Features:
- Quantitative, non-subjective results
- Increased sensitivity and broader detection range compared to rapid tests
RANGES
- Working range: 0.4–100.0 μIU/mL
PRECISION
- Intra-lot Precision: Intra-lot precision was determined by testing of TSH reference materials using 10 test devices from the same lot. CV ≤ 15%.
- Inter-lot Precision: Inter-lot precision was determined by testing of TSH reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤20%.
ACCURACY
- TSH 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 TSH reference materials at 0.4-100.0 μIU/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
CATALOG # | PRODUCT | QUANTITY | SPECIMEN |
F1030 |
TSH FIA Test |
25/kit |
Serum, Plasma |