Seralite® – FLC, a free light chain rapid test, has featured in 3 respected scientific journals, Clinical Chemistry and Laboratory Medicine (CCLM), British Journal of Haematology (BJH) and BMC Nephrology. These peer reviewed publications have highlighted several benefits of using Seralite® – FLC in aiding the diagnosis and monitoring of multiple myeloma patients to improving healthcare outcomes.
Free light chain rapid test fulfils analytical and performance requirements
A publication in CCLM 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.
Clinical Utility of a rapid test for FLC
The aim of the study published in the BJH 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 5573 newly diagnosed myeloma patients including 576 light chain only (LCO) and 60 non-secretory (NS) cases. The recommended Freelite® FLC >100mg/L for measuring response was confirmed and an equivalent Seralite®-FLC difference (dFLC) >20mg/L identified. Relapse was identified using a Freelite® FLC increase >200mg/L and found 100% concordance with a corresponding Seralite® dFLC increase >30mg/L.
Accelerating diagnosis in cases of Acute Kidney Injury (AKI)
Renal impairment is common in multiple myeloma and has a negative impact on survival. In patients presenting with an AKI where the underlying pathology is unknown, 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 a study published in BMC Nephrology was to assess the utility of Seralite® as a screening tool to distinguish between myeloma and non-myeloma related AKI. The publication highlights that Seralite® could reduce delays in obtaining sFLC results and accelerate diagnosis in patients with unexplained AKI.
To learn more about the results of the studies in the 3 Journals, please click on one of the links below. Alternatively, speak with a member of our team on +44 (0) 1904 406082 or [email protected].
- 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).
Full 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 (This page is no longer live)
- 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
Full 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
Full access to this publication can be obtained via the link: https://bmcnephrol.biomedcentral.com/track/pdf/10.1186/s12882-017-0661-z
To learn more about our free light chain rapid test please contact a member of our team.