The first immunoassay with clearance for evaluation of monoclonal gammopathies of undetermined significance (MGUS).1,2
N Latex Free Light Chain (FLC) kappa and lambda assays enable more-reliable management of patients with monoclonal gammopathies. Designed for use on nephelometric Atellica® NEPH 630* and BN™ Systems, these high-sensitivity assays provide:
Concordance with IMWG recommendations and other international guidelines
A single reference range independent of patients’ kidney status
Reliable results without possible value drift over time due to use of monoclonal antibodies and lot-to-lot consistency
One kit for all sample types: serum, plasma, urine, and CSF
Benefits
Unique monoclonal antibodies
One reference range for all patients
High specificity
Nephelometric technology for confidence in results
Cost-efficient packaging
Monoclonal antibodies provide significant advantages in analytical performance:
Higher consistency in results obtained from different reagent lots enables early detection of changes in disease activity and subsequent adjustments to therapy, and ultimately
contributes to improved patient management and outcomes.
In research studies, monoclonal FLC assays produced no false-positive κ/λ ratios in patients with renal impairment.3-5 In comparison, the false-positive rate of polyclonal FLC assays in patients with renal impairment was 8–36%.6,7
FLC testing in MGUS evaluation
Evaluation of monoclonal gammopathies of undetermined significance (MGUS) is very important as it is seen as a precursor to multiple myeloma. Early detection of multiple myeloma facilitates early treatment with a higher patient survival rate.