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Diagnostics for Developing Countries.

Authors
  • McNerney, Ruth1
Type
Published Article
Journal
Diagnostics
Publisher
MDPI AG
Publication Date
May 19, 2015
Volume
5
Issue
2
Pages
200–209
Identifiers
DOI: 10.3390/diagnostics5020200
PMID: 26854149
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

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.

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