Free Light Chain Lambda Assay (510k Cleared)

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Product Features

Diazyme's Free Light Chain Lambda (λ) assay has excellent across the Analytical Measuring Range (AMR) in standard mode: 6.1 – 200 mg/L ; extended mode: 6.1 – 4000 mg/L. The method comparison gave a linear regression coefficient of 0.972, a slope of 1.054 and y-intercept of 0.636 mg//L. Precision of the assay was evaluated according to the CLSI EP5-A guidelines and has a Within-Run precision from 1.1% - 6.5% and a Total Precision of 1.1% - 11.4%. The Lambda assay displays outstanding sensitivity with an LOD of 2.9 mg/L; LOQ of 6.1 mg/L; and a LOB determined to be 1.7 mg/L.

Assay Principle

Human Lambda (λ) Free Light Chain Assay is based on a latex enhanced immunoturbidimetric assay. Lambda FLC in the sample binds to specific anti-Lambda FLC antibody, which is coated on latex particles, and causes agglutination. The degree of the turbidity caused by agglutination can be measured optically and is proportional to the amount of Lambda FLC in the sample. The instrument calculates the Lambda FLC concentration by interpolation of obtained signal of a 6-point calibration curve prepared from calibrators of known concentrations.

Intended use

The Diazyme Human Lambda (λ) Free Light Chain Assay is in-tended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Lambda Free Light Chain (FLC) concentration in serum on Hitachi 917 analyzers. The measurement of Kappa FLC in conjunction with Lambda FLC aids in the diagnosis of multiple myeloma in conjunction with other laboratory findings. For in-vitro diagnostic use only.

Product Catalog Number Packaging Method/Format
Kit DZ170A R1/R2 (Dual Vial Liquid Stable) Dual Vial Liquid Stable,
Immunoturbidimetric
Calibrator DZ170A-CAL Cal: 5 Level  
Control DZ169A-CON Con: 2 Level  
Regulatory Status