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N Latex FLC kappa and N Latex FLC lambda Assays

N Latex FLC kappa and N Latex FLC lambda AssaysAdd consistency to monoclonal gammopathy testing

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 Positive	N Latex FLC kappa Assay	FREELITE kappa
60	60 (100%)	59 (98.3%)

IFE, lambda Positive	N Latex FLC lambda Assay	FREELITE lambda
59	60 59 (98.3%)	56 (94.9%)

IFE, kappa and/or lambda Positive	N Latex FLC Ratio	FREELITE FLC Ratio
115	105 (91.3%)	103 (89.6%)

Comparison of N Latex FLC Assay and FREELITE FLC assay

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

(Reference: LD OUS N Latex FLC Add consistency to monoclonal gammopathy White Paper)

	Agreement rate	Cohen’s coefficient
FLC kappa	89.7%	0.80
FLC lambda	82.4%	0.67
FLC ratio	91.8%	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)

Reference: Velthuis et al. 2011: N Latex FLC – new monoclonal-based assays for FLC. Clin Chem Lab Med 2011;49(8):1323–1332 (literature number 3)

Technical Specifications

Analytical Assay Performance

Assay principle	Latex-enhanced immunonephelometry
Sample type	Human serum, EDTA plasma, heparinized plasma^†
Reference range	FLC kappa: 6.7 – 22.4 mg/L FLC lambda: 8.3 – 27.0 mg/L FLC ratio: 0.31 – 1.56
Initial measuring ranges	3.4–110 mg/L for FLC kappa 1.9–60 mg/L for FLC lambda
Total measuring range	0.17 – ≥ 2,000 mg/L for FLC kappa 0.47 – ≥ 9,000 mg/L for FLC lambda
Measuring time	12 minutes
Onboard reagent stability	2 weeks (Atellica NEPH 630* and BN ProSpec Systems) 5 days (6 days with evaporation stoppers) on BN II System
Calibration frequency	6 weeks
Precision	Repeatability: < 5% Within-lab: < 6.5%
Antigen-excess security	FLC kappa: up to 27,100 mg/L FLC lambda: up to 57,300 mg/L

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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

Some of the medical devices/features/applications listed may not yet be licensed for sale in Canada, in accordance with Canadian Law. Due to regulatory reasons, their future availability cannot be guaranteed. Please contact your local Siemens Healthineers organization for further details.

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