WWHS Cardiac Testing Kit IFA Colloidal Gold IVD D-Dimer Diagnostic

Product Specification

【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.

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】

1. 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.
2. 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.)
3. Remove the test card from the aluminum foil bag and use it within 15 minutes.
4. Place the test card on a clean horizontal table and mark it horizontally.
5. Mix 10 µL of patient sample with 300µL of sample diluent. Apply 100 µL of diluted samples to the well of the test card.
6. 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.