D-Dimer In Vitro Diagnostic Kits IFA Colloidal Gold POCT 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.

【Inspection principle】

The principle of immunofluorescence chromatography was applied to the kit. The D-dimer antigen in the sample was first bound with the conjugated compound of fluorescent labeled D-dimer monoclonal antibody, then moved and combined with another D-dimer monoclonal antibody fixed on the nitrocellulose membrane, and the double antibody sandwich complex was formed at the detection line of the cellulose nitrate membrane. The quantitative detection results were obtained by NIR-1000 dry fluoroimmunoassay analyser.

【Main components】

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.

【Sample requirements】

1. The sample types of this product are EDTA·K2 anticoagulant plasma, EDTA·Na2 anticoagulant plasma, sodium citrate (anticoagulant tube with the ratio of sodium citrate volume to blood collection volume of 1:9), EDTA·K2 anticoagulant whole blood, EDTA·Na2 anticoagulant whole blood and sodium citrate (anticoagulant tube with the ratio of sodium citrate volume to blood collection volume of 1:9).
2. Venous blood was collected according to routine laboratory methods to avoid hemolysis.
3. After clinical samples were collected, the detection was completed within 4 hours at room temperature (15℃~30℃). The whole blood sample can be stored for 24 hours at 2℃~8℃; Plasma samples can be stored at 2℃ to 8℃ for 7 days; The plasma sample was at - 20℃. It can be stored for 30 days at room temperature.
4. Before testing, the sample must return to room temperature (15℃~30℃). The frozen samples should be completely thawed, rewarming and mixed evenly before use, and repeated freezing and thawing should be avoided.

【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.

【Note】

1. This kit is only used for in vitro diagnosis.

2. The test card and sample diluent are disposable and cannot be reused.

3. Please check the integrity and validity of the kit package before use, and then open the package. When it is stored at low temperature, it should be restored to room temperature (15℃~30℃) before opening the package for use. The reagents with damaged inner package and beyond the validity period cannot be used.

4. The requirements of specimen collection and storage should be strictly observed. If the specimen is turbid, it should be centrifuged and discarded before use.

5. The used kits should be treated as potential infectious substances, and all samples, reagents and potential pollutants should be disinfected and treated according to the relevant local regulations.

Note:

1) Any variation in operator, pipetting and washing technique, incubation time or temperature, and kit age can cause variation in
result. Each user should obtain their own standard curve.
2) If samples have been diluted, the concentration read from the standard curve must be multiplied by the dilution factor.
3) If specimens generate values higher than the highest standard, dilute the specimens and repeat the assay

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FAQ:

1. What is the MOQ?

Generally if you choose the different products, our minimum order qty. also will be different. One sample available.

2. What about the delivery time?

The goods need 7-21 work days to be made upon deposit.

3. Does your product have any warranty?

Yes, we offer 6 months limited warranty for our products.

Damage due to misuse, ill treatment and unauthorized modifications and repairs are not covered by our warranty.

4. What's your shipping method?

We provide comprehensive shipping methods.

For small quantity orders we ship by DHL Air-Express, or EMS/TNT/UPS/FEDEX Express service, it is safe and fast.

For large quantity orders we ship by Air transportation or sea transportation, we can also ship order to buyer’s cargo agent in China.