Information for patients on the SARS-CoV-2 Antigen Self Test Nasal

No, members of the public can only obtain the test from a wholesaler or distributor - Download a list of wholesalers and distributors who stock our test.

Please contact our COVID sales team by completing our webform. Please note: Roche does not sell these products directly in quantities of less than 200 boxes/units. For orders below 200 boxes - please refer to our list of wholesalers and distributors.

Please contact our COVID sales team by completing our webform. Please note; Roche does not sell these products in quantities of less than 200 boxes/units. For orders below 200 boxes - please refer to our list of wholesalers and distributors.

The SARS-CoV-2 Antigen Self Test Nasal is a lateral flow test. It can help to detect antigens of the SARS-CoV-2 virus from nasal samples in individuals who are suspected of having COVID-19. 

The course of SARS‑CoV‑2 infections can vary widely. Some people do not have any symptoms, others experience mild symptoms such as fever, cough, loss of taste or smell, or diarrhoea. But it can also cause more serious symptoms such as difficulty in breathing³. Usually, it takes 5 - 6 days for symptoms to develop after an exposure to SARS‑CoV‑2, but sometimes it can take as long as 14 days⁴.

The test can help you to quickly and easily determine whether you might be infected with SARS-CoV-2 or not. You can test yourself from the comfort of your home and you do not need any specific training as it is easy to perform.

COVID-19 antigen tests perform best when the viral load is at its highest during an infection. Outside of this window, such as at the start of the infection, or late infection, the test may not detect the virus. Therefore, regular testing (such as every few days) increases the chance of detecting COVID-19. Please refer to NHS and government websites for further guidance on this topic.

No, according to our instructions for use, the test must be performed by an adult or under close adult supervision on children under 18 years of age.

At the moment, the SARS-CoV-2 Antigen Self Test Nasal test is only available in packs of 5.

For customer notifications relating to all the lateral flow tests (including the SARS-CoV-2 Antigen Self Test Nasal) please contact burgesshill.techsupportdocs@roche.com for the latest product updates. The most recent version of the package insert for the SARS-CoV-2 Antigen Self Test Nasal can also be found here.

Each test kit contains everything you need in order to perform 5 tests. The components that you need to perform a test are:

• Test device
• Buffer tube
• Nozzle cap
• Sterile swab
• Tube holder
• Instructions for use and Quick Reference Guide

In this case, do not use the damaged test kit and use a new one. We would also recommend you report the damaged kit to wherever you got the test kit. Additionally, we would recommend you report the incident to your local Roche customer support centre via our webform

Roche gives you confidence that we offer the broadest real-world and manufacturer-independent performance evaluations available with over 30,000 samples tested^5,6,7. 

The clinical performance of the SARS-CoV-2 Antigen Self-Test Nasal was measured by head-to-head comparison with Roche’s highly sensitive reverse transcriptase polymerase chain reaction (RT-PCR) test using nasopharyngeal swab samples as a comparator, the gold standard sampling and detection method for SARS-CoV-2 detection^8,9. 

Combined study results showed that the relative sensitivity, the ability of the test to correctly identify patients with the virus, was 86.4% (91.1% in patients with a high viral load) and the relative specificity, the ability to correctly identify patients without the virus, was 99.6%. In one comparative independent self-testing study where patients followed written and illustrated instructions to sample, test and read out the results themselves, the majority of study participants considered the procedures easy to perform¹⁰.

The test has a shelf life of 24 months from the manufacturing date. The manufacturing and expiry date can be found on the back of the kit box or also on the back of the foil pouches inside the test kit.

No, the test should not be used anymore when the expiry date has passed. Please use a new in date test.

The test device can be used for a maximum of one hour after opening the sealed packaging. If the test device has been out of the sealed foil pouch for more than one hour, you should not use it anymore. Please use a new test.

The test should be used at room temperature (15 - 30 °C). 

Remove the swab from the packaging. Ensure that you only touch the handle of the swab and not the soft pad at the tip.  Slightly tilt your head backwards and insert the swab with the soft pad at the front into your left nostril. Slowly slide the swab approx. 2 cm forward (parallel to the roof of your mouth - not upwards) until you encounter resistance. You should not apply any pressure. Then rotate the swab 4 times (for a total of approx. 15 seconds) against the lining of the nasal wall before removing it from the nostril. Repeat these steps in your right nostril using the same swab. Please refer to the package insert.

