DIAMONDS-SEARCH study: Designing new tests that can diagnose the causes of fever, including COVID-19

Plain English Summary

DIAMONDS – Diagnosis and Management of Febrile Illness using RNA Personalised Molecular Signature Diagnosis – is a five-year collaborative, multi-partnered research project that will develop a new molecular diagnostic test to provide rapid diagnosis of common infectious bacterial disease, as well as viral and inflammatory diseases. It involves an international, multi-disciplinary team of researchers and scientists from across 28 institutions and 13 countries with 11 of those countries from Europe.
The DIAMONDS research team is addressing the problem that clinicians have when patients who have common symptoms (such as fever) come to hospital. Common infectious and inflammatory diseases account for up to a third of all unplanned hospital and primary care attendances. Currently, if a patient is admitted to hospital with a fever and non-specific symptoms, they could go through a whole series of investigations, such as blood tests, spinal fluid samples, MRI and CT scans, to help clinicians try to identify the cause of their symptoms. These tests can be uncomfortable, expensive and a patient could be waiting days or even weeks before they receive an accurate diagnosis and appropriate treatment, for example patients are often treated with antibiotics as a precautionary measure against serious bacterial infections, which have no effect if the real diagnosis is a self-resolving viral infection. All this puts a huge strain on the patient and the healthcare system.
When trying to find a solution to this problem, researchers have previously found that common diseases are characterised by unique patterns of gene expression (the process of DNA information being converted into instructions for cells to make proteins and other molecules). When a disease is associated with the switching on and off of genes in a patient’s blood, it forms its own ‘gene signature’. The gene signature has previously been shown to identify bacterial infections with a 95-100% accuracy.
The DIAMONDS research team will use expertise from previous gene signature research to make diagnosis faster and more accurate. The aim is to shorten the diagnosis time to under two hours, using a patient’s first blood sample. This diagnostic test may save a patient from unnecessary and potentially painful tests, as well as revolutionise the way healthcare can be delivered and have a positive impact on the health system and medical practitioners delivering healthcare.
The first part of the project is recruitment patients with conditions caused by infection and inflammation into DIAMONDS Search. Samples will be taken during the episodes of acute and convalescent illness. Selected optimal gene signatures for a wide range of infections and inflammatory conditions will be used to build a data library of the identifiable gene signatures of common inflammatory and infectious diseases. By comparing the pattern of genes in a patient’s blood sample to the hundreds of gene signatures in the library, diagnosis can be made rapidly.
Gene signatures selected from the data library will be used on both existing devices and new prototypes, such as lab-on-chip technology to create test devices, to enable diagnosis of multiple conditions on the same device - a concept called Personalised Molecular Signature Diagnosis (PMSD). PMSD-based care could transform the management of suspected infectious or inflammatory diseases, by driving more efficient and equitable organisation of the way care is delivered to the large numbers of patients presenting with symptoms of infection or inflammation.
As part of the global response to the coronavirus pandemic, the DIAMONDS consortium has re-purposed DIAMONDS Search to tackle the urgent global need for improved diagnostics to guide clinical management of patients with confirmed or suspected SARS-CoV-2. The DIAMONDS consortia is undertaking rapid development of novel host RNA-based diagnostic devices that can diagnose SARS-CoV-2 infection and comparator illnesses simultaneously at the point of testing and also to discriminate pure SARS-CoV-2 infection from that caused by co-infections, for instance with bacteria or other infections. DIAMONDS will also elucidate host gene expression signatures associated with different manifestations of Covid-19, inflammatory disease and uncontrolled viral disease.

DIAMONDS is recruiting patients of all ages with suspected and proven Covid-19, across the full spectrum of disease from mild (not admitted to hospital), moderate (admitted to ward only) and severe (intensive care). Samples and data from these highly characterised patients will be used by DIAMONDS consortium biotechnology partners to develop devices to detect diagnostic RNA signature of SARS-CoV-2 infection and signatures predictive of severe disease.

We will not be analysing the clinical information or samples while the patient is in hospital, but will be storing them to be analysed later, so the results are not likely to help manage the patient's illness and will not affect the patient's clinical care. However, the information gained by the study may help improve the diagnosis and treatment patients in the future.If we find significant results that would influence the patient's future care, the clinical care team will contact the patient.There are no disadvantages to joining the study. The small additional amount of blood and other samples taken should not make a difference to the patient's well-being.

DIAMONDS has research funding, totalling €22.5 million over five years, which is provided by the European Commission under the Horizon 2020 research and innovation programme.

Unfortunately, this study is not recruiting public volunteers at this time. This is because researchers are directly identifying volunteers in certain hospitals. Please do not contact the research team as they will not be able to respond. For more information about COVID-19 research, visit the Be Part of Research homepage.

Study website

Contact information

Prof Michael Levin
Scientific

Dept of Paediatrics
Medical School Building
Imperial College London
Norfolk Place
Paddington
London
W2 1PG
United Kingdom

ORCID ID	0000-0003-2767-6919
Phone	+44 (0)207 594 3990
Email	m.levin@imperial.ac.uk

Dr Federico Martinón-Torres
Public

Pediatría Clínica
Infectológica y Traslacional
Hospital Clínico Universitario de Santiago de Compostela
A Choupana
15706 Santiago de Compostela
15706
Spain

ORCID ID	0000-0002-9023-581X
Phone	+34 (0)981 955373
Email	Federico.Martinon.Torres@sergas.es

Study information

Eligibility

Locations

Countries of recruitment

• Austria
• England
• France
• Gambia
• Germany
• Greece
• Italy
• Latvia
• Nepal
• Netherlands
• Slovenia
• Spain
• Switzerland
• Taiwan
• United Kingdom

Study participating centres

Sponsor information

Imperial College London
University/education

2nd Floor, Medical School Building
Norfolk Place, Paddington
London
W2 1PG
England
United Kingdom

Phone	+44 (0)207 594 9480
Email	k.boland@imperial.ac.uk
Website	http://www3.imperial.ac.uk/
"ROR"	https://ror.org/041kmwe10

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

19/09/2024: The recruitment end date was changed from 30/05/2023 to 31/12/2023. Total final enrolment added.
29/05/2020: Trial's existence confirmed by the NIHR.