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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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)

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