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Laboratory diagnosis of Buruli ulcer

Portaels, F- World Health Organization WHO (2014) C_WHO
A manual for health care providers. This manual provides expert guidance on the laboratory techniques and procedures used in the diagnosis of Buruli ulcer, a disease caused by Mycobacterium ulcerans. Aimed at ... more
Accessed 07 July 2014
Accessed at 7 July 2014
Accessed on 7 July 2014
Accessed on 7 July 2014
4th edition The WHO Laboratory Biosafety Manual (LBM) has been in broad use at all levels of clinical and public health laboratories, and other biomedical sectors globally, serving as a de facto global standard that presents best practices and sets ... more
2nd edition
Mem Inst Oswaldo Cruz . 2021 Jan 29;115:e200287. doi: 10.1590/0074-02760200287. eCollection 2021. Sensitivity and negative predictive value were directly affected by sample storage conditions. RT-PCR and virus isolation showed greater dependence on well-conserved samples for an accurate diagnosis
Due to the anticipated significant rise in VL testing occasioned by Ghana’s adaptation of 2016 ART guidelines, it has become necessary to develop this VL scale-up and operational plan to assure complete client access to laboratory monitoring towar ... more
This document provides up-to-date guidance on laboratory studies as well as smallscale (semi-field) and large-scale field trials to assess the efficacy and determine field application rates of new molluscicide products for control of schistosomia ... more
Dengue is a significant public health problem. There are four dengue virus serotypes identified; however, its diagnosis is difficult due to the existence of many viruses, bacteria, and parasites producing the same clinical presentation, being present in the same geographical area and even producing ... more
Training laboratory managers, senior biologists, and technologists in quality management systems is a step towards obtaining international recognition; it is a step that all countries should take. This training toolkit is intended to provide compreh ... more
This document aims to present an algorithm for deciding whom to test and provide guidance on the laboratory tests for Zika virus infection diagnosis in order to support clinical diagnostic and case reporting through surveillance among EU Member Stat ... more
The National Guidelines for HIV-1 Viral Load Laboratory Testing support plans to scale up viral load (VL) testing to reach the 90-90-90 targets in India. This phased scale-up includes the setup of 70 additional VL testing laboratories nationally. Th ... more
Given the current situation of the COVID-19 pandemic, countries are advised to continue adopting the TB diagnostic algorithms recommended by PAHO / WHO. Despite the differences in the modes of transmission of TB and COVID-19, certain personal protection measures are relevant for both diseases. Rout ... more
Senegal has adopted the World Health Organization–Joint United Nations Programme on HIV/AIDS recommended 90-90-90 targets.5 The adoption of this strategy means that the country is expected, by 2020, to have 90% of its population living with HIV diagnosed, 90% of all those diagnosed receiving susta ... more
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 ... more
This algorithm is addressed to laboratories with established capacity(molecular, antigenic and/orserological) to detect dengue (DENV), Zika (ZIKV), and chikungunya(CHIKV) as part of the differential diagnosis for arborviruses. A BSL2 containment level is required to handle suspected samples.

Module de formation sur XPERT MTB/RIF

USAID; WHO; FIND; et al. global laboratory initiative (2017) C_WHO
In 2013, WHO and the Foundation for Innovative New Diagnostics convened a meeting of Buruli ulcer experts in Geneva, Switzerland (9) at which two priority unmet needs in diagnosis were identified: a diagnostic test for early detection of Buruli ulc ... more
FIND and Standard Diagnostics (SD) have developed a lateral flow rapid diagnostic test (RDT) to screen for T.b. gambiense HAT that is cheap and easy to use. The tests are packed individually and are stable at 40°C for up to 25 months; they are pe ... more
FIND conducted independent evaluations at the University Hospitals of Geneva (HUG), to verify the limit of detection (LOD) and the clinical performance (as reported by the manufacturers) of the following molecular test kits. The LOD analysis was performed using cultured viral stocks from a clinical ... more

