Diazyme Laboratories, Inc. products

Diazyme`s Human Lambda Free Light Chain (FLC) 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.

Diazyme`s Human Kappa Free Light Chain (FLC) 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.

Diazyme`s D-Dimer Assay is a highly sensitive liquid stable latex enhanced immunoturbidimetric test kit, designed to work on most open clinical chemistry analyzers to provide rapid results with reduced reagent cost. The D-Dimer Assay has a linearity of 0.15 - 8.0 μg/mL FEU with a correlation coefficient value of 0.939, slope of 0.979 and y intercept of -0.106. The following substances do not interfere with this assay at the levels tested less than 10% bias: Hemoglobin up to 500 mg/dL, Bilirubin 40 mg/dL, Bilirubin conjugated 40mg/dL, Triglycerides 1000 mg/dL, Ascorbic Acid 176 mg/dL, Rheumatoid Factor 100 IU/mL, Heparin 1.5 IU/mL and HAMA 490 ng/mL.