COVID-19 Antigen Rapid Test Cassette
For the qualitative detection of SARS-CoV-2 antigen in human throat swab or nasal swab

INTENDED USE
COVID-19 Antigen Rapid Test Cassette is for in vitro qualitative detection of specific antigens to SARS-CoV-2 present in human throat or nasal cavity. It cannot be used as the basis for the diagnosis and exclusion of COVID-19.
This reagent is used to detect cases with suspected symptoms of COVID-19 within 7 days. If suspected symptoms are more than 7 days, it is recommended to test with COVID-19 antibodies or nucleic acid reagents.
The main clinical symptoms of COVID-19 are: Fever, dry cough, fatigue, a few patients will have stuffy nose, runny nose and diarrhea.

PRINCIPLE
This kit uses double antibody sandwich immunoassay to detect specific antigens to SARS-CoV-2 in human throat or nasal cavity.
The membrane was precoated with SARS-CoV-2 specific antibody on the test zone and goat anti mouse IgG antibody on the control zone. During the test, the specimen is allowed to react with SARS-CoV-2 specific antibody-colloidal gold particles conjugate, which was predried on the test. The conjugate binds to the SARS-CoV-2 forming an antibody~antigen complex. The complex moves forward on the membrane by the capillary action, then the complex is captured by specific antibody to SARS-CoV-2 on the test zone to produce a visual red color line. The color of line is positive correlated with the amount of SARS-CoV-2 in specimen.
Regardless of the presence of SARS-CoV-2, as the mixture continues to move across the membrane to the control zone, the complex is captured by immobilized goat anti mouse IgG antibody to form a distinct red line.

REAGENTS AND MATERIALS PROVIDED
MATERIALS REQUIRED BUT NOT PROVIDED
1. Timer or stopwatch
2. Biohazard disposal container
3. Disposable gloves
4. Disposable sampling swab

WARNING
For Medical Professional and In Vitro Diagnostic use ONLY
Read the package insert completely before use. It is very important that the correct procedure is followed. Fail to add the patient sample may lead to a false result.

PRECAUTIONS
1. This product is an in vitro diagnostic reagent to qualitatively detect the SARS-CoV-2 antigen in human throat or nasal cavity.
2. The reagent may cause false negative results in COVID-19 patients with asymptomatic infection.
3. Do not use the test if the pouch is damaged or the seal is broken.
4. Do not modify the test procedure.
5. Do not touch the reaction zone of the reagent.
6. Each test is for single use only.
7. Make sure the test is not expired (EXP Date is indicated on the kit box).
8. All the waste and specimen should be treated in case of transmitting disease and must be properly disinfected (autoclaving is preferred) before disposal.
9. Always interpret the results under good light conditions to avoid misreading of the results.
10. Different batch of product components cannot be mixed.
11. If desiccant bag is not present in the pouch, DO NOT USE the test.
12. Always add accurate volume of specimen by following the instruction.
13. The test cassette must be used directly after unsealing. It is not allowed to divide it for use.
14. If the reagent is stored in refrigerator, it should be restored to room temperature before testing.
15. Observe the result in 15~20 minutes. Interpret the test result after 20 minutes may cause false result.

STORAGE
COVID-19 Antigen Rapid Test Cassette should be stored in dark place at 2~30°C for 24 months from the date of manufacture.
Keep the test cassette in sealed pouch until use. Once you have taken the test cassette out of the pouch, use it immediately. Do not use the test beyond the indicated expiration date.

Rebecca Yan