COVID-I9 Antigen Lateral Flow Assay

COV1D-19 Antigen Lateral Flow Assay

[Intended Use]
The COV1D-19 Antigen Lateral Flow Assay is a lateral flow immunoassay intend for the qualitative detection SARS-CoV--2 nucleocapsid antigens in nasopharyngeal swab and oropharyngeal swab from individuals who are suspected of COV1D-19 by their healthcare provider.
[Component]

• COV1D-19 Antigen Detection Cassette: 20

• Sample Extraction Reagent: 10.0 mL/vial×1 vial

• Sterilized Swab: 20

• Extraction Tube: 20

• Dropper Tip: 20

• Package Insert

[Storage Conditions and Validity]
Store at 2-30℃ for 12 months, store in a dry and cool place.
The COV1D-19 Antigen Detection Cassette should be used within 1h when taken out from aluminum foil bag.
The Sample Extraction Reagent can be stored for 1 month after opening.
[Warnings and Precautions]

• For in vitro diagnostic use only.

• For healthcare professionals and professionals at point of care sites.

• Do not use this product as the sole basis to diagnose or exclude SARS-CoV--2 infection or to inform infection status of COV1D-19.

• Do not use after the expiration date.

• Please read all the information in this leaflet before performing the test.

• The test cassette should remain in the sealed pouch until use.

• All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.

• The used test cassette should be discarded according to federal, state and local regulations.

[Specimen]

• Nasopharyngeal Swab Sample

• Oropharyngeal Swab Sample

[Test Procedure]

1. Allow the test device and specimens to equilibrate to temperature (15-30℃ or 59- 86℉) prior to testing.

2. Remove the test cassette from the aluminum foil bag.

3. Reverse the specimen extraction tube, holding the specimen extraction tube up right, transfer 2 drops (approximately 60 μL) to the specimen well(S) of the test cassette, then start the timer. See illustration below.

4. Wait for colored lines to appear. Interpret the test results at 15 minutes. Do not red results after 20 minutes.

[Interpretation of results]
Positive: Two lines appear. One colored line should be in the control region (C), and another apparent colored line adjacent should be in the test line (T).
Negative: One colored line appears in the control region (C). No line appears in the test line (T).
Invalid: Control line fails to appear.