The 2022 report reviews the global malaria diagnostics market and technological landscape to support Unitaid’s 2023–2027 strategy for quality malaria case management. The report highlights the stalled progress of malaria control efforts, the gaps in access to diagnostics and the public health im...plications of P. falciparum HRP2/3 gene deletions, which compromise the accuracy of the widely used HRP2-detecting rapid diagnostic tests (RDTs). The report analyses the malaria RDT market, noting supplier diversification, price trends and production shifts resulting from the pandemic. It also addresses the emerging point-of-care G6PD testing market, which is required to ensure the safe radical cure of P. vivax infections. It surveys technological innovation, including digital microscopy, hemozoin tests, nucleic acid detection and biosensors, while emphasising that RDTs and microscopy will remain the mainstay of case management in the near term. The report identifies market shortcomings, access barriers and opportunities to improve malaria case management and diagnostic coverage.
more
The meeting was held from 26 to 27 March 2018 to review and discuss the following topics:
Advances and challenges in the use of fTLC, and new approaches to detecting mycolactone using monoclonal antibodies (mAbs).
The status of development of rapid diagnostic tests (RDTs) targeting the MUL..._3720 protein.
The role of PCR as a reference test, and hurdles in providing a confirmatory diagnosis and in establishing a quality assurance programme.
New molecular tools with potential for implementation at a level lower than in the national or regional reference laboratory, such as loop-mediated isothermal amplification (LAMP) and recombinase polymerase amplification (RPA).
The need to harmonize and standardize methods for collection and preparation of specimens, so samples can be referred for diagnosis and stored for evaluation of new diagnostic tests in optimal conditions.
Barriers to accessing early diagnosis and treatment, including coordination at the programme level, and lack of adequate diagnostic tools.
Defining target product profiles (TPPs) to guide the development of new diagnostic tools that can be applied at different levels of the health system. Participants agreed that two TPPs would be developed to address the current gaps: (i) a rapid test for BU diagnosis at the primary health-care level; and (ii) a test for diagnosis of BU that can also assist in treatment monitoring and differential diagnosis at the district hospital or reference centre.
more
Interium guidance, 25 June 2021Timely and accurate diagnostic testing is an essential tool in preventing and controlling the spread of COVID-19. This document describes recommendations for national testing strategies and the use of PCR and rapid antigen tests in different transmission scenarios of t...he COVID-19 outbreak, including how testing might be rationalized in low resource settings. All testing should be followed by a strong public health response including isolating those who test positive and providing them care, contact tracing and quarantine of contacts.
more
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.
more
Les notes d’orientation exposent les mesures essentielles que les décideurs peuvent mettre en œuvre aux niveaux national et infranational pour les éléments suivants : tests de diagnostic de la COVID-19, prise en charge clinique de la COVID-19, atteinte des cibles en matière de vaccination con...tre la COVID-19, maintien
des mesures de lutte anti-infectieuse contre la COVID-19 dans les établissements de santé, renforcement de la confiance grâce à la communication sur les risques et à la mobilisation communautaire et gestion de l’infodémie autour de la COVID-19.
more
In 2009, WHO’s Second International Conference on Buruli Ulcer Control and Research resolved to strengthen the capacity of national laboratories to confirm cases of the disease, but advised that “efforts are still needed to develop simple diagnostic tools usable in the field as well as disabilit...y prevention methods”.
In 2013, WHO and the Foundation for Innovative New Diagnostics convened a meeting of Buruli ulcer experts in Geneva, Switzerland (9) at which two priority unmet needs in diagnosis were identified:
a diagnostic test for early detection of Buruli ulcer in symptomatic patients with sufficient positive predictive value to put patients on appropriate treatment; and
a screening test at the primary health care or community level for symptomatic patients with ulcer
more
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.
