The South African Health Products Regulatory Authority (SAHPRA) has listed the first mpox in vitro diagnostic test kit – using the WHO PQ assessment under Emergency Use Listing.
The approval of the Alinity m MPX assay, developed by Abbott Molecular and licensed to Abbott Laboratories SA (Pty) Ltd, represents a critical advancement in expanding diagnostic capacity amid mpox outbreaks.
Currently, only molecular RT-PCR (reverse transcription polymerase chain reaction) tests are considered for approval by SAHPRA – they are nasal swab tests.
The African Centres for Diseases (Africa CDC) and the WHO have noted that there is no independently validated antigen RDT (Rapid Diagnostic Tests) in the market that demonstrated the minimum clinical sensitivity of 80% that is suitable for mpox testing on tis continent, which is why antigen and antibody rapid tests kits, including self-test kits, are not recommended for use.
See more from MedicalBrief archives:
Morocco produces Africa’s first mpox tests
Incorrect diagnoses delayed SA man’s mpox treatment