SAHPRA
By Thobeka Makume
The South African Health Products Regulatory Authority (SAHPRA) has approved the first mpox diagnostic test under the World Health Organization’s (WHO) Emergency Use Listing (EUL), marking a significant step in enhancing access to testing amid the 2024 outbreak. The Alinity m MPX assay, developed by Abbott Molecular and licensed to Abbott Laboratories South Africa, is a critical tool for rapid and accurate mpox detection, strengthening South Africa’s response to the viral disease that has claimed three lives in the country this year.
A Milestone in Mpox Testing
SAHPRA’s approval of the Alinity m MPX assay, a real-time PCR test, comes as South Africa grapples with 31 confirmed mpox cases since May 2024, including six new infections and three deaths in 2025. The test, which detects monkeypox virus (clade I/II) DNA from nasal or skin lesion swabs, is designed for use by trained laboratory personnel proficient in PCR techniques. This emergency use authorization, granted through SAHPRA’s reliance on WHO’s prequalification process, ensures faster deployment of reliable diagnostics during public health crises.
“For SAHPRA to have listed this assay promptly after the WHO PQ EUL [WHO prequalification Emergency Use Listing], it marks a significant milestone in improving global access to mpox testing by leveraging regulatory reliance mechanisms,” said Dr Boitumelo Semete-Makokotlela, SAHPRA’s CEO.
This swift approval underscores South Africa’s commitment to addressing the mpox outbreak, declared a Public Health Emergency of Continental Security (PHECS) by the Africa Centres for Disease Control and Prevention (Africa CDC) in August 2024. The WHO also declared mpox a Public Health Emergency of International Concern (PHEIC) on 14 August 2024, highlighting the global urgency of the situation.
Why Rapid Testing Matters
Mpox, a viral disease caused by the monkeypox virus, spreads primarily through close contact, causing painful rashes, fever, and swollen lymph nodes. Rapid and accurate testing is vital for early detection, enabling timely treatment and containment to prevent further spread. South Africa’s 31 cases, though relatively low compared to the Democratic Republic of the Congo (DRC), where over 21,000 cases have been reported in 2024, reflect a growing regional challenge.
The Alinity m MPX assay addresses a critical gap in diagnostic capacity. In Africa, limited testing has hindered outbreak control, with only 37% of suspected cases in the DRC tested this year. SAHPRA emphasized that molecular RT-PCR tests, like the Alinity m MPX assay, are currently the only approved method for mpox detection in South Africa, as they offer high sensitivity and specificity using nasal swab samples. Antigen and antibody rapid diagnostic test (RDT) kits, including self-test kits, lack the required 80% clinical sensitivity and are not recommended.
South Africa’s Role in a Regional Crisis
The 2024 mpox outbreak, driven by the more transmissible clade Ib strain, has spread from the DRC to 12 African countries, including Burundi, Kenya, Rwanda, and Uganda, with South Africa reporting clade II cases. The Africa CDC’s PHECS declaration and WHO’s PHEIC underscored the need for enhanced surveillance, testing, and vaccination. South Africa’s approval of the Alinity m MPX assay aligns with these calls, positioning the country as a leader in regional health security.
Since the outbreak began, South Africa has strengthened its response through heightened surveillance and public awareness campaigns, particularly after detecting cases in provinces like Gauteng and KwaZulu-Natal. The National Institute for Communicable Diseases (NICD) has been monitoring the outbreak, noting that South Africa’s cases are linked to clade II, which is less deadly than clade I but still requires robust containment measures.
Regulatory Reliance and Global Collaboration
SAHPRA’s approval leverages WHO’s EUL process, a mechanism designed to fast-track access to critical medical products during emergencies. The WHO listed the Alinity m MPX assay on 3 October 2024, prompting SAHPRA to act swiftly on 22 May 2025. This reliance approach allows South Africa to bypass lengthy local assessments while ensuring safety and efficacy, a model of regulatory agility praised by experts.
“This first mpox diagnostic test listed under the Emergency Use Listing procedure represents a significant milestone in expanding testing availability in affected countries,” said Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products.
The approval also reflects South Africa’s integration into global health networks. The Africa CDC has been working with WHO and partners to distribute vaccines and diagnostics across the continent, with over 215,000 vaccine doses secured for 2024. South Africa’s proactive stance strengthens these efforts, ensuring diagnostics reach healthcare facilities in high-risk areas.
Challenges and Future Steps
Despite progress, challenges remain. The Africa CDC reported a nearly fourfold increase in weekly mpox cases across the continent, from 909 in August 2024 to 3,264 in February 2025. South Africa’s outbreak, while smaller, highlights vulnerabilities, particularly among immunocompromised individuals, such as those with advanced HIV, who face higher morbidity and mortality.
SAHPRA has cautioned against unvalidated rapid test kits, urging healthcare providers to adhere to RT-PCR testing protocols. For detailed regulatory requirements, SAHPRA’s guidance document (Issue No.: MD01-2024/25 v1) provides clarity on approved diagnostics. Meanwhile, the Africa CDC is rolling out decentralized testing in the DRC, with 56 district-level GeneXpert machines and seven qPCR units, a model South Africa could adopt to enhance access in rural areas.
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