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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
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 recommendatio
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ns by the Member States, technical partners, and others 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
This document aims to present an algorithm for deciding whom to test and provide guidance on the laboratory tests for Zika virus infection diagnosis in order to support clinical diagnostic and case
...
reporting through surveillance among EU Member States. The algorithm is not intended for clinical management of patients with suspected Zika virus infection.
The information is provisional and subject to revision when new information becomes available.
more
Laboratory biosafety guidance related to coronavirus disease (COVID-19): Interim guidance, 28 January 2021
recommended
The latest update (28 January 2021) includes the following addition and revision:
biosafety aspects for working with antigen-detecting rapid diagnostic test;
handling new variants of SAR
...
S-CoV-2 in the laboratory;
updated assay decontamination before disposal;
personal protective equipment (PPE) for specimen collection;
addressing chemical hazards and their safe disposal; and
the fourth edition of the WHO Laboratory Biosafety Manual (LBM4) is now available and the terminology in this guidance was aligned with the LBM4.
more
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
...
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.
more
The latest update (28 January 2021) includes the following addition and revision:
biosafety aspects for working with antigen-detecting rapid diagnostic test;
handling new variants of SAR
...
S-CoV-2 in the laboratory;
updated assay decontamination before disposal;
personal protective equipment (PPE) for specimen collection;
addressing chemical hazards and their safe disposal; and
the fourth edition of the WHO Laboratory Biosafety Manual (LBM4) is now available and the terminology in this guidance was aligned with the LBM4.
more
The latest update (28 January 2021) includes the following addition and revision:
biosafety aspects for working with antigen-detecting rapid diagnostic test;
handling new variants of SAR
...
S-CoV-2 in the laboratory;
updated assay decontamination before disposal;
personal protective equipment (PPE) for specimen collection;
addressing chemical hazards and their safe disposal; and
the fourth edition of the WHO Laboratory Biosafety Manual (LBM4) is now available and the terminology in this guidance was aligned with the LBM4.
more
This course will provide you with the knowledge and skills needed to implement WHO-recommended TB tests and algorithms. It includes the latest recommendations for novel tests for TB diagnosis and detection of drug resistance, as well as the most recent WHO policy guidance for the use of those tests.
...
The course also describes the processes and steps for implementing a new diagnostic test for routine use within the TB diagnostic network
more
This policy guideIine is intended for use by healthcare professionals invoIved in the management of Covid-19 in South Africa. The document provides guidance on diagnostic tests available, on antigen test
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performance and accessibility. 1t focuses on key issues such as when to
Perform antigen tests′ how to use and interpret results. Capturing and reporting testing information is also covered.
more
La récente augmentation du nombre de cas de microcéphalie et d’autres troubles neurologiques potentiellement associés à une infection à virus Zika a engendré une recrudescence des demandes de dépistage en laboratoire de cette infection. Les groupes prioritaires pour un
...
test de diagnostic doivent être constitués de personnes symptomatiques et de femmes enceintes asymptomatiques potentiellement exposées au virus Zika.
Ce document fournit des indications sur les stratégies actuelles de dépistage de l’infection à virus Zika. Il sera revu et actualisé à mesure que des informations supplémentaires deviendront disponibles.
more
The meeting was held from 26 to 27 March 2018 to review and discuss the following topics:
Advances and challenges in the use of fTLC, and new approaches to detecting mycolactone using monoclonal antibodies (mAbs).
The status of development of rapid
...
diagnostic tests (RDTs) targeting the MUL_3720 protein.
The role of PCR as a reference test, and hurdles in providing a confirmatory diagnosis and in establishing a quality assurance programme.
New molecular tools with potential for implementation at a level lower than in the national or regional reference laboratory, such as loop-mediated isothermal amplification (LAMP) and recombinase polymerase amplification (RPA).
The need to harmonize and standardize methods for collection and preparation of specimens, so samples can be referred for diagnosis and stored for evaluation of new diagnostic tests in optimal conditions.
Barriers to accessing early diagnosis and treatment, including coordination at the programme level, and lack of adequate diagnostic tools.
