TGA Approved Rapid Antigen Testing

filler

Price:
$25
Stock:
In Stock

Description

Rapid Antigen Testing is available for workplaces, schools and worksites. Prices to be discussed.

Contact us at sales@vitalpharmacysupplies.com.au for more information

Benefits:

  • Made in Australia
  • TGA approved
  • Option of Saliva or nasal Testing
  • Device is kept at room temperature
  • Test are 90% accurate
  • Test will give a positive or negative result between 5 minutes - 15 minutes.
  • Very easy non-invasive technique which takes merely seconds to preform by
  • one of our Health Practitioner or one of your trained and supervised staff
  • members.
  • The test can be collected after initial result by a pathologist for a further
  • investigation if the test is positive. The pathologist investigation will be Medicare
  • subsidised and result sent directly via SMS to the person tested.
  • If required all the specimen that collected can be further lab tested which is
  • subsided by Medicare.

The Antigen-19 Rapid testing device is an in-vitro immunochromatographic assay for the detection of the SARS-CoV-2 antigens in nasopharyngeal swab, nasal swab and oropharyngeal swab from individual suspected of Covid-19. This is a great measure to
promptly identify cases of Covid-19 infection and prevent transmission

Download Resources:

Test information

FAQ:

Where or who can the tests be supplied to?

The tests can be supplied for use by specified health practitioners at the point of care to the following:

  • Registered medical practitioners or paramedics, or an organisation, business or institution that employs or engages a registered medical practitioner or paramedic to perform or oversee performance of the test.
  • Residential care (disability and rehabilitation facilities) and aged care facilities that employ or engage health practitioners (for example, nurses) to conduct or perform the test. If the residential care or aged care facilities provide care in the home this condition would also allow for performance of the test to be conducted by a health practitioner or paramedic.
  • Organisations, businesses, or institutions (that do not have the primary function of providing healthcare services) that employ or engage health practitioners or paramedics to conduct or oversee performance of the tests. For example, rapid antigen tests are being used in the mining sector consistent with these conditions.

The tests can also be supplied to accredited laboratories and to Commonwealth, state or territory government departments, in cooperation with their relevant health departments.

Can tests be performed by persons who are not health practitioners?

Yes, but the 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.

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.

What is the accuracy of rapid antigen tests?

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.

In the wider Australian community settings where there are low rates of COVID-19, the tests are less accurate as there is a higher risk of both false positive and false-negative results.

For this reason, whilst a goal of no or very low community transmission is being pursued, performing confirmatory testing by PCR is very important if someone gets a positive test from a rapid antigen test.

Why has the TGA imposed conditions on supply for rapid antigen tests?

The TGA has approved a significant number of rapid antigen tests.

So that they are appropriately used, and the results interpreted correctly, they can currently only be legally 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.

The conditions were recently updated to clarify:

  • in what circumstances the tests can be supplied
  • who can perform the test; and
  • the requirements for supervision of testing.

These conditions reflect the importance of correct interpretation of results, advice and treatment being available at the time of testing. The requirement for healthcare professional involvement and the prohibition on self-testing reflects the critical importance of immediate notification of positive cases to state and territory health authorities so that contact tracing and processes to manage outbreaks can immediately start.

In a potential later scenario, where low-level community transmission is being tolerated in a vaccinated population, it may be appropriate to review these requirements.

What is meant by health practitioner? Is this the same as a healthcare professional?

Health practitioner is defined in Section 3 of the Therapeutic Goods Act 1989and is not necessarily the same as a healthcare professional. The conditions of inclusion on rapid antigen tests refer specifically to a health practitioner and not 'healthcare professional'.

Health Practitioner as defined by the Therapeutic Goods Act 1989 means:

a person who, under a law of a State or internal Territory, is registered or licensed to practice in any of the following health professions:

  • Aboriginal and Torres Strait Islander health practice
  • dental (not including the professions of dental therapist, dental hygienist, dental prosthetist or oral health therapist)
  • medical
  • medical radiation practice
  • nursing
  • midwifery
  • occupational therapy
  • optometry
  • pharmacy
  • physiotherapy
  • podiatry
  • psychology

The list above includes medical practitioners, pharmacists, and nurses along with others, but not for example pharmacy assistants, dental assistants, or personal care workers in aged care. Paramedics are not included in the definition of Health Practitioner in the Act but have been specified as a suitable health practitioner for the purposes of supply and use of rapid antigen tests.

The registration or licensing of a health practitioner can be checked through the Australian Health Practitioner Agency (AHPRA)(link is external). For the purposes of rapid antigen testing health practitioner also includes a person registered under a law of a state or territory to practice paramedicine (as specified in the conditions of inclusion).

