Features:

• • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests

  Range

  • Working range: 0.2-8.0 mg/L

  Precision

  Intra-lot Precision

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

  Inter-lot Precision

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

  Accuracy

  • Cys-C 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 Cys-C reference materials at 0.4-8.0 mg/L was tested, and the correlation coefficient (R) is ≥ 0.9900.
  • 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