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Blood collection for the development of a point-of-care troponin platform

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

Status
Recruiting
Phases
Unknown
Study type
Unknown
Source
ISRCTN
Registry ID
ISRCTN13589405
Enrollment
120
Registered
2024-05-17
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnosis of myocardial infarction Circulatory System

Interventions

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 t

Sponsors

Psyros Diagnostics
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: 1. Age <18 years 2. Inability to give consent

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

England, United Kingdom

Contacts

Public ContactSteve Ross
sar@prolightdx.com+44 (0)7793202169

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026