Introduction:

SARS-CoV-2 Antigen Test Kit (LFIA) is a colloidal gold immunochromatography for the rapid qualitative detection of SARS-CoV-2 nucleocapsid antigens present in human anterior nasal samples in vitro. The test kit is designed for use as self-testing. This test kit is intended use for individuals by 18 or older with clinical symptoms of SARS-CoV-2 infection or who are suspected of COVID-19. Sensitivity up to 97% and Specificity up to 100%.

Kit Contents:

· Test Cassette (individually in a foil pouch with desiccant) * 5

· Lysis Buffer and Dropper * 5

· Anterior Nasal Swab * 5

· Instruction For Use (IFU)

· Bio-Safety Bag * 5

*Sampling method: Anterior Nasal Swab (CE0197)

Procedure:

1. Tear the seal of the lysis buffer and place it on the test-tube rack (on package box)

2. Insert the swab (stick with larger absorbent tip) into a nostril (2.5cm). Be sure to collect any nasal drainage that may be present. Carefully rotate the swab in a circular path against the inside of the nostril at least 5 times. Using the same swab repeat the procedure in the other nostril.

3. Insert the swab into the lysis buffer and rotate the swab against the inner tube wall 10 times.

4. Squeeze the swab from the outer tube wall 5 times. Lift the swab above the buffer solution, squeeze the swab from the outer tube wall one time to leave the sample in the tube as much as possible.

5. Break the swab and cover the dropper.

6. Add 4 drops processed sample extract into the sample well.**

7. Read the results in 15 minutes.***

**Open the foil pouch, then lay the test cassette on a clean flat surface.

***Result observed after 20 minutes is invalid.

Display of the result:

If both the quality control C line and the detection T line appear --> positive result

If only the quality control C line appears and the detection T line is not visible, the sample contains no SARS-CoV-2 antigens or the SARS-CoV-2 antigens concentration is lower than the limit of detection --> negative result

If C line does not appear, T line is not complete, or a reddish-purple background affects the interpretation --> invalid result, new test must be performed

Origin: China

Storage Instructions:

Test kit should be stored away from direct sunlight at 2°C to 30°C

Test kit should be used within 1 hour after opening the foil pouch

Manufacture date and expiry date: show on package

Warning and precautions:

1. This test kit is used for in vitro diagnosis only.

2. Store the kit in room temperature before testing

3. Do not re-use

4. Do not use the test kit if the pouch is damaged, the seal is broken or the test cassette is wet or polluted

5. Do not use expired test kit

6. When collecting an anterior nasal swab sample, use only the Anterior Nasal Swab provided in the Kit

Million Source Limited