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*The InnoScreen™ COVID-19 Antigen Rapid Test Kit is included the Australian Register of Therapeutic Goods (ARTG/TGA) for Supply in Australia 372335*

The emergence of infective coronavirus (SARS-CoV-2) has generated significant global concern, especially with the disease (“COVID-19”) achieving pandemic status. While laboratory testing of nasopharyngeal swabs for active virus load represents the gold standard of infection testing and tracing, implementing on-site rapid testing for COVID-19 allows the potential for businesses to significantly reduce the waiting times associated with COVID-19 testing while also help maintain a COVID-safe workplace. In this light, AusHealth has partnered with Innovation Scientific and is now offering InnoScreen COVID-19 Antigen Rapid Test kits for sale to business clients. 

Why should we conduct on-site rapid testing?

On-site screening may provide an immediate indication as to the possible infectivity of any individual on a given worksite, which will allow management to take swift and appropriate actions to maintain workplace safety. However, on-site rapid testing is not a substitute for maintaining good practice when it comes to infection control, COVID-safe plans and hygiene procedures should also be implemented.

Is the INNOSCREEN™ COVID-19 Antigen Rapid Test Kit listed on the ARTG (TGA)?

Yes, it is. Find the InnoScreen COVID-19 Antigen Rapid Test Device listed on the TGA site here.

What is included in each kit?

Each kit contains all the equipment required to perform 20 individual tests.

  • Individually packed test device - 20
  • Extraction tube with buffer - 20
  • Sample collection swab - 20
  • Tube stand - 1
  • Instruction Guide - 1

Who should conduct testing using the InnoScreen COVID-19 Antigen Rapid Test kits?

Tests must be conducted or supervised by a health practitioner as defined in Section 3 of the Therapeutic Goods Act 1989. Additionally, they must undergo training provided by AusHealth on correct use of the device and interpretation of the test result.

Will you supply training? 

Yes, training can be found on this page. Video, phone and conferencing support is also available.

How accurate are the results ?

All results obtained from the InnoScreen COVID-19 Antigen Rapid Test kits should be considered indicative only and should not be relied upon for diagnostic purposes. The manufacturer has stated a test specificity of 99.25% and an overall sensitivity rate of 83.33%. This means that there may be cases where a COVID-19-positive donor returns a negative test, particularly in the very early and late stages of infection due to the reduced viral load at these time points. For this reason, any symptomatic donors that return a negative test should be sent for immediate confirmation testing at a COVID-19 testing clinic and should not return to the workplace until a negative test result is obtained. 

Who can purchase the test?

AusHealth is able to sell to government, health practitioners and companies who employs or engages a health practitioner as defined in Section 3 of the Therapeutic Goods Act 1989 who is responsible for performing or supervising the performance of the test and undertakes suitable training on the testing device (training pack supplied by AusHealth).

Further clarification of these rules can be found on the TGA website here.

 

If you purchase the InnoScreen COVID-19 Antigen Rapid test kit you need to meet the criteria set out by the TGA, namely "Conditions specific to COVID-19 rapid antigen point-of-care tests". This criteria is:

  1. The person in whose name the device is included in the Register (the sponsor) may only supply the device to one or more of the following:
    1. a laboratory that is an accredited pathology laboratory within the meaning of the Health Insurance Act 1973;
    2. a medical practitioner who is registered under a law of a state or territory to practice medicine, a person registered under a law of a state or territory to practice paramedicine (a paramedic), or an organisation, business or institution that employs or engages a medical practitioner or a paramedic, where the medical practitioner or the paramedic is responsible for performing or supervising the performance of the test, and both the medical practitioner and the paramedic (and any person acting under their supervision to perform the test) have received training in the correct use of the device and the interpretation of the test result;
    3. a residential care or aged care facility that employs or engages a paramedic (as defined above) or a health practitioner within the meaning of the Therapeutic Goods Act 1989, where the paramedic or the health practitioner is responsible for performing or supervising the performance of the test, and both the paramedic and the health practitioner (and any person acting under their supervision to perform the test) have received training in the correct use of the device and the interpretation of the test result;
    4. an organisation, business or institution that does not have the primary function of providing healthcare services but employs or engages a paramedic (as defined above) or a health practitioner within the meaning of the Therapeutic Goods Act 1989, where the paramedic or the heath practitioner is responsible for performing or supervising the performance of the test, and both the paramedic and the health practitioner (and any person acting under their supervision to perform the test) have received training in the correct use of the device and the interpretation of the test result;
    5. a department of the Commonwealth, state or territory, with responsibility for health, or a department or other agency of the Commonwealth, state or territory acting on its behalf.

As an ongoing effort to streamline the use of the rapid tests and to ensure the kits are performed in accordance with the guidelines set by TGA, we need to ensure that the you understand how to perform the tests proficiently and are trained sufficiently.

We therefore have a link to our tutorial and the brochures provided by Innovation Scientific. Please watch the tutorial and familiarise yourself with the product before using the test kits.

Please call Siobhan from AusHealth on 0407 720 368 for further training or any questions you may have. Our technical team is there if you need advice or further training or support. On completing the training, please fill out the online form below and submit it for our records.

Video Tutorial

 


Mandatory eligibility criteria

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