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

SARS-CoV-2 Antigen Self Test Nasal

Available now for self-testing

Reliable SARS-CoV-2 antigen test results in just 15 minutes

The SARS-CoV-2 Antigen Self Test Nasal is intended for unsupervised testing in the home or other environment

Negative test results do not exclude infection with COVID-19 (so face masks, social distancing and good hygiene practice must be maintained)

Positive test results or symptomatic persons require immediate confirmatory testing with a polymerase chain reaction (PCR) test

Testing in your hands

The SARS-CoV-2 Antigen Self Test Nasal provides reliable results for individuals suspected of having COVID-191. The Self Test can be performed by you, the patient, whenever and wherever needed.

Schnelles Ergebnis

Quick results

 

The result is available in just 15 minutes.

This rapid antigen test for COVID-19 can help enable you to quickly assess whether you may be infected or not. If you test positive, you can immediately follow official advice on further testing and self-isolation.

Einfache und angenehme Anwendung

Easy to use

 

As the swab only has to be inserted into the lower nasal cavity, collection of the sample is relatively simple and comfortable. All the necessary materials are included within the kit and there are only 4 short steps required to complete the test.

Hohe Genauigkeit

Reliable results

 

The test determines your infection status with a high level of accuracy and precision1.

Many of the SARS-CoV-2 variants have been analysed using the test and do not alter the reliability of the results2.

The following items are required to perform the test and are included in each kit:

Take a sample

1. Take a sample

 

Wash your hands before performing the test. Take the swab out of the packaging, being careful to only touch the swab by the handle. Tilt your head back slightly. Insert the swab into one nostril. Slowly push the swab forward about 2 cm (parallel to the roof of your mouth) until you feel resistance. Do not apply any pressure. Turn the swab 4 times (for a total of approx. 15 seconds) against the inside of the nose and then remove it from the nose. Repeat with the same swab in the other nostril.

Please see the Instructions for Use and Quick Reference Guide.

Dissolve the sample

2. Dissolve the sample (in the extraction buffer)

 

Place the swab in a tube with extraction buffer. Squeeze the tube at the bottom and turn the swab back and forth more than 10 times. Continue to squeeze the sides of the tube while removing the swab to force all of the liquid out of the swab. Press the dispenser cap firmly onto the tube.

Please see the Instructions for Use and Quick Reference Guide.

Apply the sample to the test cassette

3. Apply the dissolved sample to the test cassette

 

Place the test strip on a flat surface. Hold the tube vertically over the round marked area (not the rectangular result window). Drop exactly 4 drops on the field. To do this, gently squeeze the tube if necessary. 

Please see the Instructions for Use and Quick Reference Guide.

Check the result

4. Check the result

 

Set a timer and read the test result after 15-30 minutes. If the test result is read after more than 30 minutes, the result may be incorrect.

Please see the Instructions for Use and Quick Reference Guide.

Interpreting the test results correctly1

Interpretation of your results

Positive test result

 

The presence of a test line visible to the naked eye (T), no matter how faint, together with a control line (C) means a positive test result.

A positive result means that you are very likely to have COVID-19.

Please go directly to obtain a laboratory PCR test.

Please click here for your local state/territory health department.

Negative test result

 

The presence of a control line (C) (no matter how weak it is) but no test line (T) means a negative result.

It is unlikely that you have COVID-19. Negative test results do not exclude infection with COVID-19 (so face masks, social distancing and good hygiene practice must be maintained)

Negative results do not rule out a SARS‑CoV‑2 infection and should not be used as the sole basis for treatment or patient management decisions, including decisions about infection control. Individuals who have tested negative and continue to show COVID‑19‑like symptoms should contact their doctor/primary care physician.

Invalid test result

 

If no control line (C) is visible, the result should be considered invalid (the test has not worked properly and a result should not be interpreted).

Look carefully: even if the control line is weakly visible to the naked eye, the test can be considered valid. You may not have performed the test correctly. Read the instructions for use carefully and repeat the test.

If the test results are still invalid, please contact your doctor/primary care physician.

Instructional video

Quick Reference Guide

 

Download the Quick Reference Guide for patients
using the Roche SARS-CoV-2 Antigen Self Test Nasal

Instructions for Use

 

Download the Instructions for Use insert for the
Roche SARS-CoV-2 Antigen Self Test Nasal

Antigen Testing User Guide

 

Everything you need to know about testing with the
SARS-CoV-2 Antigen Self Test Nasal

 

 

Navify Pass

NAVIFY® Pass

Your personal COVID-19 Test Solution

 

NAVIFY® Pass is a free digital COVID-19 solution that can be used for your personal record of home testing using the Roche SARS-CoV-2 Antigen Self Test Nasal or for authentication of test result entry requirements for organisations using NAVIFY® Pass.

NAVIFY® Pass can be downloaded from both the Apple App Store and Google Play.

Download from Apple App Store

Download from Google Play

NAVIFY is a trademark of Roche. All other product names and trademarks are the property of their respective owners.

