Usability studies for Covid-19 self-testing kits requirements

Usability studies for Covid-19 self-testing kits requirements

On the 5th of March 2020, Minister of Health Zweli Mkhize confirmed the spread of the virus to South Africa, with the first known patient being a male citizen who tested positive upon his return from Italy. The vast range of self-testing kits as well as risks associated with the use of the self-testing kits require that the South African population is taken into consideration. This will ensure that all aspects of safety, performance and quality of the self-test kits are adequately addressed through the guidelines.

2022 Mar

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Document Number: MD035
Version: 1
Date Updated: 24/03/2022
File Type: pdf
Category: Communication to industry
Unit: Medical Devices