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