Method Comparison and Workflow Differences Using the Same Free Light Chain Assay on 2 Analyzer Platforms

Abstract

Abstract Background The Freelite assay (The Binding Site) is utilized to quantify serum immunoglobulin free light chains (sFLC), which is crucial for diagnosing and monitoring plasma cell dyscrasias (PCDs). Using the Freelite test, we compared methods and evaluated workflow differences across two analyzer platforms. Methods sFLC concentrations were measured in 306 fresh serum specimens (cohort A) and 48 frozen specimens with documented sFLC >20 mg/dL (cohort B). Specimens were analyzed on the Roche cobas 8000 and Optilite analyzers using the Freelite κ and λ assays. Performance was compared using Deming regression. Workflow was compared by assessing turnaround time (TAT) and reagent usage. Results For cohort A specimens, Deming regression revealed a slope of 1.04 (95% CI, 0.88–1.02) and an intercept of −0.77 (95% CI, −0.57 to 1.85) for sFLCκ and a slope of 0.90 (95% CI, −0.04 to 1.83) and intercept of 1.59 (95% CI, −3.12 to 6.25) for sFLCλ. Regression of the κ/λ ratio revealed a slope of 2.44 (95% CI, 1.47–3.41) and intercept of −8.13 (95% CI, −16.82 to 0.58) with a concordance kappa of 0.80 (95% CI, 0.69–0.92). The proportion of specimens with TAT >60 min was 0.33% and 8% for the Optilite and cobas, respectively (P < 0.001). The Optilite required 49 (P < 0.001) and 12 (P = 0.016) fewer tests for sFLCκ and sFLCλ relative to the cobas. Cohort B specimens showed similar but more dramatic results. Conclusions Analytical performance of the Freelite assays was comparable on the Optilite and cobas 8000 analyzers. In our study, the Optilite required less reagent, had a slightly reduced TAT, and eliminated manual dilutions for samples with sFLC concentrations >20 mg/dL.