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Open AccessCommentary
Diagnostics 2015, 5(2), 200-209; doi:10.3390/diagnostics5020200

Diagnostics for Developing Countries

TB Alert, Community Base, 113 Queens Road, Brighton, BN1 3XG, UK
Academic Editor: Sandeep Kumar Vashist
Received: 23 March 2015 / Revised: 7 May 2015 / Accepted: 12 May 2015 / Published: 19 May 2015
(This article belongs to the Special Issue In Vitro Diagnostics)
View Full-Text   |   Download PDF [761 KB, uploaded 19 May 2015]   |  

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. View Full-Text
Keywords: IVD; point-of-care; tuberculosis; HIV; regulation; diagnostic test; infectious disease IVD; point-of-care; tuberculosis; HIV; regulation; diagnostic test; infectious disease
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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McNerney, R. Diagnostics for Developing Countries. Diagnostics 2015, 5, 200-209.

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