Bruno Mario Cesana, Simona da Molin, Nuthar Jassam, Julian H Barth, Sabrina Buoro, Martina Tosi, Gianvincenzo Zuccotti, Santica Marcovina, Simona Ferraro
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引用次数: 0
摘要
目的:英国国家健康和护理卓越研究所推荐了总维生素B12 (B12)测定的阈值,这些检测结果可互换,以确定B12缺乏症。我们评估了B12方法之间的一致性,以评估阈值是否可以假设适用于所有检测。方法:基于人类受试者池材料和97份血清样本,共检索了19项外部质量评估(EQA)活动(1791项决定),以表征Alinity和Architect(雅培诊断)、Access DXi(贝克曼库尔特诊断)、Atellica和ADVIA Centaur(西门子医疗解决方案)与Cobas(罗氏诊断)之间的协议。由于其校准器可追溯至世界卫生组织(世卫组织)国际标准(IS)代码03/178,因此被视为比较器。普通最小二乘法和Bland-Altman算法用于此目的。结果:与罗氏和其他方法相比,雅培和贝克曼方法分别高估和低估了B12浓度。我们报告了EQA和血清样本之间类似的系统或比例误差模式。只有贝克曼受到这两个错误的影响。由于一致区间的限制较宽,我们不能自信地得出Roche与其他方法的一致结论。然而,方法间偏差远低于雅培建筑师的9.4% %的理想目标,也低于西门子ADVIA Centaur。结论:血清总B12的推荐阈值不应被认为适用于所有的检测方法,因为目前可用的方法之间的一致性很差,尽管WHO IS 03/178发布,这一限制仍然存在。
Assessing the harmonization of current total vitamin B12 measurement methods: relevance and implications.
Objectives: The UK National Institute for Health and Care Excellence has recommended thresholds for total vitamin B12 (B12) assays with interchangeable results for identifying B12 deficiency. We assessed the agreement between B12 methods, to evaluate whether the thresholds may be assumed applicable to all assays.
Methods: A total of 19 External Quality Assessment (EQA) exercises (1791 determinations) based on human subjects-pool materials and 97 serum samples were retrieved to characterize the agreement between Alinity and Architect (Abbott Diagnostics), Access DXi (Beckman Coulter Diagnostics), Atellica and ADVIA Centaur (Siemens Healthcare Solution) compared to Cobas (Roche Diagnostics), considered as comparator because its calibrator traceability to the World Health Organisation (WHO) International Standard (IS) code 03/178. Ordinary least squares and Bland-Altman were used for this purpose.
Results: Abbott and Beckman methods overestimated and underestimated, respectively, B12 concentrations vs. Roche and the other methods. We reported similar systematic or proportional error patterns between EQA and serum samples. Only Beckman was affected by both errors. Due to the wide Limit of Agreement Interval, we cannot confidently conclude on the agreement between Roche and the other methods. However, the inter-method bias was well lower than the desirable goal of 9.4 % for Abbott Architect and also lower for Siemens ADVIA Centaur.
Conclusions: The recommended thresholds for serum total B12 should not be assumed applicable to all assays, due to the poor agreement among the currently available methods, a limitation that persists despite the release of the WHO IS 03/178.
期刊介绍:
Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor over 3. CCLM is issued monthly, and it is published in print and electronically.
CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Belgium (RBSLM); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); and Slovenia (SZKK); and it is affiliated to AACB (Australia) and SFBC (France).
Topics:
- clinical biochemistry
- clinical genomics and molecular biology
- clinical haematology and coagulation
- clinical immunology and autoimmunity
- clinical microbiology
- drug monitoring and analysis
- evaluation of diagnostic biomarkers
- disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes)
- new reagents, instrumentation and technologies
- new methodologies
- reference materials and methods
- reference values and decision limits
- quality and safety in laboratory medicine
- translational laboratory medicine
- clinical metrology
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