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Publication Years
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23 March 2021
The meeting addressed the last key area, that is, determining the best method or combination of diagnostic methods for a control programme for S. stercoralis infections in humans.
Dr Montresor’s presentation highlighted that whil
...
e there is currently no “gold standard” for the diagnosis of S. stercoralis, there is a felt urgency to optimize diagnostic regimens that are currently available, and in the context of population-based testing (as opposed to individual focused diagnostics in clinical settings).
In other words, the diagnostic test(s) should have good accuracy, but we should remember that in public health we do not aim at individual diagnosis: rather, we need a tool that should help to estimate the prevalence in a population.
more
The development of this target product profile (TPP) was led by the WHO Department of Control of Ne-
glected Tropical Diseases (NTD) following standard WHO guidance for TPP development. In order to
identify and prioritize diagnostic needs, a WHO N
...
TD Diagnostics Technical Advisory Group (DTAG)
was formed, and different subgroups were created to advise on specific NTDs, including a subgroup
working on the human African trypanosomiasis (HAT) diagnostic innovation needs. This group of in-
dependent experts included leading scientists, public health officials and endemic-country end-user rep-
resentatives. Standard WHO Declaration of Interest procedures were followed. A landscape analysis of
the available products and of the development pipeline was conducted, and the salient areas with unmet
needs were identified
more
Health ministries currently lack effective tools for monitoring and evaluation of schistosomiasis control programmes. Egg detection can be used, but the cost, challenges of obtaining samples, and the need for trained personnel and equipment limit the frequency of monitoring. The purpose of this TPP
...
is to guide the development of new diagnostic tools to reliably measure when prevalence is above or below a cut-off of 10% in school-aged children. Communities remaining above 10% require annual MDA, while communities below 10% can reduce MDA frequency as long as < 10% prevalence can be maintained. However, the lack of a reliable test has hindered the development of maintenance strategies. The test is also needed to track changes of prevalence > 10% to ensure that annual MDA is reducing overall prevalence.
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. Add
...
itionally, the lack of multiplex diagnostic tools capable of distinguishing Mpox from other pathogens with similar clinical presentations further complicates case detection and response efforts.
more
- The goal of diagnostic testing for Ebola and Marburg virus diseases is to identify cases to provide timely and appropriate care and to stop disease transmission.
- All individuals meeting the case definition for Ebola or Marburg virus diseases
...
should be tested.
- The recommended sample type for testing for orthoebolaviruses and orthomarburgviruses is whole blood or plasma for living patients, and oral swab for deceased individuals.
- Laboratory confirmation of Orthoebolavirus and Orthomarburgvirus infections and further species identification should be done using nucleic acid amplification testing (NAAT).
- If a suspected case tests negative (living patient) and the blood was drawn less than 72 hours after symptom onset, a second test should be performed with blood drawn more than 72 hours after symptom onset.
- All manipulations in laboratory settings of samples originating from suspected, probable or confirmed cases of Ebola and Marburg virus diseases should be conducted with appropriate biosafety measures according to a risk-based approach.
- Whole or partial genome sequencing can be used to characterize viruses and complement epidemiologic investigations.
- Member States are strongly encouraged to share genetic sequence data (GSD) in publicly accessible databases.
- Member States are required to immediately notify the World Health Organization (WHO) under the International Health Regulations (IHR) 2005 of positive laboratory results.
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 disability 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
Le défi des pays en voie de développement est la disponibilité de méthodes de diagnostic rapide et précis pour le management de la tuberculose. Des techniques moléculaires offrent cet avantage et nous avons utilisé le
...
test GeneXpert MTB/RIF dans le diagnostic de la tuberculose extra-pulmonaire pour évaluer sa performance par rapport aux méthodes conventionnelles.
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
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
...
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.
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 ant
...
igen tests in different transmission scenarios of the 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
orientations provisoires, 25 juin 2021. Des tests de diagnostic rapides et précis sont un outil essentiel pour prévenir et contrôler la propagation du COVID-19. Ce document décrit les recommandations relatives aux stratégies nationales de dépi
...
stage et à l'utilisation de la PCR et des tests antigéniques rapides dans différents scénarios de transmission de l'épidémie de COVID-19, y compris la manière dont les tests pourraient être rationalisés dans les milieux à faibles ressources. Tous les tests doivent être suivis d'une réponse de santé publique forte, comprenant l'isolement des personnes dont le test est positif et la fourniture de soins, la recherche des contacts et la mise en quarantaine des contacts.
