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 and, by Tuesday, had sickened 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 are currently 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 SARS-Cov-2, and can identify infection before a person shows symptoms. Rapid blood tests detect antibodies produced in response to the virus — but as it can take several days after infection for a person to mount an immune response, these tests can produce a false negative, said Sahpra CEO Boitumelo Semete-Makokotlela.
Rapid blood tests are potentially useful for population surveys to determine who has previously been infected, but are not appropriate for determining whether an individual is currently infected, she said.
Sahpra does not believe self-testing for Covid-19 is appropriate and plans to register rapid blood tests for use solely by healthcare professionals, she said.
SA’s biggest doctor organisation, the SA Medical Association (Sama), said rapid blood tests pose 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 are also concerns 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 a total of 38,409 tests have been conducted in public and private laboratories in SA so far.
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.
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