the package inserts of the reagents used in our laboratory during the study. Sigma values were calculated with the six sigma formula.

Results: Considering the total number of targets achieved, Sigmaanalyser performed best by meeting all CLIA goals, while Sigmalaboratory showed the lowest performance relative to biological variation (BV) desirable goals.

Conclusions: The balance between the applicability and analytical assurance of "goal-setting models" should be well established. Even if the package insert data provided by the manufacturer were used in our study, it was observed that almost a quarter of the evaluated analytes failed to achieve even "acceptable" level performance according to BV-based goals. Therefore, "state-of-the-art" goals for the Six Sigma methodology are considered to be more reasonable, achievable, and compatible with today's technologies.

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使用不同的质量规格,用西格玛标准评估临床化学检验的分析性能 - 比较分析仪的实际性能与制造商的数据。
导言:为了确保临床实验室的质量和结果的准确性符合国际标准,人们对质量管理工具/方法的兴趣逐渐增加。六西格玛以其全面质量管理系统的方法从其他方法中脱颖而出。然而,公差限值缺乏标准化限制了该方法的优势。我们的研究旨在评估罗氏 Cobas c 702 分析仪分析质量目标的适用性,并确定分析仪可实现的具体目标:研究主要从两个方面进行考察,即 Sigmalaboratory 和 Sigmaanalyser。Sigmalaboratory 是通过使用罗氏 Cobas c 702 分析仪对 21 项常规生化参数进行内部和外部质控数据计算得出的,而 Sigmaanalyser 的计算则基于本实验室在研究期间使用的试剂包装插页中提供的制造商数据。西格玛值用六西格玛公式计算:结果:考虑到达到的目标总数,Sigmaanalyser 表现最好,达到了 CLIA 的所有目标,而 Sigmalaboratory 在生物变异 (BV) 理想目标方面表现最低:结论:应在 "目标设定模型 "的适用性和分析保证之间取得平衡。在我们的研究中,即使使用了制造商提供的包装说明书数据,也发现几乎四分之一的受评估分析物甚至达不到基于生物变异的目标的 "可接受 "水平。因此,"六西格玛 "方法的 "最新 "目标被认为是更合理、更可实现、更符合当今技术的。
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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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