SARS-COV-2 antigen rapid diagnostic tests are an alternative option for diagnosing active SARS-CoV-2 infection through detection of viral proteins. Rapid antigen tests revolutionize the response to COVID-19 by providing accurate test results in 10 t...o 20 minutes instead of days, allowing tests to be done at point of care, and dramatically lowering the price of the tests. Proper training on the safe use and implementation of antigen tests is vital to ensuring quality testing. A comprehensive training package around safety, sample collection, testing, reporting and management of antigen tests can be found below. The training package includes facilitators’ guides for master trainers and trainers, training presentations, and supplementary materials to aid in the delivery of this training. more

ASLM strives to keep laboratory networks in Africa connected and informed of diagnostic tools, techniques, procedures and advancements related to C...OVID-19 testing with interactive training and information sessions using the Extended Community Health Outcomes (ECHO) model and Massive Open Online Course (MOOC) platform from Future Learn. more

October 2018

Antimicrobials are medicines, including antibiotics, antivirals, antifungals, and antiparasitics, that are used to prevent and treat infections in humans, animals, and plants. Antimicrobial Resistance (AMR) arises when bacteria, viruses, fungi, and ...parasites no longer respond to these medicines, rendering them ineffective and making infections more difficult to treat. This resistance increases the risk of disease spread, severe illness, disability, and death. Although AMR is a natural phenomenon driven by genetic changes in pathogens, it is significantly accelerated by human activities such as the misuse and overuse of antimicrobials in healthcare, agriculture, and animal husbandry. more

The Practical manual on laboratory strengthening, 2022 update provides practical guidance on implementation of WHO recommendations and best practices for TB ...x">laboratory strengthening. It is an updated version of the GLI Practical Guide to Laboratory Strengthening published in 2017 and provides the latest practical guidance on use of newly recommended diagnostics as well as guidance in key technical areas, including quality assurance and quality management systems, specimen collection and registration, procurement and supply-chain management, diagnostic connectivity, biosafety, data management, human resources, strategic planning, and model algorithms. The key changes are: inclusion of recent or updated WHO recommendations for tests to diagnose TB and detect drug resistance; alignment with the latest WHO critical concentrations for phenotypic drug-susceptibility testing (DST) and the new definitions of pre-XDR-TB and XDR-TB; updated information on building quality-assured TB testing and management capacity using the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) approach (Score-TB package1); updated information on assessing, analysing and optimising TB diagnostic networks; and updated information on the use of next-generation sequencing (NGS) to detect mutations associated with drug resistance for surveillance purposes. The document also provides references to resources and tools relevant for work on laboratory strengthening. more

ASLM in collaboration with the Africa Centres for Disease Control and Prevention, and in partnership with the Clinton Health Access Initiative, Amr...ef and Last Mile Health present the Quality Assurance Framework for SARS-CoV-2 Antigen Rapid Testing for Diagnosis of COVID-19. This framework aims to provide general technical guidance to African Union Members States on the rollout, establishment, implementation, monitoring, and evaluation of SARS-CoV-2 Ag RDT interventions so as to effectively and efficiently detect, control and minimise errors in the performance of COVID-19 laboratory testing processes. It describes the core components for quality assurance, resources mobilisation and advocacy for scale up, monitoring, evaluation, learning and accountability for SARS-CoV-2 implementation. more

