SOUTH AFRICA – South African Health Products Regulatory Authority (SAHPRA) has now approved seven COVID-19 antigen self-test kits that can be used as self-test/ at home tests by individuals as per the Instruction for Use (IFU) of the product
This SAHPRA authorisation allows organisations that received approval to market and sell the self-test kits to the public.
These test kits can be accessed at any pharmacy. Information on storage and disposal of antigen self-test kits may be found on the product’s IFU. The public is urged to comply with the proper use and disposal of the tests as per the IFU.
“These test kits offer a quick and viable alternative for COVID-19 screening. Performancetesting was done in collaboration with our National Reference Laboratory (i.e., the National Health Laboratory Services – NHLS) to ensure that quality test kits areavailable to the public. SAHPRA always ensures public safety when approving any health product,” said SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.
In the past year, SAHPRA approved the antigen test kits for use by healthcare professionals.
Covid-19 diagnostic testing was limited to nucleic acid amplification tests (NAATs) at the start of the pandemic.
Because, per the centres for disease control and prevention, Covid-19 NAATs are capable of reliably detecting small amounts of SARS-CoV-2 and are unlikely to return a false negative result.
This essentially means that the virus that causes Covid can accurately be diagnosed by a NAAT. The use of NAAT tests was only limited to selected settings, including laboratories, to be used by trained personnel.
In contrast to PCR (polymerase chain reaction) tests and NAATs, the antigen test is quicker, relatively cheap, and significantly more effective.
In October 2020, SAPHRA-approved antigen detection rapid diagnostic tests (Ag-RDT) for use in South Africa. It was employed the address the testing backlog and prioritise urgent clinical needs.
Johannesburg-based company TipTop Trade was the first in the country to obtain approval for a Covid-19 antibody test.
There are likely to be more licences awarded in the coming weeks as more companies seek and receive approval and go to market after SAHPRA’s initial prohibition of at-home testing.
Testing is essential for locating those who have got a disease, advising them to separate themselves and concentrate on their medical needs to stop the transmission of the infection to others.
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