LThe approval by CDC-Africa underlines the reliability and effectiveness of this test, potentially strengthening Morocco’s role in global health initiatives, indicates a press release from the center, based in Addis Ababa.
“This major milestone is in line 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.”, adds the same source.
Africa CDC supported Member States through this continental plan by procuring and delivering PCR and genomic sequencing test kits, as well as GeneXpert cartridges, the press release recalled, noting that it 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, according to the same source. .
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 also facilitating the data sharing.
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 statement said, explaining that the tests on this list followed a rigorous process and systematic, involving an independent review of available evidence.
Tests must meet key criteria defined by the DAC, based on the WHO target product profile for Mpox diagnostics, Africa CDC added, noting that the third edition of the recommended list was published on November 12 2024. This edition includes a locally manufactured PCR detection kit (UM6P-MAScIR MPOX qPCR 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, underlines the press release, noting that this is a major achievement in the response to Mpox.
Moldiag Managing Director Nawal Chraïbi said Moldiag is committed to supporting health resilience in Africa through the development of locally manufactured diagnostic tools.
She said Moldiag believes that strengthening local production is essential to strengthening epidemic preparedness and response on the continent, enabling public health challenges to be responded to quickly and effectively. “We are proud to align ourselves with CDC-Afrique’s vision of an autonomous and health-secure Africa”, she rejoiced.
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 CDC-Africa.
The director general of CDC-Afrique Jean Kaseya, for his part, stressed that the PCR test kit for Mpox, manufactured locally in Morocco, which passed rigorous criteria, recommended by the DAC to appear in the list, testifies that quality medical countermeasures, including diagnostics, can be made available locally during outbreaks.
He congratulated Morocco on this exceptional achievement, encouraging African Union Member States to consider the use of this testing solution as they continue to respond to the Mpox outbreak.
This crucial step will inspire local manufacturers of diagnostics and other outbreak-related products, the statement said, noting that 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.
As a reminder, the Mpox outbreak has been declared a Continental Security Public Health Emergency by Africa CDC and a Public Health Emergency of International Concern by the World Health Organization (WHO).
(with MAP)
