- All > Medicine Access and Rational Use > Antimicrobial Drug Resistance
- All > Public Health, Innovation, Intellectual Property and Trade > Research and Development (R&D) - Innovation and Financing
- All > Diagnostics and Laboratory Technology > Evaluation of Diagnostics
- Keywords > antibacterial resistance (ABR)
- Keywords > antimicrobial resistance (AMR)
- Keywords > Global Antimicrobial Resistance Surveillance System (GLASS)
- Keywords > good quality in vitro diagnostics (IVDs)
- Keywords > pharmaceutical gaps
- Keywords > research and development - priority infectious disease
- Keywords > tuberculosis
- Keywords > in vitro Diagnostic (IVD)
- Keywords > in vitro diagnostic medical devices
- Keywords > WHO Model List of Essential In Vitro Diagnostics (EDL)
(2019; 128 pages)
The increasing prevalence of antimicrobial resistance (AMR) is a serious threat to global public health and is especially burdensome in low- and middle-income countries (LMICs). The need for new diagnostics to combat AMR has been recognized. Among the diagnostics needed are: (i) rapid tests that distinguish between bacterial and viral infections; (ii) tests for pathogen identification (ID); and (iii) tests for antimi¬crobial susceptibility patterns.
In order to address these needs, the World Health Organization (WHO) has undertaken in this report to map available and pipeline diagnostics against AMR, identify gaps in the availability of such diagnostics in LMICs, and establish a research and development (R&D) priority list of diagnostics against AMR for the next 3–5 years. In the second phase of the pro¬ject, WHO will develop consensus target product pro¬files (TPPs) for the highest-priority diagnostics on the R&D priority list.
While the increasing prevalence of AMR is a growing concern for viral, parasitic and fungal infections, an-tibacterial resistance (ABR) has now become a major global health issue that requires urgent solutions, in-cluding new diagnostics. Therefore, this report focuses on commercially available diagnostics to combat ABR and prioritizes the following key parameters: (i) diagnostics to improve clinical/syndromic management of patients to reduce the overprescription of antibiotics; (ii) antibiotics exhibiting the highest proportion of re¬sistance as set forth in Annex I hereto; (iii) diagnostics that can be performed at primary and secondary care facilities in LMICs; (iv) diagnostics targeted at pathogens primarily related to community-acquired infections (CAIs) and secondarily to bacterial infections that are most frequently acquired in hospitals (HAIs); and (v) diagnostics to help distinguish bacterial from nonbacterial infections.
It should be noted that tuberculosis (TB) is a lead¬ing infectious disease that causes mortality world¬wide, and drug-resistant Mycobacterium tuberculosis (MTB), the cause of TB in humans, is in the top 10 list of WHO priorities. Extensive landscaping of diagnostics and drug-resistance testing for MTB has already been performed, and a number of TPPs have been developed for priority diagnostic needs. Links to these materials are provided later in this report. Given the extensive work that has already been done with respect to diagnostics for MTB, these diagnostics are not a focus of this report. Nonetheless, because of the importance of TB, the report includes priorities for TB diagnostics R&D in addition to priorities for other targeted bacterial pathogens.