CARESTART™ COVID-19

RAPID ANTIGEN TEST

Reliable, rapid lateral flow immunochromatographic assay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2 present in nasal samples. 

The CareStart™ COVID-19 Antigen provides results in just 10 minutes, making it highly suitable for quick action at the point-of-care. Anterior (shallow) nasal sampling collects from the front area of the nose and is therefore less invasive, reduces patient discomfort and simplifies the overall testing procedure. 

Anterior nasal swab samples may be particularly useful for children and elderly people, especially when used for frequent testing. This simplified collection method also allows for the option for patients to self-collect under supervision, offering reduced physical contact and exposure and further protection for healthcare practitioners.

Results in 10 minutes.

  • Quick and convenient

  • Used with a shallow nasal swab

  • Locally and internationally validated

  • Manufactured in the USA by Access Bio

Test kit components:

  • All components are included in the kit (20 tests per kit): 

  • 20 x test device (individually wrapped in a foil pouch)

  • 20 x pre-prepared extraction vials with buffer solution and 20 x vial caps 

  • 20 x sterile anterior nasal swab

  • Instructions for use and quick reference guide 

  • Positive and negative controls

Test Procedure:

1.

Asset 19.png

Remove the test device from its packaging, placing it on a clean, flat surface.

2.

Asset 15.png

Locate the nasal swab and carefully remove it from its packaging, ensuring not to touch the swab tip.

Gently insert the swab 2 – 3cm into your nostril.

3.

Asset 12.png

Slowly rotate the swab at least 5 times in a circular path over the surface of the nostril for a total of 15 seconds.

Using the same swab, repeat on your other nostril, also for a total of 15 seconds.

4.

Asset 9.png

Locate the extraction vial and gently peel off the aluminium foil seal.

5.

Carefully place the swab into the extraction vial and rotate the swab vigorously at least 5 times.

6.

Remove the swab by rotating against the extraction vial, while squeezing the sides of the vial to release the liquid from the swab.

7.

Close the vial by firmly pushing in the cap provided.

8.

Thoroughly mix the vial by swirling and flicking the bottom of the tube.

9.

Invert the extraction vial and hold the sample vertically above the sample well on the test device.

Squeeze the vial gently and allow 3 drops of sample to fall into the sample well.

10.

Wait for 10 minutes for the results.

It is important that the test device is not moved or lifted during this time.

Results should not be read before 10 minutes or after 15 minutes.

11.

Dispose all testing components, including the test device, in an appropriate hazardous waste bin.

8.

Thoroughly mix the vial by swirling and flicking the bottom of the tube.

Reading the Results:

COVID-19 positive

Asset 7.png

A positive result shows 2 lines: 

– A red line at ‘C’
– A blue line at ‘T’ 

Any faint coloured line should
be considered as positive.

COVID-19 negative

Asset 6.png

A negative result shows:

– ONE (1) red line at ‘C’.

Inconclusive result

Asset 5.png

If the red line is not visible, the result is invalid. Another test will be required.

Squeeze the vial gently and allow 3 drops of sample to fall into the sample well.

In the case of a positive result, you must immediately:

1.

Undergo a laboratory-based
PCR test.

2.

Contact your local Public Health Unit and follow their instructions.

3.

Self-isolate until you receive
a negative PCR test result
or as instructed.

Registration of CareStart™ COVID-19 Antigen

Entered in the Australian Register of Therapeutic Goods, 342512 Authorised by FDA under an Emergency Use Authorization (EUA) CE Mark certification.

Conditions of supply for rapid antigen tests

‘The TGA requires that rapid antigen tests are currently supplied under specific conditions. These include for use by trained health practitioners, and trained staff under their supervision, to ensure a suitable health practitioner is available to provide immediate clinical advice and treatment if required.

Testing can be performed by persons who are not a health practitioner however testing needs to be performed under the overall supervision of a health practitioner, medical practitioner or paramedic, and the person performing the test has been trained in the correct use and interpretation of the tests. Where it is not possible for a health practitioner to be physically present, the supervision does not need to be direct.

Everyone who will perform the test needs to be trained in the correct use of the device (including specimen collection) and interpretation of results. This training needs to be undertaken prior to commencement of any testing.

Use of the test by untrained persons and testing performed outside the supervision of a health practitioner would mean that the person or organisation could be liable if something goes wrong with the performance or interpretation of the test.

This device cannot currently be supplied for self-testing (home-use).’

If you would like more information on the above products or would like to place a trade order, please fill in the contact form below.

4 + 8 =