The occurrence of a high percentage of couterfeit medicines on the global medicines market is often attributed to a lack of effective regulation and a weak enforcement capacity. This review, while focusing on counterfeit medicines
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and medical devices in developing countries, will present information on their impact and how these issues can be addressed by regulation and control of the supply chain using technology appropriate to the developing world.
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Executive summary On 27th and 28th April 2021, the division of Disease Control and Prevention in collaboration with Public Health England, organized a virtual consultative meeting as part of the con
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sultations with Member States and partners for the development of the Africa CDC five years strategic plan for the prevention and control of Non-communicable Diseases … Report: Expert and stakeholder virtual consultation meeting to develop the Africa CDC Non-Communicable Diseases and Mental Health Strategy
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treat TB
Description of Research Outputs, 2009 - 2014
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)
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for malaria. It provides a comparative measure of their performance in a standardized way to distinguish 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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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
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analysis to identify gaps and evaluated current and nascent HAT diagnostics that may provide solutions.
We conducted literature reviews and interviews with key stakeholders to identify use cases for HAT diagnostics, understand current practices, and analyze progress toward more robust diagnostics across
different biomarkers.
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A technical guide for sputum smear microscopy, initiated by the International Union against Tuberculosis, is designed to be an easy to use reference standard for the collection, storage and transport of sputum specimens
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and for the examination of sputum smears by direct microscopy. This edition includes updates addressing bio-safety and quality assurance aspects of sputum smear microscopy.
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These Guidelines on prudent use of antimicrobials in human health are based on a technical report prepared by the European Centre for Disease Prevention and Control (ECDC) with input from EU Member States experts
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and stakeholders, which should be referred to for details of the methodology used in creating the guidelines as well as for additional references
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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:
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Identify use cases and understand current diagnostic practices and tools associated with each use case.
- Analyze progress toward robust diagnostics for HAT across different biomarkers.
- Develop recommendations for steps to improve the availability, access, and adoption of HAT diagnostic tools.
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The portable diagnostic imaging technology covered by this document will serve not only the pressing demands for tuberculosis screening and triage but also other diseases. Therefore, the requirement
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s, accessories, hardware and software packages listed in the following specifications are described in detail in order to serve also other pathologies and conditions, like trauma and pneumonia.
Through the definition of "minimum technical requirements", this document is recommended to support decision-making regarding the selection, incorporation, allocation and use of portable X-ray systems and is intended for health care providers, managers of imaging departments, procurement and regulatory agencies, policymakers and planning officers in ministries of health, as well as biomedical engineering professionals, medical physicists, the private health sector, medical device industry and intergovernmental and international agencies.
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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
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laboratory services and TB, HIV, and hepatitis programme managers.
It may also be of interest 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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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
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and less expensive method to test for SARS-CoV-2 than the reference method, nucleic acid amplification tests (NAATs). This interim guidance offers recommendations on the priority uses of antigen-detecting rapid diagnostic tests (Ag-RDTs) in specific populations and settings, including (i) for primary case detection in symptomatic individuals suspected to be infected and asymptomatic individuals at high risk of COVID-19, (ii) for contact tracing, (iii) during outbreak investigations and (iv) to monitor trends of disease incidence in communities. Ag-RDTs meeting minimum performance requirements can be used outside of clinical and laboratory settings, including in communities, by trained operators in accordance with instructions. The guidance additionally provides recommendations on implementation, product selection and storage.
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Following review of evidence and advice from the Technical Advisory Group (TAG) on Tuberculosis (TB) Diagnostics and
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Laboratory Strengthening, the World Health Organization (WHO) announces that current WHO recommendations for the use of interferon-gamma release assays (IGRA) are also valid for Beijing Wantai’s TB-IGRA and Qiagen QuantiFERON-TB Gold Plus products. This expands the range of tests available to detect TB infection. Full details are provided in this WHO policy statement.
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BMC Medicine201614:112 DOI: 10.1186/s12916-016-0660-0
Lancet Glob Health 2021 Published Online December 13, 2021 https://doi.org/10.1016/S2214-109X(21)00463-
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 ea
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sy to use. The tests are packed individually and are stable at 40°C for
up to 25 months; they are performed on fresh blood obtained from a finger prick, and no instrument or electricity is required. The RDT detects host antibodies to infection in populations that are at risk, or in suspect individuals. Positive cases are subjected to further confirmatory methods to identify HAT patients.
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Despite the development of point-of-care diagnostic tests for syphilis, chlamydia, gonorrhoea, and trichomoniasis, none comply with all WHO criteria. This analysis overviews landscape analyses of point-of-care diagnostic technologies for Chlamydia t
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rachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and syphilis, available and in the pipeline. The target audience for the target product profiles is broad and includes clinicians, researchers working on diagnostics, laboratory experts, including, microbiologists and virologists, public health experts, epidemiologists, developers, and representatives for manufactures, including biotech engineers, policy-and decision-makers as well as representatives from regulatory bodies and agencies, donor agencies and international organizations.
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Zika and dengue viruses remain significant public health threats. These viruses share the same Aedes (Stegomyia) mosquito vectors and geographic distributions but infections cannot be readily distin
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guished clinically and need to be differentiated from each other, and from other circulating arboviral and non-arboviral pathogens, using laboratory tests. This document provides guidance on current testing strategies for Zika and dengue virus infections with updates to the previous interim guidance for laboratory testing for ZIKV, addressing pregnant and non-pregnant patients respectively, and incorporates current guidance for dengue virus diagnostic testing. The choice of laboratory assays and interpretation of test results require careful consideration of epidemiology, patient history, and limitations of existing diagnostic tests.
This interim guidance is for use by staff of laboratories testing for Zika and dengue virus infections and for clinical practitioners and public health professionals providing clinical management or surveillance.
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