Seralite® – FLC, a quantitative rapid test, featured in three respected scientific journals: Clinical Chemistry and Laboratory Medicine (CCLM); British Journal of Haematology (BJH); and BMC Nephrology.
In each of the publications, the authors highlighted several user and patient-management benefits when using Seralite® – FLC to aid the diagnosis and monitoring of patients with multiple myeloma and related conditions.
The authorship includes Professor Mark Drayson from the University of Birmingham; along with other experts from the University of Leeds, Newcastle University, Radboud University Medical Center, Netherlands, Erasmus University Medical Center Rotterdam, Netherlands, Harvard University, USA, and the University of Arkansas, USA.
Campbell, J. P. et al (2016). Development of a rapid and quantitative lateral flow assay for the simultaneous measurement of serum κ and λ immunoglobulin free light chains (FLC): inception of a new near-patient FLC screening tool. Clinical Chemistry and Laboratory Medicine (CCLM).
This publication 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.
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.
Access to this publication can be obtained via the link: https://www.degruyter.com/view/j/cclm.ahead-of-print/cclm-2016-0194/cclm-2016-0194.xml
Chérina K.A. Fleming et al (2019). Method comparison of four clinically available assays for serum free light chain analysis. Clinical Chemistry and Laboratory Medicine (CCLM).
This publication compares four clinically available Serum Free Light Chain Assays (sFLC): Seralite® FLC Serum (Abingdon Health), 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.
Access to this publication can be obtained via the link: https://www.degruyter.com/view/j/cclm.2020.58.issue-1/cclm-2019-0533/cclm-2019-0533.xml
Heaney, J. L. J. et al (2017). Diagnosis and monitoring for light chain only and oligosecretory myeloma using serum free light chain tests. British Journal of Haematology
This paper features detailed clinical validation of Seralite®-FLC and highlights the importance of clinically validating different Free Light Chain methods fully to understand appropriate thresholds.
The aim of the study was to guide interpretation of Free Light Chain (FLC) testing in clinical practice and specifically discusses appropriate clinical cut-offs for Seralite®-FLC. The study examined blood and urine analysis from 5,573 newly diagnosed myeloma patients including 576 light chain only and 60 non-secretory cases.
The authors conclude that as a rapid test, Seralite®-FLC is able to overcome delays in FLC result availability to accelerate patient diagnosis and quickly inform on patient responses to therapy.
Access to this publication can be obtained via the link: http://onlinelibrary.wiley.com/doi/10.1111/bjh.14753/full
Heaney, J. L. J. et al (2017). Multiple myeloma can be accurately diagnosed in acute kidney injury patients using a rapid serum free light chain test. BMC Nephrology
This publication examines the use of Seralite®-FLC in the rapid diagnosis of multiple myeloma in Acute Kidney Injury patients (AKI). Renal impairment is common in multiple myeloma patients and has a negative impact on survival. In patients presenting with AKI where the underlying pathology is unknown, it is recommended that multiple myeloma should be investigated as a potential cause.
The International Myeloma Working Group recommends screening for myeloma using serum immunoelectrophoresis (IFE), serum protein electrophoresis(SPE), and serum free light chain (sFLC) assays. The timescales for routine IFE, SPE and sFLC may not be compatible with the emergency setting of a patient presenting with AKI.
The aim of the study was to assess the utility of Seralite®-FLC as a screening tool to distinguish between myeloma and non-myeloma related AKI. The publication highlights that Seralite®-FLC could reduce delays in obtaining sFLC results and accelerate diagnosis in patients with unexplained AKI.
Full access to this publication can be obtained via the link: https://bmcnephrol.biomedcentral.com/track/pdf/10.1186/s12882-017-0661-z