2San Covid-19 Rapid Self-Test

Description

2San Covid-19 Rapid Self-Test is a quick and easy self-test that helps detect the presence of the SARS-CoV-2 virus. It works by identifying the virus’s nucleocapsid protein from a simple anterior nasal swab. This test is intended for people showing symptoms of COVID-19. Not suitable for children under 2 years of age.

Directions

BEFORE STARTING

1. Wash and dry hands before you begin to perform the test.

PREPARE MATERIALS

2. Ensure you have all required testing components. Place the kit components on a flat surface.

NOTE:

Ensure all test components are at room temperature (15-30°/59-86°) before use.

3. Check the expiration date of the test kit before use.

WARNING: The test must not be used beyond the expiration

date listed on the packaging. Use of expired tests can lead

to incorrect results.

4. Remove large blue cap from the TUBE.

5. Place TUBE in the Tube Holder (round opening in kit box).

COLLECT SAMPLE

6. Remove the SWAB from its wrapper.

Do not touch the tip of the swab.

7. Gently insert the entire absorbent tip of the swab (3/4 of an inch) into the nostril.

WARNING: Do not insert the swab any further if you feel any resistance.

8. Firmly and slowly brush against the nasal wall in a circular motion at least 5 times. Take at least 15 seconds to collect the specimen and be sure to collect any nasal drainage on the swab.

WARNING: Be sure to rub BOTH nostrils with the same SWAB.

NOTE: With children, you may not need to insert the swab as far into the nostril and you may need another person to steady the child’s head while swabbing. Wear safety mask or other face covering when collecting swabs from children or others.

NOTE: Failure to swab properly may cause false negative results.

PROCESS THE SAMPLE

9. Immediately place the SWAB into the liquid inside the TUBE, and ensure it is touching the bottom of the TUBE.

10. Remove the TUBE from the tube holder.

11. Stir the swab vigorously at least 15 times.

12. Place the tube back into the tube holder. Keep the swab inside of the tube for 1 minute.

13. Start timer for 1 minute.

14. After 1 minute, take the tube out of the tube holder.

Remove the swab while squeezing the sides of the tube to express as much liquid as possible from the swab.

WARNING: Be sure to squeeze the tube while removing the swab.

15. Dispose the SWAB in the trash.

16. Screw the large blue cap back onto the TUBE. Place TUBE in the Tube Holder. ADD SAMPLE TO THE TEST CASSETTE

17. Remove the TEST CASSETTE from the sealed pouch and lay it flat.

18. Twist to open the small white cap at the top of the TUBE.

19. Add 4 drops of sample into the sample well of the TEST CASSETTE. WAIT AND READ TEST RESULTS

20. Wait 10 minutes. And then read the result at 10 minutes as described in the section READ AND INTERPRET RESULT below.

WARNING: Do not read the result before 10 minutes or after 20 minutes.

DISPOSE THE TEST KIT

21. Screw back the small white cap.

22. After the test is completed, dispose of the kit and its components in the trash.

READ AND INTERPRET RESULT

UNDERSTANDING YOUR RESULTS

WARNING: Do not read the result before 10 minutes or after 20 minutes.

Results read before 10 minutes or after 20 minutes may result in false or invalid results.

Look carefully for a C line for a valid test result. For positive result, look carefully for a T line.

Positive Result

If the Control (C) line and the Test (T) line are visible, the test result is Positive. Any faint visible pink or purple test (T) line with the control (C) line should be read as positive. You do not need to perform repeat testing if you have a positive result at any time.

A positive test result means that proteins from the virus that causes COVID-19 were found in your sample and it is very likely you have COVID-19 and are contagious. You should self-isolate following local guidelines.

Please contact your healthcare provider to discuss your tests results and receive follow-up care. In rare instances, individuals may have co-infections with other bacteria or viruses that this test is not designed to detect. This means that the virus detected by this test may not be the definitive or the only cause of your disease. There is a very small chance that this test can give you a positive test result that is wrong (false positive).

Negative Result

If the Control(C) line is visible, but the Test(T) line is not visible, the test is negative.

To increase the chance that the negative test result for COVID-19 is accurate, you should test again in 48 hours if you have symptoms on the first day of testing.

A negative test result indicates that the virus that causes COVID-19 was not detected in your sample. A negative result is presumptive, meaning it is not certain that you do not have COVID-19. A negative result is presumptive because despite a negative result you may still have COVID-19 and may be contagious. False negative results can occur if you read your test result before 10 minutes have passed or when your sample has only a low amount of virus in it. Low amount of virus can occur if you take your sample at a time when your symptoms just started appearing, or when you already started to feel better at the end of your infection. If you test negative and continue to experience COVID-19-like symptoms, (e.g., fever, cough, and/or shortness of breath) you should seek follow up care with your health care provider.

Invalid Result

If a Control (C) line is NOT visible, DO NOT CONTINUE reading the results. It means that. your test result is INVALID. An invalid test result means that the test is unable to determine if you are infected with SARS-CoV-2 (COVID-19) or not. The test needs to be repeated with a new kit and sample.

Test Kit Includes

1 Test Cassette; 1 Tube; 1 Swab; 1 Quick Reference Instruction

WARNINGS

• Do not use this test when you have symptoms for more than 5 days or if you have no symptoms.

• Do not use on individuals under 2 years of age.

• Serial testing should be performed in individuals with negative results at least twice over three days (with 48 hours between tests) for symptomatic individuals. You may need to purchase additional tests to perform this serial (repeat) testing.

• Check the test’s expiration date. Do not use kit past its expiration date. Use of expired tests can lead to incorrect results.

• Do not reuse the test cassette, processing solution, or swab.

• Not for use with viral transport media (VTM).

• When collecting a sample, only use the swab provided in the kit.

• Inadequate or inappropriate sample collection, test storage, or test transport may yield false test results.

• Testing should be performed in an area with good lighting.

• Keep test kit and materials out of the reach of children and pets before and after use. Avoid exposure of your skin, eyes, nose, or mouth to the solution in the tube. Do not ingest any kit components. The reagent solution contains harmful chemicals (see table below). If the reagent solution contacts the skin, eyes, nose, or mouth, flush with large amounts of water. If irritation persists, seek medical advice. https://www.poisonhelp.org or 1-800-222-1222.

Chemical Name; Harms (GHS Code) for each ingredient; Concentration

ProClin 300; Causes serious eye irritation (H319) Cause mild skin irritation (H316); 0.02%

Tris-HCl; Causes eye irritation (H320) Causes skin irritation (H315); 1.2%

Tween 20; Causes eye irritation (H319) Causes skin irritation (H315); 0.5%