The need for a sufficient number of low level sera in comparisons of different serum vitamin B12 assays

Eight radiochemical methods for the assay of vitamin B12 in serum were compared with the microbiological assay with Lactobacillus leichmannii ATCC 7830 using 198 individual sera of patients. There was a good agreement between the results of most samples with some kits and the microbiological assay. However, especially in the sera of vitamin B12-deficient patients large discrepancies between the results could occur. These variations were due to both the kits used and the performance of the assays in different laboratories. A sufficient number of non-pooled sera of vitamin B12-deficient patients should be included in investigations to validate radiochemical methods.