Laboratoires Abbott Cie

SAHPRA Approves First WHO-Listed Mpox Diagnostic Test as South Africa Reports 31 Cases

• The South African Health Products Regulatory Authority (SAHPRA) has approved the Alinity m MPX assay, the first WHO Emergency Use Listed mpox diagnostic test, marking a significant milestone in expanding testing access during the ongoing outbreak. • South Africa has reported 31 confirmed mpox cases since May 2024, including six new infections and three deaths in 2025, as the country strengthens its response to the viral disease. • The real-time PCR test detects monkeypox virus DNA from nasal or skin lesion swabs and is designed for use by trained laboratory personnel, addressing critical diagnostic gaps in the region. • SAHPRA's swift approval leverages WHO's Emergency Use Listing process, demonstrating regulatory agility and positioning South Africa as a leader in regional health security amid the continental outbreak.