Sofarmapiu covid-19 nasal test

Product Description

The Sofarmapi Covid-19 Nasal Self-Test is an easy-to-use medical device for the rapid and reliable detection of SARS-CoV-2 nucleocapsid protein antigens directly at home.

Indications

The Sofarmapi Covid-19 nasal self-test is indicated for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasal swab specimens. It is intended for use in symptomatic individuals who meet the case definition for COVID-19 as well as in those who are at risk of developing COVID-19. in asymptomatic subjects, limited to contacts of confirmed or probable cases of COVID-19 and healthcare workers at risk.

Directions for Use and Dosage

Wash your hands with soap and water for at least 20 seconds before and after the test. Remove the cap from the extraction swab tube and place the tube in the tube holder in the box.

• Nasal Swab Sample Collection:
  1. Remove the sterile swab from the pouch.
  2. Insert the swab into the nostril until you feel slight resistance. Slowly rotate the swab, rubbing it along the inside of the nostril 5-10 times against the nasal wall.
  3. Gently remove the swab.
  4. Using the same swab, repeat step 2 in the other nostril.
  5. Withdraw the swab.
• Sample Preparation:
  1. Place the swab in the extraction tube, make sure it touches the bottom, and shake the swab to mix well.
  2. Remove the swab by pressing the head of the swab against the inside of the extraction tube.
  3. Close the cap.
• Test Procedure:
  1. Remove the test cassette from the sealed foil pouch.
  2. Invert the sample extraction tube and add 3 drops of the extracted sample to the well (S) of the test cassette.
  3. Read the result after 15 minutes.

Warnings

• For self-testing only: in vitro self-diagnostic use. Do not use after the expiration date.
• Do not eat, drink, or smoke in the area where samples or kits are handled.
• Do not drink the swab liquid contained in the kit.
• Handle the swab with care and avoid contact with skin or eyes. Rinse immediately with plenty of running water if contact occurs.
• Do not use if the foil pouch is damaged or torn. The test kit has been opened.
• This test kit should only be used as a preliminary test and repeatedly abnormal results should be discussed with a doctor or medical professional.
• Strictly follow the indicated time.
• Use the test only once. Do not disassemble or touch the test window of the test cassette.
• The kit should not be frozen or used after the expiration date printed on the package.
• Testing for children should be under the guidance of an adult.
• Wash your hands thoroughly before and after handling.
• Please ensure that an adequate amount of sample is used for testing. Too much or too little sample may cause a reaction. lead to inaccurate results.

Storage

The kit should not be frozen or used after the expiration date printed on the package.

Format

The kit contains:

• 1 test cassette
• 1 sterile swab
• 1 package insert
• 1 extraction solution