S100-β POCT Test Kit FIA Rapid Antigen Test Kits NIR-1000 Dry Fluoroimmunoassay analyser

【Product Name】S100.pdf

Diagnostic Kit for S100β protein(Immunochromatographic assay)

【Intended Use】

The kit should be stored at 4℃~30℃, out of direct sunlight. It is valid for 18 months. The test card should be used within 15 minutes after unsealing under the environment of 15℃~30℃ and 20% ~ 90% relative humidity. The sample buffer is disposable and used immediately after opening the cap.

The production date, batch number and expiration date are shown in the outer package of the product.

【Components】

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

【Applicable Instrument】

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 and correctly select the corresponding sample type on the instrument.
3. Take out the ID card, make sure that the batch number of the ID card is consistent with that of the test card, and insert the ID card into the ID card port of the instrument.
4. Take out the test card from the aluminum foil bag and use it within 15 minutes.
5. Place the test card on a clean horizontal table and mark it horizontally.
6. Mix 100 µL of urine sample with 200µL of sample diluent. Apply 100 µL of diluted samples to the well of the test card.
7. Insert the test card into NIR-1000 dry fluoroimmunoassay analyser and click the “instant test” button to read the results at 10 minutes after addition of samples.

【Reference interval】

S100β normal reference value is less than 0.20ng/mL. It is strongly recommended that each laboratory should determine its own normal and abnormal values.

【Interpretation of test results】

1. The kit can be used for auxiliary test only. If test result is abnormal, retest timely and judge combined with clinical symptoms.
2. For samples whose S100β concentration is lower than 0.05ng/mL and higher than 10.00ng/mL, test result is “＜0.05ng/mL” and “＞10.00ng/mL” respectively.

【Performance】

1. Limits of detection

No higher than 0.05ng/mL

2. Accuracy

The relative deviation to the target value is limited to ±15.0%.

3. Precision

The within and between assay coefficient of variations are within 15%.

4. Linear range

Within the linear range [0.05,10.00]ng/mL, the linear correlation coefficient R≥0.990.

【Note】

1. The kit can be used for in vitro diagnosis only.

2. Test card and buffer solution are single-use and they 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. Take the test card out of the aluminum foil bag and carry out experiment in 15min. Do not place it in the air for a long time to avoid dampness.

5. It is required to strictly comply with the requirements for sample collection and storage. If the sample is turbid, please centrifuge and precipitate it before use.

6. The kit used should be disposed of as latent infective material, and all samples, reagents and latent contaminants should be disinfected and disposed of according to relevant local regulations.