Diagnostics for Developing Countries
Open accessAbstract
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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Availability issues, such as geographical constraints, resource shortages, or long waiting times, can cause significant diagnostic errors even when specific tests exist.
“Second, availability issues, such as geographical constraints, resource shortages, or long waiting times, can cause significant diagnostic errors even when specific tests exist [189,190].”
From Toward Safer Diagnoses: A SEIPS-Based Narrative Review of Diagnostic Errors (2026) · cites this paper as [190]
The Introduction (page unavailable) says laboratories may be geographically inaccessible and under-resourced, and that particular tests may not reach much of the population. Section 3.1 (page unavailable) adds that a community-based rapid test may detect more cases than a more sensitive test confined to a specialized laboratory. These passages support missed diagnoses despite the existence of tests, but do not establish long waiting times or quantify the errors as significant. (LLM, conf=0.83)
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- Authors
- McNerney, R.
- Affiliations
- TB Alert, Community Base, 113 Queens Road, Brighton, BN1 3XG, UK
- Corresponding author
- McNerney, Ruth
- ORCID
- McNerney, Ruth
- Venue
- Diagnostics
- Publisher
- MDPI AG
- Published
- 2015-05-19
- Volume
- 5
- Issue
- 2
- Pages
- 200-209
- ISSN
- 2075-4418 (ISSN-L)
- PMC
- PMC4665590
- OpenAlex
- W2104188515
- Cited by
- 111
- References
- 34
- Citations by year
- 2026: 9 · 2025: 12 · 2024: 7 · 2023: 8 · 2022: 5 · 2021: 14 · 2020: 15 · 2019: 14 · 2018: 9 · 2017: 12 · 2016: 4 · 2015: 2
- FWCI
- 4.48
- Type
- journal article
- Language
- en
- Open access
- gold
- dx.doi.org
- Licence
- Locations
- Diagnostics (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Topics
- Physical Sciences › Engineering › Biomedical Engineering › Biosensors and Analytical Detection
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Biotechnology and Related Fields
- Keywords
- diagnostic testing, infectious diseases, low-income countries, point-of-care testing, rapid testing, in vitro diagnostics, diagnostic access, test performance, environmental robustness, immunosuppression, regulatory approval, regulatory harmonization, production capacity, market entry costs
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