维生素 B12 参考区间。

Vitamin B12 reference intervals.

机构信息

Department of Clinical Biochemistry, Aalborg University Hospital.

Department of Clinical Medicine, Aalborg University.

出版信息

Dan Med J. 2023 May 23;70(6):A12220771.

PMID:37341359

Abstract

INTRODUCTION

P-Vitamin B12 is a commonly used biochemical test. Evaluation of test results and diagnosis of vitamin B12 deficiency are challenging, and the role of different biochemical methods remains unclear.

METHODS

The aim of this study was to establish reference intervals for plasma vitamin B12 concentration using different immunoassays (method 1: Alinity, Abbott Laboratories; method 2: Cobas 6000, Roche Diagnostics; method 3: Atellica IM, Siemens Healthineers). Direct reference intervals were established among blood donors (n = 129) and indirect reference intervals among adult patient results of plasma vitamin B12 concentration requested by general practitioners in the North Denmark Region from 15 August to 15 October 2022 (n = 34,181). Finally, the frequency of low vitamin B12 concentration using different uniform cut-offs was evaluated.

RESULTS

Direct reference intervals (2.5-97.5 percentiles) were as follows for method 1: 168-553 pmol/l; method 2: 202-641 pmol/l; and method 3: 211-551 pmol/l. Indirect reference intervals were as follows for method 1: 133-541 pmol/l; method 2: 172-619 pmol/l; and method 3: 182-162-206 pmol/l. When different cut-offs were applied to patient results, the frequency of having a vitamin B12 concentration below 250 pmol/l differed by biochemical method: 33% (method 1), 17% (method 2) and 14% (method 3).

CONCLUSION

Measurement of plasma vitamin B12 concentration using different immunoassays revealed results and reference intervals that were not interchangeable. Clinical guidelines for the diagnosis of vitamin B12 deficiency should consider the biochemical methods used.

FUNDING

None.

TRIAL REGISTRATION

None.

摘要

简介

P-维生素 B12 是一种常用的生化测试。评估测试结果和诊断维生素 B12 缺乏具有挑战性，不同生化方法的作用仍不清楚。

方法

本研究旨在使用不同的免疫测定法（方法 1：雅培实验室的 Alinity；方法 2：罗氏诊断的 Cobas 6000；方法 3：西门子健康的 Atellica IM）为血浆维生素 B12 浓度建立参考区间。在献血者（n = 129）中建立直接参考区间，并在 2022 年 8 月 15 日至 10 月 15 日期间，由北丹麦地区的全科医生要求检测的成年患者的血浆维生素 B12 浓度的间接参考区间（n = 34181）。最后，评估使用不同统一截止值的低维生素 B12 浓度的频率。

结果

方法 1 的直接参考区间（2.5-97.5 百分位数）如下：168-553 pmol/l；方法 2：202-641 pmol/l；方法 3：211-551 pmol/l。方法 1 的间接参考区间如下：133-541 pmol/l；方法 2：172-619 pmol/l；方法 3：182-162-206 pmol/l。当将不同的截止值应用于患者的结果时，使用不同生化方法的维生素 B12 浓度低于 250 pmol/l 的频率有所不同：33%（方法 1）、17%（方法 2）和 14%（方法 3）。