Evaluation of the N-latex serum free light chain assay on the Siemens BNII analyzer and agreement with The Binding Site FreeLite assay on the SPAPlus

Clinical Biochemistry
Nicole M A White-Al HabeebIvan M Blasutig

Abstract

To evaluate the Siemens N-latex kappa free light chain (κFLC) and lambda FLC (λFLC) assays on the BNII nephelometer and assess agreement with The Binding Site Freelite FLC assays on the SPAPlus. Over 180 patient serum samples from routine analysis of κFLC and λFLC measured by the Freelite assay were collected for the study and measured with the N-latex κFLC and λFLC assays to assess precision, linearity, method comparison and dilutional effects. Complex precision showed coefficients of variation of 4.8-7.2% for the κFLC assay and 3.6-6.0% for the λFLC assay. Linearity assessment showed both assays were linear (κFLC, y=1.00x-0.09 and λFLC, y=1.050x-1.252). Qualitative method comparison showed 87.9% (116/132) agreement and Cohen's kappa of 80.4% between the κFLC assays and 72.6% (98/135) agreement and Cohen's kappa of 55.4% for the λFLC assays. Quantitative method comparison for κFLC<150mg/L was y=0.92x+2.21, R=0.661 and for λFLC<150mg/L was y=7.90x-137.96, R=0.526. Dilutional effects including antigen excess and non-linearity were also examined. The N-latex assay showed good precision and linearity with reasonable agreement to the Freelite assay. However, the assays should not be used interchangeably to monitor patients.

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Citations

Apr 13, 2018·Clinical Chemistry and Laboratory Medicine : CCLM·Harald HegenStefan Presslauer
Apr 22, 2018·Clinical Chemistry and Laboratory Medicine : CCLM·Xavier BossuytMartine Vercammen
Oct 16, 2019·Critical Reviews in Clinical Laboratory Sciences·Laura CaponiMaria Franzini
Oct 19, 2019·Biochemia Medica·Dragana ŠeguljaDunja Rogić
May 24, 2020·The Journal of Applied Laboratory Medicine·Christopher W FarnsworthAnn M Gronowski
Mar 5, 2021·Clinical Biochemistry·Luis J Morales-García, María S Pacheco-Delgado
Jul 24, 2020·Clinica Chimica Acta; International Journal of Clinical Chemistry·Laura CaponiMaria Franzini
Aug 17, 2021·Biochemia Medica·Massimo DavesGiuseppe Lippi

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