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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 se
...
lf-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
L’expansion de la mise en œuvre des approches de suivi du traitement par la réalisation de tests de mesure de la charge virale et de tests de diagnostic chez le nourrisson sera indispensable pou
...
r garantir la qualité des soins et des traitements ainsi que le succès des programmes. Le fait de choisir le réseau de diagnostic, les types d’échantillons ainsi que les interventions et les stratégies les plus appropriés dans chaque pays et pour chaque partenaire au niveau national et régional permettra de soutenir cet effort, de renforcer la collaboration et d’optimiser les investissements réalisés dans la mise en œuvre des tests en vue d’obtenir des effets manifestes.
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
Three classess of tests are now recommended in the latest consolidated guideles on tests for tuberculosis infection. It includes for the first-time a new class of Mycobacterium tuberculosis antigen-
...
based skin tests (TBSTs), and the two existing classes of tests: the tuberculin skin test (TST) and the interferon-gamma release assays (IGRAs).
IGRAs and TBSTs use Mycobacterium tuberculosis complex specific antigens and represent a significant advancement to TST which has been used for over half a century.
more
Available in Arabic, Chinese, English, French, Portuguese, Russian and Spanish
https://apps.who.int/iris/handle/10665/334254
Putting HIV and HCV to the test - A product guide for point-of-care CD4 tests and laboratory-based and point-of-care HIV and HCV viral load tests
Medecins Sans Frontieres (Access Campaign)
(2017)
C2
3rd Edition – July 2017
www.msfaccess.org
Interferon-γ Assays - Description and Assessment of a New Tool in the Diagnosis of Tuberculosis.
Haür B et al. Interferon-γ-Tests in der ...Pneumologie 2006; 60: 29-44
Les procédures décrites dans cette POS concernent à la fois l'environnement dans lequel les tests
index sont effectués (par exemple, la construction d'une infrastructure qui garantit la confidentialité,
les formulaires disponibles sur place,
...
le stockage des données physiques et numériques) et
également les actions requises des agents de santé qui effectuent le test index. Les personnes
chargées de la mise en œuvre de ces POS devront également connaître les POS concernant
l'identification et la réponse face à la violence dans le contexte des tests index. Les recommandations
relatives au contenu des services d'intervention en cas de violence sont fournies en Annexe A
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
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
Despite the development of point-of-care diagnostic tests for syphilis, chlamydia, gonorrhoea, and trichomoniasis, none comply with all WHO criteria. This analysis overviews landscape analyses of point-of-care diagnostic technologies for Chlamydia t
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rachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and syphilis, available and in the pipeline. The target audience for the target product profiles is broad and includes clinicians, researchers working on diagnostics, laboratory experts, including, microbiologists and virologists, public health experts, epidemiologists, developers, and representatives for manufactures, including biotech engineers, policy-and decision-makers as well as representatives from regulatory bodies and agencies, donor agencies and international organizations.
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Tests zur Detektion einer Infektion mit SARS-CoV-2 (neuartiges Coronavirus) sowie zum Nachweis von Antikörpern gehören zu den sog. In-vitro-Diagnostika (IVD). Das erstmalige Inverkehrbringen von In-vitro-Diagnostika auf dem deutschen Markt ist nac
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h §§ 25 und 30 Medizinproduktegesetz (MPG) anzeigepflichtig. Das DIMDI betreibt dafür die Datenbank "In-vitro-Diagnostika-Anzeigen (MPIVDA)", in welcher demnach auch Daten von "Corona-Tests" von den anzeigepflichtigen deutschen Herstellern und Bevollmächtigten bzw. Einführern erfasst werden.
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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 referen
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ce 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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The speed of developing diagnostics for SARS-CoV-2, the causative agent of coronavirus disease 2019 (COVID-19), has been quite remarkable. Diagnostics have focused on nucleic acid amplification testing (NAAT) to identify infected individuals in acute-phase disease for timely implementation of mitiga
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tion strategies and case management. More and more immunodiagnostics, mostly rapid diagnostic tests, are being made available as an alternative to NAATs. This type of test can be used out-of-laboratory conditions at large scale.
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