Advisory

Rapid Antigen Tests Approved for Import into Fiji

Last Updated on 3 months by Publishing Team

POINT OF CARE TESTS

Rapid antigen point of care tests are tests that can be performed by health professionals, or trained persons under their supervision. This ensures a suitable health professional, or trained person under their supervision is available to ensure an adequate sample is collected, the results are interpreted correctly, and immediate clinical advice and treatment can be provided if required.

Conditions for the supply of COVID-19 Antigen Rapid Diagnostic Tests listed as Point of Care Tests

  • Any person who imports and/or distributes the device shall only supply the device to one or more of the following:
    a. An accredited pathology laboratory
    b. A pharmacist who is registered under the Pharmacy Profession Act 2011 to practice pharmacy where:
    i. the pharmacist is responsible for performing or supervising the performance of the test; and
    ii. the pharmacist 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;
    c. A health professional according to the interpretation in the Medical and Dental Practitioners Act where:
    i. the health professional is responsible for performing or supervising the performance of the test; and
    ii. the health professional 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
    iii. the device is only used to test employees or contractors; or a patient under the direct care of the health professional;
    d. An organisation, business, or institution that employs or engages a health professional or a paramedic where:
    i. the health professional or the paramedic is responsible for performing or supervising the performance of the test; and
    ii. 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
    iii. the device is only used to test employees, contractors, or students of the organisation, business, or institution;e. A hospital or any public health facility
  • The device must not be supplied for the purpose of self-testing.
  • The distributor must maintain records that demonstrate the device has been supplied in compliance with these conditions.
  • A list of all rapid antigen point-of-care tests approved for supply in Fiji is available on the MOH website and will be regularly updated as new tests are approved or if tests are canceled or withdrawn.
    RDT lists Point of Care

    Adapted from COVID-19 rapid Antigen Point of Care Testing: Guidance for implementation and checklist for businesses, 2022, Therapeutic Goods Administration, used with permission of the Australian Government
    https://www.tga.gov.au/sites/default/files/covid-19-rapid-antigen-tests-guidance-and-checklistbusinesses.pdf

    RAPID ANTIGEN SELF-TESTS (HOME USE TESTS)

    These are tests that can be used unsupervised at home without the involvement of a health professional. The person collects the sample, performs the test, and interprets the results by themselves.

    IMPORT and DISTRIBUTION of SELF-TEST

    1) A list of all COVID-19 rapid antigen self-tests (home use tests) that are approved for supply in Fiji is available on the Ministry of Health website along with the manufacturer’s instructions for how to use the tests.
    RDT list of Self-Test

2) This list is regularly updated as new tests are approved or if tests are canceled or withdrawn.

3) No import permit is required for the import, export, or distribution of Self-Test kits in the list, however,

4) An import permit may be required for a Self-Test kit not yet included in the list.

5) Self-Test or Home use Test kits can be purchased from pharmacies or from any other retail outlet that stocks the test.

6) All distributors of self-tests should supply the device in accordance with the conditions of the manufacturer

7) The distributor must also maintain records relating to all supplies of rapid antigen self-tests and be able to provide this information when required.

8) Companies, businesses, organisations, or institutions can purchase rapid antigen self-tests for their workers to use at home or on-site.

9) Businesses that choose to use a COVID-19 rapid self-test do not need to comply with the requirements for supervision of testing.

10) It is important that any business considering implementing rapid antigen testing takes into consideration the implications of testing in these environments, including:

  • processes to maintain the confidentiality of patient information
  • a procedure for possible closure of the business and isolation of staff if a positive result is received from a rapid antigen test, and
  • any Ministry of Health directions around rapid antigen testing and reporting of positive test results.

11) For any positive result, follow the Ministry of Health’s advice on what needs to be done next.

12) Do not just repeat the test in the hope of the second test being negative.

13) If symptoms persist or a person still feels unwell despite obtaining a negative result with a self-test, contact the nearest healthcare facility for a PCR test.

Disposal of Self-Tests or Home-use Test

  1. Follow the instructions provided with the home use test on how to dispose of it. Some tests come with a plastic bag for placing the contents of the swab etc. into before placing this in the household rubbish bin.
    Adapted from COVID-19 rapid Antigen Point of Care Testing: Guidance for implementation and checklist for
    businesses, 2022, Therapeutic Goods Administration, used with permission of the Australian Government
    https://www.tga.gov.au/sites/default/files/covid-19-rapid-antigen-tests-guidance-and-checklistbusinesses.pdf
  2. If no bag is provided, place the used items from the test into a small plastic bag which is then sealed. This bag should then go straight into another bag which should be sealed and then disposed of in the household rubbish.
  3. Wash hands thoroughly after disposal in line with good COVID safe practices.
  4. The distributor must also maintain records relating to all supplies of rapid antigen self-tests and be able to provide this information to the overseas supplier.