Information note.
This information note provides a strategic overview of key implementation considerations for diagnostic integration using these devices, and is primarily intended for use by national laboratory services and TB, HIV, and hepatitis programme managers.
It may also be of inte...rest to managers of maternal, newborn and child health programmes and sexual and reproductive health programmes, international and bilateral agencies, and organizations that provide financial and technical support to the relevant national health programmes.
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The document titled "Manual for Stratifying Malaria Risk and the Elimination of Foci" by PAHO provides guidance for countries in the Americas on how to systematically assess and classify malaria transmission risk at subnational levels. It outlines a standardized approach to stratification and the id...entification of active transmission foci, helping public health authorities prioritize interventions, allocate resources efficiently, and implement targeted strategies to accelerate progress toward malaria elimination.
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The COVID-19 pandemic exposed critical gaps in the global response to health crises, particularly in the financing of pandemic prevention, preparedness, response, recovery, and reconstruction. This chapter presents a comprehensive framework for pandemic financing that spans the entire pandemic cycle..., emphasizing the need for timely, adequate, and effective financial resources. The framework is designed to support
policymakers in both low- and middle-income countries (LMICs) and high-income nations, providing a guide to appropriate financing tools for each stage of a pandemic, from prevention and preparedness to response and recovery. Key economic concepts such as global public goods, time preference, and incentives are explored to underscore the complexities of pandemic financing.
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Relapsing malaria caused by Plasmodium vivax parasites poses a significant challenge to global malaria elimination efforts. About one third of the population remains at risk of contracting P. vivax malaria, and 85% of P. vivax infections stem from reactivated latent parasites, leading to chronic ana...emia and increased morbidity and mortality. In addition to diagnostic tools that can detect the acute, blood-stage of P. vivax, new tools are needed to detect the dormant infections before they reactivate and contribute to morbidity and onwards transmission
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Preferred product characteristics and clinical development considerations
These guidelines promote the delivery of people-centred health services for STIs by providing evidence-based recommendations related to decentralization, integration, task sharing and digital health. These recommendations complement existing WHO guidelines for STI testing, treatment and management, ...and other service delivery interventions, such as self-care interventions. All the recommendations will be incorporated into the forthcoming WHO consolidated guidelines on STI prevention and care.
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The new WHO guidelines provide clinical management recommendations for four of the most widespread arboviruses affecting humans: dengue, chikungunya, Zika, and yellow fever.
An integrated approach is vital, as these four diseases often present with similar symptoms, especially in the early stages... of infection, and multiple arboviruses may circulate simultaneously in certain regions. This makes clinical differentiation challenging, particularly where diagnostic testing is not readily available.
This guideline is available in online format on the MAGICapp platform
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Access to safe, effective and quality-assured health products and technologies is crucial for achieving universal health coverage and primary health care goals. The continued growth of the aging population; increasing burden of noncommunicable diseases; growing burden of mental health issues; climat...e change; shifting patterns of vector borne diseases, fungal disease and waterborne diseases; antimicrobial resistance; and new infectious hazards create an ongoing need for equitable access to safe, effective and quality-assured health products and technologies, and renewed investments in research and development for innovative health products and technologies.
The coronavirus pandemic exposed the inequalities in access to health products, highlighting the need for longer-term strategies to strengthen access to health products and technologies outside of and in emergency situations. While technological and scientific advances present an opportunity to increase access to health products and technologies, the risk of increasing inequality due to higher prices for new health products and technologies; the persisting problem of substandard and falsified medical products; a lack of skilled workforce in many low- and middle-income countries; and a lack of data for decisionmaking and for measuring progress present significant challenges.
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Despite being a preventable and curable infectious disease, tuberculosis (TB) has continued to elude global controll efforts. In 2023, 8.2 milion people with TB were diagnosed and notified to the WHO, the hightest number ever reported since WHO began tracking.
The overall objective of this approach is to accelerate efforts toward malaria elimination by increasing
access to early diagnosis and treatment. The specific objectives are to: Minimize the barriers that the population faces in accessing timely, quality diagnosis and treatment. Reduce the time bet...ween diagnosis and the start of treatment. Reduce the parasite reservoir in symptomatic infected persons through early treatment. Maximize the transmission-blocking strategy by taking early action on gametocytes. Decrease the incidence of P. vivax relapses.Ultimately, disrupt malaria transmission and prevent mortalit.
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This document provides technical guidance for manufacturers seeking World Health Organization (WHO) prequalification of in vitro diagnostic devices (IVDs) for malaria, with a focus on rapid diagnostic tests (RDTs) for symptomatic patients. It summarises the minimum performance requirements, includin...g analytical and clinical performance standards, and emphasises considerations relating to diverse specimen types, testing environments and user populations in low- and middle-income countries. The guidance is aligned with the criteria and prequalification processes of the WHO Global Malaria Programme, while clarifying that demonstration of clinical utility is outside the scope of prequalification.
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This document provides technical guidance for manufacturers seeking World Health Organization (WHO) prequalification of in vitro diagnostic devices (IVDs) for malaria, with a focus on rapid diagnostic tests (RDTs) for symptomatic patients. It summarises the minimum performance requirements, includin...g analytical and clinical performance standards, and emphasises considerations relating to diverse specimen types, testing environments and user populations in low- and middle-income countries. The guidance is aligned with the criteria and prequalification processes of the WHO Global Malaria Programme, while clarifying that demonstration of clinical utility is outside the scope of prequalification.
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Adolescents and young adults aged 10-24 remain underserved in the global response against HIV. Combination prevention, treatment and care programmes use a mix of evidence-based interventions to meet the current HIV prevention needs of adolescents and young adults. However, there needs to be a focus ...on priority interventions that are evidence-based, practical, contextual and sustainable. This document highlights interventions and recommendations that have passed through the evidence-based lens of the WHO.
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This report was developed by the WHO TB Vaccine Accelerator Finance and Access working group, co-led by WHO, Gavi and the Government of South Africa. It sets out the working group’s shared vision for equitable access to novel TB vaccines and will advance a shared understanding of the current lands...cape and its possible evolution in the future. It identifies six urgently needed solutions to accelerate access and financing and highlights the roles of different stakeholders to support the implementation of these solutions.
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The report aims to capture lessons from the COVID-19 pandemic and to highlight the opportunity for more ambitious global action: expanding sustainable access to vaccines for all towards the Immunization Agenda 2030 and pandemic prevention, preparedness and response efforts. The report is organized i...n two sections: the first section provides WHO insights on global vaccine market dynamics, drawing from data provided by Member States, which are, in turn, analysed and displayed in the second section.
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The Human Resources for Health policy (HRH) will provide guidelines and the direction toward strengthening the planning, management, utilization and monitoring of health sector human resources; not forgetting responses to the contemporary challenges and developments in the sector including the mobil...ity and motivation of human resources; and advancements in technology.
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