COVID-19 Antigen Rapid Test Kit (Colloidal Gold)

1.【CATALOG NO. AND PACKING SPECIFICATION 】

2.【INTENDED USE】

The COVID-19 Antigen Test Kit is used for rapid qualitative detection of SARS-CoV-2 virus nucleocapsid antigen in the anterior nasal cavity (wet nasal cavity) of the suspected sars-cov-2 patients within 7 days after symptoms.

Only for in vitro diagnostic use.【STORAGE AND STABILITY】

1. Store at 2℃ to 30℃ in the sealed pouch up to the expiration date (24 months).

2. Keep away from sunlight, moisture and heat.

3. DO NOT FREEZE.

4. When the humidity is below 60%, use it within 1 hour after opening. When the humidity is above 60%, use it immediately after opening. Production date, expiry date will be in the label.

3.【TEST PROCEDURE】

1. Specimen extraction

1. Add 0.5mL (about 10 drops) of the sample extraction buffer into the extraction tube.
2. Insert the swab into the extraction tube which contains 0.5mL of the extraction buffer. Roll the swab at least 6 times while pressing the head against the bottom and side of the extraction tube.
3. Leave the swab in the extraction tube for 1 minute.
4. Squeeze the tube several times with fingers from outside of the tube to immerse the swab. Remove the swab. The extracted solution will be used as test sample.
5. Fit the dropper tip with filter on top of the extraction tube tightly.

2. Detection operations:

1. Open a pouch containing a test cassette. Place the test cassette on a dry, horizontal work surface.
2. Add 2 drops (about 60μl) of sample solution extract to the sample well of the test cassette.
3. Observe the results showed within 10-15 minutes, and the results showed after 15 minutes have no clinical significance.

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4.【INTERPRETATION OF RESULTS】

Negative : Only a red line appears in the quality control area (C), and no line appears in the test area (T).

Positive : Two red lines appear. One is in the test area (T) and the other is in the quality control area (C).

Invalid : No red line displays in the quality control area (C). This indicates that the incorrect operation or the test cassette has deteriorated or damaged. Repeat the test with a new kit. If the problem persists, stop using this lot number immediately and contact your local supplier.

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Biovantion Inc is independent from international department of Bioneovan Co., Ltd., which established in 2 0 0 5, is an in vitro diagnostic reagents manufacturer engaged in the research, development, production, and focus on clinical testing for infectious diseases, such as Hepatitis virus, Noro virus, Parvo virus test kits, our products include rapid test cassette and Elisa kits.

All our products have been registered in National Medical Products Administration of China, in year 2020 we get Certificate of ISO 13485:2016 – QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES from SGS. More importantly, we have awarded the registration certificate from National Medical Products Administration for Diagnostic Kit for IgM Antibody to COVID-19 and IgG antibody to COVID-19 during the outbreak in China, and also we developed COVID-19 Antigen test ; Neutralizing Antibody Test, these products selling well all overthe world