A health practitioner, including a medical practitioner or paramedic, who performs or supervises rapid antigen testing, takes on full responsibility for all testing conducted under their supervision including keeping records of such training. For further information see the question 'What are the responsibilities of the health practitioner?'

Who requires training?

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.

As a minimum, the supplier of the test needs to provide training to the health practitioners or paramedics performing or overseeing testing. Once trained, a health practitioner or paramedic can train persons under their supervision to conduct the test.

Suppliers (sponsors) will need to have procedures in place for performing training, and a means of assessing and recording the competency of the person being trained. Certification for such training is not necessary.

Suppliers should also provide health practitioners with a checklist for training staff under their supervision.

Why is training required?

Training in adequate sample collection and correct performance of the test is essential to minimise user errors which can impact test interpretation and accuracy.

All health practitioners or paramedics and persons under their supervision must be trained in the correct use of the device. Staff must also be trained in appropriate specimen collection and infection control procedures. Transmission-based precautions must also be used when collecting and handling potentially infectious specimens not just for SARS-CoV-2, but also for other infectious diseases.

Feedback from those already using these tests has confirmed the importance of ensuring adequate specimens are collected to avoid inaccuracies due to poor specimen collection, and the need for supervision of testing, particularly for the management of false positive results. Both depend on appropriate training and supervision.

Can training be performed on-line?

Face-to-face training is preferable but interactive on-line training would be acceptable. All individuals undergoing training would still need to have access to samples of the test to practice with and be able to ask questions during the training session(s). Just providing a video for someone to watch would not be sufficient.

Why does the testing need to be supervised by a health practitioner?

Testing by, or under the supervision of, a suitably qualified health practitioner, medical practitioner or paramedic allows for immediate clinical advice to be provided in relation to:

  • the correct collection of a patient sample
  • the correct interpretation of results
  • appropriate patient management or treatment if required
  • handling of positive results
  • arrangements for confirmatory testing and notifications to health authorities for the purpose of surveillance and contact tracing.

The practitioner is also responsible for the supervision of the way testing is conducted and making sure records are maintained for individual patients. Currently, with rapid antigen tests, there is no automated process for recording and including the results in an individual's patient record or for automatically notifying state and territory health authorities of a positive test.

 What are the responsibilities of the health practitioner?

The health practitioner, medical practitioner or paramedic remains responsible for the conduct of testing. They must be available (either in person, or available on the phone or by videoconference) to provide assistance or advice, as required, to persons under their supervision in the correct use of the device and the interpretation of the test results.

The responsible practitioner must also ensure that anyone performing the test under their supervision is appropriately trained in:

  • infection control practices, including assessment of any site-specific work, health, and safety risks
  • the collection of samples, or where applicable, the supervision of self-collection in order to verify patient identification, sample collection, test performance and test results
  • the correct use of the device and interpretation of test results
  • protocols for recording results and requirements for notification of positive results
  • protocols and referral processes for recollection and confirmatory testing
  • protocols for reporting any problems or adverse events associated with performance of the test, including false negative or false positive results, to the Therapeutic Goods Administration.

Failure to appropriately supervise testing may amount to professional misconduct. The practitioner remains liable at all times for the conduct of the testing.

What requirements are there for reporting the results of testing for monitoring and contract tracing?

The health practitioner, medical practitioner or paramedic performing, or supervising performance of, the test is responsible for ensuring protocols are in place for notifying positive results as per the national guidelines developed by the Communicable Disease Networks Australia (CDNA)

These guidelines outline Australia's national minimum standard for surveillance, laboratory testing and contact management for COVID-19. There may be additional state and territory requirements that need to be complied with.

Failure to manage positive results (including confirmatory testing) can have significant public health consequences.

Is it okay for the sample for testing to be self-collected? Does self-collection of a specimen also need to be supervised?

Yes, samples may be self-collected but this must be supervised. This is an important step in the testing process.

Where a sample is self-collected by an individual, the collection must be supervised to verify patient identification and ensure an appropriate sample is collected. Poor sample collection is a common cause of error and can result in false negative results. Whoever is performing the actual rapid antigen test must also be able to verify which person the sample was collected from.

It is important to note the following if self-collection of a sample is necessary this must be conducted under the direct supervision of a person who has been trained in sample collection.

Further information on self-collection of specimens can be found in advice from members of the Public Health Laboratory Network

What about testing performed remotely with a medical practitioner?

The conditions allow for rapid antigen tests to be supplied to medical practitioners who may arrange for the tests to be available at a clinic or other site that can facilitate supervision of the collection of the test via video. Trained staff would need to be available onsite to perform or supervise collection of the sample (if self-collected) and to perform the test during the consultation with the medical practitioner.

