23-05-2025
Sahpra approves first mpox diagnostic test to enhance global health efforts
South Africa has approved the first mpox diagnostic test, bolstering efforts to improve testing access across the globe.
Image: Se-Anne Rall/IOL
The South African Health Products Regulatory Authority (Sahpra) has made significant strides in combating mpox (formerly known as monkeypox) by approving the Alinity m MPX assay as the first in vitro diagnostic (IVD) test for the virus.
This approval, facilitated through reliance on the World Health Organization's (WHO) Prequalification (PQ) assessment and Emergency Use Listing (EUL), marks a pivotal moment in enhancing global access to mpox testing.
According to Dr Boitumelo Semete-Makokotlela, Sahpra's Chief Executive Officer, the timely listing of this diagnostic assay is a considerable milestone in efforts to leverage regulatory reliance mechanisms for improved health outcomes.
'For Sahpra to have been able to list this assay timeously, post a WHO PQ EUL, this marks a significant milestone in aiding global access to mpox testing by leveraging regulatory reliance mechanisms,' she stated.
In the backdrop of ongoing mpox outbreaks, the emergency use approval of the Alinity m MPX assay, developed by Abbott Molecular Inc. and licensed to Abbott Laboratories South Africa (Pty) Ltd, is paramount.
The nature of mpox necessitates rapid and accurate testing for early detection, timely treatment, and overall effective containment of the virus. Currently, only nasopharyngeal RT-PCR (reverse transcription polymerase chain reaction) tests are under consideration by SAHPRA for mpox diagnostics.
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Healthcare agencies, including the African Centres for Disease Control and Prevention (Africa CDC) and WHO, have emphasised that there is a lack of independently validated antigen rapid diagnostic tests (RDTs) in the market with a clinical sensitivity of at least 80% for mpox testing.
As a result, antigen and antibody rapid test kits, including self-test versions, are not recommended at this time.
The regulatory requirements for mpox diagnostics can be found in a detailed communication to industry stakeholders, specifically under Issue No.: MD01-2024/25 v1.
The document is readily available on Sahpra's official website, which provides guidance on further WHO recommendations regarding mpox diagnostics.
IOL
