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CTK BIOTECH, INC.
D-Dimer Fluorescence ImmunoAssay Test
Model: D-Dimer FIA Test
Description
The D-Dimer Fluorescence ImmunoAssay (FIA) Test is a lateral flow chromatographic fluorescence immunoassay for the quantitative detection of D-Dimer in human plasma or whole blood using the RaFIA system. This test is intended for in vitro diagnostic use only and was developed to detect D-Dimer within three minutes without the use of cumbersome laboratory equipment, and requiring minimally trained laboratory personnel.
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Features
• Quantitative, non-subjective results
• Increased sensitivity and broader detection range compared to rapid tests
• Working range: 0.1–10.0 mg/L
• Intra-lot precision was determined by testing of D-Dimer reference materials using 10 test devices from the same lot. CV ≤ 15%.
• Inter-lot precision was determined by testing of D-Dimer reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 15%.
• D-Dimer control materials with three different concentrations were tested by every lot of test device, and the deviations were within ±15%.
• A serial concentration of D-Dimer reference materials at 0.1–10.0 mg/L was tested, and the correlation coefficient (R) is ≥0.9900.
• Increased sensitivity and broader detection range compared to rapid tests
• Working range: 0.1–10.0 mg/L
• Intra-lot precision was determined by testing of D-Dimer reference materials using 10 test devices from the same lot. CV ≤ 15%.
• Inter-lot precision was determined by testing of D-Dimer reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 15%.
• D-Dimer control materials with three different concentrations were tested by every lot of test device, and the deviations were within ±15%.
• A serial concentration of D-Dimer reference materials at 0.1–10.0 mg/L was tested, and the correlation coefficient (R) is ≥0.9900.
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