Product Description

1. COVID-19 Antigen Rapid Test (Oral Fluid) is a single use test kit intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 in human oral fluid.

2. Home use with self-collected oral fluid samples

Target Group

1. Intended for use in symptomatic individuals meeting the cases definition for COVID-19

2. Asymptomatic individuals limited to contacts of confirmed COVID-19 cases or probable cases

3. At-rish health workers

4. Individuals with the following symptoms, such as fever, fatigue, dry cough, nasal congestion, runny nose, sore throat, myalgia and diarrhea.

Active Ingredients

1. Goat anti Mouse IgG

2. Mouse IgG

3. Nucleocapsid protein antibody 1

4. Nucleocapsid protein antibody 2

Before testing

Do not place anything in the mouth including food, drink, gum or tobacco products for at least 10minutes prior to collection.

Wash your hands with soap and water for at least 20 seconds before testing. If soap and water are not available, use hand sanitizer with at least 60% alcohol.

Directions for use

Step 1: Specimen collection

Remove the funnel and plastic tube; fit the funnel onto the tube

Deepyly cough 3-5 times.

Note: Wear a face mask or cover your mouth and nose with a tissue when you are coughing and keep distance with other people.

Gently spit oral fluid into the funnel.

The oral fluid (non-bubble) should just reach the height of scale line.

Note: If there’s not enough oral fluid collected, repeat the above specimen collection steps.

Place the used funnel into the plastic Biosafety Bag.

Step 2: Specimen preparation

1Tear to open the buffer and add entire buffer to the tube with oral fluid. Fit the tube tip onto the tube. Gently squeeze the tube 10-15 times to mix well.

Step 3: Testing

Remove the test device from the sealed foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.

Place the test cassette on a flat and level surface.

Invert the tube and add 2 drops of solution to the specimen well(S) of the test device and then start the timer.

Do not move the test cassette during test developing.

Step 4: Read the results at 15minutes

Do not interpret the result after 20 minutes.

After test is completed, place all the components of the test kit in plastic Biosafety Bag and dispose according to local regulation. Do not reuse any used components of the kit.

Wash hands thoroughly after test disposal and disinfect the area where test was performed.

If you Covid-19 test is positive, contact a healthcare provider immediately for RT-PCR test confirmation. Alternatively, report to MOH via MySejahtera App.

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