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
 
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N Latex FLC kappa and N Latex FLC lambda Assays

N Latex FLC kappa and N Latex FLC lambda Assays

Free Light Chains (FLC) kappa and lambda assays1 for use on BN™ II and BN ProSpec® Systems are designed for improved management of patients with monoclonal gammopathies. Optimized lot-to-lot to reproducibility leads to consistent and reliable results that allow safe diagnosis 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 on the BN II and BN ProSpec Systems.

  • High specificity based on monoclonal antibodies
  • Excellent lot-to-lot reproducibility
  • Pre-reaction protocol ensuring 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 Assist with Refined Management Strategy

Since 2009, the determination of free light chains (FLC) is part of the officially recommended screening panel for multiple myeloma.2,3 Furthermore, FLC determination provides prognostic information and helps in monitoring therapy success. Reliable results are a prerequisite for a consistently high sensitivity in screening and a sensitive detection of changes in follow-up.

Can Optimized 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 reliable and convenient way to determine free light chains on Siemens automated immunonephelometric systems.
          

Excellent lot-to-lot consistency

  • Adds consistency to patient results. Reliable follow-up of patients with different reagent lots.
  • Allows accurate patient screening and monitoring of therapy, e. g. for myeloma patients.
  • Ensures optimized patient management by earlier recognition of a potential relapse or resulting therapy adjustments – overall an improved patient outcome.

 

Improved antigen excess security

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

 

Convenient packaging concept

  • Reduce costs by high flexible and reagent independent packaging concept: all components can be ordered separately. Neither waste nor lack of standard and controls.
  • Add confidence to screening and monitoring of monoclonal gammopathies with assays and systems from Siemens.
Assay principle Latex-enhanced immunonephelometry
Sample type Serum, heparin, and EDTA plasma
Measuring time 12 minutes
Reference range FLC kappa: 6.7 – 22.4 mg/L
FLC lambda: 8.3 – 27.0 mg/L
FLC ratio: 0.31 – 1.56
Total measuring range 0.17 –  ≥ 2,000 mg/L for FLC kappa
0.47 – ≥ 6,000 mg/L for FLC lambda
Initial measuring range 3.5 – 110 mg/L for FLC kappa
1.9 – 60 mg/L for FLC lambda C
Once-opened reagent stability 4 weeks
Calibration frequency 6 weeks
Precision Repeatability: < 5%
Within-lab: < 6.5%
Antigen excess security FLC kappa: up to 23,000 mg/L
FLC lambda: up to 57,000 mg/L

Technical Specifications

Comparison of immunoassays against immunofixation, number of abnormal results:

IFE, kappa positive N Latex FLC kappa assay Competitive FLC kappa assay
60 60 59 (98.3%)
     
IFE, lambda positive N Latex FLC lambda assay Competitive FLC lambda assay
59 59 (98.3%) 56 (94.9%)
     
IFE, kappa and/or lambda positive N Latex FLC ratio assay Competitive FLC ratio
115 105 (91.3%) 103 (89.6%)

Comparison of N Latex FLC and a competitive FLC assay

(N=152, categorized as abnormal low, normal, abnormal high):

  Agreement rate Cohen’s coefficient
FLC kappa 90.1% 0.76
FLC lambda 81.5% 0.65
FLC ratio 92.2% 0.87

Lot-to-Lot Comparison

Comparison of 3 independent reagent lots including 2 different (lot-independent) standard lots (N=95)

Assays

Analytical Assays Performance

Assay principle Latex-enhanced immunonephelometry
Sample type Serum, heparin, and EDTA plasma
Measuring time 12 minutes
Reference range FLC kappa: 6.7 – 22.4 mg/L
FLC lambda: 8.3 – 27.0 mg/L
FLC ratio: 0.31 – 1.56
Total measuring range 0.17 –  ≥ 2,000 mg/L for FLC kappa
0.47 – ≥ 6,000 mg/L for FLC lambda
Initial measuring range 3.5 – 110 mg/L for FLC kappa
1.9 – 60 mg/L for FLC lambda C
Once-opened reagent stability 4 weeks
Calibration frequency 6 weeks
Precision Repeatability: < 5%
Within-lab: < 6.5%
Antigen excess security FLC kappa: up to 23,000 mg/L
FLC lambda: up to 57,000 mg/L

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Related Products, Services & Resources

1. (Not existing – TBA)
2. Kyle RA, Raikumar SV; Leukemia 2009; 23: 3-9.
3. Dispenzieri A, Kyle R, Merlini G, et al.; Leukemia 2009; 23: 215-24.

The products/features (mentioned herein) are not commercially available in all countries. Due to regulatory reasons their future availability cannot be guaranteed. Please contact your local Siemens Healthineers organization for further details.