Antimicrobial resistance (AMR) has emerged as a leading cause of death in the African region, surpassing fatalities from malaria, HIV, and TB. In response to this critical threat, the region has adopted the AMR Global Action Plan and the ...="attribute-to-highlight medbox">African Union Framework for Antimicrobial Resistance Control 2020 – 2025, which is tailored to meet the specific needs of African nations through a coordinated approach. While most countries in the region have developed and prioritized National Action Plans (NAPs) to tackle AMR, the overall response remains inadequate given the magnitude of the threat, which endangers human, animal, environmental, aquatic, and plant health. Africa bears a significant burden of infectious diseases, accounting for approximately 95% of malaria deaths, 70% of people living with HIV, and 25% of TB deaths globally. In 2019, AMR was linked to approximately 55,000 deaths from HIV, 30,000 from malaria, and 255,000 overall. Major drivers of AMR in the region include the overuse and misuse of antimicrobials in human and food systems, migration, suboptimal vaccination rates, and environmental contamination from hospital and pharmaceutical effluents. Additionally, there is a lack of access to quality-assured antimicrobials and diagnostics, compounded by inadequate knowledge about AMR. Unlike high-income countries, where indiscriminate antimicrobial use is the primary factor driving AMR, African countries face additional challenges, including a lack of access to clean and safe water, poor Water, Sanitation, and Hygiene (WASH) programs, inadequate infection prevention measures, and suboptimal vaccinations for preventable diseases. One in three hospitals in the region lacks clean, safe running water, and one in eight people defecate openly due to inadequate sanitation. Investments in WASH, infection prevention, and biosecurity could save approximately 700,000 lives annually. Addressing AMR in Africa requires a comprehensive, multi-sectoral approach involving the entire society. Sustainable access to antimicrobials, including antibiotics, vaccines, and therapeutics, is crucial, as lack of access leads to more morbidity and mortality than AMR itself. Support for the region should focus on preventing infections, strengthening health and food systems, developing human resources, ensuring sustainable access to diagnostics and therapeutics, and investing in laboratory infrastructure to support surveillance and data generation. more

The Mapping Antimicrobial Resistance and Antimicrobial Use Partnership (MAAP) project has conducted a multi-year, multi-country study that provides stark insights on the under-reported depth of the antimicrobial resistance (AMR) crisis across Africa... and lays out urgent policy recommendations to address the emergency. MAAP reviewed 819,584 AMR records from 2016-2019, from 205 laboratories across Burkina Faso, Cameroon, Eswatini, Gabon, Ghana, Kenya, Malawi, Nigeria, Senegal, Sierra Leone, Tanzania, Uganda, Zambia, and Zimbabwe. MAAP also reviewed data from 327 hospital and community pharmacies and 16 national-level AMC datasets. more

Second Edition AIDS Medicines and diagnostics services July 2015

Limited coverage of laboratory services and long turnaround times from real-time reverse transcription-polymerase chain reaction (rRT-PCR) for the detection of Severe Acute Respiratory Syndrome Coro...navirus 2 (SARS-CoV-2) has been insufficient to meet the demands in many African countries in response to the COVID-19 pandemic. Rapid antigen diagnostic tests (AgRDTs) are potentially useful as they can inform healthcare workers and individuals of their infection status at point-of-care testing more

16 Dec. 2020 This document provides guidance to Ministries of Health (MOHs), laboratory personnel and implementing partners in African Union Member States on the application of rapid antigen tests ...to COVID-19 testing. The guidance serves as reference for policymakers, laboratory leads, implementing partners, and experts on use case scenarios and associated testing algorithms for COVID-19 antigen tests. It recommends the use of antigen tests to increase access to testing and enable timely results for persons with or without symptoms in specific settings. The document will be reviewed and updated as more evidence becomes available regarding the use of rapid antigen tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) from global studies and evaluation efforts. more

The Africa Centres for Disease Control and Prevention (Africa CDC) Biosafety and Biosecurity Initiative was launched by the ...to-highlight medbox">Africa CDC in April 2019 with the aim of strengthening the African Union (AU) Member States’ biosafety and biosecurity systems and enabling them to comply with national and international requirements for biosafety and biosecurity including the International Health Regulations (IHR) (2005), the Biological Weapons Convention (BWC), and United Nations Security Council Resolution (UNSCR) 1540 and the multi-country Global Health Security Agenda (GHSA). The World Health Organization (WHO) Joint External Evaluation (JEE) and the Global Health Security Index report confirmed the known capacity gaps in biosafety and biosecurity among Africa Union Member (AU). The regional consultations by Africa CDC conducted between 2019-2021 highlighted the deficiency or limited availability of standardized and regionally recognized training programs in the continent, limiting biosafety and biosecurity capacity building efforts in the region. In response, Africa CDC working with AU Member States developed a home grown, implementable and accessible professional training and certification program that is both recognized and endorsed by AU Member States. The Regional Training and Certification Program for Biosafety and Biosecurity Professionals, for African Biosafety and Biosecurity Professionals (RTCP-BBP) has four (4) areas of specialization, namely Selection, Installation, Maintenance and Certification of Biological Safety Cabinets Biorisk Management Design and Maintenance of Facilities Handling High Risk Pathogens (Biocontainment Engineering) Biological Waste management more

