Features:

• • • Quantitative, non-subjective results
    • Increased sensitivity and broader detection range compared to rapid tests
    • Range
      •  Working range: 0.5-500.0 ng/mL

      Precision

       Intra-lot Precision

      •  Intra-lot precision was determined by testing of CEA reference materials using 10 test devices from the same lot.  CV ≤ 15%.

      Inter-lot Precision

      •  Inter-lot precision was determined by testing of CEA reference materials using 30 test devices from three consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.

      Accuracy

      • CEA control materials with three different concentrations were tested by every lot of test device, and the deviations were within ±15%.

      Linearity

      • A serial concentration of CEA reference materials at 1-500.0 ng/mL was tested, and the correlation coefficient (R) is ≥ 0.9900.

      Hook Effect

      •  There is no Hook effect when the level is 100000.0 ng/mL.

      Reagents and Materials provided:

      1. Individually sealed foil pouches containing:
         1.  One test device
         2.  One desiccant
      2. Detection buffer tubes
      3. SD card
      4. Instructions for Use

      Materials required but not provided:

      1. Clock or timer
      2. RaFIA Immunofluorescence Analyzer
      3. RaFIA Immunofluorescence Incubator