COVID-19 Rapid Swab Antigen Test

The Hotgen COVID-19 Swab Antigen Rapid Test is a test for the qualitative determination of SARS-CoV-2 antigen in human samples obtained from nasal swabs . The test can be used for rapid detection of SARS-CoV-2 antigen in subjects suspected of being infected with COVID-19 within the first 7 days of the onset of symptoms. The result is available within 15 minutes .

Children and minors must be supported by an adult to carry out the test.

CE 93/42 certified medical device

How to use the COVID-19 Swab Antigen Rapid Test:

Before using the test, wash and dry your hands thoroughly. To perform the test, remove the swab from the package trying not to touch the padded tip with your hands. Gently insert the swab approximately 1.5 cm into the nostril until resistance is felt. With moderate pressure, roll the swab 4-6 times in the nostril for at least 15 seconds. Repeat the procedure with the same swab in the other nostril as well.

After collecting the sample, remove the purple cap from the reagent tube and immerse the swab. Keep the swab immersed in the buffer solution for at least 15 seconds . It is recommended to rotate the swab several times and press the cushioned tip to the bottom of the tube. Before removing the swab from the tube, squeeze the cushioned tip by squeezing the flexible tube from the outside. Close the tube with the appropriate purple cap.

Open the package and place the test card on a flat surface. Remove the transparent cap and add 4 drops of the compound into the well of the card (indicated with S). Read results after 15 minutes. Seal all used components of the COVID-19 Rapid Buffer Antigen Test kit in the appropriate biowaste bag. The test cannot be reused .

Interpretation of COVID-19 Rapid Swab Antigen Test results:

POSITIVE : the test is successful if two red bands appear in the reading window . One red or purple band appears in the control region (denoted C) and the other near the test region (denoted T).

NEGATIVE : the test fails if only one red-purple band is visible in the control region (indicated with C). This indicates the absence of the SARS-CoV-2 virus or that the virus concentration is below the detection limit of the kit.

INVALID : The test is invalid if no red-purple lines appear in the reading window . Also, results read after 30 minutes are invalid. It is recommended to retest with a new Hotgen COVID-19 Rapid Swab Antigen Test kit.

COVID-19 Rapid Swab Antigen Test Warnings

This kit is for in vitro diagnostic use only. Read carefully and strictly follow the instructions before testing. Only use the components supplied in the kit. Do not use damaged components. The kit provides only a qualitative result and is unable to quantify the concentration of SARS-CoV-2 antigen in the sample. If the test carried out is positive, it is advisable to promptly inform your general practitioner and take steps to carry out a confirmation molecular swab.

Storage COVID-19 Rapid Antigen Test Swab

Store at a temperature ranging from 4°C to 30°C.

Contents of the COVID-19 Swab Antigen Rapid Test

Each COVID-19 Swab Antigen Rapid Test kit contains:

• 1 SARS-CoV-2 Antigen Test Card.
• 1 extraction tube with buffer.
• 1 disposable sterile swab.
• 1 biohazard waste bag.
• Instructions for Use.