Evaluation of Serum Beta-2-Microglobulin Assay on Beckman Coulter Chemistry Analyzer

Background: Beta-2 microglobulin (β2M) has various clinical usages and is an important prognostic marker for multiple myeloma. Although there are concerns of harmonization between assays, performance evaluation and method comparison reports are rare. Here, we evaluated the performance of Beckman-Coulter β2M assay. Methods: The precision and linearity of the Beckman Coulter β2M assay were evaluated. Beckman-Coulter results were compared to DiaSorin Liaison results. The manufacturer provided reference interval was verified. Results: Within-laboratory imprecision percentage coefficient of variation was 1.73% and 2.19% for low- and high-level control material, respectively. The linearity was confirmed over a range of 0.08 to 15.60 mg/L. Passing-Bablok regression analysis showed that y (Beckman-Coulter) = 0.978 x (Liaison) + 0.079 (r = 0.996) with a mean difference of 1.0%. All healthy subjects were within the range of manufacturer provided reference interval. Conclusions: The analytical performance of the Beckman-Coulter β2M assay was clinically acceptable.