The African Center for Disease Control and Prevention (Africa CDC), through its Diagnostics Advisory Committee (DAC), has recommended the first real-time PCR test for mpox manufactured locally in Morocco. “The approval by Africa CDC underlines the reliability and effectiveness of this test, potentially strengthening Morocco’s role in global health initiatives,” indicates the center in a press release published this Wednesday, stressing that “this major milestone is in agreement with the African Union’s continental effort to strengthen the self-sufficiency of African public health systems to improve the continent’s effectiveness in preparing for and responding to disease threats.
It has been 93 days since the declaration of the mpox epidemic as a Continental Security Public Health Emergency by Africa CDC and a public health emergency of international concern by the World Health Organization (WHO), continues the same source , recalling that during this 100-day mission period, a joint Africa CDC/WHO continental plan was launched.
Africa CDC supported Member States through this continental plan by procuring and delivering PCR and genomic sequencing test kits, as well as GeneXpert cartridges. He also trained Member States on sample collection and transport, biosafety and biosecurity, and molecular testing for mpox. The Africa CDC DAC provided critical advice to Member States, recommending specific RT-PCR tests for purchase and use – advisory support that has proven valuable to 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. It also makes data sharing easier. During this mpox emergency, Africa CDC worked through the DAC to publish two editions of a recommended list of RT-PCR tests for mpox. The tests on this list followed a rigorous and systematic process, involving an independent review of the available evidence. Tests must meet key criteria defined by the DAC, based on the WHO target product profile for mpox diagnostics.
The third edition of the recommended list was released on November 12, 2024. This edition includes a locally manufactured PCR detection kit (UM6P-MAScIR MPOXq PCR 1.0), manufactured by Moldiag, Morocco. The DAC reviewed the evidence regarding this test based on established criteria, including independent evaluation data from the National Institute of Biomedical Research (INRB) in the Democratic Republic of Congo (DRC) and concluded that it meets to all major criteria. This is a major achievement in the response to mpox. Moldiag Managing Director, Ms. Nawal Chraibi, said: “At Moldiag, we are committed to supporting health resilience in Africa through the development of locally manufactured diagnostic tools. We believe that strengthening local production is essential to strengthen epidemic preparedness and response on the continent, allowing us to respond quickly and effectively to public health challenges. We are proud to align with Africa CDC’s vision of a self-reliant and health-secure Africa. »
The local manufacturing of diagnostics constitutes one of the five strategic pillars of the action framework “A New Public Health Order for Africa”, launched by the African Union through Africa CDC. Dr. Jean Kaseya, Director General of Africa CDC, said: “Africa CDC is leading an ambitious but very crucial continental agenda on the local manufacturing of medical countermeasures, an essential element for the health security of the continent. The mpox PCR test kit, manufactured locally in Morocco, which passed rigorous criteria, recommended by our DAC for inclusion in the list, testifies that quality medical countermeasures, including diagnostics, can be made available locally during epidemic periods. I would like to congratulate Morocco on this exceptional achievement and encourage African Union Member States to consider the use of this testing solution as they continue to respond to the mpox epidemic. »
“This crucial step will inspire local manufacturers of diagnostics and other outbreak-related products. Africa CDC is committed to working with these manufacturers and key stakeholders to ensure that necessary medical products are available for the health security of the continent”, concludes the press release.
