Phone Screen Testing Antimicrobial Resistance

The screen of our smartphone mirrors our health status by accumulating the microbes we carry. Phone Screen Testing (PoST) is a PCR-based test of smartphone screen swab samples that can identify people carrying infectious pathogens. We will use PoST for AMR population monitoring to improve and optimise healthcare services.

Dr Rodrigo Young, Founder and Executive Director of Diagnosis Biotech, Principal Investigator at University College London, UK.  

AMR contributed to c.5 million deaths in 2019 (27.3 deaths per 100,000 in sub-Saharan Africa) and threatens to cost US$ 1 trillion in healthcare costs and up to US$3.4 trillion in GPD losses by 2030. 

Hospitals are highly exposed to AMR as they treat high-risk patients, manage infections and interact with the wider community through patients, visitors and healthcare workers (HCWs). Infection prevention and control measures limit the exposure of patients and are achieved by modified infrastructure and behavioural practices. Additionally, antimicrobial stewardship is crucial in minimising AMRs.  

Infection dissemination reflects hospital interactions; efforts focus on limiting AMR entry. Patients are screened before surgery and either treated with decontamination therapy or their surgery delayed until tested negative. HCWs are regularly screened. These approaches do not account for the time lag between sampling and hospital entry. For patients, this could represent up to a week of community exposure before surgery. This approach is a consequence of a lack of tools for dynamic and real-time surveillance. 

PoST offers a cost-effective, non-invasive and quick screening solution. Sampling of phone screens and molecular testing will allow enhanced AMR monitoring to lower its impact. 

PoST-AMR will benefit any patient admitted for a procedure; enabling rapid review and (i) entry to the care pathway if negative; and (ii) conventional testing and decontamination therapy before entry to care, if positive. Both routes will improve outcomes for patients, ensuring appropriate and timely treatment and avoiding delays. 

Significant problems for the efficient management of hospitals are the flow of patients through the system but also the lack of screening of HCWs. Acquisition of AMR by a patient can extend their stay, delay their recovery, and result in complications associated with the above.  

AMR contributes to strained healthcare budgets, limiting resources available for other essential services and can prevent progress towards achieving wider health coverage in Africa (the mean extra-patient cost due to AMR is estimated at around $1300, with 30% attributed to productivity loss in Ghana).

During the COVID-19 pandemic, we saw the impact on patients isolated with no visitors allowed. Similar situations arise where vulnerable patients are kept isolated to protect them from potential infections, we are seeing this approach to minimise exposure in the context of AMR. PoST-AMR could benefit this patient group whose visitors could be screened before admittance to the ward.

A public good is broadly defined as a benefit to the well-being of the public and must be globally accessible under fair, reasonable, and non-discriminatory terms. A solution may provide a public good in the form of knowledge, data, services, products, or other configurations. PoST-AMR will deliver public good directly through improved healthcare, and indirectly through the generation of knowledge/information. 

As a tool for enhanced screening for AMR in hospital communities, PoST-AMR will benefit the individual patient by smoothing their movement through the care pathway. If they screen and subsequently test positive for an AMR organism, their healthcare intervention will be modified to ensure patient safety. This benefits the individual and limits patient ‘bed blocking’ due to hospital-acquired infection.  

As PoST-AMR is a non-invasive tool its use will facilitate screening of wider communities and larger numbers of participants, providing data on the prevalence and diversity of the microbial communities associated with the owner. The data obtained will inform both healthcare policy and academic dialogue. It can be expected that this will lead to publications in the scientific press as well as data sets for further investigation. 

PoST-AMR is a non-invasive tool with rapid turnaround which will improve engagement with vulnerable populations. We have seen such a benefit in patient care through the Find and Treat service for active case finding in tuberculous; the addition of a rapid diagnostic to the mobile X-ray service had significant improvements in patient uptake of treatment. 

UCL is central to UCL Partners, a health innovation partnership serving five million people across London and the SE of England, together with our networks in Africa, e.g. PANDORA-ID-NET, which gives us a unique perspective on the scope and importance of our solution for patients. As part of these networks, we have a good sight of the possible benefits of our model for AMR surveillance. The triage of patients and HCWs to minimise their exposure to community-acquired AMR is a major benefit for patients and healthcare facilities. There is well-documented evidence that AMR causes increased mortality, bed-blocking and a financial burden on the system. A non-invasive system with rapid readout will encourage increased engagement by the community. Roll out of PoST-AMR to a wider surveillance remit, will enable the acquisition of enhanced surveillance data and inform public health policy. 

Year 1: 

• Validate PoST for MRSA monitoring of HCWs and patients in hospitals in Zambia, comparing it to existing methods. 

