Evaluation of two serum free light chain quantitation methods, Freelite and Seralite, in the clinical laboratory with a view to switching immunoassay.

ABSTRACT

BACKGROUND: Serum free light chain (sFLC) quantitation is central for plasma cell dyscrasias. Several assays are available and switching sFLC methods may be advantageous in certain laboratories. This study performed Freelite and Seralite simultaneously for samples received by the clinical laboratory over a 10 month period and compared quantitation and its impact on interpretation of patient results. METHODS: Patients (N = 189) included multiple myeloma (MM) and related plasma cell cancers, monoclonal gammopathy of unknown significance (MGUS), AL amyloidosis and renal impairment. sFLC quantitation and clinical agreement was assessed between methods. RESULTS: Clinical agreement was substantial at diagnosis (κ = 0.647, p < .01) and moderate for monitoring (κ = 0.591, p < .01). Good concordance was seen for MM and related plasma disorders and MGUS, with poorer agreement seen for AL amyloidosis. Case studies illustrated agreement in pattern of myeloma disease activity. Bland-Atman plots showed small mean bias but increasing variation between methods with increasing FLC concentrations. Passing-Bablok analysis confirmed systematic differences in quantitation between methods. CONCLUSIONS: Despite differences in quantitation, overall, agreement was seen between the different sFLC platforms in relation to the clinical interpretation. As a rapid test without the need for large and expensive analysers, Seralite may be highly applicable in certain laboratories to enable in-house testing.