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Related Experiment Video

Updated: Jul 26, 2025

The Caco-2 Cell Bioassay for Measurement of Food Iron Bioavailability

The Caco-2 Cell Bioassay for Measurement of Food Iron Bioavailability

Published on: April 28, 2022

Vitamin B12 reference intervals.

Stine Linding Andersen^1,2, Annebirthe Bo Hansen¹, Peter Hindersson³

¹Department of Clinical Biochemistry, Aalborg University Hospital.

Danish Medical Journal

|June 21, 2023

Summary

This summary is machine-generated.

Different immunoassays yield non-interchangeable plasma vitamin B12 results and reference intervals. Clinical guidelines for diagnosing vitamin B12 deficiency must account for the specific biochemical methods employed.

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Area of Science:

Clinical Chemistry
Biochemical Diagnostics
Laboratory Medicine

Background:

Plasma vitamin B12 testing is crucial for diagnosing deficiency, but interpretation is complex.
The performance of various biochemical methods for vitamin B12 assessment is not well-defined.

Purpose of the Study:

To establish plasma vitamin B12 concentration reference intervals using three different immunoassays.
To evaluate the frequency of low vitamin B12 concentrations based on assay method and cut-offs.

Main Methods:

Plasma vitamin B12 concentrations were measured using Alinity (Abbott), Cobas 6000 (Roche), and Atellica IM (Siemens) immunoassays.
Direct reference intervals were determined in blood donors (n=129).
Indirect reference intervals were established using patient data (n=34,181) and the frequency of low vitamin B12 was analyzed.

Main Results:

Direct reference intervals varied significantly between the three methods.
Indirect reference intervals also showed considerable differences across the immunoassays.
The proportion of patients with vitamin B12 below 250 pmol/l ranged from 14% to 33% depending on the method used.

Conclusions:

Plasma vitamin B12 measurements and their reference intervals are not interchangeable across different immunoassays.
The choice of biochemical method significantly impacts the interpretation of vitamin B12 levels.
Clinical guidelines should incorporate assay-specific information for accurate vitamin B12 deficiency diagnosis.