ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2018
The Manufacturers' Perspective on World Health Organization Prequalification of In Vitro Diagnostics.
Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
What it found
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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
10 citing papers in PubMed.
- The pharmaceutical industry's multifaceted role in neglected tropical disease control: from market failure to global health innovation.Tropical medicine and health · 2026Review
- 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
- Resilience Against Resistance: Exploring Cutting-edge Therapies for Methicillin-resistantCurrent medicinal chemistry · 2025Review
- Defining a malaria diagnostic pathway from innovation to adoption: Stakeholder perspectives on data and evidence gaps.PLOS global public health · 2024Article
- Antibiotic resistance in plant growth promoting bacteria: A comprehensive review and future perspectives to mitigate potential gene invasion risks.Frontiers in microbiology · 2022Review
- Current state of commercial point-of-care nucleic acid tests for infectious diseases.The Analyst · 2021Review
- Rapid Methods for Antimicrobial Resistance Diagnostics.Antibiotics (Basel, Switzerland) · 2021Review
- Regulation of HIV self-testing in Malawi, Zambia and Zimbabwe: a qualitative study with key stakeholders.Journal of the International AIDS Society · 2019Article
- Assessment of eight nucleic acid amplification technologies for potential use to detect infectious agents in low-resource settings.PloS one · 2019Article
- How to implement new diagnostic products in low-resource settings: an end-to-end framework.BMJ global health · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In vitro diagnostic devices (IVDs) help clinicians determine specific conditions, monitor therapeutic efficacy, and prevent drug resistance development. While stringent regulatory authorities (SRAs) regulate IVDs in most high-income countries, regulatory authorities in many low- and middle-income countries (LMICs) are nonexistent or do not enforce rigorous standards. In 2010, the World Health Organization established its Prequalification of In Vitro Diagnostics (PQDx) program to ensure "access to safe, appropriate and affordable" IVDs, especially in LMICs with little or no domestic regulatory frameworks, thereby reaching underserved populations. However, challenges in PQDx policies and procedures include an overloaded pipeline, timelines not publicly available, confusion about which products PQDx focuses on, perceived burden for documenting changes to prequalified products, overlap with SRA approvals, and uncertainty around long-term financing. PQDx can maximize its impact by considering the perspective of IVD manufacturers; similarly, IVD manufacturers should exercise adequate quality control over their submissions and associated processes.
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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.