Human Practices - GOLD
The design of our Cas-Find project and its intended future usage has evolved as we delved into the complex issues that surround the design and implementation of a self-testing STI diagnostic tool.
STIs, Luciferase, and Cas-Find
In our first meetings, we brought together different ideas and experiences. It became clear that STI diagnosis is something we all thought that there was limited access to on our University campus, and decided on a self testing kit for chlamydia before branching out to STIs in general. As we had a luciferase expert as our secondary PI, Dr Amit Jathoul, we decided to investigate how we could use a split luciferase system as part of our diagnostic tool.
Luciferase Diagnostics Expert- false positives and hardware
During the planning stages, we had an informal chat with Dr Patrick Hardinge, a diagnostics researcher at Cardiff University, who works with Lumora, a diagnostic company who have designed a tool using luciferase and BART amplification to detect specific bacterial food contamination.
Patrick was full of useful advice, stressing that the reduction of false positives should be a vital component of our design, recommending that we should adopt a system that requires two independent events to bring about a 'positive' result. This fed into the design of our use of dual guide RNAs in our CRISPR-Cas9 experimental system that eventually became the Cas-Find project.
He also helped us think about the future product that Cas-Find may eventually become by recommending that we kept a cheap photodiode in our plans when designing the output mechanism for the tool.
Risk Assessments, GM regulation, and regulatory bodies
After a two-week process of risk assessments through various channels, our application to take live bacterial samples expressing luciferase proteins out to Techniquest for an outreach event was rejected by Rachel Coombe, a Biological Safety Officer at Cardiff University. We decided to take this experience as an opportunity to learn more about GM regulations from Rachel. She advised us that cell-free kits are easier to license, and stressed the importance of regulatory bodies, such as the HSE and, more specific to our project, the MHRA. This affected the planning of our Cas-Find project, providing the impetus for the ultimate design of a cell-free system in the final proposed diagnostic tool.
From this, we consulted the MHRA, which gave us an insight into the criteria used to assess the safety of a medical device before it is approved. They helped us understand CE rating approval, and the PHS' decision making on self-testing diagnostics.
Should Cas-Find be used for a self-testing kit? Surveys, ethics, social work, HIV charities
Meanwhile, Asal investigated the ethics of using a tool such as Cas-Find as a self-testing kit, spurred on by a conversation on 'burying results' and 'pre-test counselling' with a retired HIV social worker, Emily Engel.
In addition to obtain a snapshot of public opinion about self-testing STI kits, Asal conducted a short survey. She then consulted an ethicist at Kings Colllege (Dr Jillian Craigie) for feedback on interpreting the survey as well as public comments. This led to seeking empirical data on BioSure's HIV self testing kits by contacting employees at the HIV charities, Terrence Higgins Trust (Emily Rosselli) and National Aids Trust (Nadia Ramjhun).
All of these strands evolved into a final essay to inform our decision making when considering whether Cas-Find should be applied for use in a self-testing kit.
- Emily Engel- retired HIV specialist social worker
- Dr Jillian Craigie- Ethicist at Kings College London
- Nadia Ramjhun- National Aids Trust for leading us to a resource
- Emily Rosselli- Terrence Higgins Trust for leading us to a resource