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 their performance in a standardized way to distingu...ish between well and poorly performing tests.
These results constitute the laboratory evaluation component of the WHO prequalification process for malaria RDTs and inform the current WHO procurement recommendations. In round 8, 35 RDTs from 17 manufacturers were assessed. For the first time the evaluation included an assessment of product performance against a panel of P. falciparum parasites with pfhrp2/3 gene deletions and therefore not expressing HRP2.
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Timely detection of novel coronavirus (2019-nCoV) infection cases is crucial to interrupt the spread of this virus. We assessed the required expertise and capacity for molecular detection of 2019-nCoV in specialised laboratories in 30 European Union/European Economic Area (EU/EEA) countries. Thirty-...eight laboratories in 24 EU/EEA countries had diagnostic tests available by 29 January 2020. A coverage of all EU/EEA countries was expected by mid-February. Availability of primers/probes, positive controls and personnel were main implementation barriers.
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The Practical manual on laboratory strengthening, 2022 update provides practical guidance on implementation of WHO recommendations and best practices for TB laboratory strengthening. It is an updated version of the GLI Practical Guide to Laboratory Strengthening published in 2017 and provides the la...test practical guidance on use of newly recommended diagnostics as well as guidance in key technical areas, including quality assurance and quality management systems, specimen collection and registration, procurement and supply-chain management, diagnostic connectivity, biosafety, data management, human resources, strategic planning, and model algorithms. The key changes are:
inclusion of recent or updated WHO recommendations for tests to diagnose TB and detect drug resistance;
alignment with the latest WHO critical concentrations for phenotypic drug-susceptibility testing (DST) and the new definitions of pre-XDR-TB and XDR-TB;
updated information on building quality-assured TB testing and management capacity using the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) approach (Score-TB package1);
updated information on assessing, analysing and optimising TB diagnostic networks; and
updated information on the use of next-generation sequencing (NGS) to detect mutations associated with drug resistance for surveillance purposes.
The document also provides references to resources and tools relevant for work on laboratory strengthening.
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On 13 August 2024, Africa Centres for Disease Control and Prevention (Africa CDC) declared the ongoing Mpox outbreak a Public Health Emergency of Continental Security (PHECS). This was followed the next day by the World Health Organization (WHO), which extended the alert internationally as a public ...health emergency of international concern (PHEIC). After these declarations, many countries have made efforts to mobilize resources to introduce or expand laboratory testing, surveillance, and response activities. In particular, as the number of suspected cases surges in the Democratic Republic of Congo (DRC), Burundi, and the Central African Republic, and an increasing number of new countries report cases, there is an urgent need to implement testing to strengthen the Mpox response. However, access to appropriate quality assured diagnostics is a challenge. There is limited information on important characteristics, such as available test kits’ performance and ability to detect relevant clades.
To address the challenge of mpox access in the continent, the Africa CDC Diagnostic Advisory Committee (DAC) met in Kigali from 19-23 August 2024 to review the available evidence on molecular tests for Mpox and to shortlist tests that may be useful for Mpox testing in countries. The shortlist aims to provide guidance to Africa CDC, countries and partners on appropriate high-quality molecular tests to procure and use for the mpox response.
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The Interim Guidance on Cholera Rapid Diagnostic Tests (RDTs) by the Global Task Force on Cholera Control (GTFCC) provides recommendations for using RDTs to detect cholera in areas with limited laboratory capacity. It highlights the advantages of RDTs, such as rapid detection (within 30 minutes), ea...se of use by non-laboratory personnel, and their role in early outbreak identification and surveillance. However, it emphasizes that RDTs should not replace culture or PCR testing, as they vary in sensitivity (58-100%) and specificity (60-100%). The document advises on proper test selection, storage, training, and integration into national surveillance systems to enhance cholera response efforts.
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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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based on the WHO Bench Aids for the diagnosis of intestinal parasites;
Tutor’s Guide: perform specific laboratory techniques; identify intestinal parasites by genus and species; quantify helminth eggs in faeces by Kato-Katz procedure.
- The goal of diagnostic testing for Ebola and Marburg virus diseases is to identify cases to provide timely and appropriate care and to stop disease transmission.
- All individuals meeting the case definition for Ebola or Marburg virus diseases should be tested.
- The recommended sample type ...for testing for orthoebolaviruses and orthomarburgviruses is whole blood or plasma for living patients, and oral swab for deceased individuals.
- Laboratory confirmation of Orthoebolavirus and Orthomarburgvirus infections and further species identification should be done using nucleic acid amplification testing (NAAT).
- If a suspected case tests negative (living patient) and the blood was drawn less than 72 hours after symptom onset, a second test should be performed with blood drawn more than 72 hours after symptom onset.
