The WHO Cholera Rapid Diagnostic Test (RDT) Target Product Profile outlines the key requirements for developing improved cholera RDTs. It highlights the need for fast, accurate, and easy-to-use tests for early outbreak detection in resource-limited settings. The document sets desired and acceptable ...performance criteria, including high sensitivity and specificity, rapid results (under 15 minutes), and usability by non-laboratory personnel. The tests should be affordable, stable in extreme conditions, and require minimal training. The goal is to enhance cholera surveillance and outbreak response, ensuring quick containment and improved public health outcomes.
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On 13 August 2024, Africa Centres for Disease Control and Prevention (Africa CDC) declared the ongoing Mpox outbreak a Public Health Emergency of Continental Security (PHECS). This was followed the next day by the World Health Organization (WHO), which extended the alert internationally as a public ...health emergency of international concern (PHEIC). After these declarations, many countries have made efforts to mobilize resources to introduce or expand laboratory testing, surveillance, and response activities. In particular, as the number of suspected cases surges in the Democratic Republic of Congo (DRC), Burundi, and the Central African Republic, and an increasing number of new countries report cases, there is an urgent need to implement testing to strengthen the Mpox response. However, access to appropriate quality assured diagnostics is a challenge. There is limited information on important characteristics, such as available test kits’ performance and ability to detect relevant clades.
To address the challenge of mpox access in the continent, the Africa CDC Diagnostic Advisory Committee (DAC) met in Kigali from 19-23 August 2024 to review the available evidence on molecular tests for Mpox and to shortlist tests that may be useful for Mpox testing in countries. The shortlist aims to provide guidance to Africa CDC, countries and partners on appropriate high-quality molecular tests to procure and use for the mpox response.
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SARS-COV-2 antigen rapid diagnostic tests are an alternative option for diagnosing active SARS-CoV-2 infection through detection of viral proteins. Rapid antigen tests revolutionize the response to COVID-19 by providing accurate test results in 10 to 20 minutes instead of days, allowing tests to be ...done at point of care, and dramatically lowering the price of the tests.
Proper training on the safe use and implementation of antigen tests is vital to ensuring quality testing. A comprehensive training package around safety, sample collection, testing, reporting and management of antigen tests can be found below.
The training package includes facilitators’ guides for master trainers and trainers, training presentations, and supplementary materials to aid in the delivery of this training.
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Limited coverage of laboratory services and long turnaround times from real-time reverse transcription-polymerase chain reaction (rRT-PCR) for the detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has been insufficient to meet the demands in many African countries in response... to the COVID-19 pandemic. Rapid antigen diagnostic tests (AgRDTs) are potentially useful as they can inform healthcare workers and individuals of their infection status at point-of-care testing
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This document outlines minimum requirements of laboratory testing for COVID-19 and link laboratory testing with surveillance and contact tracing to guide the outbreak response by national health authorities using a reduced number of tests performed. The strategies are organized according to stages o...f transmission: (1) No cases reported or observed (Stage 0); (2) Imported cases (Stage 1); (3) Localized community transmission (Stage 2); (4) Large-scale community transmission (Stage 3). For each stage, the recommended approaches indicate which testing strategy to prioritize when there are severe limitations on laboratory testing. The document is based on the current epidemiology of COVID-19 and available molecular testing methods.
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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.
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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.
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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.
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To meet the need for laboratory diagnosis to be integrated in community care, the new 2022 Update describes point-of-care tests that can be performed both in district laboratories and peripheral healthcare facilities by non-specialist staff. Also included are recently developed self-tests.
This training toolkit by the European Laboratory Initiative for TB, HIV and Viral Hepatitis provides a unique combination of practical guidance and expert advice on the interpretation of selected WHO-endorsed tests for drug-resistant tuberculosis (DR-TB).
This report, published in conjunction with a summary overview of results of rounds 1–8, is the eighth and final report in a series of laboratory-based evaluations of rapid diagnostic tests (RDTs) for malaria. It provides a comparative measure of their performance in a standardized way to distingui...sh between well and poorly performing tests.
These results constitute the laboratory evaluation component of the WHO prequalification process for malaria RDTs and inform the current WHO procurement recommendations. In round 8, 35 RDTs from 17 manufacturers were assessed. For the first time the evaluation included an assessment of product performance against a panel of P. falciparum parasites with pfhrp2/3 gene deletions and therefore not expressing HRP2.
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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 expensive 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.
