The South African Health Products Regulatory Authority (SAHPRA) has announced the approval of the first WHO Emergency Use Listing (EUL) for a test kit for mpox.

This approval represents a significant advancement in enhancing global access to mpox testing through a reliance process.

According to SAHPRA, the emergency use authorisation for the Alinity m MPX assay, developed by Abbott Molecular and licensed to Abbott Laboratories South Africa, is a crucial step in expanding diagnostic capabilities during mpox outbreaks.

Since the outbreak began in May 2024, South Africa has reported about 31 infections, including six cases recorded this year and three deaths.

SAHPRA stressed that rapid and accurate testing is essential for early detection, timely treatment, and effective containment of the virus.

This is after the Centre for Disease Control and Prevention (Africa CDC) declared Mpox a Public Health Emergency of Continental Security (PHECS) in Africa in August 2024.

"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," CEO of SAHPRA, Dr Boitumelo Semete-Makokotlela, said.

Currently, SAHPRA only considers molecular RT-PCR (reverse transcription polymerase chain reaction) tests for approval, which involve nasal swab samples.

The watchdog also noted that the Africa CDC and World Health Organisation (WHO) have indicated that there are no independently validated antigen rapid diagnostic test (RDT) kits available in the market that demonstrate a minimum clinical sensitivity of 80%, suitable for mpox testing in Africa.

This means mpox antigen and antibody rapid test kits, including self-test kits, are not recommended for use.

For more details on the regulatory requirements for mpox diagnostics, go to Issue No.: MD01-2024/25 v1.