Improved human free light chain diagnostic immunoassay reagents

Important results from the project

The aim has been to develop, validate and launch new reagents and calibrators for a turbidimetric test (PETIA) of free light chains in serum (sFLC) that can be analyzed on open clinical chemistry instruments. Completion: IgY antibodies specific for sFLC kappa and lambda have been produced and verified by proteomics. The IgY´s have been conjugated with optimized nanoparticles to ensure sensitivity and reproducibility in the assay. Calibrator and control materials have been produced and buffers have been optimized.

Expected long term effects

Reagents necessary for the final PETIA product have been developed during the project: high affinity IgY antibodies for sFLC, optimized nanoparticles for conjugation, calibrator and control materials and the buffers needed for the reagents. The new PETIA is being evaluated at 2 clinical sites for validation of the sensitivity and reproducibility, method comparison, and sFLC reference range determination using the new sFLC PETIA.

Approach and implementation

The project has been implemented as a Eurostars project and the structure has followed that template with work packages (WP) and tasks in the WP. The work has been carried out together with a Norwegian company, NABAS (main partner) and Uppsala University Hospital (UU). The division of WP with shared responsibility means that Getica has been able to work relatively autonomously from NABAS and UU. Weekly online meetings have been held, and after the Corona restrictions were lifted, there have also been physical meetings held.