Rapid Antigen Tests
Rapid Antigen Tests (RATs) provide a quick and convenient way to test for a COVID-19 infection. Combination RATs that include testing for COVID-19 and influenza A/B are now approved for use in Australia by the Therapeutic Goods Administration (TGA), although their commercial availability may be lower than RATs for COVID-19 only. The tests can be done anywhere and typically involve a swab sample being self-collected from the throat, nose (or both) and from nasal secretions or saliva.
RATs can detect viruses during the acute phase of infection (just prior to symptom development and during symptomatic infection), however, they are not as reliable as a Polymerase Chain Reaction test (PCR).
For further information, the TGA has published Q&As on COVID-19 only and combination RATs.
Use of RATs for patients
Routine pre-screening for patients for face-to-face consultations
The Therapeutic Goods Administration provide the below advice for health professionals on screening of patients using RATs:
As a precautionary measure, health practitioners may choose to voluntarily screen patients under their care for COVID-19 but there is no requirement that they must do this. In some cases, this may be more convenient for patients than having to obtain test kits personally.
Any testing of patients would be through an arrangement between the particular healthcare professional and the patient. If healthcare practitioners wish to test patients using point of care tests, they are responsible for sourcing the test kits themselves. They can charge patients a reasonable amount as a privately billed service to recoup costs of testing, but the person being tested should first consent to any additional payments before being tested.
Individual patients who test positive will still be responsible for checking to see if they need to report their results to the relevant state or territory health authorities and to report positive results if required to do so.
Except for pharmacists, healthcare practitioners are not permitted to provide a general testing service for members of the public (i.e. for people who are not their patients who are preparing for or are in the course of a consultation).
If your practice implements routine pre-screening for patients attending the practice for face-to-face consultations, you will need to consider:
- the logistics of having patients attend the practice early to undertake the test and await their result
- what alternative arrangements for consultations can be made if the patient returns a positive result.
Use of RATs by the practice team
Routine screening of team members and contractors
There is no requirement to implement routine screening of practice team members and contractors. Still, practices may choose to implement a rapid antigen testing program to support business continuity and patient and team member safety and for surveillance within the practice.
The introduction of such a program should be documented as part of your COVIDSafe plan and should consider:
- whether self-testing (at home or in the practice) or point-of-care testing (requiring health professional supervision) is appropriate
- the frequency of testing
- the logistics of at work and pre-work screening
- how results are collected and documented
- how you will manage a positive result
- the cost of acquiring RATs.
The Australian government provides guidance for business owners on using COVID-19 rapid antigen tests in your business.
Sale of RATs
While general practices can charge patients for pre-consultation screening using RATs, the sale of RATs by a practice for patients’ home use is not advised.
GPs/practices could potentially be held liable for issues arising (for example, false positives / negatives, too much reliance, malfunctions) under product liability laws, and medical indemnity insurance generally does not provide coverage for product liability issues, as this is a different type of risk. Should your practice wish to pursue this avenue further, the RACGP would recommend seeking specific legal advice from your medical defence organisation.
Reporting of positive RATs by patients, or the practice
There are currently reporting requirements in place for COVID-19 positive RATs. Patients currently cannot report positive flu cases determined via RAT. Each state and territory have their own reporting system.
If a patient or team member tests positive to COVID-19 as part of a routine pre-screening, the person being tested must report the positive result. If a patient reports a COVID-19 positive RAT to you, you should ensure a notification is made, but the notification can be made by the patient or team member themselves via the local reporting mechanism below. It would be prudent to document this discussion in the patient’s clinical notes.
The Australian Health Protection Principal Committee (AHPPC) statement on rapid antigen testing of COVID-19 for current high community prevalence environment
The AHPPC released a statement on rapid antigen testing for current high community prevalence environment which proposes that RATs can be used for the following 3 purposes, for which testing recommendations and comments are provided:
- As a diagnostic test as an alternative to PCR for those at high risk of having COVID-19. In most circumstances in the current high-prevalence environment, a positive RAT should be accepted as a diagnosis of COVID-19.
- To manage outbreaks.
- To help early identification of cases in high-risk settings.