D-Dimer Rapid Test Kit WWHS FIA POCT Fluorescence Immunoassay

D-Dimer Rapid Test Kit WWHS FIA POCT Fluorescence Immunoassay

Ⅰ.Product name

D-Dimer Rapid Quantitative Test(Fluorescence immunoassay)

Ⅱ.Product Form Description

The components in different batches of kits cannot be used interchangeably.
 

Ⅲ.Reagent use 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.

Ⅳ.Why to choose us?

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.

Ⅴ.Note

1. D-Dimer Rapid Quantitative Test 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 D-Dimer Rapid Quantitative Test 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 D-Dimer Rapid Quantitative Test 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.

Ⅵ.D-Dimer.pdf