Features:

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

RANGES:

• Working range: 5.0-200000.0 mIU/mL

PRECISION:

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

• Inter-lot Precision: Inter-lot precision was determined by testing of β-hCG reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.

ACCURACY:

•  β-hCG control materials with two different concentrations were tested by every lot of test device, and the deviations were within ±15%.

LINEARITY:

•  A serial concentration of β-hCG reference materials at 5.0-200000.0 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
  4. 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