Blood collection for the development of a point-of-care troponin platform
| ISRCTN | ISRCTN13589405 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13589405 |
| IRAS number | 333438 |
| Secondary identifying numbers | IRAS 333438, NIHR206488 |
- Submission date
- 18/04/2024
- Registration date
- 17/05/2024
- Last edited
- 17/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
The measurement of cardiac biomarkers in blood (particularly troponin) to aid in the diagnosis of heart attack (myocardial infarction) is well established. If the concentration of troponin is sufficiently low when first measured, a significant proportion of chest pain patients can be safely discharged, which could be expedited by a point-of-care test.
Psyros Diagnostics are developing a point-of-care blood testing platform that will allow rapid measurement of troponin, based on a novel technology that uses single-molecule-counting. Individual troponin molecules are tagged with a photoactive reagent, then captured on a fluorescent sensor surface. Once bound, activation with light bleaches the fluorescence around each molecule allowing single molecules to be counted.
As part of the product development process, it is critical to have access to fresh whole-blood patient samples to validate that the test works sufficiently well before committing to a full-blown clinical study for regulatory approval. As part of the development process, it is also important to confirm that variations in the haematocrit of the blood (the percentage of red cells in the blood) do not impact the troponin measurement being carried out.
Who can participate?
Adults over 18 years, who have arrived at A&E with chest pains and symptoms of myocardial infarction.
What does the study involve?
In this study, fresh whole blood samples will be collected by venepuncture from chest pain patients known to have elevated troponin levels. These samples will then be measured on a prototype instrument.
In addition, a fraction of the blood taken will have the cellular components removed and the acellular plasma will be stored for future testing. No cellular material will be stored for more than 24 hours.
We aim to collect up to 120 samples over a 6-12 month timeframe. Samples will be collected in batches of approximately 20 and tested on prototype instruments. The data will then be fed into performance optimisation and the system will be re-tested on the next batch of samples.
What are the possible benefits and risks of participating?
The only benefit is the satisfaction of assisting in a study. The main risk is localised bruising at the point where the blood sample is taken.
Where is the study run from?
Psyros Diagnostics (UK)
When is the study starting and how long is it expected to run for?
April 2024 to September 2025
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
Dr Steve Ross, sar@prolightdx.com
Contact information
Public, Scientific, Principal Investigator
Psyros Diagnostics
Building 500
Discovery Park
Sandwich
CT13 9FE
United Kingdom
 ORCID ID |
0000-0002-2230-5169 |
|---|---|
| Phone | +44 (0)7793202169 |
| sar@prolightdx.com |
Study information
| Study design | Blood sample collection study to confirm prototype in vitro diagnostic performance |
|---|---|
| Primary study design | Other |
| Secondary study design | |
| 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 | Blood sample collection for final product development and estimation of clinical sensitivity and specificity of a point-of-care troponin test based on single molecule counting |
| Study objectives | The study will provide fresh blood and samples for testing a prototype point-of-care blood test for troponin. The results will be used to confirm that the system functions properly, give the same result for plasma and whole blood and can compensate for variations in hematocrit. |
| Ethics approval(s) |
Not yet submitted (United Kingdom) |
| Health condition(s) or problem(s) studied | Diagnosis of myocardial infarction |
| Intervention | Blood collection study for testing on prototype point-of-care in vitro diagnostic platform. Participants are first consented to take additional blood samples. They are given up to 3 hours to review the participant information sheet. If they consent, then up to 20 ml of blood is taken into lithium heparin tubes. This takes approximately 5 minutes. There is no further intervention or follow-up. |
| Intervention type | Other |
| Primary outcome measure | The concentration of troponin in the blood sample is measured 10 times to estimate the imprecision of the prototype device being tested. Similarly, the concentration of troponin is measured in the corresponding plasma sample 10 times to estimate the imprecision in the measurement. The measured concentration in the blood and plasma samples from all patients are compared to estimate the degree of correlation. Blood samples are taken at a single timepoint. |
| Secondary outcome measures | The measured hematocrit on the prototype device is compared to the measurement on a hematocrit centrifuge to estimate the correlation. Blood samples are taken at a single timepoint. |
| Overall study start date | 18/04/2024 |
| Completion date | 01/09/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 90 Years |
| Sex | Both |
| Target number of participants | 120 |
| Key inclusion criteria | 1. Capacity to give consent 2. >18 years of age 3. Presentation at ED with chest pains and symptoms of myocardial infarction 4. Measured troponin concentration > 10 ng/L in previous 24 hours. |
| Key exclusion criteria | 1. Age <18 years 2. Inability to give consent |
| Date of first enrolment | 01/08/2024 |
| Date of final enrolment | 01/08/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
SE1 7EH
United Kingdom
Sponsor information
Industry
Building 500
Discovery Park
Sandwich
CT13 9FE
England
United Kingdom
| Phone | +44 (0)1304 799850 |
|---|---|
| ajm@prolightdx.com | |
| Website | https://prolightdx.com/en/ |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/07/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during the current study are not expected to be made available due to the fact they are used during product development. |
Editorial Notes
19/04/2024: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