more
9 March 2022, Timely and accurate diagnostic testing for SARS-CoV-2 is an essential part of a comprehensive COVID-19 response strategy. Ag-RDTs can be performed by individuals in which they collect their own specimen, perform a simple rapid
...
test and interpret their test result themselves at a time and place of their choosing, termed COVID-19 self-testing. This interim guidance provides a new recommendation that COVID-19 self-testing, using SARS-CoV-2 Ag-RDTs, should be offered as part of SARS-CoV-2 testing services. It also includes implementation considerations that can guide decisions on whether, and how, to adopt self-testing in different contexts, including the populations being prioritized; the disease prevalence in that population; and the impact on accessibility of testing, health care services and result reporting.
more
The development of this target product profile (TPP) was led by the WHO Department of Control of Neglected Tropical Diseases (NTD) following standard WHO guidance for TPP development. In order to identify and prioritize diagnostic needs, a WHO NTD D
...
iagnostics Technical Advisory Group (DTAG) was formed, and different subgroups were created to advise on specific NTDs, including a subgroup working on the human African trypanosomiasis (HAT) diagnostic innovation needs. This group of independent experts included leading scientists, public health officials and endemic-country end-user representatives. Standard WHO Declaration of Interest procedures were followed. A landscape analysis of the available products and of the development pipeline was conducted, and the salient areas with unmet needs were identified.
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
L’objectif des lignes directrices 2024 est de fournir des recommandations actualisées et fondées sur
des données probantes sur les principaux sujets prioritaires. Ceux-ci concernent notamment les critères élargis et simplifiés de mise sous traitement pour les adultes, mais aussi désormais
...
pour les adolescents, l’élargissement des critères d’éligibilité au traitement
antiviral prophylactique pour les femmes enceintes
afin de prévenir la transmission mère-enfant du VHB,
l’amélioration des tests de diagnostic de l’infection par le
VHB grâce à l’utilisation de tests de mesure de la charge
virale du VHB (ADN) sur le lieu de soins (“point-of-care
tests”) et d’approches réflexes pour la recherche de
l’ADN du VHB, et les critères pour déterminer à qui et
comment faire le test pour rechercher une infection par
le VHD.
more
Lineamientos técnicos para el usode la rueba de Lipoarabinomanano (LAM) como apoya diagnostico en patientes con VIH y sospecha de tuberculosis
Alabí Montoya, F.J.; C.G. Alvarenga Cardoza, K.M. Díaz de Naves
Ministerio de Salud El Salvador
(2021)
C1
LAM test as a diagnostic aid in patients with HIV and suspected tuberculosis: technical guidelines
The Alere Filariasis Test Strip (FTS) is a rapid diagnostic test recommended for mapping, monitoring and transmission assessment surveys (TAS) for
...
the qualitative detection of Wuchereria bancrofti antigen in human blood samples. The FTS has replaced the Binax Now filariasis immunochromatographic test (ICT), which also detects the same antigen in blood samples. The Brugia Rapid point-of-care cassette test (BRT) manufactured by Reszon Diagnostics is recommended for use during TAS to detect IgG4 antibody against Brugia spp. in human blood samples.
Read the Filariasis Test Strip (FTS) Bench Aid. This bench aid provides detailed instruction on the proper use of the new Filariasis Test Strip used for the detection of Wuchereria bancrofti antigen.
more
TECHNICAL SPECIFICATIONS FOR TEST SELECTION ESSENTIAL IN VITRO DIAGNOSTIC TESTS FOR SARS-COV-2
Interim guidance, 6 October 2021
Direct detection of SARS-CoV-2 viral proteins (antigens) in nasal swabs and other respiratory secretions using lateral flow immunoassays (also known as rapid diagnostic tests, RDTs) offers a faster and less expensiv
...
e method to test for SARS-CoV-2 than the reference method, nucleic acid amplification tests (NAATs). This interim guidance offers recommendations on the priority uses of antigen-detecting rapid diagnostic tests (Ag-RDTs) in specific populations and settings, including (i) for primary case detection in symptomatic individuals suspected to be infected and asymptomatic individuals at high risk of COVID-19, (ii) for contact tracing, (iii) during outbreak investigations and (iv) to monitor trends of disease incidence in communities. Ag-RDTs meeting minimum performance requirements can be used outside of clinical and laboratory settings, including in communities, by trained operators in accordance with instructions. The guidance additionally provides recommendations on implementation, product selection and storage.
more