Defining target product profiles (TPPs) to guide the development of new diagnostic tools that can be applied at different levels of the health system. Participants agreed that two TPPs would be developed to address the current gaps: (i) a rapid test for BU diagnosis at the primary health-care level; and (ii) a test for diagnosis of BU that can also assist in treatment monitoring and differential diagnosis at the district hospital or reference centre.
more
Diagnosing asthma in children represents an important clinical challenge. There is no single gold-standard test to confirm the diagnosis. Consequently, over- and under-diagnosis of asthma is frequent in children. A task force supported by the Europe
...
an Respiratory Society has developed these evidence-based clinical practice guidelines for the diagnosis of asthma in children aged 5–16 years using nine Population, Intervention, Comparator and Outcome (PICO) questions. The task force conducted systematic literature searches for all PICO questions and screened the outputs from these, including relevant full-text articles. All task force members approved the final decision for inclusion of research papers. The task force assessed the quality of the evidence using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.
The task force then developed a diagnostic algorithm based on the critical appraisal of the PICO questions, preferences expressed by lay members and test availability. Proposed cut-offs were determined based on the best available evidence. The task force formulated recommendations using the GRADE Evidence to Decision framework.
Based on the critical appraisal of the evidence and the Evidence to Decision framework, the task force recommends spirometry, bronchodilator reversibility testing and exhaled nitric oxide fraction as first-line diagnostic tests in children under investigation for asthma. The task force recommends against diagnosing asthma in children based on clinical history alone or following a single abnormal objective test. Finally, this guideline also proposes a set of research priorities to improve asthma diagnosis in children in the future.
more
Zika and dengue viruses remain significant public health threats. These viruses share the same Aedes (Stegomyia) mosquito vectors and geographic distributions but infections cannot be readily distinguished clinically and need to be differentiated from each other, and from other circulating arboviral
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and non-arboviral pathogens, using laboratory tests. This document provides guidance on current testing strategies for Zika and dengue virus infections with updates to the previous interim guidance for laboratory testing for ZIKV, addressing pregnant and non-pregnant patients respectively, and incorporates current guidance for dengue virus diagnostic testing. The choice of laboratory assays and interpretation of test results require careful consideration of epidemiology, patient history, and limitations of existing diagnostic tests.
This interim guidance is for use by staff of laboratories testing for Zika and dengue virus infections and for clinical practitioners and public health professionals providing clinical management or surveillance.
more
Cotonou declaration on buruli ulcer
recommended
Cotonou Declaration oBuruli Ulcer
Cotonou, Benin, 30 March 2009
Neglected tropical diseases kill, weaken or incapacitate millions of people every year, causing permanent physical suffering, social stigmatization and reduced productive capacity. Buruli ulcer, one such disease, causes immense suffer
...
ing and disabilities, especially among children. Delayed schooling and loss of productivity are considerable among the affected populations. These adverse consequences tend to aggravate poverty in affected communities. Globally, the disease has been reported in 30 countries. In WHO’s African Region, Buruli ulcer has been confirmed in 12 countries and is suspected in 10 others.
Significant progress has been made in the past 10 years in knowledge of Buruli
ulcer, investments in related research, control of the disease, and improvement
of tools for case diagnosis and development of treatment protocols. Substantial achievements have been made in diagnosis, treatment, immunology and epidemiology. Despite these achievements, little is known about the exact mode of transmission of the disease, and there is no simple diagnostic test usable in the field.