The medical practitioner supervising testing via video must also be trained in the correct use of the device and the interpretation of the test results.

The use of a Medicare Benefits Schedule (MBS) item, telehealth or otherwise, is not appropriate for this form of testing service.

Can remote supervision of sample collection and testing be performed by video?

The conditions allow for rapid antigen tests to be supplied to business or organisations that employ/engage relevant health practitioners to perform or oversee performance of testing. Preferably such testing would be performed on-site under the supervision of a trained health practitioner, or trained person under their supervision. Where employees are distributed across multiple geographical locations businesses or organisation may need to consider establishing 'testing hubs' to facilitate supervised testing.

However, there may be circumstances where it is necessary for certain essential workers (such disability or aged care home care workers) to have the test performed off-site under remote supervision. In this situation the business or organisation could establish protocols to allow for remote supervision of testing under strict criteria outlined below.

A business or organisation would need employees to attend on-site training by a health practitioner in how to self-collect a sample and perform and interpret the test. Once this was completed the employee could be provided with a number of tests they could use off-site under remote supervision.

To ensure compliance with the conditions of supply and use of rapid antigen tests the site collection centre would need to:

  • Record how many tests were supplied to the employee
  • Identify who would be responsible for the remote supervision arrangements for that employee
  • Have protocols in place to facilitate remote supervision of testing
  • Have protocols in place for recording when testing is performed, by whom and who the supervising health practitioner (or trained person under their supervision) was.
  • Ensure availability of a health practitioner, or trained person under their supervision, at the time the employee needs to perform the test.

The health practitioner, or trained person under their supervision, would need to ensure:

  • Training is provided to each person on how to self-collect a sample and how to perform the test as per the instructions for use.
  • A copy of the instructions for use for the test is provided to the employee. This is particularly important as the tests come in boxes of 20 or more with only one copy of the instructions for use. All employees being provided with the test need to have access to a copy of the instructions for use that is in a language that is most easily understood by them.
  • The employee is provided with instructions for how to access remote supervision (e.g., via mobile phone) and records and report results.

Please note, employees who are themselves a relevant health practitioners for the purposes of the conditions on supply and use of rapid antigen tests (e.g. a registered nurses) are able to perform the test on themselves once they are trained in the correct use and interpretation of the test, including self-collection of a sample. Remote supervision is not required in this circumstance, but the business or organisation still needs protocols in place for recording such testing as mentioned in the criteria above.

Businesses or organisations wanting to implement rapid antigen testing of their works should refer to the additional guidance on our website that provides further information on what processes and protocols you need to have in place to safely conduct testing. This includes protocols for training of staff and assessing on-going competency. It is not sufficient to rely on the initial training provided by the supplier of the test.

Why is home testing not allowed?

The supply of home tests for COVID-19 is currently illegal as COVID-19 is a serious disease and testing should be performed by a suitably qualified health practitioner who is able to provide immediate clinical advice and treatment if required.

There is also a potential risk that some individuals could be motivated to conceal or not report a positive test, especially if they felt that their symptoms were mild and, for example they might lose employment income, be unable to go on holiday, or miss an important family event.

Although these tests can detect the virus in the acute phase of infection from symptomatic patients, in community settings where there are low rates of COVID-19 there is a high risk of false positive and false negative results and therefore the results can be susceptible to misinterpretation. This risk increases with inadequate sample collection.

Can a freight company or other business purchase tests for their workers?

Yes, a freight company or other business can purchase rapid antigen tests but only if it engages or employs a health practitioner or paramedic who will be responsible for performing the test or supervising the performance of the test by trained staff.

The practitioner and any staff under their supervision performing the test must be trained in the correct use and interpretation of the test. The practitioner also has other responsibilities related to supervision of testing. Please see additional responses to questions about training and supervision.

Businesses or organisations wanting to implement rapid antigen testing of their works should refer to the additional guidance on our website that provides further information on what processes and protocols you need to have in place to safely conduct testing. This includes protocols for training of staff and assessing on-going competency. It is not sufficient to rely on the initial training provided by the supplier of the test.

I am an interstate freight business will the State/Territory government accept rapid antigen testing for drivers?

Each State and Territory have their own conditions around what is required and accepted for testing including what is acceptable for the three-day testing in NSW.

It should also be noted that drivers may self-collect a sample under supervision but the test itself must be performed or supervised by a fully trained health practitioner, medical practitioner or paramedic unless the criteria for remote supervision is met, see question on remote supervision. For further information see questions on training and supervision.

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