FERR Real Time PCR Kits FIA IVD Rapid Quantitative Test Kit 25T POCT Assay

Product Specification

【Product name】

Diagnostic Kit for Serum Ferritin(Immunochromatographic assay)

【Package specification】

25 Tests/kit

【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.

【Test 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 20 µL of patient sample with 400µL 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 5 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 5 minutes, and press the [real time detection] key, and the instrument will automatically interpret the test results.

【Reference interval】

Through the determination of serum samples from 301 healthy people aged 10 ~ 87, the results were statistically analyzed.

【Performance】

1. Analysis sensitivity

No higher than 5ng/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 ~ 500ng/ml), the linear correlation coefficient R≥0.990.

【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.

FAQ

Q: What's the minimum order quantity (MOQ)?
A: For most of our medical products, even order for only one unit is warmly welcomed.

Q: Can you do OEM/ private label?
A: Of course we can do OEM/private label for you.

Q: How about your delivery time?
A: 2~10 day depends your order quantity.

Q: What is your terms of delivery?
A: DHL, UPS, FedEx, TNT, EMS, customer's freight forwarder is also available.

Q: What is your terms of payment?
A: Trade Assurance, T/T in advance, L/C, Western union, paypal
Please suggest your preferred payment method.

Q: Do you have certification?
A: ISO13485, CE

Q: Do you test all your goods before delivery?
A: Yes, we have 100% test before delivery

Q:How about after-sale serive ?
A:We will send you any parts within 15 months warranty, and supply you technology support for long time, solve problem as soon as possible