Africa CDC Diagnostic Advisory Committee (DAC) for In-vitro diagnostics (IVDs)

Elizabeth Mutisya (Lab Tech)
  1. Background

The Africa Centres for Disease Control and Prevention (Africa CDC), officially launched in Addis Ababa, Ethiopia, on 31 January 2017, is the African Union’s autonomous health agency with the mandate to promote the prevention and control of diseases in Africa. It envisions a safer, healthier, integrated and better-prepared Africa, whereby Member States are capable of effectively responding to outbreaks of infectious diseases and other public health threats. The agency’s mission is to strengthen the capabilities of Africa’s public health institutions to detect and respond quickly and effectively to disease outbreaks and other health burdens through an integrated network of continent-wide preparedness and response, surveillance, laboratory, and research programs.

In December 2018, Africa CDC in collaboration with partners launched the Africa Collaborative initiative to Advance Diagnostics (AFCAD) to increase access to quality assured diagnostics in the continent. During the COVID-19 pandemic, access to much needed diagnostics was limited. Following a joint continental strategy adopted by the Ministers of Health of the Africa Union, a Laboratory Technical Working Group was established that guided and provided technical support to Africa CDC and Member States in establishing and strengthening COVID-19 testing capacities and capabilities. This working group helped in increasing diagnostics access by mobilizing resources for test kits and supplies, facilitating the implementation of quality assurance including external quality assessment, and supporting the expansion of COVID-19 testing through the introduction of rapid antigen tests. 

The establishment of a functional African Medicine Agency (AMA) that will oversee the continental regulatory harmonization of medical products such as drugs, vaccines, and medical devices, is expected to be a significant boost for access. The African Union has mandated AU NEPAD to operationalize the African Medicines Agency via the African Medicines Regulatory Harmonization (AMRH) Programme. The Africa Medical Device Forum (AMDF) is serving as a technical committee for medical devices under the AMRH Programme. Africa CDC through the AFCAD has key competencies in in-vitro diagnostics (IVDs) that can support the AMDF. Africa CDC has set up a system that includes strong biobanking and evaluation networks that can be used in running performance evaluations for IVDs. In addition, Africa CDC is proposing a technical group of experts that will form the Diagnostic Advisory Committee (DAC) for IVDs that will play the pivotal role of critically reviewing the diagnostic data from evaluations and making recommendations for approval. It is expected that this DAC will work to provide technical support to AMRH Programme through AMDF in matters related to the evaluation and reviewing of data on IVDs to be submitted for certification/prequalification and others support to Africa CDC in improving access to Diagnostics in Africa.

2.0. Purpose

The purpose of the DAC is to provide technical support to the African Medicine Regulatory Harmonization (AMRH) programme through the AMDF TC in the regulation of IVDs to improve access to diagnostics in Africa. 

3.0. Scope:

The Scope of the DAC will be to provide laboratory expertise and advisory support which will advance access to quality assured diagnostics to the AMDF through information sharing of performance, and validation reports of diagnostics. The DAC will also provide technical support to other Africa CDC diagnostics priorities.  

4.0. Role and responsibilities:

The DAC will have the following roles and responsibilities:

Support Africa CDC by:

  • advising on the list of diagnostics for priority diseases
  • serving as a resource group to boost the creation of an enabling environment for local production of diagnostics.
  • Providing technical assistance in the introduction of diagnostic solutions, best practices and innovations that elevate the laboratory services for clinical care, surveillance, and outbreak response.
  • establishing partnerships and mobilizing resource
  • communicating broadly of the Africa CDC engagement on improving access to diagnostics in Africa

Support AMRH Programme through AMDF by:

  • Providing data required to publish a list of diagnostics that will be recommended for approval by NRAs from member states.
  • setting criteria for joint performance evaluation and review of Centres of Excellence (COEs)
  • suggesting action plans for empowerment of selected COEs
  • amplifying the successes of the AMDF and AMRH Programme globally to earn the necessary political backing and financing and provide constructive criticism for future improvement.

Support AFCAD through:

  • advocacy and dissemination of AFCAD strategies

5.0. Membership Composition

The DAC membership will be composed of selected National Public Health Institutes and National Reference laboratories, continental and global partners, and organizations with a proven track record in diagnostics. Members are subject matter experts nominated to the DAC by their organizations or institutions for a four-year term with possibility of renewal. New organizations can join, and existing organizations can be removed as members of the DAC based on consensus [performance and level of participation] by the members.

NameInstitution
Lesley ScottWits Diagnostic Innovation Hub
Lucia Hans(Vice-chair)NHLS South Africa
Anafi MatakaAfrica Society for Lab Medicine
Sikhulile MoyoBotswana Harvard Partnership
Cheikh DiagneIPD-Dakar, Senegal
William AmpofoNoguchi Memorial Institute
Mwatilu Mwau KEMRI-Kenya
Akenji Blaise MboringongNational Public Health Laboratory Cameroon
Yap BOUMPasteur Institute Bangui, Central African Republic
Hicham OUMZIL(Chair)Faculté de médecine et de pharmacie.  Université Mohamed V . Rabat. Morocco
External DAC members 
Clement ZehUS CDC/PEPFAR
Kekeletso KaoFIND
Trevor PeterCHAI
Fatim Cham – JallowGlobal Fund
Yared Tedla GebrehiwotUS CDC Ethiopia

6.0. Accountability and Mode of operation

The DAC will be accountable to the Head of the AMRH, the chair of the AMDF and the Centre Director for Laboratory Systems. The Centre for Laboratory Systems of Africa CDC will serve as the secretariat. The DAC will select from within its membership one Chairperson who will be assisted by a co-chair. The chairmanship will have a tenure of office for a period of 2 years. 

The DAC will meet quarterly; agenda driven meetings may be organized in between meetings. Quorum is considered attained in the presence of 80% of voting members of the DAC. The decision-making process will be by consensus. However, if consensus is not reached, a 50+1 voting system will be employed to reach an agreement. The DAC may establish sub-working groups as deemed necessary. Membership will be reviewed periodically, and organizations will assign replacements if a DAC member cannot continue to serve the DAC.

From time to time, the level of participation of the DAC members will be reviewed, and if found unsatisfactory, the membership will be revised accordingly.

7.0. Administrative arrangements

Africa CDC will cover the budget for the activities of the secretariat. Africa CDC will also cover costs for travel logistics of technical working group members during the meetings. However, if organizations from where members are drawn are also willing to provide support, this will be acceptable and most welcome. An honorarium will be given for each activity carried out such as meetings and site visits.

Dr Yenew Kebede Tebeje

Head, Division of Laboratory Systems Africa CDC

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