Tuesday, 25 June, 2024
HomeRegulatorySAHPRA authorises COVID home tests

SAHPRA authorises COVID home tests

South Africa’s medicines regulator has finally authorised COVID-19 home-test kits, after repeated calls for this for more than a year, now allowing people to conduct their own checks at home at a fraction of the cost of laboratory tests.

The SA Health Products Regulatory Authority’s (SAHPRA) green-lighting of the self-administered rapid antigen tests will bring the country in line with countries like the UK, Germany and US, which encourage wide-scale self-testing as one of the tools for curbing the pandemic.

SAHPRA CEO Boitumelo Semete said they had needed to ensure the kits were reliable, easy to use, and that people knew how to interpret the results before giving them the go-ahead, reports BusinessLIVE.

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.”

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, while a PCR test conducted in a private laboratory costs R500.

There are no restrictions on where the kits may be sold, said Humor Diagnostica MD Christelle Le Roux, which plans to sell its kits to pharmaceutical wholesalers and employer groups such as mining houses, but will not market directly to consumers. The company had yet to receive its first shipment, and expected the tests to cost consumers less than R100, she said.

Mohammed Majam, head of medical technologies at Ezintsha, a subdivision of the Wits Health Consortium, welcomed SAPHRA’S authorisation, saying the delays were partly due 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 1mm deaths, so this isn’t over by a long shot,” he said.


BusinessLIVE article – Medicines regulator authorises SA’s first home tests for Covid-19 (Open access)


See more from MedicalBrief archives:


SAHPRA comes under pressure over illegality of home testing


Home testing is ‘single most powerful tool’ in reducing COVID transmission


Rapid antigen test found more effective than PCR assay — Large US study




MedicalBrief — our free weekly e-newsletter

We'd appreciate as much information as possible, however only an email address is required.