24 Nov SAHPRA approves antigen self-test kits for public use
Pretoria, 24 November 2022 – In the past year, the South African Health Products Regulatory Authority (SAHPRA) approved the antigen test kits for use by healthcare professionals.
SAHPRA has now approved seven (7) 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. 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 proper use and disposal of the tests as per the IFU.
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. For the detailed list of approved self-test kits, please visit this link: https://www.sahpra.org.za/medical-devices/medical-devices-and-in-vitro-diagnostics-test-kits/.
Using antigen self-test kits
When using the COVID-19 antigen self-test kit/s, the results will either be positive or negative. What does this mean? If one gets a positive result, it is necessary to get a Real-Time Polymerase Chain Reaction (RT-PCR) test as a confirmatory test. It is also important to note that a negative result does not mean that the person does not have SARS COVID-19. If a person has or shows symptoms of SARS COVID-19, they should have a RT-PCR test done and follow medical advice accordingly.
“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,” indicates SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.