PRECAUTIONS
Please read all the information in this package insert before performing the test.
• For self-testing in vitro diagnostic use only. Do not use after expiration date.
• Do not eat, drink or smoke in the area where the specimens or kits are handled.
• Do not drink the buffer in the kit. Carefully handle the buffer and avoid it contacting skin or eyes, rinse with plenty of running water immediately if contacting.
• Store in a dry place at 2-30 °C (36-86 °F), avoiding areas of excess moisture. If the foil packaging is damaged or has been opened, please do not use.
• This test kit is intended to be used as a preliminary test only and repeatedly abnormal results should be discussed with doctor or medical professional.
• Follow the indicated time strictly.
• Use the test only once. Do not dismantle and touch the test window of the test cassette.
• The kit must not be frozen or used after the expiration date printed on the package.
• Test for children should be under the guidance of an adult.
• Wash hands thoroughly before and after handling.
• Please ensure that an appropriate amount of samples are used for testing. Too much or too little sample size may lead to deviation of results.
PROCEDURE
Wash your hands with soap and water for at least 20 seconds before and after test. If soap and water are not available, use hand sanitizer with at least 60% alcohol. Remove the cover of the tube with Extraction buffer and place the tube in the tube holder in the box.
Nasal swab specimen Collection
1. Remove the sterile swab from the pouch.
2. Insert the swab into your nostril until you feel slight resistance (Approx. 2cm up your nose). Slowly twist the swab, rubbing it along the insides of your nostril for 5-10 times against the nasal wall.
3. Gently remove the swab.
4. Using the same swab, repeat step 2 in your other nostril.
5. Withdraw the swab
Specimen Preparation
1. Place the swab into the Extraction tube, ensure it is touching the bottom and stir the swab to mix well. Press the swab head against to the tube and rotate the swab for 10-15 seconds.
2. Remove the swab while squeezing the swab head against the inside of the Extraction tube.
3. Place the swab in the biosafety bag.
4. Close the cap or fit the tube tip onto the tube.
Testing
1. Remove the test cassette 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 plat and level surface.
2. Invert the specimen extraction tube and add 3 drops of extracted specimen to the sample well(S) of the test cassette and start the timer. Do not move the test cassette during test developing.
3. Read the result at 15 minutes. Do not read the result after 20 minutes.
POSITIVE:* Two colored lines appear. One colored line should be in the control region (C) and another colored line should be in the Test region (T).
*NOTE: The intensity of the color in the test line region (T) will vary based on the amount of SARS-CoV-2 antigen present in the sample. So any shade of color in the test region (T) should be considered positive. A positive results means it is very likely you have COVID-19, but the positive
samples should be confirmed to reflect this. Immediately go into self-isolation in accordance with the local guidelines and immediately contact your general practitioner/doctor or the local health department in accordance with the instructions of your local authorities. Your test result will be checked by a PCR confirmation test and you will be explained the next steps.
NEGATIVE: One colored line appears in the control region (C). No apparent colored line appears in the test line region (T).
You are unlikely to have COVID-19. However, it is possible for this test to give a negative result that is incorrect (a false negative) in some people with COVID-19. This means you could possibly still have COVID-19 even though the test is negative. In addition, you can repeat the test with a
new test kit. In case of suspicion, repeat the test after 1-2 days, as the coronavirus cannot be precisely detected in all phases of an infection.
Even with a negative test result, distance and hygiene rules must be observed, migration/traveling, attending events and etc. should follow your local COVID guidelines/requirements.
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test or contact with a COVID-19 test center.
SUMMARY
The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days.
The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases .
