The South African Health Products Regulatory Authority (SAHPRA) has approved the first mpox diagnostic test under the World Health Organization's Emergency Use Listing (EUL), marking a critical advancement in the country's response to the ongoing viral outbreak that has claimed three lives this year. The Alinity m MPX assay, developed by Abbott Molecular and licensed to Abbott Laboratories South Africa, represents a significant step in enhancing diagnostic capabilities as South Africa grapples with 31 confirmed cases since May 2024.
Swift Regulatory Response to Growing Outbreak
SAHPRA's approval of the real-time PCR test comes as South Africa faces mounting pressure from the 2024 mpox outbreak, which has spread across 12 African countries. The test, designed to detect monkeypox virus (clade I/II) DNA from nasal or skin lesion swabs, received emergency use authorization through SAHPRA's reliance on WHO's prequalification process, enabling faster deployment during public health emergencies.
"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.
The approval follows WHO's listing of the Alinity m MPX assay on October 3, 2024, with SAHPRA acting swiftly on May 22, 2025. This regulatory agility demonstrates South Africa's commitment to addressing the outbreak, which was declared a Public Health Emergency of Continental Security (PHECS) by the Africa Centres for Disease Control and Prevention in August 2024.
Addressing Critical Diagnostic Gaps
The approval addresses a significant gap in diagnostic capacity across Africa, where limited testing has hindered outbreak control efforts. In the Democratic Republic of the Congo (DRC), the epicenter of the current outbreak with over 21,000 reported cases in 2024, only 37% of suspected cases have been 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 due to their high sensitivity and specificity. The regulatory authority specifically noted that antigen and antibody rapid diagnostic test kits, including self-test kits, lack the required 80% clinical sensitivity and are not recommended for use.
The test is designed for use by trained laboratory personnel proficient in PCR techniques, ensuring accurate results that are crucial for early detection, timely treatment, and effective containment of the virus. Mpox, caused by the monkeypox virus, spreads primarily through close contact and causes painful rashes, fever, and swollen lymph nodes.
Regional Context and South Africa's Strategic Position
South Africa's 31 cases, while relatively modest compared to the DRC's figures, reflect the growing regional challenge posed by the 2024 outbreak. The current outbreak is driven by the more transmissible clade Ib strain, though South Africa has reported clade II cases, which are less deadly but still require robust containment measures.
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 cases have been detected in provinces including Gauteng and KwaZulu-Natal, with the National Institute for Communicable Diseases monitoring the outbreak closely.
"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.
Regulatory Innovation and Global Collaboration
SAHPRA's approval leverages WHO's EUL process, a mechanism designed to fast-track access to critical medical products during emergencies. This reliance approach allows South Africa to bypass lengthy local assessments while ensuring safety and efficacy, representing a model of regulatory agility that could be adopted by other African nations.
The approval reflects South Africa's integration into global health networks, with the Africa CDC working alongside WHO and partners to distribute vaccines and diagnostics across the continent. Over 215,000 vaccine doses have been secured for 2024, and South Africa's proactive diagnostic stance strengthens these continental efforts.
Implementation Challenges and Future Outlook
Despite this progress, significant challenges remain in the regional response. The outbreak has highlighted vulnerabilities, particularly among immunocompromised individuals such as those with advanced HIV, who face higher morbidity and mortality rates from mpox infection.
SAHPRA has issued guidance cautioning against unvalidated rapid test kits and urging healthcare providers to adhere to RT-PCR testing protocols. The regulatory authority's guidance document (Issue No.: MD01-2024/25 v1) provides detailed requirements for approved diagnostics.
The Africa CDC is implementing decentralized testing strategies in the DRC, deploying 56 district-level GeneXpert machines and seven qPCR units. This model could potentially be adapted for South Africa to enhance diagnostic access in rural areas, further strengthening the country's outbreak response capabilities.
As the continental outbreak continues to evolve, South Africa's swift approval of the Alinity m MPX assay positions the country as a leader in regional health security, demonstrating how regulatory reliance mechanisms can accelerate access to critical diagnostics during public health emergencies.
