Storage and Stability

- Store the test kit at 2 - 30°C with a valid period of between 90 days to 24 months.

Precautions

- Always keep out of the reach of children. Small parts of the kit can be a choking hazard.

- If extraction solution splashes your body or into eyes, please wash with water.

- This product can only be used for the detection of proteins from SARS-CoV-2 not for any other viruses or pathogens.

- Leave the test sealed in its pouch until just before use. Do not use if pouch is damaged or open

- Do not touch the swap tip when handling the swab sample

- Do not use the kit past its expiration date

- Do not mix components from different kit lots. All kit components are single use items. Do not use with multipool specimens. Do not reuse the used test card

- Use of gloves is recommended when conducting testing.

- Wear safety mask or other face covering when collecting anterior nares swab specimen from a child or another individual.

- Dispose of its components and patient samples in household waste.

FAQ’s

1. Who can use the lateral flow test kit?

- The lateral flow test is suitable for use by anyone who wants to understand their COVID-19 status. It can be used if you have symptoms of COVID-19 (symptomatic) or without (asymptomatic). Suitable for use for routine testing before visiting friends or family and before returning to work or school.

2. Who can administer the test?

- Adults aged 18+ - self-test with assistance if needed.

- Adolescents aged 12 – 17 – self-test with adult supervision. The adult may conduct the test as necessary.

- Children under 12 – should be tested by an adult. Do not conduct this test if you do not feel confident testing a child.

- Please carefully follow the how to take a test guidance enclosed with your test kit.

3. How do I take the test?

- This test requires collecting a nasal sample only. Please carefully follow the how to take a test guidance enclosed with your test kit.

- Remove the lid from the top of the extraction tube with sample extraction solution and keep the tube vertical.

- Gently insert the tip of the swab into one nostril. Using gentle rotation push the swab less than 2.5cm from the edge of the nostril.

- Rotate the swab around the inside wall of your nostril at least 5 times. Repeat the same process with the same swab in the other nostril. Insert the swab after sampling to the extraction tube and rotate the swab for 30 seconds.

- Rotate the swab 5 times while squeezing the side of the tube. Remove the swab while squeezing the tube, discard the swab in the kit bag.

- Attach the lid of extraction tube on firmly. Mix thoroughly by swirling and flicking the tube. Gently squeeze the extraction tube and add 4 drops of solution into the sample well (S).

- Read the result visually in 15-30 min, don’t read results after 30 min.

- Put all of the used test kit contents in the kit bag provided and put this in household waste. If necessary, discarded all used tests according to local regulations. Wash your hands thoroughly after disposal.

4. What do my results mean?

- Your results will be visible in 15 -30 minutes on the test cassette. Use the instructions in the box and this guide below to read your results.

- Negative - If your result is negative, you’ll see one line next to the C (control)

- Positive - If your result is positive, there will be two lines. These may be faint. There will be a line next to the C and one next to the T.

- Invalid - If your result is void, there will be no lines or one line next to the T.

5. What do I do if my result is positive?

- A positive result means that an active coronavirus infection was detected at the time you took the test. If you have a positive test result, you should try to stay at home and avoid contact with other people for 5 days after the date of your test. Find out more about how to self-isolate on the Government website.

6. What does a negative result mean?

- A negative result means that an active coronavirus infection was not detected at the time you took the test. Therefore, it is likely that you were not infectious when the test was done.

7. Where can I take the test?

- You’ll need to take your test somewhere you can comfortably take a swab from your nose. Ideally take your test at home away from other people in case you have a positive result.

8. Do I need a lateral flow test to travel?

- Our at-home lateral flow tests are not suitable for travel purposes and do not include certification for travel.

9. Do I need to report the result of the test to NHS?

- Please note, the NHS portal does not accept results/QR code reports from consumer bought tests. It can only be used for free NHS supplied tests.

10. How sensitive is the test?

- Diagnostic sensitivity = 97.1% (93.1%~98.9%)

- Diagnostic specificity = 99.5% (98.2%~99.9%)

Accuracy = 98.8% (97.6%-99.5%)

11. Does the smell from the Swab affects its use?

- The swabs are manufactured and packaged in a sterile environment; they may emit a slight smell briefly upon opening the packaging, but this is of the products used to manufacture and will not affect their use.

12. How many drops of sample fluid is needed to get a result?

- Add 4 drops of sample fluid to the test card to get the result

Manufacturer Contact Information

ACON Biotech (Hangzhou) Co., Ltd., No. 210 Zhenzhong Road, West Lake District, Hangzhou, P.R. China, 310030. MedNet EC-REP GmbH, Borkstrasse 10, 48163 Muenster, Germany.