Description

SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography). The product is intended for the qualitative detection of antigen against SARS-CoV-2 in clinical samples (nasal swab). Kit containing 25 tests

For Professional Use Only

Intended Use
The product is intended for the qualitative detection of antigen against SARS-CoV-2 in clinical samples (nasal swab).

Summary
Coronavirus, as a large virus family, is a single positive stranded RNA virus with envelope. The virus is known to cause major illnesses such as colds, Middle East Respiratory Syndrome (MERS), and Severe Acute Respiratory Syndrome (SARS). The core protein of SARS-CoV-2 is the N protein (Nucleocapsid), which is a protein component located inside the virus. It is relatively conserved among β-coronaviruses and is often used as a tool for the diagnosis of coronaviruses. ACE2, as a key receptor for SARS-CoV-2 to enter cells, is of great significance for the research of viral infection mechanism./p>

Principle
The current test card is based on the specific antibody-antigen reaction and immunoanalysis technology. The test card contains colloidal gold labeled SARS-CoV-2 N protein monoclonal antibody which is pre-coated on the combination pad, matched SARS-CoV-2 N protein monoclonal antibody immobilized on the Test area (T) and corresponding antibody in the quality control area (C). During testing, the N protein in the sample combines with the colloidal gold labeled SARS-CoV-2 N protein monoclonal antibody which is pre-coated on the combination pad. The conjugates migrate upward under capillary effect, and subsequently captured by the N protein monoclonal antibody immobilized in the Test area (T). The higher the contents of N protein in the sample, the more the conjugates captures and the darker the color in the test area is. If there is no virus in the sample or the virus content is lower than the detection limit, then there is no color demonstrated in the test area (T). Regardless of the presence or absence of the virus in the sample, a purple stripe will appear in the quality control area (C). The purple stripe in the quality control area (C) is a criterion for the judgment of whether or not there is enough sample and whether or not the chromatography procedure is normal.

Component
The product consists of test cards, Instructions for use, sample treatment solution. And in each test card bag, it includes one SARS-CoV-2 antigen detection card and one package of desiccant. The test card consists of gold standard mat (coated with colloidal gold labelled SARS-CoV-2 N protein monoclonal antibody), sample mat, nitrocellulose membrane (Test area (T) is coated with an SARS-CoV-2 N protein monoclonal antibody; the quality control area (C) is coated with goat anti-mouse antibody), absorb- ing paper, and hydrophobic stiff card.

Storage and Stability
It should be stored at 4°C~ 30°C, be kept dry and away from sunlight. The shelf life is 12 months. For per test card, it should be used within 1 hour after unsealing. Production Date and Expiration date are shown in the package label.

Sample Requirements
The product is used to test the human nasal swab sample. Sample collection: During the collection procedures for samples, take care to make proper protection, and avoid direct contact with the sample. In case of accidental contact, disinfection treatment should be carried out in time and necessary measures should be taken. Nasal swab sample: gently and slowly insert the swab into the nasopharynx through the nasal cavity. When resistance is encountered, the swab will arrive at the posterior nasopharynx. After a few seconds of suction, gently rotate the swab, then take out the swab to obtain the nasal swab sample. Sample preservation: after sample collection, please complete the test within 1 hour. The sample should come to room temperature before testing.

Test Method
Please read the instruction for use carefully before performing the test. Before testing, restore the reagents and sample to room temperature.
1. Remove the test card from the test card bag and use it within 1 hour, especially in the environment with room temperature higher than 30 ° C or in high humidity.
2. Place the test card on a clean platform. Drip 5 drops of the sample treatment solution to well A.
3. Thread the swab head through the bottom of well B into well A and rotate it two rounds clockwise and counterclockwise respectively in the sample treatment solution.
4. Remove the protective cover of the fixing glue. Stick the left and right sides together and start timing. Wait until the purple band appears. The test result should be read within 15-20 minutes.

The Explanation of the Testing Results
• Positive (+): There appear purple stripes in both quality control area (C) and either test area (T).
• Negative (-): There is only one purple stripe in the quality control area (C), and without purple stripe in either test area (T).
• Invalid: There is no purple stripe in the quality control area (C), or there is blue stripe in the quality control area (C), indicating incorrect operating procedures or the test card has already deterio- rated. Under this condition, it must read the instruction for use again carefully, and then use the new test card to test again. If the problem still exists, stop using the products with same lot number and contact the local suppliers immediately.

Limitation of Procedure
1. The test results of this product should be comprehensively judged by the physician in combination with other clinical information, and should not be used as the only criterion;
2. The product is used to test the SARS-CoV-2 antigen of the clinical sample.

No more offers for this product!

Shipping Policy

TERMS & CONDITIONS
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Copyright

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Transactions

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Disclaimer

The information you find on this website, have the meaning of a general informative reference. Although we make every reasonable effort for its accuracy, you should keep in mind that we do not provide any guarantee of validity. Consequently, we do not have any responsibility or liability to you or anyone else for any loss or damage that may arise, directly or indirectly, from the use of this information.

