Thursday, 25 April, 2024
HomeWeekly RoundupMedicines regulator warns against unapproved COVID-19 blood tests

Medicines regulator warns against unapproved COVID-19 blood tests

South Africa’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. According to a Business Day report, 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 South Africa. 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 South Africa 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.

The report says 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.

[link url="https://www.businesslive.co.za/bd/national/health/2020-03-31-medicines-regulator-do-not-use-rapid-home-test-kits-for-covid-19/"]Full Business Day report[/link]

MedicalBrief — our free weekly e-newsletter

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