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

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Vitamin B12 testing shows significant variation between analytical platforms. Establishing method-specific reference intervals is crucial for accurate clinical interpretation of vitamin B12 status.

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Area of Science:

  • Clinical Chemistry
  • Laboratory Medicine
  • Analytical Science

Background:

  • Serum vitamin B12 measurement is key for assessing vitamin B12 status.
  • Current methods lack standardization, leading to result variability.
  • This variability impacts the trueness of vitamin B12 results.

Purpose of the Study:

  • To establish reference intervals for vitamin B12.
  • To compare these intervals across three common analytical platforms.
  • To address the need for method-specific reference ranges.

Main Methods:

  • Recruited a prospective reference population of healthy individuals.
  • Measured serum vitamin B12 samples using Roche, Beckman, and Siemens platforms.
  • Applied IFCC CRIDL criteria for subject recruitment.

Main Results:

  • 300 adult subjects were analyzed.
  • Roche and Siemens platforms showed close agreement in reference intervals (190-678 ng/mL and 181-562 ng/mL, respectively).
  • The Beckman DXi platform yielded a lower reference interval (110-562 ng/mL).

Conclusions:

  • Reference intervals align with prior studies but may differ from manufacturer data.
  • Method-specific reference intervals are vital for accurate clinical decisions.
  • Laboratories should utilize locally derived intervals pending further standardization.