







| Cystatin C Assay | |||
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| Product Features Diazyme’s Cystatin C assay is a convenient cost effective dual liquid stable latex enhanced immunoturbidimetric method for this critically important emerging marker in the early detection and diagnosis of renal disease. The assay is highly sensitive with a sensitivity of 0.068 mg/dL, and an extended linear range up to 8.0 mg/dL. The Diazyme method has an excellent correlation with existing commercially available products and is highly precise with intra and inter %CV <5.0%. Packaged for optimal operator convenience, reagent transfer can be eliminated for most chemistry systems with instrument specific packaging options including Roche Hitachi 917 series, Olympus AU (400/600/640/680), Beckman Synchron CX, LX and DXC and Dade Dimension and Expand. Reagents are stable for 24 months from date of manufacture when stored at 2°-8°C. |
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Assay PrincipleDiazyme's Cystatin C Assay is based on a latex enhanced immunoturbidimetric assay. Cystatin C in the sample binds to the specific anti-Cystatin C 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 Cystatin C in the sample. The instrument calculates the Cystatin C concentration of a patient specimen by interpolation of the obtained signal of a 6-point calibration curve. |
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| Intended use The Diazyme Cystatin C assay is an in vitro diagnostic test for the quantitative determination of Cystatin C in serum or plasma by latex enhanced immunoturbidmetric method. The measurement of Cystatin C is used as an aid in the diagnosis and treatment of renal disease. For in vitro diagnostic use only. |
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| Product | Catalog Number | Packaging | Method/Format |
| Kit (360 Tests) | DZ133C-K | R1: 1 x 100 mL R2: 1 x 20 mL |
Latex Enhanced Immunoturbidity Assay |
| Calibrator | DZ133C-Cal | 5 x 1 mL | |
| Control | DZ133C-Con | 2 x 1 mL | |
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