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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 cu
...
rrent low disease prevalence, the positive predictive 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 cu
...
rrent low disease prevalence, the positive predictive 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
This WHO information note provides an updated list of recommended criteria for selecting RDTs for malaria, and highlights the performance of RDTs evaluated by the WHO malaria RDT product testing programme. It also provides an overview of additional
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considerations in the procurement of rapid tests.
more
This Indicator-Based Pharmacovigilance Assessment Tool (IPAT) was developed as a comprehensive performance metric for pharmacovigilance and medicine safety systems.
This document aims to provide interim guidance for microbiology and virology experts, other laboratory professionals, laboratory managers, infectious disease programme managers, public health profes
...
sionals and other stakeholders that provide primary, confirmatory or advanced testing for SARS-CoV-2, including genomic sequencing, or are involved in making decisions on establishing or scaling up capability and capacity to detect and characterize circulating SARS-CoV-2 variants.
more
This manual is designed primarily to assist managers of national malaria programmes and national reference laboratory responsible for quality assurance of malaria microscopy control. The information is also applicable to non-governmental organizatio
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ns and funding agencies investing in quality management systems for malaria microscopy.
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
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laboratory of Instituto Nacional de Investigación 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.
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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 te
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ster 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
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On September 10, 2022, the Ministry of Health (MOH) announced a cholera outbreak in Aleppo governorate with 15 laboratory confirmed cases reported between August 25 and September 9, 2022. Activities under this plan seek to address the immediate need
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s stemming from this outbreak and highlight response priorities across all areas of the response and key sectors involved. This plan initially focuses on the Health, Water Sanitation and Hygiene (WASH), and Risk Communication and Community Engagement (RCCE) responses for an initial period of 90 days. The activities detailed in this plan are also within the programmatic scope of the 2022-2023 Humanitarian Response Plan (HRP).
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This publication aims to provide updated guidance on the specific use of yellow fever laboratory assays in the context of surveillance to be used across the Global Yellow Fever Laboratory Network fo
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r disease surveillance. In the recent years, new commercial assays became available and are now recommended for use by WHO and this publication will support national program on the use of compound laboratory assays as per the most recent recommended testing algorithms. This piece is aligned with the elimination effort set in the comprehensive global strategy to eliminate yellow fever epidemics (EYE) strategy 2017-2026 and where its advisory laboratory technical working group actively contributed to its development. The target audiences are policy-makers and health workers.
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Benchmarking is a strategic process often used by businesses and institutes to standardize performance in relation to the best practices of their sector. The World Health Organization (WHO) and partners have developed a tool with a list of benchmark
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s and corresponding suggested actions that can be applied to implement the International Health Regulations 2005 (IHR) and strengthen health emergency prevention, preparedness, response and resilience capacities.
The first edition of the benchmarks was published in 2019 to support countries in developing, implementing and documenting progress of national IHR or health security plans (e.g. national action plan for health security (NAPHS), national action plan for emerging infectious diseases, public health emergencies and health security and other country level plans for health emergencies). The tool has been updated to incorporate lessons from COVID-19 and other health emergencies, to align with the updated IHR monitoring & evaluation framework (IHR MEF) tools and the health systems for health security framework, and to support strengthening health emergency prevention, preparedness, response and resilience (HEPR) capacities and the Preparedness and Resilience for Emerging Threats (PRET) initiative.
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Version 4
The purpose of these standard operating procedures (SOPs) is to offer policy guidance and to provide performance standards on how to respond to any type of poliovirus outbreak or event in a timely and effective
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manner, and specifically, to stop an outbreak within 120 days.
more
16 Dec. 2020
This document provides guidance to Ministries of Health (MOHs), laboratory personnel and implementing partners in African Union Member States on the application of rapid antigen tests to COVID-19 testing. The guidance serves as referen
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ce for policymakers, laboratory leads, implementing partners, and experts on use case scenarios and associated testing algorithms for COVID-19 antigen tests. It recommends the use of antigen tests to increase access to testing and enable timely results for persons with or without symptoms in specific settings. The document will be reviewed and updated as more evidence becomes available regarding the use of rapid antigen tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) from global studies and evaluation efforts.
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Au total, 18 laboratoires de 13 pays ont participé aux quatre cycles d'AQE : 10 laboratoires de huit pays africains endémiques, dont quatre ont participé aux quatre cycles et trois à trois cycles. Les résultats globaux ont montré que la performance
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médiane de ces laboratoires s'est améliorée au cours des quatre cycles. Cependant, la proportion de laboratoires rapportant des cas faussement positifs reste élevée et indique un problème de spécificité probablement dû à une contamination. La proportion de laboratoires rapportant à la fois des résultats faussement positifs et faussement négatifs soulève la question de la qualité des données rapportées par l'OMS en Afrique ainsi que des résultats des études menées dans ces différents laboratoires dans divers pays.
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An Indicator-based Approach - This manual presents an indicator-based approach for rapidly assessing pharmaceutical management systems and programs. The manual contains a set of 46 indicators of performance, grouped under eight topics of pharmaceuti
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cal management, with each topic being covered by a subset of indicators. Thirty-four of the indicators are quantitative, that is, expressed as numbers. Twelve are qualitative, in that they describe the presence or absence of a policy or management system, and in some cases, the degree of implementation.
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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 performance and accessibility. 1t focuses on
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key issues such as when to
Perform antigen tests′ how to use and interpret results. Capturing and reporting testing information is also covered.
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The overall objective of this implementation plan is to define the strategy for implementation of the Xpert MTB/RIF test for rapid detection of TB and rifampicin (RIF) resistance in Tanzania, within the context of the National Tuberculosis and Leprosy Programme (NTLP) strategic plan and other nation
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al health guidelines. It is intended to serve as the main guiding document for national, regional and local programme managers, clinicians, coordinators, laboratory staff and other health workers; national and regional reference laboratories; local and international implementing partners; and donors involved in TB control.
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This resource consists of technical guidelines for District Medical Officers, counselors and laboratory technicians for second-line antiretroviral therapy drugs, operational guidelines for pilot roll-out in two centres and
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laboratory guidelines for viral-load testing and standard operating procedures.
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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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Prepared as an outcome of ICMR Expert Group on Immunophenotyping of Hematolymphoid Neoplasms | Coordinated by Division of Non Communicable Diseases | This document addresses on various issue related to good quality practices in laboratory work up of
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flow cytometric immunophenotyping and will be of use to pathologists, cytometrists, hematologists, technologists and scientists working in this field.
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