COVID-19 point-of-care tests

The following non-standard conditions of inclusion in the ARTG apply to serology-based point-of-care tests for COVID-19.

1. The person (the sponsor) in relation to whom the Device is included in the ARTG may only supply the Device to:
   1. laboratories that are accredited pathology laboratories; and/or
   2. medical practitioners who are registered under a law of a State or Territory; and/or
   3. health care professionals in residential and aged care facilities; and/or
   4. the Commonwealth, State or Territory department of health; and/or
   5. an agency of the Commonwealth, State or Territory acting on behalf of the Commonwealth, State or Territory department of health.

Further clarification relating to the specific conditions of supply is provided below.

Condition (1)(a)

Accredited pathology laboratories in this context are pathology laboratories accredited by the National Association of Testing Authorities (NATA) and the Royal College of Pathologists of Australasia (RCPA) for Human Pathology Testing (under the Health Insurance Act 1973) and are eligible for claiming medicare benefits for approved pathology services.

Condition (1)(b)

Condition (1)(b) includes supply to organisations that employ a medical practitioner registered with the Australian Health Practitioner Regulatory Agency (AHPRA) under the Health Practitioner National Law as is in force in each state and territory. A medical practitioner may then conduct/oversee/guide the performance of testing by a registered/enrolled nurse.

Condition (1)(c)

Condition (1)(c) includes supply to residential (i.e. disability and rehabilitation facilities) and aged care facilities that employ health care professionals (this includes either a medical practitioner as specified in 1(b) or a registered/enrolled nurse) who will conduct the test. This condition would not allow for testing in a home care setting.

Condition (1)(d)and (e)

1(d) and (e) of the conditions allow for supply of a device to the Government or an acceptable agency included in the list of Australian government departments and agencies and has been appointed/contracted to acquire COVID-19 test kits on behalf on the Commonwealth, State or Territory department of health.

Note: The above conditions do not currently allow the supply of COVID-19 serology-based tests for use at the point-of-care to other healthcare professionals (i.e. pharmacists).

The following four conditions are imposed on the supply of COVID-19 rapid antigen tests included in the Register:

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 person who is registered under a law of a state or territory to practice pharmacy (a pharmacist), where:
      1. the pharmacist is responsible for performing or supervising the performance of the test; and
      2. the person mentioned in subparagraph (i) and any other 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 health practitioner within the meaning of the Therapeutic Goods Act 1989 (other than a pharmacist) or a person registered under a law of a state or territory to practice paramedicine (a paramedic), where:
      1. the health practitioner or the paramedic is responsible for performing or supervising the performance of the test; and
      2. the person mentioned in subparagraph (i) and any other 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; and
      3. the device is only used to test employees or contractors; or a patient under the direct care of the health practitioner or the paramedic;
   4. a residential care or aged care facility, or a home care service provider, that employs or engages a health practitioner within the meaning of the Therapeutic Goods Act 1989 or a paramedic, where:
      1. the health practitioner or the paramedic is responsible for performing or supervising the performance of the test; and
      2. the person mentioned in subparagraph (i) and any other 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; and
      3. the device is only used to test residents, employees or contractors of, or visitors to, the residential care or aged care facility, or clients, employees, or contractors of the home care service provider;
   5. an organisation, business or institution that employs or engages a health practitioner within the meaning of the Therapeutic Goods Act 1989 or a paramedic where:
      1. the health practitioner or the paramedic is responsible for performing or supervising the performance of the test; and
      2. the person mentioned in subparagraph (i) and any other 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; and
      3. the device is only used to test employees, contractors or students of the organisation, business or institution;
   6. 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.
2. The device must not be supplied for the purpose of self-testing.
3. The sponsor of the device must provide training to a person mentioned in subparagraphs (1)(b)(ii), (1)(c)(ii), (1)(d)(ii), or (1)(e)(ii) in the correct use of the device and the interpretation of the test result, prior to that person performing or supervising the performance of the test.
4. The sponsor must maintain records that demonstrate the device has been supplied in compliance with these conditions, including any kits supplied by distributors and on-sellers.

Post market surveillance report

5. The sponsor must provide a post market surveillance report, which includes the following information:
   1. the numbers of tests supplied in Australia and overseas;
   2. any adverse events, reported problems, issues or complaints associated with the use or interpretation of the device, including numbers of any reported false positive or false negative results for tests supplied in Australia and overseas;
   3. for each type of problem, issue or complaint, provide the manufacturer’s analysis of the issue and its risks, as well as any emerging trends.
6. The report is to be sent to the TGA (at the email address postmarketdevices@health.gov.au) for:
   1. the period beginning on the day when this condition is imposed, and ending on the next 30 June;
   2. each of the next three financial years;
   3. before 1 October after that reporting period.

What is meant by supervision of testing?

Supervision is a key responsibility for controlling the risks to patient safety and welfare that may arise while providing a testing service. Supervision of testing goes to the professional conduct of a practitioner. Failure to appropriately supervise testing may amount to professional misconduct. The practitioner remains liable at all times for the conduct of the testing.

Once appropriately trained in the correct use of the device, persons under the supervision of a health practitioner, including a medical practitioner and pharmacist, may perform the test. The relevant health practitioner responsible for supervision of testing is required to ensure all persons performing the test (including sample collection, performing tests and interpreting test results) under their supervision are appropriately trained in all matters related to good testing practice, including:

• 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;
• where relevant, protocols for recording results and any reporting requirements so they can advise individuals when they are required to report a positive test result to their state or territory health department; and
• protocols for reporting any problems or adverse events associated with performance of the test to the Therapeutic Goods Administration.

As different States and Territories may have different recommendations for rapid antigen testing and for reporting positive results, individuals should be referred to their website for any local requirements including;

• whether confirmatory PCR testing is required;
• any specific health advice including isolation requirements; and
• how and whether the result is required to be reported to your State or Territory health department.