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South Africa has recorded its first case of monkeypox today, 23 June 2022. The Minister of
Health Dr. Joe Phaahla explained that he received a report from the National Health
Laboratory Services’ CEO that they have confirmed through laboratory tests the first case of
monkeypox in South Africa. ...South Africa's monkeypox patient zero is a 30-year-old man from
Johannesburg.
The South African Health Products Regulatory Authority (SAHPRA) has prepared an
information sheet to better understand monkeypox, the symptoms to treatment.
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Following review of evidence and advice from the Technical Advisory Group (TAG) on Tuberculosis (TB) Diagnostics and Laboratory Strengthening, the World Health Organization (WHO) announces that current WHO recommendations for the use of interferon-gamma release assays (IGRA) are also valid for Beij...ing Wantai’s TB-IGRA and Qiagen QuantiFERON-TB Gold Plus products. This expands the range of tests available to detect TB infection. Full details are provided in this WHO policy statement.
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It is Zika virus (ZIKV) that most often causes these neurological effects it appears to be the only arbovirus than can cause congenital malformations such as microcephaly. In any case, more scientific tests are needed to establish the causal relationship between the virus and this malformation (7-10...).
This document is a practical tool designed to help health workers improve clinical diagnosis and provide timely care for patients infected
with the dengue, chikungunya, or Zika virus. It is intended mainly for
health workers in primary care facilities where laboratory diagnosis of
arboviruses is not always available. However, this guide may also be
very useful in hospitals that provide second- and third-level care, as it
describes the clinical manifestations of each of the three most important
arboviral diseases currently found in the Region, the elements for
differential diagnosis, and their clinical behavior.
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Blended Learning Modulef or the Health Extension Programme
In this study session, you will learn about the general features of faeco-oraldiseases: the main types commonly found in Ethiopia, their general symptomsand signs, how to treat mild cases and when to refer patients with severeconditions for... specialised treatment, or laboratory tests to confirm thediagnosis. You will also learn about the importance of giving effective healtheducation to your community on ways to prevent and control faeco-oraldiseases.
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The waves of yellow fever transmission in the Region of the Americas in 2016–2018 involved the largest number of human and epizootic cases to be reported in several decades. Yellow fever is a serious viral hemorrhagic disease that poses a challenge for health professionals. It requires early recog...nition of signs and symptoms, which are often nonspecific, and it can mimic other acute febrile syndromes. Early detection of suspected or confirmed cases, monitoring of vital signs, life support measures, and treatment of acute kidney failure continue to be the recommended strategies for case management. This report is the result of discussions among experienced specialists in the Americas on the clinical management of yellow fever patients, especially during outbreaks and epidemics, in the context of current medical and scientific evidence and taking into account the technical guidelines already available in the countries of the Region. It includes flowcharts for initially addressing patients with clinical suspicion of yellow fever and proposes a minimum package of laboratory tests that may be useful in contexts where resources are limited. In addition, it considers aspects of health system organization for dealing with yellow fever outbreaks and epidemics.
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- 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.
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Under-diagnosis of asthma in ‘under-fives’ may be alleviated by improved inquiry into disease history. We assessed a questionnaire-based screening tool for asthma among 614 ‘under-fives’ with severe respiratory illness in Uganda. The questionnaire responses were compared to post hoc consensu...s diagnoses by three pediatricians who were guided by study definitions that were based on medical history, physical examination findings, laboratory and radiological tests, and response to bronchodilators. Children with asthma or bronchiolitis were categorized as “asthma syndrome”. Using this approach, 253 (41.2%) had asthma syndrome. History of and present breathing difficulties and present cough and wheezing was the best performing combination of four questionnaire items [sensitivity 80.8% (95% CI 77.6–84.0); specificity 84.7% (95% CI 81.8–87.6)]. The screening tool for asthma syndrome in ‘under-fives’ may provide a simple, cheap and quick method of identifying children with possible asthma. The validity and reliability of this tool in primary care settings should be tested.
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La Centrale d’Achats des Médicaments Essentiels et Consommables Médicaux (CAME) du
Benin est chargée d’assurer la disponibilité et l’accessibilité des produits de santé dans le secteur
publique et privé à but non lucratif. Lors de la mise en oeuvre des subventions du Fonds Mondial, l...es
Récipiendaires Principaux des différentes subventions avaient choisi la CAME comme agent
d’approvisionnement pour l’acquisition, la gestion des stocks et la distribution des produits médicaux
acquis dans le cadre de ces subventions (produits pharmaceutiques et autres produits médicaux tel
que les moustiquaires, les équipements de laboratoire et de radiologie, les préservatifs, les tests de
diagnostique rapide et non rapide, les insecticides et les seringues).
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