ArticleBMJ global health2018
How to implement new diagnostic products in low-resource settings: an end-to-end framework.
Article in BMJ global health, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 17 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
17 citing papers in PubMed.
- Defining a target product profile for antimicrobials to treat severe paediatric bacterial enteric infections in low- and medium-income countries, caused byJAC-antimicrobial resistance · 2026Review
- A Decision Tree Cost Analysis of Intracranial Bleed Detection Using a Near-Infrared Device Across Various Healthcare Levels.Journal of market access & health policy · 2026Article
- The evolution of next-generation lateral flow assays for bacterial and fungal diagnostics.Mikrochimica acta · 2026Review
- Expert consensus on pre-eclampsia risk screening tools for low- and middle-income countries: Development of a new Target Product Profile.PLOS global public health · 2026Article
- The REAsmash serious game for the post-stroke diagnosis of distractor inhibition: contrast between immersive and non-immersive virtual reality test versions.European journal of physical and rehabilitation medicine · 2025Article
- Improving the efficiency of the regulatory approvals of HIV in vitro diagnostics in low- and middle-income countries: Perspective of the IAS Industry Liaison Forum diagnostic partners.PLOS global public health · 2025Article
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- Defining a malaria diagnostic pathway from innovation to adoption: Stakeholder perspectives on data and evidence gaps.PLOS global public health · 2024Article
- Optical imaging for screening and early cancer diagnosis in low-resource settings.Nature reviews bioengineering · 2024Article
- Landscape analysis of NTD diagnostics and considerations on the development of a strategy for regulatory pathways.PLoS neglected tropical diseases · 2022Article
- REASSURED Multiplex Diagnostics: A Critical Review and Forecast.Biosensors · 2022Review
- Advances and challenges in automated malaria diagnosis using digital microscopy imaging with artificial intelligence tools: A review.Frontiers in microbiology · 2022Review
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- Costs along the TB diagnostic pathway in Uganda.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2021Article
- Perspectives and practices of health workers around diagnosis of paediatric tuberculosis in hospitals in a resource-poor setting - modern diagnostics meet age-old challenges.BMC health services research · 2020Article
- Implementing COVID-19 (SARS-CoV-2) Rapid Diagnostic Tests in Sub-Saharan Africa: A Review.Frontiers in medicine · 2020Review
Corrections and comments
- Erratum issuedCorrection:2018
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Diagnostics developers often face challenges introducing in-vitro diagnostic (IVD) products to low- and middle-income countries (LMICs) because of difficulty in accessing robust market data, navigating policy and regulatory requirements and implementing and supporting products in healthcare systems with limited infrastructure. Best practices recommend the use of a phase-gate model with defined activities and milestones by phase to successfully move a product from concept to commercialisation. While activities for commercialisation of products in high-income countries (HICs) are well understood, the activities required for introduction of IVDs in LMICs are not. In this paper, we identify the key activities needed for IVD product development and implementation and map them to the various phases of the model, paying particular attention to those activities that might be conducted differently in LMICs.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.