【Product name】
D-Dimer Rapid Quantitative Test(Fluorescence immunoassay)
【Package specification】
20 Tests/box
【Intended use】
This kit is used for quantitative determination of D-dimer in human
whole blood and plasma.
| Name | Quantity | Component |
| Test card | 25 | It is composed of fluorescent pad (coated with fluorescent labeled
D-dimer monoclonal mouse antibody), nitrocellulose membrane (coated
with D-dimer monoclonal mouse antibody and Goat anti mouse IgG
antibody), absorbent paper and backing |
| Sample buffer | 25(300μL/tube) | Phosphate buffer |
| ID card | 1 | Record the standard curve information of this kit |
The components in different batches of kits cannot be used
interchangeably.
【Storage conditions and validity】
The test card should be stored at 4℃~30℃, dry, dark and no
freezing. It should be stored in sealed aluminum foil bag and valid
for 12 months. The test card should be returned to room temperature
(15℃~30℃) before opening. It 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】
NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech.
Inc.
【Procedure】
- Before the test, please read the instructions completely. If the
test card and sample are stored in cold storage, they should be
balanced at room temperature (15-30)℃ for not less than 30min
before use.
- Start NIR-1000 dry fluoroimmunoassay analyser according to the
instruction manual of the instrument, and carry out quality control
verification according to the instruction manual of the
instrument(Note: the reagent has been calibrated in advance, and
the calibration curve parameters of each batch of reagent have been
stored in the information card. The information card is inserted
before use, so it is not necessary to calibrate again, and the test
can be carried out only after the quality control is passed;
Otherwise, the cause should be found out before testing.)
- Remove the test card from the aluminum foil bag and use it within
15 minutes.
- Place the test card on a clean horizontal table and mark it
horizontally.
- Mix 10 µL of patient sample with 300µL of sample diluent. Apply 100
µL of diluted samples to the well of the test card.
- Insert the test card into NIR-1000 dry fluoroimmunoassay analyser,
press the [timing detection] key, automatically time for 10
minutes, automatically judge the test results, and display the
quantitative results on the screen. Or insert the test card into
the analyzer after timing for 10 minutes, and press the [real time
detection] key, and the instrument will automatically interpret the
test results.
【Performance】
1. Analysis sensitivity
No more than 40ng/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 (40 ~ 10000ng/ml), the linear correlation
coefficient R≥0.990.
Packing: Standard packing, neutral packing, OEM packaging are
welcome;
Delivery: According to the specific quantity of the product;
Payment: Credit Card, Paypal, Local Bank, Western Union, T/T, etc.
Shipping: International Express, by Air, by Sea, etc;
1. International Express
For MOQ (2ctns to 5ctns),we will recommend you ship the goods by
international express(DHL, FedEx, EMS, TNT etc, are all available.)
The goods will be shipped within 10~15 days after received the full
payment.
2. Air Transportation
Between 5ctns to 10ctns, we will recommend you ship the goods by
air. The goods will be shipped within 15~30 days after received the
full payment.
3. Sea Transportation
More than 10 ctns we will recommend you ship the goods by sea. The
goods will be shipped within 30~45 days after received the full
payment.
