Product Description

2019nCov Ag Rapid Test Kit

What is a lateral Flow Antigen Test Kit?

2019-nCoV Rapid Lateral Flow Antigen Test Kit is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of SARS-CoV-2 virus antigen in nasopharyngeal swab specimens. 2019-nCoV Rapid Lateral Flow Antigen Test Kit cannot be used as the basis to diagnose or exclude SARS-CoV-2 infection.

The Principle:

2019-nCoV Rapid Lateral Flow Antigen Test is an immunochromatographic lateral flow device that employs the principle of double antibody sandwich method. Colloidal gold conjugated ant -SARS- CoV-2 antibodies are dry-mobilized on the test device. When the specimen is added, it migrates by capillary diffusion through the strip to re-hydrate the gold conjugate complexes. If present at or above the limit of detection on, SARS-CoV-2 viral antigens will react with the gold conjugate complexes to form particles, which will continue to migrate along the strip until the Test Zone (TJ where they are captured by the immobilized ant -SARS-CoV-2 antibodies to form a visible red line.

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PRINCIPLE OF THE TEST

This test uses double-antibody sandwich to legally detect the antigen of novel coronavirus (2019-nCoV) in saliva samples. During detection, the gold labeled anti-2019-nCoV monoclonal antibody in the labeling pad binds to the 2019-nCoV antigen in the sample to form a complex, and the reaction complex moves forward along the nitrocellulose membrane under the action of chromatography, it is captured by the anti-2019-nCoV monoclonal antibody pre-coated by the detection zone (T) on the nitrocellulose membrane, and finally a red color reaction line is formed in the T zone. If the sample does not contain 2019-nCoV antigen, a red color reaction line cannot be formed in the T zone. Regardless of whether the sample to be tested contains 2019-nCoV antigen, a red reaction line will always form in the quality control area (C).

MATERIALS AND COMPONENTS

Materials provided with the test

Materials required but not provided

• Timer

STORAGE AND STABILITY

• Store the test as packaged between 2-30°C.
• The Test stable until the expiration date printed on the outer packing, the product will be expired after 24 months.
• Do not use beyond the expiration date.
• Do not freeze any contents of the test
• The test must remain in the sealed pouch until use.

TEST PROCEDURE

Before test, please read the instructions carefully.

• Take the cassette to equilibrate to room temperature.
• Unpack the aluminum foil bag, take out the cassette.
• Insert the absorber end of the cassette into mouth. Make sure cassette is horizontal statement.

• Actively swab the inside of the mouth and tongue to collect oral fluid.
• Remove the absorber end from the mouth when the purple color move across the result window in the center of the test device.
• Wait for 10 minutes and read the results.

NOTE:

*When sampling, gently hold it in mouth and let saliva naturally adsorb on the sponge.

*Do not eat, drink, or smoke prior to the test for at least 30 Minutes.

*Any saliva specimen is appropriate for testing but the saliva specimen collected in the morning, before mouth rinsed, eating or drinking, is recommended