Novel point-of-care tools for early infant diagnosis of HIV

World Health Organization (2017) C_WHO
HIV Diagnostics Information Note WHO/HIV/2017.16
Laboratory monitoring & evaluation tool Xpert Pre-installation Checklist Accessed December 2017
African Journal of Laboratory Medicine | Vol 7, No 2 | a770 | 06 December 2018
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 mee ... more
In 2009, WHO’s Second International Conference on Buruli Ulcer Control and Research resolved to strengthen the capacity of national laboratories to confirm cases of the disease, but advised that “efforts are still needed to develop simple diagnostic tools usable in the field as well as disabilit ... more
Interim guidance, 6 October 2021 Direct detection of SARS-CoV-2 viral proteins (antigens) in nasal swabs and other respiratory secretions using lateral flow immunoassays (also known as rapid diagnostic tests, RDTs) offers a faster and less expensive method to test for SARS-CoV-2 than the reference ... more
Technical Report AIDS Medicines and diagnostics service July 2015
Molecular methods for antimicrobial resistance (AMR)diagnostics to enhance the Global Antimicrobial Resistance Surveillance System
Drugs, Diagnostics, Vaccines, Preventive Technologies, Research toward a cure, and immune-based and gene therapies in development
The strategy focuses on mobilizing and coordinating partners, experts and resources to help countries enhance surveillance of the Zika virus and disorders that could be linked to it, improve vector control, effectively communicate risks, guidance and protection measures, provide medical care to thos ... more
23 March 2021 The meeting addressed the last key area, that is, determining the best method or combination of diagnostic methods for a control programme for S. stercoralis infections in humans. Dr Montresor’s presentation highlighted that while there is currently no “gold standard” for the ... more
This document describes the key areas that national governments should consider for the introduction and scale-up of point-of-care (POC) diagnostics within national programmes, as new innovative POC technologies are being introduced into the market. ... more
The development of this target product profile (TPP) was led by the WHO Department of Control of Neglected Tropical Diseases (NTD) following standard WHO guidance for TPP development. In order to identify and prioritize diagnostic needs, a WHO NTD Diagnost ... 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 ... more