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It should not be considered, in any case, that the responsibility lies with the “Hypermall.club”

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Refund Policy

TERMS OF RETURNS – CHANGES

1. Returns are made on products with their tab and their original packaging.

2. Returns are made within 15 days from the day of receipt of the order by the customer from the courier company.

3. The return-change must be accompanied by a copy of the Retail Receipt or the change card.

4. With the return of the product, you will have to place a new online order where you will state in the comments that IT CONCERNS CHANGE.

5. If you want a refund, it will be necessary to send us along with the receipt of your order an accompanying note with: The IBAN number, the name of the beneficiary and the bank where you declare the refund.

6. Changes are made through our online store or the corresponding store hosted at hypermall.club, with the Retail Receipt or change card.

7. Items changes in discount or offer are changed at the current price and do not change after the end of discounts and offers.

PROCEDURE FOR CHANGE OF NON-DEFECTIVE PRODUCT

1. Send the product at the recipient’s charge hypermall.club, with the Courier company obligatorily together with a copy of the Retail Receipt, stating in a note the reason for the change / return of the product.

2. In the return package you mention: To e-Target Mesogeion 2 – Athens tower building B1st floor – Athens – 115 27.

3. At the same time you place a new order with the product you want in the online store and in the COMMENTS field you enter the word CHANGE and the number that it is a change as well as the number of the Retail Receipt.

4. When we receive the product of the shipment, the process of sending the new order will begin.

PROCEDURE FOR RETURNING A NON-DEFECTIVE PRODUCT

1. Send the product at your own expense, with a courier company, together with a copy of the Retail Receipt, stating the reason for changing / returning the product.

2. In the return package you mention: To e-Target Mesogeion 2 – Athens tower building B1st floor – Athens – 115 27.

3. The package includes your complete details (name, contact phone, account number, IBAN, bank) and a mandatory copy of the Retail Receipt.

4. Once we receive the product, the copy of the receipt and your complete details, the refund process begins.

5. The deposit is made within a period of 15 working days from the receipt of the product (value of the product without shipping costs). DEFECTIVE PRODUCTS: All parcels are inspected by company personnel before shipment. However, in case you find a problem, you should send an email to info@hypermall.club within 24 hours from the time of delivery, expressing your reservations. In case the product is defective and the wear is normal, the product is sent to hypermall.club with the courier company Courier at the recipient’s expense, according to the Return-Exchange procedure. The product is replaced and returned to the customer at the expense of hypermall.club. In order for a product to be accepted as defective, the wear must not be from misuse of the product. In case it is found that the damage is due to misuse of the customer, then the same product is returned to the customer with shipping costs borne by the customer.

Cancellation / Return / Exchange Policy

TERMS OF RETURNS – CHANGES

1. Returns are made on products with their tab and their original packaging.

2. Returns are made within 15 days from the day of receipt of the order by the customer from the courier company.

3. The return-change must be accompanied by a copy of the Retail Receipt or the change card.

4. With the return of the product, you will have to place a new online order where you will state in the comments that IT CONCERNS CHANGE.

5. If you want a refund, it will be necessary to send us along with the receipt of your order an accompanying note with: The IBAN number, the name of the beneficiary and the bank where you declare the refund.

6. Changes are made through our online store or the corresponding store hosted at hypermall.club, with the Retail Receipt or change card.

7. Items changes in discount or offer are changed at the current price and do not change after the end of discounts and offers.

PROCEDURE FOR CHANGE OF NON-DEFECTIVE PRODUCT

1. Send the product at the recipient’s charge hypermall.club, with the Courier company obligatorily together with a copy of the Retail Receipt, stating in a note the reason for the change / return of the product.

2. In the return package you mention: To e-Target Mesogeion 2 – Athens tower building B1st floor – Athens – 115 27.

3. At the same time you place a new order with the product you want in the online store and in the COMMENTS field you enter the word CHANGE and the number that it is a change as well as the number of the Retail Receipt.

4. When we receive the product of the shipment, the process of sending the new order will begin.

PROCEDURE FOR RETURNING A NON-DEFECTIVE PRODUCT

1. Send the product at your own expense, with a courier company, together with a copy of the Retail Receipt, stating the reason for changing / returning the product.

2. In the return package you mention: To e-Target Mesogeion 2 – Athens tower building B1st floor – Athens – 115 27.

3. The package includes your complete details (name, contact phone, account number, IBAN, bank) and a mandatory copy of the Retail Receipt.

4. Once we receive the product, the copy of the receipt and your complete details, the refund process begins.

5. The deposit is made within a period of 15 working days from the receipt of the product (value of the product without shipping costs). DEFECTIVE PRODUCTS: All parcels are inspected by company personnel before shipment. However, in case you find a problem, you should send an email to info@hypermall.club within 24 hours from the time of delivery, expressing your reservations. In case the product is defective and the wear is normal, the product is sent to hypermall.club with the courier company Courier at the recipient’s expense, according to the Return-Exchange procedure. The product is replaced and returned to the customer at the expense of hypermall.club. In order for a product to be accepted as defective, the wear must not be from misuse of the product. In case it is found that the damage is due to misuse of the customer, then the same product is returned to the customer with shipping costs borne by the customer.

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