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Expert opinion of the European Tuberculosis Laboratory Initiative core group members for the WHO European Region.
In 2019, an estimated 10 million individuals fell ill with tuberculosis (TB) and 3 million of them were not reported to have beendiagnosed and notified. The gap is proportionately even wider for drug-resistant TB. Of the estimated 465 000 patients with rifampicin-resistant and multi-drug resistant T
...
B (RR/MDR-TB), only 206 030 (44%) were diagnosed and notified.For the first time, the World Health Organization (WHO) has provided global estimates of the incidence of isoniazid resistance: in 2019, there were 1.4 million incident cases of isoniazid-resistant TB, of which 1.1 million were susceptible to rifampicin. Most of these people were not diagnosed with drug-resistant TB and did not receive appropriate treatment.
more
Aлгоритм лабораторной диагностики и мониторинга лечения туберкулеза легких и туберкулеза с лекарственной устойчивостью на основе применения современных быстрых
...
молекулярных методов.
Экспертное заключение членов основной группы Европейской лабораторной инициативы, подготовленное для Европейского региона ВОЗ.
more
Hendra virus (HeV) continues to pose a serious public health concern as spillover events occur sporadically. Terminally ill horses can exhibit a range of clinical signs including frothy nasal discharge, ataxia or forebrain signs. Early signs, if detected, can include depression, inappetence, colic o
...
r mild respiratory signs. All unvaccinated ill horses in areas where flying foxes exist, may potentially be infected with HeV, posing a significant risk to the veterinary community. Equivac® HeV vaccine has been fully registered in Australia since 2015 (and under an Australian Pesticides and Veterinary Medicines Authority special permit since 2012) for immunization of horses against HeV and is the most effective and direct solution to prevent disease transmission to horses and protect humans. No HeV vaccinated horse has tested positive for HeV infection. There is no registered vaccine to prevent, or therapeutics to treat, HeV infection in humans. Previous equine HeV outbreaks tended to cluster in winter overlapping with the foaling season (August to December), when veterinarians and horse owners have frequent close contact with horses and their bodily fluids, increasing the chance of zoonotic disease transmission. The most southerly case was detected in 2019 in the Upper Hunter region in New South Wales, which is Australia's Thoroughbred horse breeding capital. Future spillover events are predicted to move further south and inland in Queensland and New South Wales, aligning with the moving distribution of the main reservoir hosts. Here we (1) review HeV epidemiology and climate change predicted infection dynamics, (2) present a biosecurity protocol for veterinary clinics and hospitals to adopt, and (3) describe diagnostic tests currently available and those under development. Major knowledge and research gaps have been identified, including evaluation of vaccine efficacy in foals to assess current vaccination protocol recommendations.
more
This document is a guide defining requirements for quality and safety for malaria rapid diagnostic testing services to safeguard the quality of the results, the safety of the operators and patients
...
and that of the environment for use by national malaria control programmes, regulators, implementers and rapid diagnostic providers.
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 po
...
int-of-care diagnostic technologies for Chlamydia trachomatis, 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
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
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
18 Janaury 2021
EU/EEA Member States and the UK have increased their laboratory capacity tremendously over the past 11 months as the majority of the Member States reported sufficient testing capacity until March 2021.
Many countries are adding ra
...
pid antigen detection tests (RADT) to their testing strategies in order to reduce pressure on RT-PCR testing.
Some Member States have already included RADT in their case definition.
The main bottlenecks, such as shortages of laboratory consumables and human resources, as well as sample storing facilities, continue to exist and may affect the overall laboratory response to COVID-19.
more
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
- 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
Diagnostic de l’ulcère de Buruli au laboratoire
recommended
Manuel destiné au personnel de santé. Le présent manuel est un guide spécialisé sur les techniques et les méthodes de laboratoire à utiliser pour le diagnostic de l’ulcère de Buruli, une maladie provoquée par Mycobacterium ulcerans. Desti
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né aux techniciens et aux scientifi ques de laboratoire travaillant sur cette maladie, le présent manuel décrit les méthodes exactes à mettre en oeuvre pour réaliser un certain nombre de tests diagnostiques. Les procédures recommandées, utilisables dans l’ensemble du système de santé, sont adaptées aux services périphériques, des districts et centraux et ce, conformément aux ressources, compétences et matériel variables que l’on trouve classiquement dans les pays où l’ulcère de Buruli est endémique.
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The pandemic has emphasized the high risk of avoidable harm to patients, health workers, and the general public, and has identified a range of safety gaps across all core components of health systems at all levels.
The rapid review ‘Implication
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s of the COVID-19 pandemic for patient safety’ explores impacts that the COVID-19 pandemic did have on patient safety in terms of risks and avoidable harm, specifically in terms of diagnostic, treatment and care management related issues as well as highlights the main patterns of these implications within the broader health system context.
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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 recommanda
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tions relatives aux stratégies nationales de dépistage 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.
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SOP- Quality Assurance of Malaria Diagnostic Tests
Technical specifications for selection of essential in vitro diagnostic tests for SARS-COV-2, 14 June 2021
TECHNICAL SPECIFICATIONS FOR TEST SELECTION ESSENTIAL IN VITRO DIAGNOSTIC TESTS FOR SARS-COV-2
Timely detection of novel coronavirus (2019-nCoV) infection cases is crucial to interrupt the spread of this virus. We assessed the required expertise and capacity for molecular detection of 2019-nCoV in specialised laboratories in 30 European Union/European Economic Area (EU/EEA) countries. Thirty-
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eight laboratories in 24 EU/EEA countries had diagnostic tests available by 29 January 2020. A coverage of all EU/EEA countries was expected by mid-February. Availability of primers/probes, positive controls and personnel were main implementation barriers.
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Protocol for the use of rapid tests for the detection of antibodies against SARS - COV-2/COVID-19
