A peer-reviewed publication1 published in Clinical Chemistry and Laboratory Medicine (CCLM) reported Seralite® FLC Serum (Seralite) produced good clinical concordance when compared with three other clinically available Serum Free Light Chain Assays (sFLC): N-Latex FLC (Siemens), Sebia FLC (Sebia) and Freelite (Binding Site).
This study was critical in highlighting the importance sFLCs and why they are important in the screening of monoclonal gammopathies, prognostic stratification and monitoring response to therapies.
The authors, Chérina K.A. Fleming et al, analysed assay performance using 193 anonymous sera samples, with varying FLC-ratios, from patients with Multiple Myeloma, Light Chain Multiple Myeloma, MGUS (monoclonal gammopathy of unknown significance) and Smouldering Myeloma, AL amyloidosis and Waldenström macroglobulinemia.
The study was conducted by Erasmus University Medical Center Rotterdam and Radboud University Medical Center and observed ‘good agreements for κFLC, λFLC and FLC ratio between all four assays’ and ‘clinical concordances were high and ranged from 86% to 92%’.
The study also noted that Seralite’s ‘advantage’ is that it can generate ‘rapid FLC results using a portable diagnostic device, facilitating near-patient testing’.
The British Journal of General Practice (2017) reported that in comparison to other cancer patients, myeloma patients are likely to have more visits to their GP before being diagnosed in an accident and emergency (A&E) department (Source: Myeloma Academy). Seralite’s ability to work in variety of clinical settings means it is able to support more rapid diagnosis and monitoring of patients and assist faster decision-making.
Abingdon Health launched Seralite to support clinicians in providing patients with the best possible diagnosis and monitoring service. This study further highlights the benefits rapid testing in regulated settings and that greater uptake of rapid tests is required in healthcare. Not only in the diagnosis of multiple myeloma and other cancers, but for all diseases and conditions.
Seralite® FLC Serum uses lateral flow immunoassay and reader technology for the quantitative measurement of kappa (K) and lambda (λ) immunoglobulin free light chains (FLCs) in serum. The format of this rapid test enables a free light chain service to be offered in all clinical laboratories. This enables the provision of FLC results in ~10 minutes rather than days or weeks. With this simple to use, compact, rapid test, clinicians are able to monitor patients in “real time” supporting faster decision making.
1: Chérina K.A. Fleming, Tim Swarttouw, Corrie M. de Kat Angelino, Joannes F.M. Jacobs, Henk Russcher. Method comparison of four clinically available assays for serum free light chain analysis. Clinical Chemistry and Laboratory Medicine (CCLM), 20190533, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2019-0533.