The RCPA has raised serious concerns over changes made by the Therapeutic Goods Administration (TGA) to a legal instrument which regulates certain self-testing in vitro diagnostic medical devices (IVDs) in Australia. The changes come following a consultation by the TGA to review what tests it will allow manufacturers to provide directly to patients to perform on themselves. Doctor Michael Dray, President of the RCPA explains these concerns.

“The RCPA is alarmed at the suite of infectious disease tests the TGA has added to this regulatory instrument, despite repeated concerns being raised. This includes the addition of self-tests for infections which represent moderate-high public health risks and high personal risks, such as Hepatitis B and C, Influenza and Syphilis. Diagnosis for many of these infections is not entirely straightforward, and in many instances requires a number of different assays with various targets to arrive at a diagnosis, which then needs careful interpretation by a pathologist.

“Australian laboratories strive for the highest levels of performance and regulatory compliance when testing for these infections. Yet, due to these changes, an individual will be able to complete self-tests for these same diseases in their own home without adequate supervision or oversight. If someone is unwell, it is essential that they go and see a doctor for appropriate assessment and management.”

Effective 1 October 2020, the Therapeutic Goods (Medical Devices Excluded Purposes) Specification 2020 was remade to include self-tests for: Hepatitis B & C; Chlamydia trachomatis; Neisseria gonorrhoea; Treponema pallidum (syphilis); Herpes simplex virus (HSV) 1 & 2; Influenza (but not pandemic strains); and Diabetes, kidney disease and cardiovascular disease (not infectious).

Doctor Lyn Waring, Chair of the RCPA’s Microbiology Advisory Committee, explains that there are concerns surrounding the quality of self-test kits,

“Australia has a high-quality health care service backed by high-quality pathology services with one of the best quality assurance programs in the world. Unfortunately, these self-tests will not be subject to the same regulations as laboratory testing and it is not clear what quality assurance standards the tests will have. If the quality of the test being used in the community is not sufficiently high, then there is the possibility of false positive and/or false negative results which can have a severely detrimental effect.

If a patient receives a false negative and is inappropriately managed, then this can cause huge problems. Likewise, if a patient receives a false positive then it can cause high levels of anxiety and stress unnecessarily. We know that self-tests are not going to perform as well as a pathology test performed in a NATA/RCPA accredited laboratory, no matter how good they are.

“If someone is unwell, then they must go and see their doctor who should use the highest quality pathology test to provide an accurate diagnosis to best inform subsequent patient management. With influenza for example, if a patient has a high fever and rigor and they are unwell but receive a negative result, then they need to be reviewed by a medical practitioner as it could be something very serious like sepsis. If there is concern about members of the population not gaining access to the testing due to avoidance of medical care, there are better strategies than self-testing, such as outreach programs, to find such people, confirm if they are infected and also enrol them in treatment programs.

“Another concern is the fact that the self-tests that have been added to this instrument are all mostly for notifiable infectious diseases, meaning we track them in the community to see how prevalent they are and also if preventive programs are being successful. This also includes being able to monitor any strategies that are in place to treat people. If we have no knowledge of who is being tested and how they are being tested, then it is difficult to monitor the success or otherwise, of management strategies in the community,” said Dr Waring.

The use of self-tests has potential significant public health consequences in outbreak management. By losing the ability to monitor diseases of public health significance, the ability to detect outbreaks early is greatly reduced and the potential to prevent transmission within the community is also lost.