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Professor Mark Drayson’s review of Seralite® – FLC

In this series of videos, Professor Mark Drayson, Director at the University of Birmingham’s Clinical Immunology Service, discusses  Seralite®– FLC, a rapid lateral flow test for the quantification of kappa (K) and lambda (λ) immunoglobulin free light chains (FLCs) in serum.  Professor Drayson will cover the technical and clinical validation of Seralite®-FLC as well as some of the differences observed between different FLC methods.

Part 1: The identification and extensive validation of Seralite®– FLC monoclonal antibodies



The transcript of ‘Part 1: Prof. Mark Drayson discusses Seralite® – FLC’

“Seralite is part of a second-generation of improved free light chain tests and they’re based on monoclonal antibodies that we developed here at the University of Birmingham. So within that stable, we’ve got Seralite, which is based on a lateral flow format. So it will simultaneously quantitate kappa and lambda free light chains levels with the same, or better, precision and accuracy as the conventional laboratory assays. And it’s not hindered by the problem that some of those lab assays have which is in antigen excess.”

“We’ve made many monoclonal antibodies that are specific for free light chains. But, quite a lot of them won’t identify all patients. So, we had to go through our whole bank of monoclonal antibodies against either free kappa or free lambda, and not only validate that they detected free light chains and didn’t detect light chains bound to whole immunoglobulin. We also had to test those monoclonals against a few thousand myeloma patients to be sure that picked up all of them. And so in our routine clinical practice, we’ve used these monoclonals, actually for detecting free light chains in urine over several years, during which time we’ve showed by the comparison with the gold standard  immunofixation of light chains in urine we showed that the monoclonals didn’t miss any of 6,500 patients.”

Part 2: The clinical validation of the monoclonal antibodies used in Seralite®-FLC



The transcript of ‘Part 2: Prof. Mark Drayson discusses Seralite® – FLC’

“To validate Seralite in Free Light Chain only patients and in Non Secretory patients, we took really an unprecedented number of patients, we had 576 Light Chain only patients. Then on top of that, we had a further 60 patients who were Non Secretory as defined by immunofix negative in serum and urine. So, when we look at can Seralite make the diagnosis in these patients? It had 100% sensitivity. So, the next question is, how does Seralite perform in assessing response to anti-myeloma therapy? and then how does it perform in assessing and monitoring patients during remission to see if they are relapsing?”

“We had 100% sensitivity and specificity on those questions looking at Seralite in, I suppose, at least a third of those 576 plus 60 patients. So, it measured response in Light Chain only patients with very good correlation with clinical findings and other laboratories findings and similarly identified relapse, again correlating very well with clinical and other laboratory features.”

Part 3: The differences observed between different Free Light Chain methods



Part 4: How to switch between different Free Light Chain methods

Coming soon

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