WHO Expert Consultation on Rabies. 3rd report

Abela-Ridder, B. World Health Organisation (WHO) (2018) C_WHO
WHO TRS N°1012. Key updates include: (i) surveillance strategies, including cross-sectoral linking of systems and suitable diagnostics; (ii) the latest recommendations on human and animal immunization; (iii) palliative care in lowresource setting ... more
HIV-1 drug resistance (HIVDR) genotyping is an essential component of the WHO global HIVDR surveillance strategy. Plasma “gold standard” specimen type for HIVDR genotyping, but its use may not be feasible in rural, remote areas in low- and middle-income countries, since preparing and storing it ... 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 ... more
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 ... more
Meeting Report 27-29 October 2020 The overall goal of the meeting was to discuss recent changes in treatment regimens and diagnostics for drug-resistant TB and to determine how these impact on the definition of XDR-TB, with a view to revising this ... more
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 ... more
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 ... more
This report, published in conjunction with a summary overview of results of rounds 1–8, is the eighth and final report in a series of laboratory-based evaluations of rapid diagnostic tests (RDTs) for malaria. It provides a comparative measure of ... more
This is a case-ascertained prospective investigation of all identified health care contacts working in a health care facility in which a laboratory confirmed 2019-nCoV infected patient (see 2.2 Study population) receives care. Note that this study c ... more
The household transmission investigation is a case-ascertained prospective study of all identified household contacts of a laboratory confirmed 2019-nCoV infection (see 2.2 Study population). It is intended to provide rapid and early information on ... more
ASLM in collaboration with the Africa Centres for Disease Control and Prevention, and in partnership with the Clinton Health Access Initiative, Amref and Last Mile Health present the Quality Assurance Framework for SARS-CoV-2 Antigen Rapid Testing for Diagnosis of COVID-19. This framework aims to pr ... more
WHO has a unique combination of technical public health and scientific expertise, and a global operational footprint, with field offices in more than 150 countries. In 2020, this global, technical, and operational reach meant WHO was able to support countries around the world in every aspect of COVI ... more
This document aims to provide interim guidance for microbiology and virology experts, other laboratory professionals, laboratory managers, infectious disease programme managers, public health profes ... more
In support of the London Declaration goals, PATH aims to catalyze engagement of the diagnostics industry and product development efforts. As part of this work, PATH conducted a diagnostic landscape analysis to identify gaps and evaluated current and ... more
Self-care interventions are evidence-based, quality drugs, devices, diagnostics and/or digital products which can be provided fully or partially outside of formal health services and can be used with or without the direct supervision of health care ... more
Monkeypox is an emerging viral zoonosis with symptoms similar to those observed in smallpox patients, although less severe. Since the global eradication of smallpox in 1980, monkeypox has emerged as the most important orthopoxvirus in humans. The Advisory Committee on Variola Virus Research (ACVVR) ... more
A survey was conducted in countries in all six WHO regions and focused on the building blocks that are considered prerequisites to combat antimicrobial resistance: a comprehensive national plan, laboratory capacity to undertake surveillance for resi ... more
This report investigates the impact of potential misclassification of samples on HIV prevalence estimates for 23 surveys conducted from 2010-2014. In addition to visual inspection of laboratory results, we examined how accounting for potential miscl ... more
The two-year impact report for the Access to COVID-19 Tools (ACT) Accelerator details impact, case studies and timelines of key milestones for the Diagnostics, Therapeutics and Vaccines pillars, as well as the Health Systems and Response Connector.
Annual and medium-term budget preparation processes are the platforms through which specific plans are transformed into actual resource allocation decisions. The aim of this Process Guide is to support key stakeholders involved in these processes (such as the Cabinet, Ministries of Finance and Healt ... more
ASLM in collaboration with the Africa Centres for Disease Control and Prevention, and in partnership with the Clinton Health Access Initiative, Amref and Last Mile Health present the Quality Assurance Framework for SARS-CoV-2 Antigen Rapid Testing for Diagnosis of COVID-19. This framework aims to pr ... more
Communication to Healthcare Professionals Mar-2020 This guideline is intended to assist healthcare professionals in the participation of very important process of continuous surveillance of safety and efficacy of the health products which are used in their clinical practice. Continuous evaluation o ... more
The development of this target product profile (TPP) was led by the WHO Department of Control of Ne- glected Tropical Diseases (NTD) following standard WHO guidance for TPP development. In order to identify and prioritize diagnostic needs, a WHO NTD Diag ... more
Lateral-flow rapid diagnostic tests (RDTs) continue to play a vital role in global health in the management and diagnosis of infectious diseases, including malaria, HIV and COVID-19. Visually interpreted RDTs, more than any other class of diagnostics ... more
Six months after its launch on 24 April, the Access to COVID-19 Tools (ACT) Accelerator has already delivered concrete results in speeding up the development of new therapeutics, diagnostics, and vaccines. Now mid-way through the scale-up phase, the ... more
Hepatitis B (HBV) infection is a major public health problem and cause of chronic liver disease. The 2024 HBV guidelines provide updated evidence-informed recommendations on key priority topics. These include expanded and simplified treatment criteria for adults but now also for adolescents; expa ... more
Medical devices are used for the prevention, diagnosis and treatment of illness and diseases and for rehabilitation. WHO developed guidance on medical device donation in 2011, which has been now reviewed, with new evidence, new references on considerations for medical device solicitation and provisi ... more
The USAID | DELIVER PROJECT, Task Order 4, developed this guide for quantifying health commodities; it will assist technical advisors, program managers, warehouse managers, procurement officers, and service providers in (1) estimating the total commodity needs and costs for successful implementation ... more
The overall goal of the programme, to reduce the malaria morbidity and mortality by 75% (using 2012 as baseline) by the year 2020, continued to be pursued in 2014. The following areas were identified as some of the priorities for the year: Malaria Case Management under which we have Malaria in Pregn ... more
The intent of these guidelines is to develop a holistic, coordinated, proactive and technology driven strategy for management of biological disasters through a culture of prevention, mitigation and preparedness to generate a prompt and effective response in the event of an emergency. Th ... more
The goal of this Global Action Plan is to articulate synergistic actions that will be required to prevent HIVDR from undermining efforts to achieve global targets on health and HIV, and to provide the most effective treatment to all people living with HIV including adults, key populations, pregnant ... more
This National Action Plan addresses actions needed to be taken in order to combat antimicrobial resistance (AMR) in the country. It is obligatory to raise awareness of antimicrobial resistance and promote behavioral change through public communication programmes that targets human, animal and plant ... more
Supply of essential medicines and health technologies (6 April 2020) This paper is one of a set of technical guidance papers developed by the WHO Regional Office for Europe to provide practical information and resources for decision-makers on measures to strengthen the health system response to C ... more
First published in 2020, this toolkit is intended for clinicians working in acute care, managing adult and paediatric patients with acute respiratory infection, including severe pneumonia, acute respiratory distress syndrome, sepsis and septic shock. The main objective is to provide key tools for us ... more
Interim guidance. 12 May 2021. The Continuity of essential health services: Facility Assessment Tool can be used by countries to rapidly assess the capacity of health facilities to maintain the provision of essential health services during the COVID-19 pandemic. It can help to alert the authorities ... more
This technical guidance aims to provide guidelines to laboratories and relevant stakeholders in the European Union (EU), European Economic Area (EEA) and other countries in the WHO European region in making decisions on establishing sequencing capacities and capabilities, in making decisions on whic ... more
n light of the potential risk posed by SARS-CoV-2 variants, in January 2021 WHO organized an ad hoc consultation to discuss the development of an R&D agenda in response to existing and emerging SARS-CoV-2 variants. The key objectives were to identify the critical research questions related to var ... more
To guide One Health capacity building efforts in the Republic of Guinea in the wake of the 2014–2016 Ebola virus disease (EVD) outbreak, we sought to identify and assess the existing systems and structures for zoonotic disease detection and control. We partnered with the government ministries resp ... more
This analysis focused on the chronic form of HAT caused by T. b. gambiense, as it contributes to the majority of disease burden. Information from the literature review, product development landscape, and stakeholder interviews was compiled to: - Identify use cases and understand current diagnosti ... more
This brief update on tuberculosis (TB) in the African region covers the state of TB in the WHO African region, strategic priorities and targets and the impact of COVID-19 on essential services. This is followed by key figures for the region, the role of WHO in country support and, recognizing the im ... more
Under-diagnosis of asthma in ‘under-fives’ may be alleviated by improved inquiry into disease history. We assessed a questionnaire-based screening tool for asthma among 614 ‘under-fives’ with severe respiratory illness in Uganda. The questionnaire responses were compared to post hoc consensu ... more
This publication is based on the list of clinical interventions selected from clinical guidelines on prevention, screening, diagnosis, treatment, palliative care, monitoring and end of life care. This publication addresses medical devices for six types of cancer: breast, cervical, colorectal, leukem ... more

