This guide includes information relevant for tuberculosis (TB) program and laboratory managers, as well as Ministry of Health officials across disease programs interested in establishing integrated solutions for specimen referral. Though TB-focused in name, it offers integration-oriented assessment,... design, and monitoring guidance related to improving coordination and efficiency, and is relevant for other programs as well. Country case studies include viral load and early infant diagnosis (EID) in Uganda and EID in Ethiopia.
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Prequalification of Male Circumcision Devices
PQMC_007 v1 16 December 2011
The WHO BioHub Biosafety & Biosecurity: criteria and operational modalities sets out the requirements to which laboratories wishing to receive biological materials as part of this international exchange system should abide, to ensure safe and secure operations. These provisions are in accordance wit...h the recommendations of the WHO Laboratory Biosafety Manual 4th edition (LBM4), adopting an evidence- and risk-based approach to enable scalable and adaptable biosafety provisions and actions, proportionate to the assessed risk
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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.
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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 M...UL_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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Capability and Performance
Health Systems for Outcomes Publication | This report summarizes the findings of a qualitative study on health workers’ performance and career in Rwanda to identify bottlenecks, strengths and shortcomings for human resources in the health sector, as perceived by both health workers and users of he...alth services.
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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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The microbiology laboratory database software.
WHONET is a desktop Windows application for the management and analysis of microbiology laboratory data with a particular focus on antimicrobial resistance surveillance. WHONET, available in 28 languages, supports local, national, regional, and global ...surveillance efforts in over 2,300 hospital, public health, animal health, and food laboratories in over 130 countries worldwide.
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Building laboratory testing capacity
This document aims to provide interim guidance for microbiology and virology experts, other laboratory professionals, laboratory managers, infectious disease programme managers, public health professionals 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.
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This Indicator-Based Pharmacovigilance Assessment Tool (IPAT) was developed as a comprehensive performance metric for pharmacovigilance and medicine safety systems.
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 organizations and funding agencies investing in quality manage...ment systems for malaria microscopy.
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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 for disease surveillance. In the recent years, new commercial assays became available and are now recomm...ended 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 benchmarks and corresponding suggested actions that can be a...pplied 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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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 needs stemming from this outbreak and highlight respons...e 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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