On August 13, 2024, the Africa CDC declared the mpox outbreak a Public Health Emergency of Continental Security (PHECS). The following day, the WHO declared it a Public Health Emergency of International Concern (PHEIC). A coordinated, continent-wide... response is essential, co-led by the African Union (AU) through the Africa CDC and the World Health Organization (WHO), in close collaboration with global partners working under a unified plan, budget, and monitoring framework. more

This guidance addresses rationale, risk-based scenarios, practical considerations prior to adoption of the self-testing products, quality assurance, safety and ethical considerations, and data management considerations for COVID-19 self-testing. The... Africa CDC recommends the use of rapid antigen self-testing within two key scenarios. The first includes testing for case identification within scenarios with a high risk of infection, including symptomatic cases and contacts of a confirmed case. The second scenario involves general screening within scenarios of low or unknown risk exposure allowing for self-care such as before gatherings with at-risk individuals and prior to participation in events involving members of different households. Within these scenarios, a positive test result indicates likelihood of current infection, while a negative test result indicates a lower risk of active infection, though it does not rule out infection altogether. All positive cases should be managed following the national COVID-19 management protocol of Member States.ssur more

A Situational Assessment and Five-YearAction Plan for the Africa CDC Strengthening Regional Public Health Institutions and Capacity for Surveillanc...e and Response Program more

This document describes the key areas that national governments should consider for the introduction and scale-up of point-of-care (POC) diagnostics within national programmes, as new innovative POC technologies are being introduced into the market.... The next steps taken to include these new innovations within the broader context of national diagnostic networks of conventional laboratories could influence the achievement of the 2030 Fast Track targets for ending the AIDS epidemic.
POC diagnostics, when strategically introduced and integrated into national diagnostic networks, may help catalyse changes that improve the way diagnostics and clinical services are delivered. This document distils this understanding based on programmatic and market experiences of introducing POC diagnostics through catalytic investments in POC HIV technologies across numerous countries in sub-Saharan Africa. more

Due to the anticipated significant rise in VL testing occasioned by Ghana’s adaptation of 2016 ART guidelines, it has become necessary to develop this VL scale-up and operational plan to assure complete client access to laboratory monitoring towar...ds the achievement of the third 90 of the HIV care cascade. The plan will enhance VL testing, monitoring whilst improving the clinical and laboratory interface for improved client care. more

The Mapping Antimicrobial Resistance and Antimicrobial Use Partnership (MAAP) project has conducted a multi-year, multi-country study that provides stark insights on the under-reported depth of the antimicrobial resistance (AMR) crisis across Africa... and lays out urgent policy recommendations to address the emergency. MAAP reviewed 819,584 AMR records from 2016-2019, from 205 laboratories across Burkina Faso, Cameroon, Eswatini, Gabon, Ghana, Kenya, Malawi, Nigeria, Senegal, Sierra Leone, Tanzania, Uganda, Zambia, and Zimbabwe. MAAP also reviewed data from 327 hospital and community pharmacies and 16 national-level AMC datasets. more

The Mapping Antimicrobial Resistance and Antimicrobial Use Partnership (MAAP) project has conducted a multi-year, multi-country study that provides stark insights on the under-reported depth of the antimicrobial resistance (AMR) crisis across Africa... and lays out urgent policy recommendations to address the emergency. MAAP reviewed 819,584 AMR records from 2016-2019, from 205 laboratories across Burkina Faso, Cameroon, Eswatini, Gabon, Ghana, Kenya, Malawi, Nigeria, Senegal, Sierra Leone, Tanzania, Uganda, Zambia, and Zimbabwe. MAAP also reviewed data from 327 hospital and community pharmacies and 16 national-level AMC datasets. more

The Mapping Antimicrobial Resistance and Antimicrobial Use Partnership (MAAP) project has conducted a multi-year, multi-country study that provides stark insights on the under-reported depth of the antimicrobial resistance (AMR) crisis across Africa... and lays out urgent policy recommendations to address the emergency. MAAP reviewed 819,584 AMR records from 2016-2019, from 205 laboratories across Burkina Faso, Cameroon, Eswatini, Gabon, Ghana, Kenya, Malawi, Nigeria, Senegal, Sierra Leone, Tanzania, Uganda, Zambia, and Zimbabwe. MAAP also reviewed data from 327 hospital and community pharmacies and 16 national-level AMC datasets. more