Vitamin B12 reference intervals on Beckman, Roche and Siemens analytical platforms.

IF 2.1 4区医学 Q3 MEDICAL LABORATORY TECHNOLOGY Annals of Clinical Biochemistry Pub Date : 2023-11-01 Epub Date: 2023-09-12 DOI:10.1177/00045632231202211

Nuthar Jassam, Thomas Bancroft, Ahai Luvai, Wycliffe Mbagaya, Julian H Barth

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Abstract

Background: Vitamin B12 status is assessed primarily by measuring total serum B12 using competitive binding methods. The lack of availability of a standard material and high-level reference measurement procedure affect the trueness of B12 results; this results in variation between methods. This study aimed to determine the reference intervals for vitamin B12 on three routine analytical platforms.

Method: A prospective reference population of healthy individuals was recruited according to the IFCC CRIDL criteria. Vitamin B12 samples were measured on Roche, Beckman and Siemens analytical platforms.

Results: In total, 300 adult subjects were recruited; the central 95th centile values for B12 for Roche (190-678 ng/mL) and Siemens (181-562 ng/mL) analytical platforms were in a close agreement. Beckman DXi, however, showed a significantly lower reference limit (110-562 ng/mL). All reference intervals are in keeping with previously published data but some are not in agreement with manufacturer provided reference interval.

Conclusion: As the quality of the reference intervals plays a significant role in clinical outcome, it is of great importance that laboratories use a method-specific reference interval and if possible, locally derived reference intervals until further method standardization occurs.

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贝克曼，罗氏和西门子分析平台的维生素B12参考区间。

背景:维生素B12状态的评估主要是通过使用竞争结合法测量血清总B12。缺乏可用的标准材料和高水平参考测量程序影响B12结果的准确性;这导致了不同方法之间的差异。本研究旨在确定三个常规分析平台上维生素B12的参考区间。方法:根据IFCC CRIDL标准招募健康个体的前瞻性参考人群。维生素B12样品在罗氏、贝克曼和西门子分析平台上测定。结果:共招募成人受试者300人;罗氏(190-678 ng/mL)和西门子(181-562 ng/mL)分析平台中B12的中心95百分位值非常接近。然而，Beckman DXi显示的参考限值明显较低(110-562 ng/mL)。所有参考区间与先前公布的数据一致，但有些与制造商提供的参考区间不一致。结论:参考区间的质量对临床结果起着重要的作用，因此在进一步的方法标准化之前，实验室使用特定方法的参考区间，如果可能的话，使用当地衍生的参考区间是非常重要的。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Annals of Clinical Biochemistry Biochemistry, Genetics and Molecular Biology-Clinical Biochemistry

CiteScore

5.20

自引率

4.50%

发文量

期刊介绍： Annals of Clinical Biochemistry is the fully peer reviewed international journal of the Association for Clinical Biochemistry and Laboratory Medicine. Annals of Clinical Biochemistry accepts papers that contribute to knowledge in all fields of laboratory medicine, especially those pertaining to the understanding, diagnosis and treatment of human disease. It publishes papers on clinical biochemistry, clinical audit, metabolic medicine, immunology, genetics, biotechnology, haematology, microbiology, computing and management where they have both biochemical and clinical relevance. Papers describing evaluation or implementation of commercial reagent kits or the performance of new analysers require substantial original information. Unless of exceptional interest and novelty, studies dealing with the redox status in various diseases are not generally considered within the journal''s scope. Studies documenting the association of single nucleotide polymorphisms (SNPs) with particular phenotypes will not normally be considered, given the greater strength of genome wide association studies (GWAS). Research undertaken in non-human animals will not be considered for publication in the Annals. Annals of Clinical Biochemistry is also the official journal of NVKC (de Nederlandse Vereniging voor Klinische Chemie) and JSCC (Japan Society of Clinical Chemistry).