A peer reviewed scientific publication featuring detailed method evaluation of Seralite®-FLC has been published in CCLM and is now available online. The authorship includes Key Opinion Leaders from Birmingham University such as Professor Mark Drayson along with experts in the field from the Radboud University Medical Center, Netherlands and Harvard University, USA.
The article discusses and evaluates the Seralite®-FLC method in detail and covers assay interference, imprecision, lot-to-lot variability, linearity and utility of a competitive-inhibition design for the elimination of antigen-excess. In addition, the publication presents and discusses preliminary clinical validation data from over 300 patients and compares the diagnostic results with other commercially available Free Light Chain Immunoassays.
The key conclusions from this publication are:
“To overcome the reliance on laboratory analysers for the measurement of FLC, Seralite® fulfils a number of important analytical and performance requirements. Firstly, as reported herein, Seralite® exhibits a broad calibration range from 2.5 to 200 mg/L for both κ and λ FLC. This extensive range enables accurate quantitation of healthy donor sera and similar enumeration of normal polyclonal FLC as the Freelite® assay”
“Seralite® enables sensitive measurement of low levels of FLC indicative of immunosuppression or immunoparesis and avoids the low-sensitivity ‘gaps’ that are a feature of Freelite®.”
“Seralite® results presented herein show good linearity on serial dilutions of sera containing high levels of monoclonal FLC. A related problem that affects existing FLC assays on certain analysers – that Seralite® overcomes – is the problem of antigen excess. In this study, we report one Freelite® false negative and numerous occasions where high FLC levels were initially low on Freelite® that subsequently gave higher results when less sample (i.e. more dilute sample) was added. To address this issue, Seralite® has a competitive inhibition format that eliminates this risk, and any samples with high iFLC above the calibration range of the assay are identified as being above 200 mg/L and should be re-diluted.”
This important publication validates the use of Seralite®-FLC within clinical laboratories and highlights important technical advantages of using the unique format of Seralite®-FLC such as lack of antigen excess. Full access to this article can be obtained via the link http://www.degruyter.com/view/j/cclm.ahead-of-print/cclm-2016-0194/cclm-2016-0194.xml. (the page is no longer live)