ANALYSIS: SAHPRA doubtful of covid home testing kits - Groundup (20 October 2021)

Since April this year the UK and US started using free kits for rapid antigen testing, which are simple to use (much like pregnancy tests) and provide reasonably reliable results within 30 minutes or less. If the test shows a positive result, the person should go for a PCR (polymerase chain reaction) test to confirm if they are Covid-19 positive. In contrast to antigen tests, PCR tests have to be processed in a laboratory.

However, in March 2020, the South African Health Products Regulatory Authority (SAHPRA), which regulates the use of all health products in the country, released the regulatory requirements for Covid-19 Rapid Tests stating that test kits may not be advertised or sold to the public, are intended for use by professionals only, and are not intended for self-testing. Yuven Gounden, spokesperson for SAHPRA, said the decision was made due to a fear of misinterpretation as a person who is infected may proceed to act as if they are uninfected and spread infection.

Meanwhile, rapid antigen tests from 20 different manufacturers have been approved by SAHPRA for use by medical professionals.

According to an article in Nature, people should think of rapid antigen tests as “tests of infectiousness, not of infection.

Harvard epidemiologist Michael Mina suggests that home testing could hugely curb outbreaks.

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