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
6 July 2021. The “WHO consolidated guidelines on tuberculosis. Module 3: Diagnosis - Rapid diagnostics for tuberculosis detection 2021 update” is the latest document replacing the one issued in 2020. Three new nucleic acid amplification test (NAAT) classes are endorsed by WHO and included in the... latest consolidated guideline
more
HAT diagnosis relies on laboratory techniques because clinical signs and symptoms are unspecific. Serodiagnostic tests exist only for Tbg and are based on the detection of specific antibodies, thus they are not confirmatory of infection. With the current low disease prevalence, the positive predicti...ve value of serological tests is particularly low. Field-applicable tools include the card agglutination test for trypanosomiasis (CATT) used mainly in active screening by specialized mobile teams, and the rapid diagnostic tests that are more suitable for individual testing at point-of-care. Confirmation of Tbg infection requires microscopic examination of body fluids necessitating specific training. The best performing methods are laborious and reach 85–95% diagnostic sensitivity when performed by skilled personnel.
more
HAT diagnosis relies on laboratory techniques because clinical signs and symptoms are unspecific. Serodiagnostic tests exist only for Tbg and are based on the detection of specific antibodies, thus they are not confirmatory of infection. With the current low disease prevalence, the positive predicti...ve value of serological tests is particularly low. Field-applicable tools include the card agglutination test for trypanosomiasis (CATT) used mainly in active screening by specialized mobile teams, and the rapid diagnostic tests that are more suitable for individual testing at point-of-care.
more
WHO recommends replacing western blotting and line immunoassays with simpler tests in HIV testing services. These simpler tests include rapid diagnostic tests (RDTs) that can be used at the point-of-care, and enzyme immunoassays (EIAs).
These tests get results to the client faster, produce accura...te results more often, cost less, can be performed by various cadres of health providers, and can thus facilitate greater access and uptake of HIV testing services among those who need it most.
more
L’Organisation mondiale de la Santé (OMS) recommande aux services de dépistage du VIH (SDV) de remplacer les Western blots et les immunodosages sur bandelettes par des tests plus simples de dépistage du VIH, comme des tests de diagnostic rapide TDR) qui peuvent être utilisés sur les lieux de ...soins, et des tests immunoenzymatiques.
more
Operational Guidelines for the national and district health workers & planners.
These new approaches include use of selective chemotherapy, Rapid Diagnostic Tests (RDTs), Zinc for treatment of cholera in children and complementary use of OCV
The TACT training manuals and patient leaflet were developed as part of the ACT Consortium's initiative to improve malaria case management by promoting the correct use of rapid diagnostic tests (RDTs). The TACT ("Targeting ACTs") initiative aims to ensure that artemisinin-based combination therapies... (ACTs) are used appropriately, treating only confirmed malaria cases and guiding alternative care for other febrile illnesses.
Please download the manuals and leaflets from the website
more
Les manuels de formation TACT et la brochure destinée aux patients ont été élaborés dans le cadre de l'initiative du consortium ACT visant à améliorer la prise en charge du paludisme en encourageant l'utilisation correcte des tests de diagnostic rapide (TDR). L'initiative TACT (Targeting ACTs...) vise à garantir l'utilisation appropriée des combinaisons thérapeutiques à base d'artémisinine (ACT), en ne traitant que les cas de paludisme confirmés et en orientant les patients vers d'autres traitements pour les maladies fébriles non liées au paludisme. Les manuels proposent une formation interactive sur le lieu de travail pour aider les personnels de santé à passer d'un traitement présomptif à un diagnostic fondé sur des tests, conformément à la politique de l'OMS. La brochure d'accompagnement destinée aux patients, disponible en anglais et en swahili, s'appuie sur des récits illustrés pour expliquer l'utilité et le fonctionnement des TDR, répondre aux inquiétudes les plus courantes et encourager la confiance dans les résultats des tests. Ces documents, dont la clarté et la compréhension ont été testées au préalable, permettent d'opérer des changements durables dans la pratique clinique et la communication avec les patients au sein des établissements de soins primaires tanzaniens.
Accessed on 03/07/2025.
more