Technical specifications series for submission to WHO prequalification: diagnostic assessment;TSS-3
DPDx Laboratory Identification of Parasites of Public Health Concerns
Including Life cycle
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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The ongoing global pandemic of SARS-CoV-2 (Covid-19) poses unique diagnostic and clinical management challenges in regions where seasonal epidemic-prone diseases are endemic. Diseases such as dengue, malaria, seasonal influenza, leptospirosis, chikungunya, scrub typhus and bacterial infections often... present with febrile syndromes that mimic or co-exist with SARS-CoV-2 infection, complicating diagnosis and treatment. This document provides guidelines for preventing, diagnosing and managing such co-infections. A high level of suspicion is essential during the monsoon and post-monsoon seasons, taking into account region-specific disease prevalence. While the WHO's case definition for SARS-CoV-2 is broad and sensitive, the need for parallel testing for co-infections, in accordance with the protocols of the MoHFW, ICMR, NVBDCP and NCDC, is necessitated by overlapping clinical features. Ensuring the availability of reliable rapid diagnostic kits and applying integrated clinical and laboratory approaches are crucial to improving patient outcomes in the context of concurrent infections.
Accessed on 26/08/2025.
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The poster is a public health communication tool designed to prevent the transmission of diseases such as chikungunya, dengue and Zika. The poster emphasises that Aedes mosquitoes bite aggressively during the day and sometimes at night, and recommends the key prevention strategies.
Accessed on 27.../08/2025.
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The eEML is a comprehensive, freely accessible online database containing information on essential medicine
This document provides an overview of malaria rapid diagnostic tests (RDTs) for Principal Recipients (PRs) of Global Fund grants, indicating their eligibility for procurement under the Global Fund's Quality Assurance Policy. The included products have been assessed and approved by the WHO Prequalifi...cation of Diagnostics Programme (WHO PQ), the relevant regulatory authorities of the GHTF founding members or the Global Fund Expert Review Panel for Diagnostics (ERPD). Updates are made based on new evidence and regulatory assessments.
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This operational guide addresses important infection prevention and control (IPC) measures that should be implemented during a diphtheria outbreak and primarily addresses respiratory Corynebacterium diphtheriae (C. diphtheria).
The Virtual cGMP Training Marathon for Vaccine Manufacturing: Principles into Practice took place from 12 Sep to 10 Oct 2023 to continue to provide manufacturers & regulators with a comprehensive array of topics to build understanding of current WHO & international GMP standards, technological advan...cements, industry practices and regulatory expectations specific to the vaccine manufacturing context. Some of the topics include computer system validation, data integrity, challenges in lyophilization and others. Real world examples and case studies will be used to show how to interpret current and recently new good manufacturing practices requirements from a practical point of view and to implement appropriate approaches.
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This document provides detailed guidance on laboratory testing for suspected diphtheria cases during significant outbreaks or in low-resource settings. It aims to supplement and build on other existing WHO guidance documents on surveillance standards, diagnostics and research on Corynebacterium by p...roviding key considerations for laboratories that allow the rationalization and optimization of testing during outbreaks. The recommendations given here have been prepared by WHO in consultation with, and reviewed by, global experts with experience in laboratory analysis of Corynebacterium species and in outbreak settings, or with expertise in developing new technologies for diphtheria research and diagnosis. Unless otherwise stated, the considerations provided apply to diphtheria outbreaks caused by toxin-producing C. diphtheriae with a classical respiratory diphtheria presentation.
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Anaemia is a global public health concern, especially afflicting adolescent girls, women 15–49 years of age, pregnant women, and children in low- and middle-income countries. WHO estimates that in 2019 30% (571 million) of women aged 15–49 years, 37% (32 million) of pregnant women, and 40% (269 ...million) of children 6–59 months of age were affected by anaemia, with the WHO African Region and South-East Asia
Region being most affected(
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En esta nota técnica se explican los 20 aspectos que deben considerarse para evaluar el estado y la seguridad del equipo y los suministros de laboratorio. No se incluyen en este trabajo las instrucciones para los evaluadores de los puntos 93 (Estado y seguridad del equipo médico en las salas de op...eraciones y salas de recuperación) y 94 (Estado y seguridad del equipo de radiología e imagenología), que también forman parte del índice de seguridad hospitalaria.