App Store Logo
Play Store Logo

Recording the result in NAVIFY® Pass

Navify Pass

 

1. Select the Home Test Icon
Navify Pass

 

2. Scan the code on the test device
Navify Pass

 

3. Enter the Result

NAVIFY® Pass

Your personal test record

Navify Personal

 

Create your personal, secure, NAVIFY® Pass account. Scan your Roche SARS-CoV-2 Antigen Self Test Nasal QR and input your result. Your record will be stored for your personal use.

NAVIFY® Pass

For event or workplace entry

Navify Workplace

 

If an event or workplace uses NAVIFY® Pass, you can show your unique QR for scanning. The entry marshal will only see a tick for approved access, without sharing personal test details.

Frequently asked questions

Ordering the test

Ordering the test

Our stockists include:

Amazon

Blooms the Chemist

Body Care

Capital Chemist

Chemistworks

Chempro Online

Covax Australia

healthSAVE Pharmacy

Impressive Medical Supplies

Kogan

Medical Test Kits

My Deal

Pharmacy Choice

Rapid Proof

Rapid Test Trace

Rimstar Group

Staying Safe

TerryWhite Chemmart

Wellbeing Services

No, members of the public can only obtain the test from a pharmacy or supplier. 

 

Our stockists include:

Amazon

Blooms the Chemist

Body Care

Capital Chemist

Chemistworks

Chempro Online

Covax Australia

healthSAVE Pharmacy

Impressive Medical Supplies

Kogan

Medical Test Kits

My Deal

Pharmacy Choice

Rapid Proof

Rapid Test Trace

Rimstar Group

Staying Safe

TerryWhite Chemmart

Wellbeing Services

Please contact us on 1800 497 069 9am-7pm AEST / 9am-8pm AEDT, 7 days per week or by completing the form below.

Please note: Roche does not sell these products directly in quantities of less than 234 boxes. Orders below 234 boxes will need to be purchased from a pharmacy or supplier.

Please note: Roche does not sell these products directly in quantities of less than 234 boxes. Orders below 234 boxes will need to be purchased from a pharmacy or supplier.

 

Our stockists include:

Amazon

Blooms the Chemist

Body Care

Capital Chemist

Chemistworks

Chempro Online

Covax Australia

healthSAVE Pharmacy

Impressive Medical Supplies

Kogan

Medical Test Kits

My Deal

Pharmacy Choice

Rapid Proof

Rapid Test Trace

Rimstar Group

Staying Safe

TerryWhite Chemmart

Wellbeing Services

General questions

General questions

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 your local state/territory health department 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 contact us on 1800 497 069 9am-7pm AEST / 9am-8pm AEDT, 7 days per week, or by completing the form below.

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

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:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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 on 1800 497 069 9am-7pm AEST / 9am-8pm AEDT, 7 days per week or by completing the form below.

Test specifications

Test specifications

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

How to handle the tests

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 Instructions for Use.

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/primary care physician and notify us on 1800 497 069 9am-7pm AEST / 9am-8pm AEDT, 7 days per week or by completing the form below.

 

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/primary care physician and notify us on 1800 497 069 9am-7pm AEST / 9am-8pm AEDT, 7 days per week or by completing the form below.

 

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.

Dispose of the kit components in your household waste (not recycling) or according to your local guidelines. The remaining liquid in the tube should not be released into the drainage system or water bodies.

Result interpretation

Result interpretation

A positive test result means it is very likely that you have COVID‑19.

Please go directly to obtain a laboratory PCR test.

Please click here for your local state/territory health department.

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 us on 1800 497 069 9am-7pm AEST / 9am-8pm AEDT, 7 days per week or by completing the form below.

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: [email protected] 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.

 

Do you still have questions?

 
For Technical Support please call 1800 497 069 9am-7pm AEST / 9am-8pm AEDT, 7 days per week
 
Or contact us via the form below and a member of the team will get back to you.

 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 [email protected] or call 1800 809 361.

 

To contact your local state/territory health department click on the following link:
https://www.health.gov.au/about-us/contact-us/local-state-and-territory-health-departments

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  1. SARS-CoV-2 Rapid Antigen Test, Instructions for use for patients, special approval BfArM 5640/S-025/21 for patient self-application
  2. Roche Diagnostics Solutions Memo, 02 February 2021
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  12. Public Health England (PHE). https://www.gov.uk/government/publications/sars-cov-2-lateral-flow-antigen-tests-evaluation-of-vui-20201201/sars-cov-2-lateral-flow-antigen-tests-evaluation-of-vui-20201201. Accessed 4 May 2021.
  13. FINDDX. https://www.finddx.org/wp-content/uploads/2021/03/COVID-variants-report-FINAL-12MAR2021.pdf Accessed 4 May 2021.
  14. The Lancet. https://www.thelancet.com/journals/lanmic/article/PIIS2666-5247%2821%2900147-6/fulltext Accessed 8 July 2021.