Evaluation of digital microfluidic molecular point-of-care testing for the diagnosis of respiratory pathogens
| ISRCTN | ISRCTN57715622 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57715622 |
| IRAS number | 363005 |
| Secondary identifying numbers | SMARTUK01 |
- Submission date
- 21/10/2025
- Registration date
- 24/10/2025
- Last edited
- 24/10/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
When a patient presents at the Emergency Department (ED) with clinical signs of respiratory infection, the time it takes to diagnose and initiate appropriate treatment can influence the patient’s outcome and disposition. The quicker the therapeutic regime is started, the better the outcome for the patient. Furthermore, the sooner the presence of a pathogen is confirmed, the quicker the patient can be appropriately isolated to stem the spread of infection. This is a prospective, single-centre, single-visit, diagnostic performance evaluation study. The study aims to compare the performance of the current gold standard testing diagnostic device (called Cepheid) to the novel testing device (called Logicore System) in terms of turnaround time to receipt of diagnosis and sensitivity/accuracy of the devices.
Who can participate?
Patients presenting to the ED at Addenbrooke's Hospital with clinical symptoms of respiratory tract infection who will require standard of care diagnostic testing in line with the Trust Infection Prevention and Control policy.
What does the study involve?
Patients need to have a nasopharyngeal swab (up the nostril) taken for diagnostic testing with the Cepheid device as part of the standard care pathway outside the study. Those who are recruited into the study will simply have an additional nasopharyngeal swab taken simultaneously (one swab from each nostril). One swab will be tested by Cepheid as usual, and the second swab will be tested by the Logicore System. In this way, each participant will act as their own control. There is no treatment in the study; participants will return to the standard care pathway in the ED.
What are the possible benefits and risks of participating?
There is no particular benefit to individual participants from taking part in the study. There are no payments to participants for taking part, and the study has no bearing on the clinical care each participant receives. However, participants may experience a sense of altruism from taking part in a study aiming to reduce diagnostic time and spread of infection for future patients with respiratory infections in the ED.
Whenever a nasopharyngeal swab is used, there is a potential risk of discomfort and/or a small possibility of a nosebleed. This will be explained to the participants during the informed consent process, and staff are trained in the swabbing procedure to minimise the likelihood of discomfort and/or nosebleeds. The ED research nurse (or designated member of the research team) will wear standard Personal Protective Equipment and follow standard measures for cleaning and disinfection to reduce the potential risk of spreading infection between staff and patients, in line with the CUH Infection Control and Prevention Guideline.
Where is the study run from?
Logilet (UK) Ltd, UK.
When is the study starting and how long is it expected to run for?
August 2025 to April 2026. The study will be open to recruitment from December 2025 to March 2026, dependent on approvals, contracts and training being in place.
Who is funding the study?
Logilet (UK) Ltd, UK.
Who is the main contact?
