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Publication Years
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Category
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Toolboxes
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1
Die Liste wird kontinuierlich aktualisiert und beinhaltet die entsprechenden Tests zur professionellen Anwendung, die sich nach aktueller Kenntnis des BfArM in Deutschland in Verkehr befinden und laut den Herstellerangaben die jeweils aktuellen durc
...
h das Paul-Ehrlich-Institut (PEI) in Abstimmung mit der Robert Koch-Institut (RKI) festgelegten Mindestkriterien für Antigen-Tests erfüllen.
more
Die Infografik „Welche Tests gibt es, um eine Corona-Infektion zu erkennen?“ zeigt auf einen Blick die Eigenschaften und Unterschiede der drei verschiedenen Corona-Tests und wie sie angewendet w
...
erden.
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 contre 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
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
Lateral-flow rapid diagnostic tests (RDTs) continue to play a vital role in global health in the management and diagnosis of infectious diseases, including malaria, HIV and COVID-19. Visually interpreted RDTs, more than any other class of diagnostic
...
s, 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
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
...
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.
more
Mpox Molecular Diagnostic Tests(RT-PCR)
recommended
March 2025. Access to appropriate, quality-assured diagnostics remains a challenge. There is limited information on key characteristics of available test kits, including their performance, reliability, and ability to detect relevant Mpox clades. Additionally, the lack of multiplex diagnostic tools c
...
apable of distinguishing Mpox from other pathogens with similar clinical presentations further complicates case detection and response efforts.
more
Asthma is a very commom condition. It cannot be cured, but can controlled with effective medication, good technique, and good monitoring by the patients are having no or few symptoms, no attacks needingg hospital visits and no or little emergency reliever medication use. Another way of assessing ast
...
hma control is to do tests that measure the function of your lungs. These tests are sometimes also done to help with the diagnosis of asthma.
more
Technical specifications series for submission to WHO prequalification: diagnostic assessment;TSS-3
The Global Schistosomiasis Alliance Diagnostic Workstream has developed a communications piece listing all commercially available diagnostics for schistosomiasis
This document provides technical guidance for manufacturers seeking World Health Organization (WHO) prequalification of in vitro diagnostic devices (IVDs) for malaria, with a focus on rapid diagnostic tests (RDTs) for symptomatic patients. It summar
...
ises the minimum performance requirements, including analytical and clinical performance standards, and emphasises considerations relating to diverse specimen types, testing environments and user populations in low- and middle-income countries. The guidance is aligned with the criteria and prequalification processes of the WHO Global Malaria Programme, while clarifying that demonstration of clinical utility is outside the scope of prequalification.
more
Malaria remains a significant global health concern, with 249 million cases and 408,000 deaths reported in 2022, primarily in sub-Saharan Africa. The most vulnerable populations are children under five and pregnant women. Rapid and accurate diagnosis using microscopy or malaria rapid diagnostic
...
tests (mRDTs) is essential to ensure timely treatment, prevent severe disease and promote the rational use of antimalarial drugs. This UNICEF Technical Bulletin provides guidance on the procurement, quality assurance and selection of WHO-prequalified mRDTs, including considerations for areas with a high prevalence of pfhrp2/3 gene deletions. The bulletin also highlights UNICEF’s approach to sustainability, product verification and long-term arrangements with manufacturers, which ensure a reliable supply while supporting integrated child health management programmes. The bulletin serves as a valuable resource for countries, partners and programmes involved in the implementation of malaria case management and diagnostics.
more
This document provides technical guidance for manufacturers seeking World Health Organization (WHO) prequalification of in vitro diagnostic devices (IVDs) for malaria, with a focus on rapid diagnostic tests (RDTs) for symptomatic patients. It summar
...
ises the minimum performance requirements, including analytical and clinical performance standards, and emphasises considerations relating to diverse specimen types, testing environments and user populations in low- and middle-income countries. The guidance is aligned with the criteria and prequalification processes of the WHO Global Malaria Programme, while clarifying that demonstration of clinical utility is outside the scope of prequalification.
more
In conclusion, the current evidence does not support the use of mpox antigen RDTs in the field. More data are expected from independent evaluations conducted by Africa CDC, FIND or other organizations
In most malaria-endemic countries, temperatures frequently exceed the recommended storage temperatures for malaria RDTs. Correct storage of the RDTs may be difficult, especially during transport and in locations where air-conditioning is unavailable.
This publication is intended to support health p
...
ersonnel who use RDTs. It describes the basic principles for management and storage of RDT stock; outlines practical solutions for protecting RDTs against high temperatures during storage and transport; and describes how to manage waste generated from RDT use in health clinics and central and peripheral storage facilities.
more
The Interim Guidance on Cholera Rapid Diagnostic Tests (RDTs) by the Global Task Force on Cholera Control (GTFCC) provides recommendations for using RDTs to detect cholera in areas with limited laboratory capacity. It highlights the advantages of RD
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Ts, such as rapid detection (within 30 minutes), ease of use by non-laboratory personnel, and their role in early outbreak identification and surveillance. However, it emphasizes that RDTs should not replace culture or PCR testing, as they vary in sensitivity (58-100%) and specificity (60-100%). The document advises on proper test selection, storage, training, and integration into national surveillance systems to enhance cholera response efforts.
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Report for WHO Meningitis guideline revision
Dr Thomas Waite, April 2014
Field Epidemiology Services, Public Health England; UK
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
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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
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