Features:

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

RANGES

• Working range: 4%–15%

PRECISION

• Intra-lot Precision
  Intra-lot precision was determined by testing of HbA1c reference materials using 10 test devices from the same lot. CV ≤ 15%
• Inter-lot Precision
  Inter-lot precision was determined by testing of HbA1c reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.

ACCURACY

• HbA1c 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 HbA1c reference materials at 4%–15% 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