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:
- Individually sealed foil pouches containing:
a. One test device
b. One desiccant - Detection buffer tubes
- SD card
- Instructions for Use
MATERIALS REQUIRED BUT NOT PROVIDED:
- Clock or timer
- RaFIA Immunofluorescence Analyzer
- RaFIA Immunofluorescence Incubator
- REAGENTS AND MATERIALS PROVIDED:
- Individually sealed foil pouches containing:
a. One test device
b. One desiccant - Detection buffer tubes
- SD card
- Instructions for Use
MATERIALS REQUIRED BUT NOT PROVIDED:
- Clock or timer
- RaFIA Immunofluorescence Analyzer
- RaFIA Immunofluorescence Incubator
- Individually sealed foil pouches containing:
- Individually sealed foil pouches containing:
CATALOG # | PRODUCT | QUANTITY | SPECIMEN |
F1000 |
β-hCG FIA Test |
25/kit |
Serum, Plasma |