HOME TESTS: NO RAPID RESPONSE
Covid home tests have become easily available, yet they remain illegal in SA. Some experts suggest a lack of regulation on the matter is setting the country back
For just R150, you can buy a Covid rapid test from an address in Fish Hoek, Cape Town. In nearby Muizenberg, there’s a couple who sell the tests to any buyer who wants to ensure they’re not infectious before they venture out.
Word-of-mouth and Facebook groups help people track down tests, with some sellers offering home delivery. A pharmacy in Cape Town’s southern suburbs was selling the rapid tests for R250. A few days later, they were sold out.
But all these Covid home tests — used to detect antibodies and current viral infections — are illegal in SA.
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. In the UK, for example, all travellers or citizens arriving in the country must take a rapid test on their second day and immediately isolate if they test positive.
But with SA two years and four waves into the pandemic, the use of home tests by nonmedical professionals is still not permitted by the SA Health Products Regulatory Authority (Sahpra). This is 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.
Rapid self-tests have been widely available to ordinary people for months, even though they are illegal, says Mohammed Majam, a researcher at Wits Health Institute’s Ezintsha unit. He’s part of a team working on Covid self-test guidelines that will be submitted to the regulator.
The problem, as Vardas points out, is that there are hundreds of varieties of rapid tests available globally — but “not all are created equal”. They vary in quality, with some providing a correct positive just 50% of the time. That’s no better than a coin toss.
This would seem to support the case for regulation. In the US, for example, the Food & Drug Administration publishes a list of tests it recommends, and the ones best avoided.
“That is exactly the job that Sahpra should be doing,” says Vardas.
Asked if it would not be better to regulate self-tests, rather than have a range of brands of varying quality sold on the black market, Sahpra says only that people and organisations selling the products to all-comers are doing so “illegally”.
“The consequences can be dire,” says Sahpra CEO Boitumelo Semete-Makokotlela.
One business owner, who provides legal testing by health professionals, is so aggrieved that the illegal distribution of selftest kits is undercutting his business that he contacted the FM.
First, he went to two Cape Town police stations to report illegal sellers, he says. But the police weren’t interested. Next, he tried to contact Sahpra, but says he struggled to reach the correct official. He then tried the National Institute of Communicable Diseases, which referred him to the Western Cape health department, which listened to his complaint.
He believes that no-one took him seriously, and he has no idea if his report was even attended to.
The irony is that self-testing is seen by health experts as a good thing for managing disease spread. It means people with symptoms don’t delay testing. It also increases the likelihood that people will test in the first place, as rapid antigen tests are less than half the price of the gold standard PCR test, which has to be processed in a laboratory and costs at least R500.
Most labs in SA also usually require a doctor’s note before conducting a PCR test, and doctors can charge for this, which inflates the cost. Medical aids only cover the cost of two PCR tests a year, making regular testing prohibitive for most.
Majam says the self-test guidelines for rapid tests and accompanying instructions or illustrations will soon be sent to the ministerial advisory committee and the national
department of health for consideration.
If the guidelines are accepted by Sahpra, it will open the door for legal home testing for Covid, says Majam, who pushed for self-testing for HIV in the face of stiff resistance before that was permitted.
He knows how useful it can be. As a researcher conducting testing studies, he had demo rapid tests at his disposal, so when he started showing Covid symptoms at the end of December, he used one of them.
“It was helpful in that I was able to test and determine my positive status early enough and isolate. But [it also helped] to better manage my symptoms and understand the timing of symptoms,” he says.
“Would I have sought a PCR or an antigen test at a pharmacy if and when I became symptomatic?” he asks. Probably not.
Of course, testing at home meant Majam and his Covid-positive family members weren’t included in the national stats.
“Does it matter?” he asks. “I don’t think it does.”
More important is that he could manage the disease, and ensure “we were not vectors spreading it outside of our household”, he says.
“For me, Covid self-testing, like HIV selftesting, is really about empowerment and giving people the ability to decide how they need to react to protect themselves and those around them.”
According to Vardas, the rapid antigen tests are actually better at identifying infectious individuals than the PCR lab test, which looks for virus fragments.
“Rapid tests can detect a transmissible virus better than the PCR tests and therefore they are very useful for diagnosis of symptomatic people,” she says. “Unlike PCR tests that can remain positive for prolonged periods of time, antigen tests will become negative when the person is no longer infectious.”
Despite their advantages of speed and affordability, they are not perfect.
A lay person could take a nasal or throat sample incorrectly, and “self-administration or sampling of small children may compromise the sample”, Vardas says.
If a rapid test is complex or an instruction difficult to follow, a person could leave an essential step out of the process. And interpretation of the result if the positive test lines are faint can be confusing, she warns.
Majam, however, believes access to tests helps people to live normal lives. When he was symptom-free after seven days, he did a new test at home, with a negative result. This meant he could go back to work at the health institute — where his medical colleagues see high-risk patients — and he could visit his parents, who are more at risk of severe Covid.
“I was able to test my kids the day before school started, so I could be satisfied that they wouldn’t be returning while still infectious.”
These are the scenarios in which he believes testing should be required, even as Covid becomes endemic.
But does SA need more testing generally, as we learn to live with the virus?
Majam warns that while Omicron — which drove the fourth wave — was mild, there is no guarantee future variants won’t be more severe.
“I don’t think we are at the point where we can say we don’t need tests, and I think [trusting] that any future variants will all be mild may be premature,” he says.
“Covid has humbled the scientific community because we aren’t always able to keep up with the rate of change, and statements we made based on evidence at the time quickly and often become moot.
“I would therefore not neglect testing but rather reconsider scenarios of how and when it is useful.”
Covid self-testing, like HIV self-testing, is really about empowerment and giving people the ability to decide how they need to react to protect themselves and those around them
Mohammed Majam
However, Semete-Makokotlela tells the FM that Covid rapid test kits are intended for epidemiological surveys by health-care professionals to measure how widespread the virus is in a certain population.
The regulator says they are not intended for the diagnosis of acute Covid infections. “They are 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.”
Two medical professionals take issue with this, saying 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.
But he’s waiting for the go-ahead before making the product available for pharmacies to sell to consumers.
Sahpra has not ruled out self-tests, saying: “Self-test kits are not yet approved to be distributed or sold in SA. Once they are approved to be submitted, communication will be shared accordingly.”
Until then, with a cursory Facebook search and a few phone calls, consumers can hunt down illegal tests, which may or may not be accurate.