Could free rapid antigen tests cause more harm than good?
As Omicron numbers soar and Australia pivots towards large-scale use of rapid antigen tests (RAT), constituents are screaming for them to be provided free of charge.
The political response from the states has been a scramble to secure and offer supplies, hoping to avoid the backlash that has accompanied their Covid-related decisions to date.
Fortunately, however, Australia has strict pharmaceutical protections in place and the only rapid antigen tests available for distribution are listed by the Therapeutic Goods Administration (TGA).
The TGA has listed 15 different rapid antigen tests and categorised them according to their clinical sensitivity. The judgment is based on studies done by the manufacturer that show the positive percent agreement (PPA) – the percentage of individuals that produced a positive test result using a rapid antigen test, in comparison with a positive test result by PCR test.
The minimum clinical sensitivity a testing kit must achieve before it is listed is 80 per cent, which it labels as "acceptable sensitivity". A kit with 90 per cent PPA is labelled "high sensitivity" and a kit that records clinical sensitivity greater than 95 per cent is considered to have "very high sensitivity".
There are only five kits that have been given the "very high sensitivity" label:
● All Test Sars-CoV-2 Antigen Rapid Test (Nasal Swab)
● Panbio Covid-19 Antigen Self-Test (Nasal Swab)
● OnSite Covid-19 Ag Self Test (Nasal Swab)
● Lyher Novel Coronavirus Antigen Test Kit (Nasal Swab)
● V-Chek Covid-19 Antigen Test (Saliva)
Adding to the confusion however, there are some tests that reportedly, don't detect the Omicron variant or need to be used in conjunction with LED torches to interpret the results – and not unlike the burgeoning waste issue with masks, the latter brings with them significant concerns for Australian landfills and possible battery consumption by children.
The onus, therefore, is on the local supplier - whether organisation, supermarket or pharmacy - and the purchaser to do their homework and to select tests of high or very high sensitivity and specificity.
As federal government commit another $375m to buy rapid tests for the national stockpile, there is criticism that once again the issue has "fallen to the states". Victorian health minister, Martin Foley, has announced that they have bought 34m tests and hope to start handing them out next week, joining NSW which has now ordered 50m and will distribute them from the end of January.
The real issue, however, is whether these states are merely playing politics, appeasing constituents without considering the critical issue of collecting crucial data so that they may better understand community transmission and respond to the pandemic more effectively.
If, for instance, there are 30 million tests issued at a wholesale cost of $6 a piece, that's an initial spend of $180 million. To spend that amount of money and likely not be able to monitor the results or identify and assist the end user that has a positive result, means that the government is not making effective decisions regarding the protection of communities.
Worse still, indiscriminate distribution without appropriate reporting opens the very real potential of arbitrage – where millions of tests are never used for their intended purpose – instead being amassed and sold on the black market or shipped overseas for sale. Already we are seeing rapid antigen tests double in price due to price-gouging.
We only have to look at the UK Governments' experience with its initial tranche of free RAT handouts to see 'what not to do'. Approximately 1.8bn Pounds was wasted in the first provision of tests, when the government could only identify 17 per cent of end users having completed a test. That is 83 per cent potentially having headed offshore.
By spending just a fraction more than the cost of a RAT test, authorities could link each test to a proven mobile app and robust management system that effectively records consent and identification of the test user, the location of where the test is taken and access to every result.
Speaking of the current situation, Graham Gordon, CEO and founder of Gardian, and the developer of the Gardian Self Check app believes the answer lies somewhere in the middle.
"The government is already supplying rapid antigen tests to Commonwealth-subsidised residential aged care facilities, multi-purpose services and national Aboriginal and Torres Strait Islander flexible aged care program services in areas of high prevalence of COVID-19, with additional kits to NSW, QLD, ACT, VIC and SA expected to commence in early 2022.
"Perhaps a more comprehensive solution – one that would meet the health and continuity requirements of business and the general public, would be to implement a rebate system based upon tests taken in conjunction with an official app that is linked to a Medicare card. This would ensure that the results could be tracked, and support provided to 'positive' individuals, while the 'cost' of the test is rebated," said Gordon.
The Gardian Self Check app has been purpose built to deliver end-to-end traceability for each RAT test used. Each individual test is QR coded with a unique identifier number, so the software is able to check and confirm each test taken against the database of tests sold or handed out free-of-charge. That test can then be confirmed as being used and a rebate applied – ultimately ensuring that the money spent on tests is validated.
