Rapid home tests for COVID antibodies are used widely in the UK, the US and many European countries, as they are cheap, easy to administer and deliver the result within minutes, reports the Financial Mail. Yet in South Africa, where they have become easily available, they remain illegal.
But despite their illegality in South Africa, reports the Financial Mail, you can buy a COVID rapid test from an address in Fish Hoek, Cape Town for just R150. Word-of-mouth and Facebook groups help people track down tests, with some sellers offering home delivery.
Yet after two years and four waves into the pandemic, these DIY tests are still prohibited by the SA Health Products Regulatory Authority (SAHPRA), despite a group of health professionals in November calling for the regulator to allow self-testing at home.
It means, says Eftyhia Vardas, clinical virology pathologist and honorary extraordinary professor in medical virology at Stellenbosch University, that SA has been left behind by the rest of the world.
The problem is there are hundreds of varieties of rapid tests available globally but quality varies, with some providing a correct positive just 50% of the time. This makes the case for regulation: in the US, for example, the Food & Drug Administration (FDA) publishes a list of tests it recommends, and those best avoided.
“That is exactly what SAHPRA should be doing,” says Mohammed Majam, a researcher at Wits Health Instituteʼs Ezintsha unit who belongs to a team working on COVID self-test guidelines that will be submitted to the regulator.
Asked if it would be better to regulate self-tests, rather than have a range of varying quality brands sold on the black market, SAHPRA said people selling the products to all-comers are doing so “illegally”. “The consequences can be dire,” said SAHPRA CEO Boitumelo Semete-Makokotlela.
Ironically, health experts view self-testing as a good thing for managing disease spread. It means people with symptoms donʼt delay testing, and it increases the likelihood of them testing in the first place, as rapid antigen tests cost less than half the price of the standard PCR test.
Majam says the self-test guidelines for rapid tests and accompanying instructions will soon be sent to the Ministerial Advisory Committee and the Department of Health for consideration. If SAHPRA accepts the guidelines, it will open the door for legal home testing for COVID, he says.
Semete-Makokotlela told the Financial Mail that COVID rapid test kits are intended for epidemiological surveys by healthcare professionals to measure how widespread the virus is in a certain population.
They are not intended for the diagnosis of acute COVID infections, “and therefore not suitable for point-of-care diagnosis or self-testing and may not be sold directly to the public or administered by lay persons”.
But two medical professionals said rapid tests are already used by testing stations and pharmacies for diagnosis.
In fact, in December, SAHPRA approved an SA-designed and -produced rapid test, created by Medical Diagnostech. It was partially funded by the government, costs only R35 and is already used by mining hospitals for detection of disease.
That test is ready for home use too, says Medical Diagnostech CEO Ashley Uys. And, he adds, an app is being developed to help users interpret home test results. Heʼs waiting for the green light before making the product available for pharmacies to sell to consumers.
SAHPRA says it has not ruled out self-tests: “Once they are approved, communication will be shared accordingly.”
Financial Mail article – Why Covid home tests remain illegal in SA (Restricted access)
See more from MedicalBrief archives:
Home testing is ‘single most powerful tool' in reducing COVID transmission’
Israeli health chief: Swab throat as well as nose to detect Omicron variant
Rapid antigen test found more effective than PCR assay — Large US study