Target Product Profile For Readers Of Rapid Diagnostic Tests

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Target product profile for readers of rapid diagnostic tests

World Health Organization
Target product profile for readers of rapid diagnostic tests Book PDF

Author : World Health Organization
Publisher : World Health Organization
Page : 26 pages
File Size : 43,6 Mb
Release : 2023-01-31
Category : Medical
ISBN : 9789240067172

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Target product profile for readers of rapid diagnostic tests by World Health Organization Pdf

Proof and Concepts in Rapid Diagnostic Tests and Technologies

Shailendra K. Saxena
Proof and Concepts in Rapid Diagnostic Tests and Technologies Book PDF

Author : Shailendra K. Saxena
Publisher : BoD – Books on Demand
Page : 174 pages
File Size : 47,5 Mb
Release : 2016-09-07
Category : Medical
ISBN : 9789535125808

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Proof and Concepts in Rapid Diagnostic Tests and Technologies by Shailendra K. Saxena Pdf

This book gives a comprehensive overview of the recent advancements and developments of rapid diagnostic tests (RDTs) and technologies, which are quite novel approaches and might be used as laboratory bench manual for the rapid diagnosis of the various disease conditions. The book focuses on various aspects and properties of RDTs, point-of-care tests (POCTs), quality control, assurance, calibration, safety, nano-/microfluidic technologies, and fusion with DNA technologies. I hope that this work might increase the interest in this field of research and that the readers will find it useful for their investigations, management, and clinical usage.

Target product profile for next-generation drug-susceptibility testing at peripheral centres

Anonim
Target product profile for next generation drug susceptibility testing at peripheral centres Book PDF

Author : Anonim
Publisher : World Health Organization
Page : 52 pages
File Size : 41,6 Mb
Release : 2021-08-09
Category : Medical
ISBN : 9789240032361

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Target product profile for next-generation drug-susceptibility testing at peripheral centres by Anonim Pdf

The first high-priority Target Product Profile (TPPs) for new tuberculosis diagnostics were launched in April 2014. Following advances in the TB diagnostics and treatment pipelines since the release of these TPPs as well as recent updates to WHO TB treatment and diagnostics guidelines, a revision process of this TPP was initiated. The objective of the revision was to steer the R&D pipeline discussions to address current diagnostic gaps, seeking alignment with and patient and population needs.

Target product profiles for tests used for mpox (monkeypox) diagnosis

World Health Organization
Target product profiles for tests used for mpox monkeypox diagnosis Book PDF

Author : World Health Organization
Publisher : World Health Organization
Page : 24 pages
File Size : 53,8 Mb
Release : 2023-07-18
Category : Medical
ISBN : 9789240076464

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Target product profiles for tests used for mpox (monkeypox) diagnosis by World Health Organization Pdf

Circulation of monkeypox virus globally has increased demand for diagnostics, prompted rapid development of commercial kits, and driven expansion of networks of laboratories and health facilities offering diagnosis. However, a clear need for more simplified, automated and/or accessible assays remains, including those that can enable testing at decentralized sites outside the laboratory. In response, to increase access to quality-assured, accurate and affordable mpox (monkeypox) diagnosis, an expert consultation process has been initiated, resulting in the drafting of two target product profiles (TPPs): 1. Tests used for diagnosis within health care settings and laboratories (TPP1). 2. Tests used as an aid to diagnosis by detecting orthopoxvirus (OPXV) antigens, which are amenable to decentralized use, including in the community (TPP2). Generally speaking, a TPP is a planning tool for the development of health products. The primary target audience of the TPPs are manufacturers, suppliers, and researchers developing new assays. Additionally, countries and agencies evaluating and/or selecting assays for procurement and use for mpox (monkeypox) testing across both urban and rural environments, especially in settings with constrained resources, may benefit from the criteria and information presented. The TPPs are intended as a strategic reference document for comparison and transparency. The criteria lay out some of the characteristics that are most relevant to inform the expeditious development of tests that address the greatest and most urgent public health need according to WHO. As is the case with all WHO TPPs, it is recognized that access, equity, and affordability are integral parts of the innovation process and need to be considered at all stages, not just after a product is developed.