The Emergency Department Research Team at Addenbrooke's Hospital, cuh.edresearchteam@nhs.net
Contact information
Public
73 Pereira Road
Birmingham
B17 9JA
United Kingdom
| Phone | +44 (0)7968272331 |
|---|---|
| juliet_connor@outlook.com |
Scientific, Principal investigator
Cambridge University Hospitals NHS Foundation Trust, Box 87, Emergency Department, Addenbrooke's Hospital, Cambridge Biomedical Campus, Hills Road
Cambridge
CB2 0QQ
United Kingdom
| Phone | +44 (0)1223 596145 |
|---|---|
| adrianboyle@nhs.net |
Study information
| Study design | Prospective single-centre diagnostic accuracy study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Diagnostic accuracy study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Study for multiplex assessment and respiratory test evaluation |
| Study acronym | SMART |
| Study objectives | The primary objective of the study is to demonstrate that the Logicore System multiplex 6 panel respiratory pathogens point of care testing device has increased diagnostic sensitivity when compared to the current gold standard point of care multiplex panel at Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital) whilst maintaining accuracy, including Positive Predictive Value (PPV), Negative Predictive Value (NPV) and specificity. The secondary objectives are: 1) To compare the time from sample acquisition to receipt of result (turnaround time) for Logicore System point of care testing and current point of care testing (Cepheid multiplex GeneXpert), 2) To evaluate the acceptability of the Logicore System device by study participants and staff, and 3) To produce targeted Cost Benefit analysis for the Logicore System device. |
| Ethics approval(s) |
Submitted 09/10/2025, West of Scotland REC 4 (Level 2 - Administration Building, Gartnavel Royal Hospital, 1055 Great Western Road, Glasgow, G12 0XH, United Kingdom; +44 (0)141 314 0213; ggc.wosrec4@nhs.scot), ref: 25/WS/0171 |
| Health condition(s) or problem(s) studied | Point-of-care testing for diagnosis of respiratory infections in the Emergency Department setting of Addenbrooke's Hospital. |
| Intervention | This is a prospective, single-centre, diagnostic accuracy study. There is no therapeutic agent and no randomisation. Study participants will have 2 nasopharyngeal swabs taken simultaneously (one from each nostril). One swab will be tested using the gold standard point-of-care testing device (Cepheid), and the other swab will be tested using the novel point-of-care testing device (Logicore System). Therefore, participants act as their own controls for the study. Assessments take place in a single visit to the Emergency Department at Addenbrooke's Hospital. The diagnostic results and the amount of time to receive the results will be compared. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Investigational Logicore System device, Cepheid GeneXpert device. |
| Primary outcome measure | The sensitivity and accuracy of the Logicore System POC diagnostic test compared to the gold standard POC multiplex test (Cepheid GeneXpert), including Positive Predictive Value (PPV), Negative Predictive Value (NPV) and specificity measured using data collected at the time of the test during a single visit |
| Secondary outcome measures | 1. Determination of turnaround time for Logicore System, measured using time recorded by the Logicore System and documented in patients’ medical notes by research staff, and Cepheid tests measured using time documented in patients’ medical notes by research staff, at one timepoint 2. Evaluation of the acceptability of the Logicore System POCT to study participants and staff, measured using a simple Likert scale, at a single timepoint 3. Monetised savings from avoided testing and operational savings due to the reduction in time spent in ED or in isolation within the ED measured using data collected from patient medical records at one timepoint |
| Overall study start date | 18/08/2025 |
| Completion date | 30/04/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | All |
| Target number of participants | 400 |
| Key inclusion criteria | 1. Male or female 2. Any age 3. Presenting to the CUH Emergency Department 4. Symptomatic of respiratory tract infection as evidenced clinically by the presence of any of the following indicators: 4.1. Acute onset of persistent cough (with or without sputum) 4.2. Hoarseness 4.3. Nasal discharge or congestion 4.4. Shortness of breath 4.5. Sore throat 4.6. Wheezing 4.7. Sneezing 4.8. Persistent Acute respiratory distress syndrome 4.9. Influenza-like illness 4.10. Fever ≥ 37.8 degrees C 4.11. Any other symptom known to be indicative of acute respiratory episode such as palpitations, headache, anosmia (COVID) or gastrointestinal symptoms (diarrhoea) (influenza) 5. Signed consent form for participation 6. Requiring standard of care diagnostic testing as per CUH Trust IPC policy 7. Able to read and/or understand the age-appropriate participant information sheet in English |
| Key exclusion criteria | 1. Unwilling or unable to comply with study nasopharyngeal swabbing procedures 2. Those who are incapacitated or deemed to be lacking capacity to provide informed consent to participate 3. Prisoners or young offenders |
| Date of first enrolment | 01/12/2025 |
| Date of final enrolment | 31/03/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Cambridge
CB2 0QQ
United Kingdom
Sponsor information
Industry
Flat 107, 25 Indescon Square
London
E14 9DG
England
United Kingdom
| Phone | +86 18600138212 |
|---|---|
| ruichao.bai@logilet.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/05/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.0 | 09/10/2025 | 23/10/2025 | No | No |
Additional files
Editorial Notes
23/10/2025: Study's existence confirmed by the West of Scotland REC 4, UK.
