PhD project title

Blood-free, microneedle-mediated, early diagnosis of SARS-CoV-2 infection

Outline description, including interdisciplinary, intersectoral and international dimensions 

The COVID-19 pandemic has infected almost 4 million people and led to over 250,000 deaths globally.  Early detection of infection, even prior to symptom onset, is paramount in order to control infection spread in the workforce and instil confidence in returning to work for many industries.  This requires the antigen or polymerase chain reaction (PCR) test, identifying viral mRNA present (which can be detected within 24 hours of infection). However, there are substantial issues with this testing, with reports of up to 30% false negative results generated.  The major concern is the swab sample and variances in sampling techniques, as well as the fact that virus may only be present in the saliva after 5 days post-infection.  There is, therefore, urgent need for improved and more consistent sampling technologies that can be used repeatedly without discomfort to ensure accurate compliance.

We have recently shown that our easy-to-use (with no formal medical training required), patented hydrogel-forming microneedle arrays can quickly capture mRNAs from skin interstitial fluid and release them into a buffer for subsequent sensitive and specific detection by PCR. We hypothesise that such a system to detect SARS-CoV-2 could radically improve PCR testing of the workforce, avoiding need of trained medical personnel, transmission of blood-borne infections and the necessity/cost for specialised sharps disposal.

In this interdisciplinary project combining pharmaceutical formulation and molecular biology, we will optimise polymer composition and microneedle geometry to enhance mRNA capture and release. Since we have ethical approval in place for microneedle application to human volunteers, the project will involve a human study to demonstrate efficacy/reliability. Thereafter, there will be a ready route to market as medical devices have shorter regulatory pathways and we are currently advancing scaled manufacture with LTS Lohmann. The student will develop skills in formulation development, pharmaceutical/biomedical analysis and clinical translation.

Key words/descriptors

Covid-19, SARS-CoV-2, microneedles, PCR antigen testing

Fit to CITI-GENS theme(s)

• Advanced Manufacturing
• Life Sciences

Supervisor Information

First Supervisor:  Professor Ryan Donnelly                                                        School: Pharmacy

Second Supervisor:   Professor Chris Scott                                                        School: Medicine

Third Supervisor: Dr Cécilia Brun                                                                         Company: Johnson & Johnson

Name of non-HEI partner(s)

Johnson & Johnson

Contribution of non-HEI partner(s) to the project:

Dr Brun will provide insights in the development of the technology as a product, establishing technology product profile parameters for the project to aim for and establishing the sensitivities that will be needed to compare and indeed demonstrate enhanced performance over current swab sampling methodology.

. Please describe the profile of the non-HEI partner and the nature of the relationship.    

Johnson & Johnson is an American multinational corporation founded in 1886 that develops medical devices, pharmaceutical and consumer packaged goods. Its common stock is a component of the Dow Jones Industrial Average and the company is ranked No. 37 on the 2018 Fortune 500 list of the largest United States corporations by total revenue. J&J is one of the world's most valuable companies. Professor Donnelly is currently working with J&J on a funded project based on microneedle-mediated diagnosis/grading of skin diseases.

In this project, the student will spend 3 months working at the J&J Consumer Health in Paris. Here they will gain insights into industrial translation of novel technologies, develop knowledge of regulatory affairs and contribute to design of advanced manufacturing systems for microneedles