Seralite®– FLC Urine* is a rapid lateral flow test for the qualitative in vitro diagnostic identification of abnormal kappa (K) and lambda (λ) immunoglobulin free light chains (FLCs) in human urine using immunochromatography. Used in conjunction with clinical findings the test is useful for screening for abnormal levels of FLCs at an early stage, guiding the choice of further diagnostic investigation of suspected cases.
Free light chains are an important diagnostic biomarker for identifying and monitoring B-cell dyscrasias, including multiple myeloma. In multiple myeloma excess production of FLCs frequently occurs which may exceed the capacity of the kidney to metabolise these antibody fragments leading to the presence of FLCs in the urine.
This rapid non-invasive test enables a free light chain service to be offered in all clinical laboratories without the need to send away samples. This enables the provision of FLC results in minutes rather than days or weeks, accelerating the choice of further diagnostic or clinical investigation.
Seralite® – FLC Urine utilises the CE marked and FDA registered ADxLR5® Reader System, where the kappa (K) and lambda (λ) results are presented individually on screen as “not elevated” or as “elevated”.
The assay utilises highly specific, anti-K and anti-λ monoclonal antibodies. These monoclonal antibodies have been comprehensively validated demonstrating that they detect FLCs secreted from both normal and neoplastic plasma cells and have a proven high degree of specificity and sensitivity.**
Further information about Seralite®– FLC Urine can be obtained by contacting a member of our team. Please contact us on either +44(0)1904 406080 or firstname.lastname@example.org.
*Seralite®– FLC Urine is not available for sale in the USA
**Please see Resources page for a full list of references.
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20 September 2018
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