SAHPRA approves affordable,locally developed COVID-19 antigen test

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South Africa’s fight against the COVID-19 pandemic has been boosted with the latest approval by the South African Health Products Regulatory Authority (SAHPRA) of an innovative, locally developed COVID-19 antigen detection kit.

The MD SARS-nCoV-2 Antigen Device was developed by Medical Diagnostech, a local developer and manufacturer of high-quality rapid diagnostic test kits.

The approved antigen detection device is a rapid visual immunoassay for the qualitative detection of the COVID-19 Nucleocapsid protein (N-protein) antigen from nasopharyngeal swabs and can diagnose acute infection, providing information on whether the patient is currently infected. This is different to antibody tests which provide information on whether the patient has previously been infected and has elicited an immune response against the virus

Founder and CEO of Medical Diagnostech Ashley Uys, said access to cost-effective diagnostics is vital in the fight against COVID-19, especially in Africa. SAHPRA’s approval of the MD SARS-nCoV-2 Antigen Device provides just such a platform.

Uys added that the company is busy developing an application for smartphones to interpret results from the device, which will reduce subjectivity while creating a portal for data generation, interpretation and management, as well as statistical analysis, in compliance with the Protection of Personal Information Act.

These developments could not have come at a better time in South Africa, where a fourth wave of COVID-19 infections, and the discovery of the apparently highly infectious Omicron variant, have made widespread testing increasingly important.

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