Second Edition
AIDS Medicines and diagnostics services
July 2015
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 towards 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.
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Biennial Report of the Regional Director
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 innovati...ons 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.
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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.
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ASLM in collaboration with the Africa Centres for Disease Control and Prevention, and in partnership with the Clinton Health Access Initiative, Amref 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 pr...ovide 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.
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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 to 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.
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ASLM strives to keep laboratory networks in Africa connected and informed of diagnostic tools, techniques, procedures and advancements related to COVID-19 testing with interactive training and information sessions using the Extended Community Health Outcomes (ECHO) model and Massive Open Online Cour...se (MOOC) platform from Future Learn.
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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 Coronavirus 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
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A Situational Assessment and Five-YearAction Plan for the Africa CDC Strengthening Regional Public Health Institutions and Capacity for Surveillance and Response Program
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 sel...f-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
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The Practical manual on laboratory strengthening, 2022 update provides practical guidance on implementation of WHO recommendations and best practices for TB laboratory strengthening. It is an updated version of the GLI Practical Guide to Laboratory Strengthening published in 2017 and provides the la...test 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.
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The Africa Centres for Disease Control and Prevention (Africa CDC) Biosafety and Biosecurity Initiative was launched by the 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 i...nternational 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
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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 addr...ess 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.
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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 addr...ess 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.
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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 addr...ess 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.
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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 addr...ess 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 addr...ess 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 addr...ess 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