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We are committed to transparency and providing our customers with relevant information about Rapid Antigen Tests

Please note that while the information below is in line with the manufacturer's TGA approval, it is for educational purposes only.

General questions

Yes, ALL tests kits on our website are included in the Australian Register of Therapeutic Goods. Find verification via this link.

The test kits currently listed on rapidproof.com.au are distributed by Roche Diagnostics. More information about the kit can be found here.

Under TGA guidelines, we are unable to list the performance details of kits. Please refer to the Instructions for Use document for more information on accuracy.

The SARS-CoV-2 Antigen Self Test Nasal is a lateral flow test that is used to detect antigens of the SARS-CoV-2 virus in nasal samples of individuals who are suspected of having COVID-19. This test is intended for self testing (eg in the home or other environment).

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. More serious symptoms include difficulty breathing.

Usually, it takes 5 - 6 days for symptoms to develop after an exposure to SARS‑CoV‑2, but it can take as long as 14 days.

The test helps you 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.

Please note that negative test results do not exclude infection of COVID-19, and so it is important to maintain hang hygiene, face masks and social distancing practices).

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 your local state/territory health department for further guidance on this topic.

No, according to the manufacturer's 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 australia.dia_cardiology@roche.com.au for the latest product updates. The most recent version of the Instructions for Use and Quick Reference Guide for the SARS-CoV-2 Antigen Self Test Nasal can also be found here.

Kit components

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 recommend you report the damaged kit to us via our contact form.

Additionally, we would recommend you report the incident to Roche Diagnostics Australia via their webform.

Test specifications

Rapid antigen tests can detect the virus in the acute phase of infection - especially in the week before symptoms are apparent, and the first week of symptoms being apparent.

Please refer to the Instructions for Use.

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.

Any COVID-19 variants in circulation as of 13 September 2021 are detected by this test without any impact on performance.

How to handle the tests

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

Remove the swab from the packaging, ensuring that you only touch the handle of the swab and not the soft pad at the tip. 

Lightly 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 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 Instructions for Use.

No, the specimen should be tested immediately after the sample has been taken. Testing the sample at a later time can lead to inaccurate results.

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

It is ok to perform your test with this sample. If your test result is positive, it is very likely that you have COVID-19. All positive rest results must be confirmed by PCR.

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 their 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 their 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.

Result interpretation

A positive test result means it is very likely that you have COVID‑19. Please contact your doctor/primary care physician or your local health authority immediately and adhere to the local guidelines regarding self‑isolation. 

 

A positive result must be confirmed with a PCR test.

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 refer to your local state/territory health department for further guidance on this topic, including re-testing if you still suspect that you may have an infection.

If you suspect that you have an infection (i.e., if you have prolonged symptoms or if your symptoms are worsening), contact your doctor/primary care physician.

You may have another infection, or your test result may be false. You may repeat the test after 1 ‑ 2 days, as COVID‑19 cannot be detected with complete accuracy during all stages of an infection.

The test is not working correctly and you should perform another test using a different test kit. You may have performed the test incorrectly. Carefully read the Instructions for Use and repeat the test. If your test result is still invalid, please contact your doctor or a COVID‑19 test centre.

In the event you are experiencing problems with the test, please contact Roche Diagnostics Australia via our webform.

Additionally, you may wish to report poor performance or usability issues directly to the Therapeutic Goods Administration (TGA) via the Medical Device Incident Reporting scheme, email: iris@tga.gov.au or call 1800 809 361.

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 as long as the control line is also present. It could help to change the lighting 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.

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