- All manipulations in laboratory settings of samples originating from suspected, probable or confirmed cases of Ebola and Marburg virus diseases should be conducted with appropriate biosafety measures according to a risk-based approach.
- Whole or partial genome sequencing can be used to characterize viruses and complement epidemiologic investigations.
- Member States are strongly encouraged to share genetic sequence data (GSD) in publicly accessible databases.
- Member States are required to immediately notify the World Health Organization (WHO) under the International Health Regulations (IHR) 2005 of positive laboratory results.
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The latest update (28 January 2021) includes the following addition and revision:
biosafety aspects for working with antigen-detecting rapid diagnostic test;
handling new variants of SARS-CoV-2 in the laboratory;
updated assay decontamination before disposal;
personal protectiv...e equipment (PPE) for specimen collection;
addressing chemical hazards and their safe disposal; and
the fourth edition of the WHO Laboratory Biosafety Manual (LBM4) is now available and the terminology in this guidance was aligned with the LBM4.
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The present DHR-ICMR guidelines comprehensively address the various concerns regarding the clinical assessment, treatment, and laboratory diagnosis of rickettsial diseases in India and the world. It is hoped that physicians, health care workers, the scientific community, the regulatory agencies, pub...lic health care professionals and the public at large will be benefited by these guidelines.
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Guidelines for Good Clinical Laboratory Practices (GCLP) outlines the principles and procedures to be followed by medical laboratories involved in clinical research and/or patient care so as to provide quality data which can be used for health research and patient treatment. As the use of laboratory... tests (often expensive) are increasingly becoming a part of medical diagnosis and research, generation of quality data would be a cost-effective and ethically sound strategy.
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The latest update (28 January 2021) includes the following addition and revision:
biosafety aspects for working with antigen-detecting rapid diagnostic test;
handling new variants of SARS-CoV-2 in the laboratory;
updated assay decontamination before disposal;
personal protectiv...e equipment (PPE) for specimen collection;
addressing chemical hazards and their safe disposal; and
the fourth edition of the WHO Laboratory Biosafety Manual (LBM4) is now available and the terminology in this guidance was aligned with the LBM4.
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The WHO Cholera Rapid Diagnostic Test (RDT) Target Product Profile outlines the key requirements for developing improved cholera RDTs. It highlights the need for fast, accurate, and easy-to-use tests for early outbreak detection in resource-limited settings. The document sets desired and acceptable ...performance criteria, including high sensitivity and specificity, rapid results (under 15 minutes), and usability by non-laboratory personnel. The tests should be affordable, stable in extreme conditions, and require minimal training. The goal is to enhance cholera surveillance and outbreak response, ensuring quick containment and improved public health outcomes.
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Outline
• Welcome and objectives
• Microbiology, epidemiology and clinical presentation
• Surveillance for imported cases including case definitions
• Laboratory diagnosis • Infection prevention and hospital readiness
• Patient flow and actions required at each step
• Co-ord...inating a public health response
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It is Zika virus (ZIKV) that most often causes these neurological effects it appears to be the only arbovirus than can cause congenital malformations such as microcephaly. In any case, more scientific tests are needed to establish the causal relationship between the virus and this malformation (7-10...).
This document is a practical tool designed to help health workers improve clinical diagnosis and provide timely care for patients infected
with the dengue, chikungunya, or Zika virus. It is intended mainly for
health workers in primary care facilities where laboratory diagnosis of
arboviruses is not always available. However, this guide may also be
very useful in hospitals that provide second- and third-level care, as it
describes the clinical manifestations of each of the three most important
arboviral diseases currently found in the Region, the elements for
differential diagnosis, and their clinical behavior.
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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...rdles of transferring laboratory research into real-world technological implementations and the future possibilities for detecting devices for viral diagnosis are highlighted in this study.
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Prequalification of Male Circumcision Devices
PQMC_007 v1 16 December 2011
The modules (1-12) are based on materials originally developed by FIND, KNCV and Cepheid, and are in PowerPoint format for country customization. Depending on the audience, modules may be selected and adapted according to need (e.g. basic users, supervisors, clinicians). Topics covered include: Over...view of TB and diagnostics, biosafety, specimen collection, procurement, installation, Xpert MTB/RIF technology, results interpretation, reporting, troubleshooting, maintenance, a clinical guide, and quality assurance.
Please download each manual directliy from the website
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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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The modules (1-12) are based on materials originally developed by FIND, KNCV and Cepheid, and are in PowerPoint format for country customization. Depending on the audience, modules may be selected and adapted according to need (e.g. basic users, supervisors, clinicians). Topics covered include: Over...view of TB and diagnostics, biosafety, specimen collection, procurement, installation, Xpert MTB/RIF technology, results interpretation, reporting, troubleshooting, maintenance, a clinical guide, and quality assurance.
Please download each manual directliy from the website
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