A recent study of over 900,000 tests administered in Canada found that 42 per cent of the SARS-CoV-2 rapid antigen tests identified as positive tests were false, with a high cluster from one batch of tests from a single manufacturer.
Of the 1103 positive results in 903,408 rapid antigen tests conducted in 537 workplaces; 462 of the 1103 were determined to be false positives.
The investigators were able to determine the rate of false positive rapid antigen test results over a nine-month period from a twice weekly testing program implemented at workplaces throughout Canada, backed by confirmatory polymerase chain reaction (PCR) testing within 24 hours of a positive rapid test result.
Alarming as this appears on the surface, the real horror is that with a very similar Covid testing situation unfolding in Australia; without the necessary ‘test, track and trace’ protocols in place, health officials have absolutely no way of determining whether the ‘numbers’ being recorded are accurate, and worse still, if there is a bad batch they cannot identify the manufacturer, the individuals involved or even enact further care and support.
Current Covid reporting through the Service NSW website allows an individual to record their full name, address, email, date and so on, but there is no requirement to input information on the product used or even whether it was a nasal or saliva test.
What is required is an end-to-end, deep data system that ensures the test has been conducted correctly, can record the test type, batch number and expiry date – in case of a possible recall – and the details of the person that has taken the test, where and at what time, and a traceable result.
Speaking of the obvious inadequacies, Graham Gordon, CEO of Gardian and founder of the Self Check app and Test Tracker management system, said: "The results of the international study demonstrate the importance of having a comprehensive data system to quickly identify potential issues.
"With the ability to track batch issues within 24 hours, workers could return to work, problematic test batches could be discarded, and the public health authorities and manufacturers could be informed.
“If the stats gathered overseas are translated to our local situation, then that would mean 537 workplaces facing massive disruption; operations ceased, staff in isolation or worse, deep cleans, and potential supply chain issues – not to mention the economic impact,” said Gordon.
“Instead of the early detection and eradication of a product anomaly, the ripple effect on those businesses, their workforces and communities would be enormous - particularly if they were involved in essential services such as food supply, logistics or worse still, aged care.
“It is critical, when there is so much at stake, that we have the ability to test and track the process, from manufacturer and batch to individual and result. Rapid antigen tests may not be a control strategy when there is high COVID prevalence, but if monitored correctly, they do provide essential information for reducing the risk of outbreaks by breaking chains of transmission.”