1. Clinical comparison of new monoclonal antibody-based nephelometric assays for free light chain kappa and lambda to polyclonal antibody-based assays and immunofixation electrophoresis.
- Author
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Hoedemakers, Rein M.J., Pruijt, Johannes F.M., Hol, Suzanne, Teunissen, Elisa, Martens, Henk, Stam, Peter, Melsert, Roel, and te Velthuis, Henk
- Subjects
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MONOCLONAL antibody probes , *IMMUNOGLOBULINS , *ELECTROPHORESIS , *PROGNOSIS , *MEDICAL screening - Abstract
Background: New monoclonal antibody-based assays for serum-free light chains (FLC) have become available. Methods: In a clinical study with 541 patients, the new N Latex FLC assays were compared with the Freelite™ FLC assays and immunofixation electrophoresis (IF). Results: Comparison of the different FLC kappa (κ) assays showed a slope of 0.99 with a deviation of 5.0%, rs=0.92, for FLC lambda (λ) a slope of 1.22, deviation 13.8%, rs=0.90 and for the κ/λ ratio a slope of 0.72, deviation -4.6%, rs=0.72. The concordance for the FLC κ assays was 91%, for FLC λ 85% and κ/λ ratio 95%. The clinical sensitivity and specificity of the κ/λ ratios in the study were comparable: 60% and 99% for the N Latex FLC assay and 61% and 97% for the Freelite™ assay. In IF-FLC positive samples, the N Latex FLC κ/λ ratio scored 20/23 (87%) samples outside the reference range and Freelite™ 21/23 (91%). For IF-FLC negative samples, N Latex FLC assay κ/λ ratio scored 338/350 (97%) within the reference range and Freelite™ scored 332/350 (95%). Conclusions: The concordance scores and the clinical sensitivity and specificity of the new N Latex FLC assays and Freelite™ assays appeared comparable, but there are some differences in measurement of concentrations between the methods. [ABSTRACT FROM AUTHOR]
- Published
- 2012
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