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COVID-19 Antigen Rapid Test Cassette Swab (20 Test Box)

Coronavirus COVID-19 IgG/IgM Rapid Test

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⚕️Only Available for International Customers⚕️
⚕️In the USA only to High Complexity Labs⚕️

The Coronavirus Ag Rapid Test Cassette (Swab) is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect nucleocapsid protein from SARS-CoV-2 in nasopharyngeal (NP) swab. The test strip is composed of the following parts: namely sample pad, reagent pad, reaction membrane, and absorbing pad. The reagent pad contains the colloidal-gold conjugated with the monoclonal antibodies against the nucleocapsid protein of SARS-CoV-2; the reaction membrane contains the secondary antibodies for nucleocapsid protein of SARS-CoV-2.

This test is for detection of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Rapid diagnosis of SARS-CoV-2 infection will help healthcare professionals to treat patients and control the disease more efficiently and effectively.

FDA Acknowledgment Letter: FDA Letter

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Warning : This test has not been reviewed by the FDA. Negative results do not rule out SARS-CoV-2 infection, particularly those who have been in contact with the virus. Follow up testing with a molecular diagnostic test should be considered to rule out infection in these individuals.

Use of this test is limited to laboratories certified to perform high complexity testing, including testing at point-of-care when the site is covered by the laboratory's CLIA certificate of high-complexity testing.

This test is not for home-use or at-home specimen collection.

Product Non-Refundable, Non-Returnable

Orders would only be placed through our customer service

Our Price: $500.00

Product Code: AG-COVID

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Description

Product Insert

COVID-19 Antigen Test Kit Cassette Swab (20 Test Box)

COVID-19 Antigen Test Kit Cassette Swab

The Coronavirus Ag Antigen Test Kit Cassette (Swab) is an in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) swab specimens directly or after the swabs have been added to viral transport media from individuals who are suspected of COVID-19 by their healthcare provider. It is intended to aid in the rapid diagnosis of SARS-CoV-2 infections. The Coronavirus Ag Antigen Test Kit Cassette (Swab) does not differentiate between SARS-CoV and SARS-CoV-2.

Clinical Evaluation

Positive Percent Agreement (PPA): 95.7%
Negative Percent Agreement (NPA): 99.6%
Overall Percent Agreement (OPA): 98.9%

COVID-19 Antigen Test Cassette Swab Components:
- 20 Test Cassettes
- 20 Sterile Swabs
- 20 Extraction tubes & Dropper Tips
- 1 Workstation
- 2 Buffers
- 1 Package Insert
Procedure & Preparation
Specimen Collection
1. Carefully insert the swab into the nostril of the patient, reaching the surface of posterior nasopharynx, that presents the most secretion under visual inspection.
2. Swab over the surface of the posterior nasopharynx. Rotate the swab several times.
3. Withdraw the swab from the nasal cavity.
Sample Preparation Procedure
1. Insert the extraction tube into the workstation in this product. Make sure that the tube is standing firm and reaches the bottom of the workstation.
2. Add 0.8 mL (about 10 drops) of the sample extraction buffer in the extraction tube.
3. Insert the swab into the extraction tube which contains 0.3 mL of the extraction buffer.
4. Roll the swab at least 6 times while pressing the head against the bottom and side of the extraction tube.
5. Leave the swab in the extraction tube for 1 minute.
6. Squeeze the tube several times with the fingers from outside the tube to immerse the swab. Remove Swab. The extracted solution will be used as test sample.
Covid-19 Rapid Test Kit Procedure