Target product profile to detect Dracunculus medinensis presence in environmental samples

World Health Organization
Target product profile to detect Dracunculus medinensis presence in environmental samples Book PDF

Author : World Health Organization
Publisher : World Health Organization
Page : 22 pages
File Size : 47,5 Mb
Release : 2024-04-03
Category : Medical
ISBN : 9789240090781

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Target product profile to detect Dracunculus medinensis presence in environmental samples by World Health Organization Pdf

Dracunculiasis, also known as Guinea-worm disease, is caused by infection with the parasitic nematode (the Guinea worm). In May 1986, the Thirty-ninth World Health Assembly declared global elimination (i.e. eradication) of dracunculiasis as a goal. The global dracunculiasis eradication campaign, through community-based interventions, has reduced the burden of the disease from an estimated 3.5 million cases per year in 1986 to only 13 human cases and 688 animal infections during 2022. To date, however, there are no field-validated tests to detect the presence of D. medinensis-specific analytes in the environment. Although the scale of the surveillance infrastructure in countries endemic for Guinea-worm disease is impressive, initiating active surveillance and implementing disease-preventive interventions in any given area is triggered only when a host with an emergent worm is detected in that area or a nearby area. Unlike polio eradication, where an environmental diagnostic tool exists, there is no such tool for dracunculiasis eradication. Diagnostic tools that can detect evidence of analytes specific to D. medinensis in environmental samples can be used to identify geographies that are at risk for transmission of D. medinensis. Results from such environmental tools can complement surveillance data generated via active, community-based case and infection searches for subcutaneous and emergent Guinea worms and proactive or passive reporting of Guinea-worm disease. As such, environmental surveillance tools could augment current surveillance activities and enhance surveillance in a manner unprecedented for the global dracunculiasis eradication campaign. Viable environmental assays that can detect evidence of analytes (nucleic acid or other antigens) specific to D. medinensis in various environmental samples from water, aquatic animals, and perhaps aquatic animal waste, could be used to guide the targeting and implementation of disease-preventive interventions in endemic areas. For example, such tools could further inform which surface water sources should be treated with larvicide. Environmental surveillance tools could also generate additional data to inform decision-making about when and where to contract or expand active, community-based surveillance and implement other programmatic interventions. Environmental surveillance tools would be useful for generating additional surveillance data in areas with known or suspected wildlife transmission. Diagnostic tools capable of detecting D. medinensis-specific analytes in environmental samples would also generate data on the absence of Guinea worm in the environment, which could help certify countries as free of dracunculiasis transmission, ultimately facilitate the certification of dracunculiasis eradication, and support post-certification efforts.

Target product profile to detect prepatent Dracunculus medinensis infections in animals

World Health Organization
Target product profile to detect prepatent Dracunculus medinensis infections in animals Book PDF

Author : World Health Organization
Publisher : World Health Organization
Page : 21 pages
File Size : 45,5 Mb
Release : 2024-04-03
Category : Medical
ISBN : 9789240090804

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Target product profile to detect prepatent Dracunculus medinensis infections in animals by World Health Organization Pdf

Dracunculiasis, also known as Guinea-worm disease, is caused by infection with the parasitic nematode Dracunculus medinensis (the Guinea worm). In May 1986, the Thirty-ninth World Health Assembly declared global elimination (i.e. eradication) of dracunculiasis as a goal. The global dracunculiasis eradication campaign, through community-based interventions, has reduced the burden of the disease from an estimated 3.5 million cases per year in 1986 to only 13 human cases and 688 animal infections during 2022. To date, however, there are no validated tests to diagnose pre-patent D. medinensis infection. A critical part of any eradication programme involves reliably identifying infected and exposed definitive hosts. Historically, the diagnosis of Guinea-worm disease was clinical in nature and occurred via visually confirming the emergence of a white worm, roughly 10–14 months after the acquisition of infection. Currently, the definitive diagnosis involves either microscopy or, if necessary, conventional polymerase chain reaction applied to a DNA preparation from emergent worm fragments. A diagnostic tool capable of confirming active infection with D. medinensis many months before the emergence of a Guinea worm would represent a leap forward for the global dracunculiasis eradication campaign. Diagnostic modalities and platforms that can be easily used in locations where Guinea worm is observed or suspected among animal hosts are needed for the early diagnosis of prepatent Guinea worm infection to enhance follow-up and containment of infected hosts. Through the early detection and containment of Guinea worm-infected hosts, these diagnostics would ultimately serve to decrease the amount of parasite available in the environment for onward transmission. Diagnostic tools capable of detecting prepatent infection would enhance disease surveillance and provide national programme staff with additional data to identify transmission hot spots before the emergence of worms in affected areas. Diagnostic tools that can identify hosts with prepatent infection would further inform the targeting and implementation of disease-preventive interventions such as tethering of domesticated animal hosts and treating surface water sources with larvicide. Guinea worm diagnostic tools that could detect prepatent infection would also generate evidence of the absence of Guinea worm infection in definitive hosts, which could help certify countries as free of dracunculiasis transmission and ultimately facilitate the certification of dracunculiasis eradication.