Free Light Chain Kappa Assay (510k Cleared)

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Product Features

Diazyme's Free Light Chain Kappa (ƙ) assay has excellent linearity across the Analytical Measuring Range (AMR) in standard mode: 4.5 – 150 mg/L ; extended mode: 4.5 – 3000 mg/L. The method comparison gave a linear regression coefficient of 0.977, a slope of 0.958 and y-intercept of -2.536 mg//L. Precision of the assay was evaluated according to the CLSI EP5-A guidelines and has a Within-Run precision from 1.1% - 7.9% and a Total Precision of 1.7% - 11.7%. The Kappa assay displays outstanding sensitivity with an LOD of 2.0 mg/L; LOQ of 4.5 mg/L; and a LOB determined to be 1.2 mg/L.

Assay Principle

Diazyme>Human Kappa (ƙ) Free Light Chain Assay is based on a latex enhanced immunoturbidimetric assay. Kappa FLC in the sample binds to specific anti-Kappa 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 Kappa FLC in the sample. The instrument calculates the Kappa FLC concentration by interpolation of obtained signal of a 6-point calibration curve prepared from calibrators of known concentrations.

Intended use

Diazyme>The Diazyme Human Kappa (ƙ) Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Kappa 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 Format Method
Kit DZ169A R1/R2 (Dual Vial Liquid Stable) Dual Vial Liquid Stable,
Calibrator DZ169A-CAL Cal: 5 Level  
Control DZ169A-CON Con: 2 Level  
Regulatory Status