N Latex FLC kappa and N Latex FLC lambda Assays
Add consistency to monoclonal gammopathy testing

N Latex FLC kappa and N Latex FLC lambda Assays
 
Download brochure
 
N Latex FLC kappa

N Latex FLC kappa and N Latex FLC lambda Assays

Free light chain (FLC) kappa and lambda Assays for use on Atellica® NEPH 630,* BN™ II, and BN ProSpec® Systems are designed for more reliable management of patients with monoclonal gammopathies. Excellent/stable lot-to-lot reproducibility leads to improved diagnostic accuracy as well as the sensitive detection of changes in follow-up testing.

Add confidence to screening and monitoring of monoclonal gammopathies with N Latex FLC kappa and N Latex FLC lambda Assays:

  • High specificity based on monoclonal antibodies
  • Excellent lot-to-lot reproducibility
  • Pre-reaction protocol ensures high antigen-excess security
  • Flexible kit design: reagents, supplementary reagent, standard, and controls are available separately and can be freely combined

Features & Benefits

Consistent Results Help Refine Disease Management Strategies
Determination of free light chains (FLC) has been part of the officially recommended screening panel for multiple myeloma since 2009.1,2 Furthermore, FLC determination helps in monitoring therapy success. Reliable results are a prerequisite for consistently high sensitivity in screening and sensitive detection of changes in follow-up. Studies have shown the clinical concordance of the N Latex FLC Assays to competitive assays.3,4

How Can Improved Lot-to-Lot Reproducibility and Antigen-excess Security Improve the Management of Patients with Monoclonal Gammopathy?

The N Latex FLC kappa and N Latex FLC lambda Assays offer a convenient way to determine free light chains on Siemens Healthineers automated immunonephelometric systems.

Excellent lot-to-lot consistency

  • Adds consistency to patient results and the follow-up of patients using different reagent lots.
  • Allows patient screening and monitoring of therapy, e.g., for myeloma patients.
  • Ensures improved patient management by early recognition of a potential relapse or resulting therapy adjustments – this may lead to an overall improved patient outcome.

Improved antigen-excess security

  • Feel more confident through detection of high-dose hook effects.
  • Improve cost-effectiveness due to fewer dilution steps.

Convenient packaging concept

  • Reduce costs with flexible, reagent-independent packaging. All components can be ordered separately, so you can ensure an adequate supply of standard and controls while eliminating waste.
  • Add confidence to screening and monitoring of monoclonal gammopathies with assays and systems from Siemens Healthineers.

Clinical Use

Comparison of immunoassays to immunofixation electrophoresis (IFE), number of abnormal results:

IFE, kappa PositiveN Latex FLC kappa AssayFREELITE kappa
6060 (100%)59 (98.3%)
   
IFE, lambda Positive N Latex FLC lambda AssayFREELITE lambda
5960 59 (98.3%)56 (94.9%)
   
IFE, kappa and/or lambda PositiveN Latex FLC RatioFREELITE FLC Ratio
115105 (91.3%)103 (89.6%)

Comparison of N Latex FLC Assay and FREELITE FLC assay

(n = 1118, categorized as abnormal low, normal, abnormal high):

 Agreement rateCohen’s coefficient
FLC kappa89.7%0.80
FLC lambda82.4%0.67
FLC ratio91.8%0.82

 

FLC ratio method comparison

Lot-to-Lot Comparison

Comparison of three independent reagent lots, including two different (lot-independent) standard lots (n = 95)

Technical Specifications

Analytical Assay Performance

Assay principleLatex-enhanced immunonephelometry
Sample typeHuman serum, EDTA plasma, heparinized plasma, CSF, urine
Reference rangeFLC kappa: 6.7 – 22.4 mg/L
FLC lambda: 8.3 – 27.0 mg/L
FLC ratio: 0.31 – 1.56
Initial measuring ranges3.5–110 mg/L for FLC kappa
1.9–60 mg/L for FLC lambda
Total measuring range0.17 – ≥ 2,000 mg/L for FLC kappa
0.47 – ≥ 6,000 mg/L for FLC lambda
Measuring time12 minutes
Onboard reagent stability2 weeks (Atellica NEPH 630* and BN ProSpec Systems)
5 days (6 days with evaporation stoppers) on BN II System
Calibration frequency6 weeks
PrecisionRepeatability: < 5%
Within-lab: < 6.5%
Antigen-excess securityFLC kappa: up to 23,000 mg/L
FLC lambda: up to 57,000 mg/L

Share this page:

Gerelateerde producten, diensten en bronnen

*Not available for sale in the U.S.
Applications are not available in the U.S.
1. Kyle RA, Raikumar SV. Leukemia. 2009;23:3-9.
2. Dispenzieri A, Kyle R, Merlini G, et al. Leukemia. 2009;23:215-24.
3. te Velthuis H, Knop I, Stam P, et al. N Latex FLC – new monoclonal high-performance assays for the determination of free light chain kappa and lambda. Clin Chem LabMed. 2011;49:1323-32.
4. Hoedemakers RMJ, Pruijt JFM, Hol S, et al. Clinical comparison of new monoclonal antibody-based nephelometric assays for free light chain kappa and lambda to polyclonal antibody-based assays and immunofixation electrophoresis. Clin Chem

Atellica, BN and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc., or its affiliates. All other trademarks and brands are the property of their respective owners.