Table 1.
Barriers | Effect on patient | Effect on user | Effect on manufacturer | Effect on policy maker |
---|---|---|---|---|
Competence of laboratory personnel | x | |||
Distance between clinicians and diagnosticians | x | |||
High cost of test | x | |||
Continuous availability in the laboratory | x | |||
Lack of clinical outcome studies | x | |||
Costs of clinical studies | x | |||
Costs of development | x | |||
Data management and poor electronic medical records | x | |||
Finding partners (clinicians, laboratory directors, researchers, etc.) for clinical studies | x | |||
Intellectual property challenges associated with multiple innovation | x | |||
Laboratory decentralization and unlinked stewardship teams | x | |||
Lack of appropriate marketing | x | |||
Lack of pre-market commitment | x | |||
Quality and availability of primary materials | x | |||
Policy makers not understanding the development process | x | |||
Issues concerning sample taking | x | x | ||
Specimen accessibility | x | x | ||
Knowledge gaps of physicians or clinicians in the relevance of antimicrobial resistance | x | x | ||
Lack of funding | x | x | ||
Storage, transport and stability of the test | x | x | ||
Sample transport and other logistical issues | x | x | ||
Supply chain failure | x | x | ||
Limited exchange between diagnostic and pharmaceutical companies | x | x | ||
Lack of speed | x | x | x | |
Test availability | x | x | x | |
FDA validation and European certification (CE) including differences between countries | x | x | x | |
Biological hazard | x | x | x | |
Ethical aspects | x | x | x | |
Insufficient exchange between the public and private sector | x | x | x | |
Environmental aspects | x | x | x | x |
Health practice behaviour | x | x | x | x |
Communication (or lack thereof) | x | x | x | x |
Lack of support programmes | x | x | x | x |
aThe table is partially based on a prior key paper in this field81.