Bringing testing to those who are most vulnerable
Care homes were massively affected by the SARS-CoV-2 epidemic in many countries. Testing was not widely available at the start of the epidemic. College President, Professor Jo Martin, describes a clinical trial comparing methods of routine testing with rapid testing in care homes.
During the epidemic, before testing was available to the majority of care homes, we worked with a great team at Queen Mary University of London (QMUL), Barts Health NHS Trust and our local East London Health and Care Partnership to see whether we could rapidly mobilise a team and a clinical trial to compare routine testing via the NHS Roche Cobas system with rapid testing in care homes.
We were given access to Novacyt Primer Design q16 and q32 rapid testing platforms – and when I say ‘platform’ think ‘small gizmo’ not room-sized equipment. You can see from the image just how small these thermocyclers are. They can be ‘daisy-chained’ to increase capacity and we designed a continuous flow system which we are in the process of writing up.
The trial has proceeded at pace, given rapid approval via the Urgent Public Health priority ethical review system, which was supportive, and the speed and agility of this was much appreciated.
We had a core of experienced scientists and clinical virologists to support the trial, and recruited scientists, graduates and medical students to form teams running the labs and working with the care homes. The consumables and staffing costs were paid for by Novacyt. Parallel samples were run through the NHS labs weekly for comparison.
Full category 3 lab training and risk assessments were completed for the QMUL laboratory. The ‘clinical’ care home swabbing and data collection teams were all trained in the trial protocol, use of PPE, good clinical practice for research, and were all inducted accordingly. All those entering care homes were aware of infection risks and were themselves tested regularly. They were also made aware that they should raise any concerns about the trial and that they had a duty of care to flag up anything of concern observed while in a care home to a senior member of the team.
The trial has proceeded at pace, given rapid approval via the Urgent Public Health priority ethical review system, which was supportive, and the speed and agility of this was much appreciated.
Innovation has happened not just in the way we have managed to approve research studies, but also in the way in which we can work together as a system.
As we start to bring the trial to a close, it is clear that the speed of innovation during the pandemic has required new and flexible responses to get data from research work published and available as fast as possible. Colleagues all over the world have been truly exceptional in expediting high-quality research. Innovation has happened not just in the way we have managed to approve research studies, but also in the way in which we can work together as a system.
Bringing testing to those who are most vulnerable has had an added benefit with great feedback from the medical students who have supported the trial. They are telling us that they not only understand more about the testing itself, but have learnt about clinical research in diagnostics and research in a vulnerable community setting (and yes we did have a care concern raised that was escalated and dealt with). They also valued being able to go into care homes and work with the staff and residents there. Their CVs are enriched with useful and real-world learning and research experience. A spontaneous comment from one of the team around how much their communication skills had improved seemed truly heartfelt.
I learnt with them. Appreciating the wide range of settings that need our input and considering how we can support these care homes has been really valuable learning. Our next challenge is to provide better support, as a health care system, to these key services together with the diagnostics that they need.