No, the specimen should be tested immediately after the sample has been taken.

No, the sample must be collected from both nostrils using the same swab.

You can move ahead and perform your test with this sample. If your test result is positive, it is very likely that you have COVID-19. However, in case you should get a negative or invalid result, we would recommend repeating the test according to the instructions for use.

The storage temperature range is 2 - 30 °C. You should store the test in a dry, cool place without direct sunlight exposure.

No, when you open the test cassette foil pouch (pouch 1) you have to perform the test within 1 hour. You should discard the test if the test cassette has been outside of the foil pouch for more than one hour.

No. Swabs must be sterile for your own safety.

With blood in the sample, the test will not produce a reliable test result. If you have the impression that you injured yourself while taking the sample, please contact your doctor and your local Roche customer support centre via our webform.

No, please do not shake the tube. Shaking can create bubbles which might make it more difficult to apply the correct amount of drops onto the test device.

According to the instructions for use, you should apply exactly 4 drops of the extracted sample to the test device. If more than 4 drops are added and the subsequent result is negative - we would recommend repeating the test to confirm the results. If you have applied less than 4 drops, we would recommend repeating the test.

It is important that you follow the correct procedure described in the instructions for use as incorrect handling might lead to an invalid or incorrect result. The swab needs to be inserted into the tube until the soft pad is in the liquid. You should squeeze the tube at the bottom and hold it tight. It is important that you stir the swab more than 10 times while holding the tube squeezed in order to transfer the biological material from the swab to the liquid. When you remove the swab from the tube you should squeeze the tube in order to extract the liquid from the soft pad of the swab.

Yes. You should repeat the test with a new test kit.

If the buffer solution accidentally comes into contact with the skin/eyes/mucous membrane, it should be rinsed thoroughly with running water. In case of skin irritation, please contact your doctor and your local Roche customer support centre via our webform.

In the event of extensive soiling of clothing with the buffer solution (e.g. if the tube falls onto your clothes and is thus completely spilt), you should change your clothing. 

If you only spilt a few drops, you can still use the tube to perform the test. Please wipe the surface thoroughly and wash your hands afterwards. If the subsequent result is Negative, we recommend repeating the test to confirm. In case you should have spilt a considerable amount of liquid, please discard the tube and use a new test.

No, the SARS-CoV-2 Antigen Self Test Nasal is intended to be used with nasal samples only. It is not possible to use samples that were not obtained via a nasal swab, as the results might be incorrect or invalid.

No, the result needs to be read after 15 minutes, but no later than 30 minutes. If you read the result for example after 45 minutes, then your test might show an invalid or incorrect result. Please repeat the test by using a new test kit.

Please dispose of the kit components in your household or residual waste or according to your local guidelines. Remaining liquid in the tube should not be released into the drainage system or water bodies.

If you get a positive test result it means that it is very likely that you have COVID-19. Please visit the NHS and government websites for guidance on what to do next. In the meantime, it is important that you adhere to all hygiene and local safety measures and that you adhere to the local guidelines on self-isolation.  

If a negative result is shown in the result window of your test cassette, then it is unlikely that you have COVID-19. However, you should continue to observe and follow all hygiene and local safety measures. Please visit the NHS and government websites for guidance on what to do next, including re-testing if you still suspect that you may have an infection.

If you are unsure despite a negative test, please also contact your family doctor's office or the medical on-call service. Follow the instructions of the physician or health authorities and please continue to observe and follow all hygiene and local safety measures.

Please repeat the test by using a new test kit. In particular, you should collect a new sample with a new swab. In case the results continue to turn out invalid, please contact your local Roche customer support centre via our webform. If  you think you may have COVID -19, you should continue to observe and follow all hygiene and local safety measures.

Possible reasons are insufficient sample volume, incorrect sample collection, and use of expired components or not following the instructions for use correctly.

As long as you can see the control line visible with the naked eye, there is no concern and the test should be considered valid.

Even if the test line is very faint if you can see it with the naked eye it should be considered as a positive test result. It could help to change the lightning in the room (e.g. change from artificial light to daylight or increase the brightness). If in doubt, repeat the test or contact your doctor.