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Human serum vitamin B12 assay methods--a review.

D S Lee, B W Griffiths

Clinical Biochemistry

|October 1, 1985

Summary

Accurate human serum vitamin B12 assays are crucial for diagnosing pernicious anemia (PA). Current methods lack the necessary accuracy and speed, prompting a review of existing techniques and their limitations.

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Area of Science:

Clinical Chemistry
Biochemical Diagnostics

Background:

Reliable human serum vitamin B12 assays are critical for diagnosing pernicious anemia (PA).
Existing serum B12 assays, particularly commercial kits, face significant controversies and criticisms regarding their accuracy and precision.
A validated reference method for quantifying serum vitamin B12 with high accuracy, precision, and rapidity is currently unavailable.

Purpose of the Study:

To review the limitations of current human serum vitamin B12 quantitation methods.
To establish a foundation for developing a new, accurate B12 reference method in the laboratory.
To highlight the clinical need for improved vitamin B12 diagnostic tools.

Main Methods:

Literature review of existing vitamin B12 quantitation techniques.
Analysis of microbiological, radioisotopic, high-performance liquid chromatography (HPLC), and radioimmunoassay (RIA) methods.
Critical evaluation of assay accuracy, precision, and rapidity.

Main Results:

No reported reference method for serum vitamin B12 quantitation meets the required standards for accuracy, precision, and speed.
Widespread debate and criticism surround the reliability of current human serum B12 assays.
Identified limitations across microbiological, radioisotopic, HPLC, and RIA techniques.

Conclusions:

Current serum vitamin B12 assays are insufficient for reliable pernicious anemia diagnosis.
There is a pressing need for the development of a new, robust reference method for serum B12 measurement.
This review provides critical insights into existing method limitations, guiding future reference method development.

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