Evaluation of the new Sebia free light chain assay using the AP22 ELITE instrument

Clin Chim Acta. 2018 Dec;487:161-167. doi: 10.1016/j.cca.2018.09.030. Epub 2018 Sep 20.

Abstract

Background: Serum kappa and lambda free light chains (FLC) are useful in the diagnosis, prognosis and monitoring of patients with monoclonal gammopathies. The Binding Site and Siemens were the only suppliers of kits for these analyses until recently, when Sebia introduced an enzyme-linked immunosorbent assay (ELISA) on an automated instrument, DAS AP22 ELITE.

Method: Samples from routine analysis, controls and chronic kidney disease (CKD) patients were tested using the automated version of Sebia FLC ELISA with the AP22 ELITE and results were compared with Freelite on the SPA PLUS (The Binding Site).

Results: Sebia FLC ELISA showed a good performance using the AP22 ELITE. A concordance of 82% was found with the results obtained with Freelite. Sebia FLC is a reproducible assay, requiring less retesting than Freelite thanks to a broader range. Earlier findings that the results obtained are closer to the FLC monoclonal band measured by electrophoresis were confirmed. Higher kappa and lambda values obtained in CKD individuals were also shown, confirming that a kappa/lambda FLC ratio should be introduced by Sebia for CKD patients, as with The Binding Site.

Conclusions: Sebia put forward new technology that automatically measures free light chains. This technique is suitable for routine use; however, the results cannot be used interchangeably with Freelite kits.

Keywords: Chronic kidney disease; ELISA; Methods comparison; Monoclonal gammopathy; Serum free light chains.

Publication types

  • Evaluation Study

MeSH terms

  • Automation
  • Enzyme-Linked Immunosorbent Assay*
  • Humans
  • Immunoglobulin Light Chains / blood*
  • Renal Insufficiency, Chronic / blood*
  • Renal Insufficiency, Chronic / diagnosis

Substances

  • Immunoglobulin Light Chains