Age- and ethnicity-related reference intervals for serum vitamin B12

Abstract

Background: Age and ethnicity are known to influence serum vitamin B₁₂ (B₁₂) concentration, yet universal reference intervals (RIs) are typically applied by laboratories. Both lower and upper RI limits for B₁₂ are clinically relevant. Low values suggest deficiency leading to anemia and/or neurological impairment, while high values are not always an innocuous consequence of high B₁₂ intake but are associated with some cancers, autoimmune, liver, and renal diseases. This work aimed to establish age- and ethnicity-related RIs for B₁₂ using a modified indirect method based on Hoffmann's approach.

Methods: A total of 72,091 anonymized B₁₂ results (Jan 2018-Nov 2019) were analyzed from an ethnically-diverse South-East London general practice patient population. Patients belonged to five ethnic groups: Asian, Black, White, Mixed, or Other. Multiple records for the same patient and results with missing ethnicity were excluded from the analysis of adult RIs. B₁₂ analyses were performed using ARCHITECT® (Abbott Diagnostics).

Results: B₁₂ was significantly higher in Black compared with Asian and White adults. There were no differences in B₁₂ between Asian and White adults. Children (all ethnicities) between 2 and 5 years old had the highest B₁₂. Because of the small number of children (up to the age of 13) in each ethnic-related age category, all ethnic groups were combined to obtain age-related RIs. The children's RIs ranged from 159 to 1025 pmol/L for 0-1-year-olds to 276-1102 pmol/L for 2-5-year-olds. The RIs for Black and White/Asian people >13 years of age were 166-805 pmol/L and 134-511 pmol/L respectively.

Conclusions: The application of age- and ethnicity-appropriate RIs into diagnostic practice will provide a more accurate evaluation of B₁₂ status when using the B₁₂ test alone or in combination with other markers.

Keywords: Age; Ethnicity; Haptocorrin; Holotranscobalamin; Reference intervals; Vitamin B(12).