Regulator: do not use rapid home test kits for virus
• Sahpra say they are not approved in SA, urges public to report companies selling them
SA’s medicines regulator has warned the public not to use rapid blood tests for Covid-19, saying they are potentially inaccurate and may fail to detect the disease in its early stages. Covid-19 is caused by the SARS-Cov-2 coronavirus. By Tuesday, it had infected more than 1,325 people and caused three deaths in SA.
The medicines regulator has warned the public not to use rapid blood tests for Covid-19, saying they are potentially inaccurate and may fail to detect the disease in its early stages.
Covid-19 is caused by the SARS-Cov-2 coronavirus. By Tuesday, it had infected more than 1,325 people and caused three deaths in SA.
The SA Health Products Regulatory Authority (Sahpra) has appealed to the public to report any companies or individuals selling rapid blood tests for Covid-19, as none were approved for use in SA.
Its position on self-administered, rapid test kits echoes that of other regulators, such as Public Health England, which has advised against using them.
The tests conducted by private and state laboratories in SA detect fragments of SARSCov-2, and can identify an infection before a person starts showing symptoms.
Rapid blood tests detect antibodies produced in response to the virus, but as it could take several days after infection for a person to mount an immune response these tests could produce false negatives, said Sahpra CEO Boitumelo Semete-Makokotlela.
Rapid blood tests were potentially useful for population surveys to determine who had previously been infected, but were not appropriate for determining whether an individual was currently infected, she said.
Sahpra did not believe that self-testing for Covid-19 was appropriate, and planned to register rapid blood tests for use solely by healthcare professionals, she said.
SA’s biggest doctors’ organisation, the SA Medical Association (Sama), said that rapid blood tests posed a public health risk. “The danger is that a patient who is incubating, or even symptomatic, self-tests with a rapid test, and when this is negative, assumes they don’t have Covid-19 and carries on with their lives,” said Sama chair Angelique Coetzee.
There was also concern about the accuracy of rapid tests, she said. “Some of the tests kits have shown they will only detect 60% of true positive cases.”
The National Institute for Communicable Diseases (NICD) said on Tuesday that altogether 38,409 tests had so far been conducted in public and private laboratories in SA.
Densely populated Gauteng has recorded the highest number of confirmed cases of Covid-19 (618), followed by the Western Cape (324) and KwaZulu-Natal (171).
The Free State has recorded 72 cases, the Eastern Cape 12, Mpumalanga 11, Limpopo 11, North West eight and the Northern Cape three. However, 96 cases are unassigned.