Laboratory evaluation of a blood test for measuring free light chains
Research type
Research Study
Full title
A laboratory study to assess the technical performance of The Siemens N Latex Free light chain assay and the clinical sensitivity of this new monoclonal antisera Free Light Chain assay versus a polyclonal antisera Free Light Chain assay in patients with Monoclonal Gammopathy of Undetermined Significance and Multiple Myeloma
IRAS ID
186619
Contact name
Joanne Morris
Contact email
Sponsor organisation
Epsom and St Helier Hospitals NHS Trust
Duration of Study in the UK
1 years, 2 months, 1 days
Research summary
Plasma cells are blood cells produced by the bone marrow which produce antibodies, also called immunoglobulins, to help fight infection. Immunoglobulins are Y-shape molecules made up of heavy and light chains. During the process of immunoglobulin production light chains are produced in larger amounts than the heavy chains and released into the blood stream. These are called ‘free light chains’ (FLC) and can be detected in the blood using a laboratory test. Myeloma is a cancer of plasma cells which become abnormal, multiply uncontrollably and release a single immunoglobulin known as paraprotein. Monoclonal Gammopathy of Undetermined Significance (MGUS) is a non-cancerous condition in which a paraprotein is produced but most affected people remain well and no treatment is necessary. A small number of people with MGUS may develop cancers, such as myeloma. The FLC test is used by doctors to assess the risk of a begin condition such as MGUS developing into cancer, to identify patients with myeloma who need treatment and to determine the effectiveness of treatment in patients with Myeloma.
The aim of the study is to technically and clinically evaluate a newly available laboratory test for measuring FLC in blood. Over a 12 month period we will test the surplus of blood samples that have already been collected as part of routine investigations, for patients suspected to have myeloma, to measure the FLC concentration using both the old and new test. We expect the new method to have improved scientific performance when compared to the existing method. Results from the new method will be evaluated to determine if diagnosis, care pathway selection and disease progression risk assessment would be affected by using an alternative assay.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
15/EE/0362
Date of REC Opinion
1 Oct 2015
REC opinion
Further Information Favourable Opinion