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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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 |
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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 |
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AT ruthmcnerney diagnosticsfordevelopingcountries |
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