Components
| Name | Quantity | Component |
| Test cards | 25 | It is composed of fluorescent pad (coated with fluorescent labeled
AFP monoclonal antibody), nitrocellulose membrane (coated with AFP
monoclonal antibody and Goat anti mouse IgG antibody), absorbent
paper and backing |
| Sample diluent | 25(300μL/tube) | Phosphate buffer |
| ID card | 1 | With specific stand curve file |
The components in different batches of kits cannot be used
interchangeably.
Storage conditions and validity
The kit should be stored at 4℃~30℃, out of direct sunlight. It is
valid for 18 months. The test card should be used within 15 minutes
after unsealing under the environment of 15℃~30℃ and 20% ~ 90%
relative humidity.
The production date, batch number and expiration date are shown in
the outer package of the product.
Applicable instruments
Mod:NIR-1000 Dry Fluoroimmunoassay Analyzer produced by WWHS
Biotech.Inc.
Sample requirements
1. Plasma, serum and whole blood can be used as samples. The whole
blood should be collected in a tube containing heparin, citrate or
EDTA as the anticoagulant. If the serum procedure is used, collect
blood in a tube without anticoagulant and allow clotting. Hemolyzed
samples should not be used. It is recommended to use serum samples
preferentially.
2. Venous blood was collected according to routine laboratory
methods to avoid hemolysis.
3. It is highly recommended to use fresh samples instead of keeping
the samples at room temperature for a long time. After samples were
collected, the detection should be completed within 4 hours at room
temperature (15℃~30℃). The whole blood sample can be stored at
2℃~8℃ for 24 hours. Plasma and serum samples can be stored at 2℃~
8℃ for 7 days, -20℃for 30 days.
4. Before testing, the sample should return to room temperature
(15℃~30℃). The frozen samples should be completely thawed,
rewarming and mixed evenly before use. Repeated freeze-thaw cycles
should be avoided.
Performance
1. Limits of detection No more than 5.0ng /ml.
2. Accuracy
The relative deviation from the target value is within ±15%.
3. Precision
The within and between assay coefficient of variations are within
15%.
4. Linear range
Within the linear range (5~ 400ng/mL), the linear correlation
coefficient R≥0.990.
produce.AFP.pdf
