Africa CDC’s approval underlines the test's reliability and efficacy, potentially fostering Morocco's role in global health initiatives, according to a statement by the Center.
"This major milestone is in line with the African Union’s continental effort to strengthen the self-sufficiency of African public health systems towards enhancing the continent’s efficiency in preparedness and response to disease threats", says the source.
Africa CDC has supported Member States through the continental plan, by procuring and delivering PCR and genome sequencing test kits, GeneXpert cartridges. It also trained them on specimen collection and transportation, biosafety and biosecurity, and molecular testing for mpox.
Africa CDC’s DAC offered crucial guidance to Member States, recommending specific RT-PCR tests for procurement and use – an advisory support that proved invaluable for national testing strategies.
Africa CDC and AUDA NEPAD jointly established the DAC as a quality mechanism to guide the selection, evaluation, validation, verification, and adoption of laboratory diagnostic technologies, while facilitating data sharing.
During this mpox emergency, Africa CDC has worked through the DAC to publish two editions of a recommended list of RT-PCR tests for mpox, adds the statement, noting that tests on the list have undergone a stringent, systematic process involving an independent review of the available evidence.
The tests must fulfill key criteria set by the DAC based on the WHO Target Product Profile for mpox diagnostics.
The third edition of recommended list was published on 12 November 2024. The edition includes one locally manufactured PCR detection kit (UM6P-MAScIR MPOX qPCR 1.0), manufactured by Moldiag, Morocco.
The Chief Executive Officer of Moldiag, Nawal Chraibi, said that Moldiag is dedicated to supporting Africa's health resilience through the development of diagnostic tools locally manufactured.
She also emphasized, in the statement, that Moldiag believes that strengthening local production is key to empowering the continent in its epidemic readiness and response, which helps in responding swiftly and effectively to the challenges facing public health. " We are proud to align with Africa CDC's vision of a self-sufficient and health-secure Africa," she added.
Director General of Africa CDC Jean Kaseya said that the PCR test kit for mpox, locally manufactured in Morocco, which passed through stringent criteria, recommended by our DAC to be shortlisted is testament that quality medical counter measures including diagnostics can be availed locally during outbreaks.
He welcomed Morocco for this outstanding achievement, encouraging member States of the African Union to consider the use of this testing solution as they continue responding to the mpox outbreak.
Mpox outbreak has been declared a Public Health Emergency of Continental Security by Africa CDC and a public health emergency of international concern by World Health Organization (WHO).