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1
This report, published in conjunction with a summary overview of results of rounds 1–8, is the eighth and final report in a series of laboratory-based evaluations of rapid diagnostic
...
tests (RDTs) for malaria. It provides a comparative measure of their performance in a standardized way to distinguish between well and poorly performing tests.
These results constitute the laboratory evaluation component of the WHO prequalification process for malaria RDTs and inform the current WHO procurement recommendations. In round 8, 35 RDTs from 17 manufacturers were assessed. For the first time the evaluation included an assessment of product performance against a panel of P. falciparum parasites with pfhrp2/3 gene deletions and therefore not expressing HRP2.
more
July 2018
This fourth edition of the Unitaid/WHO market and technology landscape: HIV rapid diagnostic tests for self-testing report summarizes
...
the current HIV testing gap; the challenges facing efforts to scale up; and the potential role HIV self-testing (HIVST) could play to achieve the United Nation’s 90-90-90 targets. In particular, the report synthesises the existing and emerging market demand and supply of kits.
The information in this report is intended for manufacturers, donors, national programmes, researchers and other global health stakeholders who are exploring the potential role of HIVST.
more
This guide provides an overview of the major elements that must be considered before, during and after the implementation of antigen-detecting rapid diagnostic
...
tests (Ag-RDTs) for SARS-CoV-2. This guide is complementary to policy guidance issued by the World Health Organization (WHO). The guide may appeal to a range of audiences including Ministries of Health, donors, public and private organizations/agencies acting as implementing partners and community based and civil society organizations with experience working on health, especially organizations familiar with similar testing campaigns for other disease programmes like HIV and malaria
more
Market and technology landscape HIV rapid diagnostic tests for self-testing - 4th Edition
O. Ajose; C. Pérez Casas; H. Ingold; et al.
Unitaid (Innovation in Global Health); World Health Organization (WHO)
(2018)
C2
July 2018
6 July 2021. Three new nucleic acid amplification test (NAAT) classes are endorsed by WHO and included.
The latest operational handbook includes the new classes recommended by WHO. It aims at facilitating the implementation of the WHO recommendations by the Member States, technical partners, and ot
...
hers involved in managing patients with TB and DR-TB. The operational handbook provides practical information on existing and new tests recommended by WHO, step-by-step advice on implementing and scale-up testing to achieve local and national impact and lastly, model diagnostic algorithms, which are updated to incorporate the latest recommendations. An overview of budgetary considerations and information sheets on each of the newly recommended tests is provided.
more
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.
more
Expert opinion of the European Tuberculosis Laboratory Initiative core group members for the WHO European Region.
Fever Diagnostic Technology Landscape
recommended
1st edition.
Unitaid’s report describes a slate of new devices that can more efficiently identify dangerously ill children so that they can be treated immediately. These tools make it easier to recognize danger signs, and support integrated approaches to reducing childhood deaths from the three
...
greatest childhood killers: malaria, pneumonia and diarrhoea.
The report also highlights tests that can determine whether or not a child has an illness that can be treated with antibiotics. Viral infections are a common cause of childhood fevers, but cannot be cured with antibiotics. Although many children seeking care at clinics have fever, three-quarters by some estimates, only a small fraction of those have an illness that can be treated with an antimalarial or antibiotic drug
more
Lateral-flow rapid diagnostic tests (RDTs) continue to play a vital role in global health in the management and diagnosis of infectious diseases, i
...
ncluding malaria, HIV and COVID-19. Visually interpreted RDTs, more than any other class of diagnostics, fulfil WHO’s ASSURED criteria,1 enabling their use at the lowest levels of health care and in self-testing.2 Their utility is, however, compromised every time a test is incorrectly performed or interpreted or its result is not available in a timely manner for clinical decisionmaking and surveillance.
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 f
...
or 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
La détection directe des protéines virales du SRAS-CoV-2 (antigènes) dans les écouvillons nasaux et autres sécrétions respiratoires à l'aide de tests immunologiques à flux latéral (également appelés
...
tests de diagnostic rapide, TDR) offre une méthode plus rapide et moins coûteuse pour tester le SRAS-CoV-2 que la méthode de référence, les tests d'amplification des acides nucléiques (TAAN). Ces lignes directrices provisoires offrent des recommandations sur les utilisations prioritaires des tests de diagnostic rapide à détection d'antigène (TDR-Ag) dans des populations et des contextes spécifiques, notamment (i) pour la détection primaire des cas chez les personnes symptomatiques suspectées d'être infectées et les personnes asymptomatiques à haut risque de COVID-19, (ii) pour la recherche des contacts, (iii) pendant les enquêtes sur les épidémies et (iv) pour surveiller les tendances de l'incidence de la maladie dans les communautés. Les TDR-AG répondant aux exigences minimales de performance peuvent être utilisés en dehors des milieux cliniques et des laboratoires, y compris dans les communautés, par des opérateurs formés conformément aux instructions. Le guide fournit en outre des recommandations sur la mise en œuvre, la sélection des produits et le stockage
more
The WHO standard: Universal access to rapid tuberculosis diagnostics sets benchmarks to achieve universal access to WHO-recommended rapid diagnostics (WRDs), increase bacteriologically confirmed tub
...
erculosis and drug resistance detection, and reduce the time to diagnosis. WHO-recommended rapid diagnostics are highly accurate, cost-effective, reduce the time to treatment initiation, and impact patient-important outcomes.
more
Technical Report
AIDS Medicines and diagnostics service
July 2015
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
