SA medicines regulator authorises first Covid-19 home tests
The medicines regulator has for the first time authorised Covid19 home-test kits, opening the way for people to conduct their own checks at a fraction of the price of laboratory tests.
The SA Health Products Regulatory Authority (Sahpra) has faced calls for more than a year to authorise self-administered rapid antigen tests for Covid-19 and bring SA in line with countries such as the UK, Germany and US which encouraged wide-scale self-testing as one of the tools for curbing the pandemic. Sahpra CEO Boitumelo Semete said the regulator needed to ensure the self-testing kits were reliable, easy to use, and that consumers knew how to interpret the results before giving them the go-ahead.
While SA’s weekly recorded coronavirus cases and hospital admissions are low, the disease is still circulating and poses a risk to vulnerable people, she said. “Self-testing is still useful in the current context. We are not out of the red yet,” she said.
The companies granted authorisation to import home test kits are Humor Diagnostica, ICT Diagnostics, Mnandi Pharma Solutions, Rapid Testing Solutions SA, TipTop Trade, and Pro Med Diagnostics. The rapid antigen tests are expected to cost as little as R55, according to Tip Top Trade joint CEO Gabi Fisher. An antigen test administered by a health professional costs about R200. A PCR test conducted in a private laboratory costs R500.
Sahpra has not imposed any restrictions on where the selftest kits may be sold, said Humor Diagnostica MD Christelle Le Roux.
Humor Diagnostica would sell its kits to pharmaceutical wholesalers and employer groups such as mining houses, but did not intend to market direct to consumers, she said.
Humor Diagnostica had yet to receive its first shipment, and expected the tests would cost consumers less than R100, she said. Mohammed Majam, head of medical technologies at Ezintsha, a subdivision of the Wits Health Consortium, welcomed Sahpra’s move, saying the delays were due partly to the regulator trying to ensure SA had quality products on the market. “Hospital wards are not full, but in the US they have just passed 1-million deaths, so this isn’t over by a long shot. It is useful for us to have these tests in our armoury so that we can react quicker and more decisively should we have a new deadly strain rear up,” he said.
“We need to be prepared for the next pandemic, and these tools, mechanisms for approval, regulatory pathways and implementation considerations, will help us deal with (it) better.”
Majam said the value of selftesting for Covid-19 lay in empowering individuals and helping protect people at risk of severe disease, rather than contributing to health authorities’ efforts to monitor case numbers. “Surveillance is important, but I think we have much better indicators for this in terms of wastewater markers, or sentinel laboratory sites,” he said.
“With self-tests people can test themselves at the earliest onset of symptoms and make a call if they are going into a high risk situation — for instance visiting an elderly relative, or going to an indoor event where they may infect a large number of people.
“In future, we may have drugs to reduce the length of symptoms and even the severity of long Covid, and getting an earlier diagnosis will make these new medications more effective,” he said.
SELF-TESTING IS STILL USEFUL IN THE CURRENT CONTEXT. WE ARE NOT OUT OF THE RED YET