Features:

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

  RANGES

  • Working range: 0.30-200.00 mIU/mL

  PRECISION

  • Intra-lot Precision
    Intra-lot precision was determined by testing of FSH reference materials using 10 test devices from the same lot. CV ≤ 15%.
  • Inter-lot Precision
    Inter-lot precision was determined by testing of FSH reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.

  ACCURACY

  • FSH 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 FSH reference materials at 1.00-200.00 mIU/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