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Antimicrobial resistance (AMR) and malaria remain significant public health challenges in the WHO Eastern Mediterranean Region (EMR). In 2021, the region reported 1.7 million sepsis-related deaths, with 373,000 associated with bacterial AMR. High antibiotic consumption, particularly in high-income c...ountries, combined with rising usage in middle-income countries, has accelerated the emergence of drug-resistant infections. Malaria management is further complicated by biological threats, including vector insecticide resistance, PFHRP2/3 gene deletions, and antimalarial drug resistance, alongside insufficient trained personnel and limited molecular surveillance capacity. Effective strategies to address these challenges include strengthening regional and cross-border surveillance networks, designating WHO collaborating centers for molecular monitoring, enforcing national treatment policies, and raising public and healthcare provider awareness about rational antimalarial and antibiotic use. These measures, coupled with sustainable funding and enhanced therapeutic efficacy studies, are essential to reduce the development and spread of drug-resistant malaria and improve overall health outcomes in the EMR.
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The Africa Centres for Disease Control and Prevention (Africa CDC) Biosafety and Biosecurity Initiative was launched by the Africa CDC in April 2019 with the aim of strengthening the African Union (AU) Member States’ biosafety and biosecurity systems and enabling them to comply with national and i...nternational requirements for biosafety and biosecurity including the International Health Regulations (IHR) (2005), the Biological Weapons Convention (BWC), and United Nations Security Council Resolution (UNSCR) 1540 and the multi-country Global Health Security Agenda (GHSA). The World Health Organization (WHO) Joint External Evaluation (JEE) and the Global Health Security Index report confirmed the known capacity gaps in biosafety and biosecurity among Africa Union Member (AU).
The regional consultations by Africa CDC conducted between 2019-2021 highlighted the deficiency or limited availability of standardized and regionally recognized training programs in the continent, limiting biosafety and biosecurity capacity building efforts in the region. In response, Africa CDC working with AU Member States developed a home grown, implementable and accessible professional training and certification program that is both recognized and endorsed by AU Member States. The Regional Training and Certification Program for Biosafety and Biosecurity Professionals, for African Biosafety and Biosecurity Professionals (RTCP-BBP) has four (4) areas of specialization, namely
Selection, Installation, Maintenance and Certification of Biological Safety Cabinets
Biorisk Management
Design and Maintenance of Facilities Handling High Risk Pathogens (Biocontainment Engineering)
Biological Waste management
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The Assessment package has been developed for countries to evaluate the implementation of the WHO Standards for prosthetics and orthotics. It enables identification of areas in need of strengthening and facilitates relevant planning. The complete Assessment package consists of four components: Asses...sment guide: gives directions on how to organize and implement the assessment. Assessment tool: Excel instrument used to carry out assessments and record results.
User manual: explains how the Assessment tool should be used.
Planning document: Excel file into which the recommendations that are generated by the Assessment tool can be pasted for easy use in subsequent planning.
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The Africa Centres for Disease Control and Prevention (Africa CDC) Biosafety and Biosecurity Initiative was launched by the Africa CDC in April 2019 with the aim of strengthening the African Union (AU) Member States’ biosafety and biosecurity systems and enabling them to comply with national and i...nternational requirements for biosafety and biosecurity including the International Health Regulations (IHR) (2005), the Biological Weapons Convention (BWC), and United Nations Security Council Resolution (UNSCR) 1540 and the multi-country Global Health Security Agenda (GHSA). The World Health Organization (WHO) Joint External Evaluation (JEE) and the Global Health Security Index report confirmed the known capacity gaps in biosafety and biosecurity among Africa Union Member (AU).
The regional consultations by Africa CDC conducted between 2019-2021 highlighted the deficiency or limited availability of standardized and regionally recognized training programs in the continent, limiting biosafety and biosecurity capacity building efforts in the region. In response, Africa CDC working with AU Member States developed a home grown, implementable and accessible professional training and certification program that is both recognized and endorsed by AU Member States. The Regional Training and Certification Program for Biosafety and Biosecurity Professionals, for African Biosafety and Biosecurity Professionals (RTCP-BBP) has four (4) areas of specialization, namely
- Selection, Installation, Maintenance and Certification of Biological Safety Cabinets
- Biorisk Management
- Design and Maintenance of Facilities Handling High Risk Pathogens (Biocontainment Engineering)
- Biological Waste management
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Malaria is an infection caused by Plasmodium species endemic to most parts of Africa, South America, East Asia, and parts of Europe and the Middle East. At least 10 to 30 thousand of the 125 million travelers to these areas are infected each year. All visitors to endemic areas should receive counsel...ing on malaria risk, mosquito bite avoidance, and tailored chemoprophylaxis based on their medical histories and travel plans. This activity reviews the evaluation and management of chemoprophylaxis of malaria and highlights the role of the healthcare team in improving care for patients with potential exposure to this condition.
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