The use of antibiotics has revolutionized treatment and contributed to reducing the need for surgery by half. However, efforts are still needed to develop simple diagnostic tools usable in the field as well as disability prevention methods. The Global Buruli Ulcer Initiative has adopted the strategy recommended by WHO. The strategy is based on early diagnosis of the disease and the use of antibiotics for treatment upon the onset of the first signs by improving access to screening and case management at the most peripheral level of the health system.
more
Guide de recommandations rapides 11 juin 2020
Depuis son identification en Chine en décembre 2019, le nouveau coronavirus responsable de la COVID‐19 s’est rapidement propagé pour causer une pandémie. Cette maladie se manifeste par des symptômes respiratoires non spécifiques de gravité var
...
iable et peut nécessiter une assistance respiratoire importante. Son diagnostic est actuellement confirmé grâce l’identification de l’ARN du virus grâce à un test de laboratoire utilisant la technique de la transcription inverse-amplification génique (en anglais, reverse transcriptase polymerase chain reaction, soit RT-PCR.
more
The objective of the study was the validation and implementation of GeneXpert MTB/RIF for routine use in the rapid detection of tuberculosis and sensitivity to rifampicin in clinical samples; for this, 1592 respiratory samples were collected and analyzed in the laboratory of Instituto Nacional de In
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vestigación en Salud Pública Guayaquil. The analysis of the results of GeneXpert in comparison with smear microscopy showed an initial sensitivity of 99.8% and specificity of 93.2%; The analysis of discrepancies using the results of the culture as a reference method showed that the GeneXpert results considered false negatives turned out to be true negatives, the same happens with the false positives that correspond to true positives. Recalculated the sensitivity and specificity of the GeneXpert was 99.8% and 100% correspondingly. The comparison with the drugs susceptibility test showed a sensitivity of 91.4% and a specificity of 95.5% for the GeneXpert MTB/RIF system. It is concluded that the implementation of the GeneXpert system allows solution to certain problems associated with the application of conventional diagnostic methodologies, decreasing the waiting times, and increasing the sensitivity and specificity in the diagnosis of drug-resistant tuberculosis, thus generating a valuable opportunity for early diagnosis.
more
Yaws is a non-venereal endemic treponemal infection caused by Treponema pallidum sub-species pertenue, a bacterium closely related to Treponema pallidum ssp. pallidum, the agent of venereal syphilis. Yaws predominantly affects children living in tropical regions of the world. It causes lesions of th
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e skin, mucous membranes and bones which, without treatment, can become chronic and destructive. There is no widely available test to distinguish yaws from syphilis. Thus, migration of people from yaws-endemic areas to developed countries may present clinicians with diagnostic dilemmas. The other endemic treponemal infections are bejel (endemic syphilis) caused by Treponema pallidum ssp. endemicum and pinta caused by Treponema carateum.
more
Cystic Fibrosis - What Is Cystic Fibrosis
National Heart, Lung, and Blood Institute (NHLBI)
U.S. Department of Health and Human Services
(2024)
CC2
The "Cystic Fibrosis Fact Sheet" by the National Heart, Lung, and Blood Institute provides an overview of cystic fibrosis (CF), a chronic and often fatal genetic disorder affecting the respiratory and digestive systems. The document outlines the causes, genetic inheritance patterns, and symptoms of
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CF, which include thick mucus buildup, respiratory issues, and digestive problems. It also discusses diagnostic methods, such as the sweat test and genetic testing, and highlights current treatment approaches focused on symptom management, including chest therapy, medications, and potential gene therapy. The fact sheet emphasizes patient and family education to improve quality of life and support coping strategies.
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Directives nationales pour la prise en charge du paludisme en République Démocratique du Congo
Programme National de Lutte contre le Paludisme (PNLP)
Ministère de la Santé Publique, Hygiène et Prévention, République Démocratique du Congo
(2023)
C2
Le document « Directives nationales pour la prise en charge du paludisme en RDC », publié en 2023 par le PNLP et le Ministère de la Santé, définit les protocoles officiels pour diagnostiquer et traiter le paludisme sur l’ensemble du territoire. Il recommande l’usage systématique du
...
test de diagnostic rapide avant tout traitement, et l’administration des CTA pour le paludisme simple et de l’artésunate injectable pour les cas graves. Le texte insiste sur la gratuité des soins pour les enfants de moins de 5 ans et les femmes enceintes, la gestion rationnelle des médicaments et la formation continue du personnel de santé. Ces directives visent à réduire la mortalité et à atteindre l’élimination du paludisme d’ici 2030.
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