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