By Lehlohonolo Lehana.
The South African Health Products Regulatory Authority (SAHPRA), has approved the first mpox diagnostic test, bolstering efforts to improve testing access across the country.
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.
Mpox is typically a mild and self-limiting disease with a low case fatality rate. The risk of wider transmission remains low in South Africa, but anyone can contract mpox regardless of age, gender, sexual orientation and race.
South Africa has a total number of 25 cases.Twelve cases were diagnosed in Gauteng, 11 in KwaZulu-Natal and two in the Western Cape. Three have died.
None of the country’s cases are the relatively new strain, clade 1b, which seems to be deadlier than other forms of the virus. All of South Africa’s cases were infected with clade 2b, the same type of the virus that caused outbreaks in Western Europe and the United Kingdom in 2022 and 2023, according to health department.
Almost all South Africa’s cases were among gay and bisexual men, most in their twenties or thirties, and many of them were infected with HIV, but untreated.
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.
In August, the outbreak of the virus was declared a global public health emergency by the WHO for the second time in two years, following rising cases in DR Congo and its spread to neighbouring Burundi, Uganda and Rwanda.
Some Western countries have donated doses of mpox vaccines to combat the outbreak of the disease in Africa but reports say more are urgently needed.
Rwanda, which was the first to administer mpox vaccines in Africa, received 5,000 more doses, according to the Africa Centres for Disease Control and Prevention (Africa CDC).