Diagnostics for Developing Countries

Improving the availability of high quality diagnostic tests for infectious diseases is a global priority. Lack of access by people living in low income countries may deprive them of life saving treatment and reduces opportunities to prevent onward transmission and spread of the disease. Diagnostic l...

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Bibliographic Details
Main Author: Ruth McNerney
Format: Article
Language:English
Published: MDPI AG 2015-05-01
Series:Diagnostics
Subjects:
IVD
HIV
Online Access:http://www.mdpi.com/2075-4418/5/2/200
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spelling doaj-fd6370e88c984044bb903d6461b63ad32020-11-24T20:58:08ZengMDPI AGDiagnostics2075-44182015-05-015220020910.3390/diagnostics5020200diagnostics5020200Diagnostics for Developing CountriesRuth McNerney0TB Alert, Community Base, 113 Queens Road, Brighton, BN1 3XG, UKImproving the availability of high quality diagnostic tests for infectious diseases is a global priority. Lack of access by people living in low income countries may deprive them of life saving treatment and reduces opportunities to prevent onward transmission and spread of the disease. Diagnostic laboratories are often poorly resourced in developing countries, and sparsely distributed. Improved access may be achieved by using tests that do not require laboratory support, including rapid tests for use at the point-of-care. Despite increased interest, few new in vitro diagnostic (IVD) products reach the majority populations in low income countries. Barriers to uptake include cost and lack of robustness, with reduced test performances due to environmental pressures such as high ambient temperatures or dust. In addition to environmental factors test developers must consider the local epidemiology. Confounding conditions such as immunosuppression or variations in antigen presentation or genotype can affect test performance. Barriers to product development include access to finance to establish manufacturing capacity and cover the costs of market entry for new devices. Costs and delays may be inflated by current regulatory preregistration processes to ensure product safety and quality, and more harmonized approaches are needed.http://www.mdpi.com/2075-4418/5/2/200IVDpoint-of-caretuberculosisHIVregulationdiagnostic testinfectious disease
collection DOAJ
language English
format Article
sources DOAJ
author Ruth McNerney
spellingShingle Ruth McNerney
Diagnostics for Developing Countries
Diagnostics
IVD
point-of-care
tuberculosis
HIV
regulation
diagnostic test
infectious disease
author_facet Ruth McNerney
author_sort Ruth McNerney
title Diagnostics for Developing Countries
title_short Diagnostics for Developing Countries
title_full Diagnostics for Developing Countries
title_fullStr Diagnostics for Developing Countries
title_full_unstemmed Diagnostics for Developing Countries
title_sort diagnostics for developing countries
publisher MDPI AG
series Diagnostics
issn 2075-4418
publishDate 2015-05-01
description Improving the availability of high quality diagnostic tests for infectious diseases is a global priority. Lack of access by people living in low income countries may deprive them of life saving treatment and reduces opportunities to prevent onward transmission and spread of the disease. Diagnostic laboratories are often poorly resourced in developing countries, and sparsely distributed. Improved access may be achieved by using tests that do not require laboratory support, including rapid tests for use at the point-of-care. Despite increased interest, few new in vitro diagnostic (IVD) products reach the majority populations in low income countries. Barriers to uptake include cost and lack of robustness, with reduced test performances due to environmental pressures such as high ambient temperatures or dust. In addition to environmental factors test developers must consider the local epidemiology. Confounding conditions such as immunosuppression or variations in antigen presentation or genotype can affect test performance. Barriers to product development include access to finance to establish manufacturing capacity and cover the costs of market entry for new devices. Costs and delays may be inflated by current regulatory preregistration processes to ensure product safety and quality, and more harmonized approaches are needed.
topic IVD
point-of-care
tuberculosis
HIV
regulation
diagnostic test
infectious disease
url http://www.mdpi.com/2075-4418/5/2/200
work_keys_str_mv AT ruthmcnerney diagnosticsfordevelopingcountries
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