Mpox Molecular Diagnostic Tests(RT-PCR)

On 13 August 2024, Africa Centres for Disease Control and Prevention (Africa CDC) declared the ongoing mpox outbreak a Public Health Emergency of Continental Security (PHECS). The World Health Organization (WHO) followed this the next day, which extended the alert internationally as a Public Health Emergency of International Concern (PHEIC).

After these declarations, many countries have made efforts to mobilize resources to introduce or expand laboratory testing, surveillance, and response activities. As the number of mpox cases increase and significant number of countries continue reporting new cases , there is an urgent need to expand testing capacity to strengthen the joint mpox continental preparedness and response for Africa. However, access to appropriate quality assured diagnostics is a challenge. There is limited information on important characteristics, such as available test kits’ performance and ability to detect relevant clades.

To address the challenge of mpox diagnostics access in the continent, the Africa CDC Diagnostic Advisory Committee (DAC) is continuously reviewing all available evidence on molecular tests for mpox and to shortlist tests that will be useful for mpox testing in countries. The shortlist aims to provide guidance to Africa CDC, countries and partners on appropriate high-quality molecular tests to procure and use for the mpox response. Africa CDC has published two editions of the shortlisted tests.

This third edition, an update to the second edition, has included one locally manufactured PCR detection kit (UM6P-MAScIR MPOX qPCR 1.0), manufactured by Moldiag, Morocco. This test kit was evaluated in Democratic Republic of Congo (DRC) and demonstrated very good performance charactersitics and the test kit has fulfilled almost all of the criteria used by DAC for shortlistng of recommended tests. By issuing regular updates on mpox diagnostics tests including locally manufactured diagnostics, Africa CDC seeks to provide a more inclusive and representative selection of available mpox diagnostics.