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3
Technical specifications series for submission to WHO prequalification: diagnostic assessment;TSS-3
Antimicrobial resistance (AMR) is a global public health crisis that resulted in 1.14 million deaths in 2021. According to the Institute for Health Metrics and Evaluation estimates, 96 416 of thes
...
e deaths occurred in the World Health Organization (WHO) Eastern Mediterranean Region. All 22 countries/territories in the Eastern Mediterranean Region are enrolled in the global AMR
surveillance system, and 17 countries/territories reported data in 2024 (for the year 2023). The total number of isolates reported to the system increased sixfold between 2017 and 2022, but the proportion of blood isolates is relatively very low. Most of the data come from public sector laboratories or hospitals, although the private sector has increased its participation in some countries/territories recently. Three pathogens account for three quarters of all the reported pathogens – Escherichia coli
(26%), Klebsiella pneumoniae (23%), and Staphylococcus aureus (22%).
more
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 summar
...
ises the minimum performance requirements, including 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.
more
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 summar
...
ises the minimum performance requirements, including 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.
more
The elimination scenario planning (ESP) manual provides malaria-endemic countries with a comprehensive framework to assess different scenarios for moving towards this goal, depending on programme coverage and funding availability. It also helps countries set realistic timelines and provides essentia
...
l knowledge for strategic planning in the long term.
more
Ethical considerations for use of unregistered interventions for Ebola viral disease
World Health Organization
(2014)
West Africa is experiencing the largest, most severe, most complex outbreak of Ebola virus disease in history. On 11 August 2014, WHO convened a consultation where the participants concluded that in the particular context of the current Ebola outbreak in West Africa, it is ethically acceptable to of
...
fer unproven interventions that have shown promising results in the laboratory and in animal models but have not yet been evaluat-
ed for safety and efficacy in humans as potential treatment or prevention
more
The WHO guidelines provide recommended steps for safe phlebotomy and reiterate accepted principles for drawing, collecting blood and transporting blood to laboratories/blood banks.
The approach is in line with two of the five objectives outlined in the Every Newborn Action Plan (ENAP): Strategic Objective 2 – Improve the quality of maternal and newborn care; and Strategic Objective 5 – Count every newborn through measurement, programme-tracking and accountability to genera
...
te data for decision-making and action.
more
Guideline ‒ Alternative mass drug administration regimens to eliminate lymphatic filariasis
recommended
Lymphatic filariasis is a vector-borne neglected tropical disease that causes damage of the lymphatic system and can lead to lymphoedema (elephantiasis) and hydrocele in infected individuals. The global baseline estimate of persons affected by lymphatic filariasis is 25 million men with hydrocele an
...
d over 15 million people with lymphoedema. At least 36 million persons remain with these chronic disease manifestations. The disease is endemic in 72 countries. In 2016, an estimated total population of 856 million were living in areas with ongoing transmission of the causative filarial parasites and requiring mass drug administration (MDA). Lymphatic filariasis disfigures and disables, and often leads to stigmatization and poverty. Hundreds of millions of dollars are lost annually due to reduced productivity of affected patients. WHO has ranked the disease as one of the world’s leading causes of permanent and long-term disability.
more
The Leprosy Programme and Transmission Assessment (LPTA) is an activity that is carried out by internal teams towards the end of Phase 1 (see Leprosy Elimination Framework in the Annex) when a subnational jurisdiction (typically second-tier) reaches the milestone for interruption of transmission, i.
...
e., zero autochthonous child cases for a consecutive period of five years. It also needs to be done at the end of Phase 2, when the second milestone of elimination of leprosy disease has been reached. An LPTA will be carried out to document that all relevant programme criteria have been met and examine trends of epidemiological indicators in such jurisdiction to confirm that the milestone has been achieved. The LPTA includes assessment of health facilities that provide leprosy services. LPTA comprises of review of epidemiological data, health facility assessment and data validation and verification of the programme criteria through observation during a field visit. The evidence collected in this way in subnational health administrative units is compiled in a Leprosy Elimination Dossier to be submitted to WHO when the country reaches the milestone for elimination of disease in the country as whole. Countries that have not detected any new leprosy cases in the past three years or more can use the LPTA at national level prior to or as part of the verification process. Countries likely to be among the first to apply for verification may have had no new cases detected for more than 10 years.
more
2nd edition.
T The Compendium has been developed as a clear and concise instrument to facilitate the understanding and planning of delivery of high-quality care for everybody affected by TB. It incorporates all recent policy guidance from WHO; follows the care pathway of persons with signs or sympt
...
oms of TB in seeking diagnosis, treatment and care; and includes key algorithms and cross-cutting elements that are essential to a patient-centered approach in the cascade of TB care.
The Compendium is structured into 33 WHO standards and consolidates all current WHO TB policy recommendations into a single resource, with electronic links to the individual, comprehensive WHO policy guidelines
more
This is the first national Policy to combat AMR in Cambodia. It was developed based on conclusions and recommendations of a country situaytion analysis.
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.
more
Driving progress towards rabies elimination: Results of Gavi’s Learning Agenda on rabies and new WHO position on rabies immunization
This checklist is an operational tool to help national authorities develop or revise national respiratory pathogen (inclusive of influenza and coronaviruses) pandemic preparedness plans.
Communicable Diseases Control in Emergencies
recommended
A field manual