Features:

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

      RANGES

      • Working range: 1.0-80.0 ng/mL

      PRECISION

      • Intra-lot Precision
        Intra-lot precision was determined by testing of CK-MB reference materials using 10 test devices from the same lot. CV ≤ 15%.
      • Inter-lot Precision
        Inter-lot precision was determined by testing of CK-MB reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 15%.

      ACCURACY

      • CK-MB 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 CK-MB reference materials at 2.5-80.0 ng/mL was tested, and the correlation coefficient (R) is ≥0.9900.
      • REAGENTS AND MATERIALS PROVIDED:
        1. Individually sealed foil pouches containing:
           a. One test device
           b. 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