Cancer in sub-Saharan Africa

Ngwa, W.; et al. Lancet Oncology Commission (2022) C2
Lancet Oncol 2022; 23: e251–312Published OnlineMay 9, 2022 https://doi.org/10.1016/S1470-2045(21)00720-8 In sub-Saharan Africa (SSA), urgent action is needed to curb a growing crisis in cancer incidence and mortality. Without rapid interventions, data estimates show a major increase in cancer mo ... more
When is laboratory testing for Zika Virus infection reasonable? Testing algorithm for patients with and without symptoms.
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 ... more
DPDx - Laboratory Identification of Parasites of Public Health Concern Trypanosoma cruzi, is a parasitic protozoan that is the causative agent of Chagas disease (American trypanosomiasis). Currently, six distinct lineages of T. cruzi are classified ... more
This Rapid Advice Guideline updates the Interim Guidance on the “Assessment of infants with microcephaly in the context of Zika virus” published in February 2016 (WHO/ZIKV/MOC/16.3). The recommendations provides guidance on the screening, clinical assessment, neuroimaging, ... more
Biosensors and Bioelectronics: X Volume 10, May 2022, 100100; This article provides an overview of dengue disease, the working principles, the significance of the various conventional and biosensor detection strategies, the benefits and problematic conditions of the reported methods. The present hu ... more
Every day, fake medicines and medical products are sold at street corners, in open air markets or on unregulated websites in several countries in the African Region. These poor quality, unsafe medicines and pharmaceutical products promote drug resistance and lead to loss of confidence in health prof ... more
Information and Approaches for developing Country Settings
The procurement of essential medicines and other health products is a critical function in support of the effective discharge of WHO’s mandate, and WHO values the importance of the quality of essential medicines and health products that are supplied to countries. The first World Health Assembly in ... more
The Global guidance framework for the responsible use of the life sciences: mitigating biorisks and governing dual-use research (the framework) aims to provide values and principles, tools and mechanisms to support Member States and key stakeholders to mitigate and prevent biorisks and govern dual-u ... more
2nd edition. Like the original, this second edition of the guidance aims to inform the revision of existing national guidelines and standards for managing Tuberculosis (TB), many of which include guidance on children. It includes recommendations, based on the best available evidence, for improving ... more