SAHPRA Approves First WHO-Listed Mpox Test Kit, Strengthening Diagnostic Reach

In a landmark development for public health across Africa, the South African Health Products Regulatory Authority (SAHPRA) has approved the country’s first test kit for mpox (formerly known as monkeypox) under the World Health Organisation’s Emergency Use Listing (EUL). This significant step not only reinforces South Africa’s preparedness for infectious disease outbreaks but also underscores the power of international regulatory collaboration.

The approved diagnostic, the Alinity m MPX assay, was developed by Abbott Molecular and is licensed to Abbott Laboratories South Africa. This molecular RT-PCR (reverse transcription polymerase chain reaction) test uses nasal swab samples to detect the mpox virus with high specificity and sensitivity. The test received WHO prequalification and was subsequently authorised for emergency use by SAHPRA under its reliance mechanism—a regulatory approach that expedites the availability of critical medical products in public health emergencies by depending on assessments from trusted international counterparts.

Addressing a Growing Health Emergency

The approval comes amid rising concerns over the resurgence of mpox across parts of the African continent. South Africa has reported 31 confirmed cases since the current outbreak began in May 2024. Six of these infections have been recorded in 2025 alone, with three resulting in fatalities. The rising numbers prompted the Africa Centres for Disease Control and Prevention (Africa CDC) to declare mpox a Public Health Emergency of Continental Security (PHECS) in August 2024, further highlighting the urgency of scaling up diagnostic capabilities.

According to SAHPRA CEO Dr. Boitumelo Semete-Makokotlela, the swift approval of the Alinity m MPX assay demonstrates the regulator's commitment to facilitating rapid public health responses during health crises. “For SAHPRA to have listed this assay promptly after the WHO PQ EUL, it marks a significant milestone in improving global access to mpox testing by leveraging regulatory reliance mechanisms,” said Dr. Semete-Makokotlela.

Why Molecular Testing is Critical

The newly approved Alinity m MPX assay falls under the category of molecular RT-PCR tests, which are currently the only form of testing SAHPRA deems eligible for mpox detection. These tests detect viral genetic material and offer superior accuracy compared to alternative methods. SAHPRA clarified that no antigen or antibody rapid diagnostic tests (RDTs), including self-testing kits, are currently recommended for mpox in Africa. This is due to a lack of independently validated RDTs that meet the minimum clinical sensitivity threshold of 80%, as outlined by the WHO and Africa CDC.

This emphasis on accuracy is essential for managing the spread of mpox, which can cause serious health complications and disproportionately affects vulnerable populations. Rapid and reliable testing is considered a cornerstone for the early detection, isolation, and treatment of mpox cases.

A Blueprint for Future Emergencies

SAHPRA’s reliance on WHO’s EUL and its proactive approach to listing the Alinity m MPX assay signal a broader trend towards regulatory harmonisation and international cooperation. By leveraging WHO’s assessments, national authorities like SAHPRA can act swiftly without compromising on safety or efficacy, ultimately accelerating the deployment of vital diagnostics during emergencies.

This decision aligns with SAHPRA's broader strategy to support local public health responses while strengthening South Africa’s position in the global healthcare ecosystem. It also highlights the importance of regulatory agility in a world where infectious diseases continue to pose evolving threats.

Where to Learn More

Stakeholders and healthcare professionals interested in the specific regulatory and technical requirements for mpox diagnostics can refer to SAHPRA’s official guidance document: Issue No.: MD01-2024/25 v1. This document provides a comprehensive overview of acceptable test types, evaluation standards, and application procedures for emergency use authorisations in South Africa.