• Iteration of the existing automated machine, with a focus on the automated processing and PCR analysis of the sample, plus remotely sending the test results to a server for data analysis. 

Year 2: 

• Expand PoST monitoring by scaling up MRSA testing in additional hospitals in Zambia and extending the study to another African or South American site.  

• Begin to adapt and validate PoST for other relevant AMR bacteria. 

• Continue the automated machine development and define the intellectual property strategy.  

Year 3: 

• Use data to advocate for the adoption of PoST as a verified AMR screening tool in Zambia and other LMICs, through work with local authorities and partnerships with healthcare providers. 

• Finalize the minimum viable product and initiate the intellectual property work (e.g. UK and PCT).  

 Beyond Year 3: 

• Seek partnerships and funding to expand PoST implementation to other LMIC regions and eventually HICs. 

• Scaled production of the automated sampling and detection machine. 

• Finalize IP process and commercialization.  

• Build a data platform to track the local and global distribution of AMR using PoST data.

The success of our project will be the evidence that the application of the PoST-AMR triage approach removes AMR-positive (AMR+) patients and HCWs from the hospital population. The key metrics will be the number of confirmed AMR+ identified and the number of hospital-acquired infection events confirmed during the study period. This will be monitored as a dynamic metric and also compared to the conventional data collected before the intervention. Currently, UTH admits 600 patients weekly and is served by a population of 446 HCWs.  

Outcome data will be established by monitoring: 

1. The number of participants identified in triage as AMR+.
2. The proportion of AMR+ confirmed as carriers of AMR by conventional testing.
3. The proportion of AMR+ who delay hospital admission, how long that delay is and the outcome of their treatment.
4. Evidence for transmission events from unidentified AMR+ to the hospital community. 

PoST machine:

Completion of the PoST machine prototype consisting of (i) establishing the initial concept and design; (ii) conducting preliminary tests; (iii) regulatory and development preparation; (iv) developing and de-risks key aspects of subcomponents; and (v) building an Alpha system meeting these metrics: (x) 500 phone samples and reactions a day; and (y) 5 plex assays. 

• Year 1: 

• Technology development: While PCR is established, PoST requires adapting and optimizing it for AMR samples. This might involve challenges in the sensitivity and specificity of the assay. 

• Mitigation - Collaboration: Partner with academic institutions within the UCL and MIT Solve network, hardware companies such as The Technology Partner (a company specialized in building devices), and health agencies for expertise and resource sharing. 

• Next 3 years: 

• Regulatory uncertainty: Currently, there is no regulatory framework for testing infectious diseases from non-human samples, which creates uncertainty about the approval process and potential limitations for using PoST in clinical setups. 

• Mitigation - (i) Build a strong evidence base: Generate robust data from PoST trials to demonstrate its accuracy, reliability, and clinical utility. 

• (ii) Engage with regulatory bodies: Proactively engage with relevant regulatory bodies to understand their concerns and perspectives on PoST and advocate for regulatory flexibility and pathways that encourage innovation in diagnostic technologies like PoST. 

• (iii) Seek legal counsel: Hire legal experts specialising in diagnostics regulations to guide the development and approval process. 

• (iv) Collaborate with other stakeholders: Partner with healthcare providers, and patient advocacy groups (such as Doctors without Borders) to build consensus and support for PoST adoption. 

The Trinity Challenge provides an opportunity to accelerate the progress of our solution to impact practice and policy. The funds provided will leverage the development of the PoST tool to a format that will allow rollout in LMIC – targeting the very communities that are hardest hit by AMR. The underlying principle of PoST AMR aligns with the ethos of the Trinity Challenge which is action-oriented and focused on generating new insights and solutions, we are confident that PoST AMR is an innovative approach to provide new insights in the transmission and control of AMR in the light of the Sustainable Development Goals agenda, 

A key challenge with any surveillance tool is the resource to scale up its production and rollout in different settings, we look to the Trinity Challenge for support in this area. Further to this PoST-AMR will produce large data sets for analysis and the Trinity Challenge partners include groups who have experience in this area (e.g. Institute for Health Metrics and Evaluation, Amazon and Meta) and their support will be invaluable. 

A key area where we will look for support is in the tools to analyse the large datasets that the use of PoST-AMR has the potential to produce. As indicated above there are Trinity Challenge partners who could assist with this. Beyond this, we would also seek input from organisations such as the Gates Foundation and FIND both of whom have interests in this area. We have had positive initial discussions with both of these organisations. 

If possible, we would also appreciate getting feedback from members of MIT’s Institute of Medical Engineering & Science as well as MIT’s Department of Biological Engineering on our sampling machine.  

EMail from UCL mentioning this call.