GUM remote testing V4.0
Research type
Research Study
Full title
Verifying remote low volume blood tests for genitourinary infections including syphilis and bloodborne viruses
IRAS ID
326111
Contact name
Cressida Auckland
Contact email
Sponsor organisation
Royal Devon University Healthcare NHS Trust
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Capillary blood samples can be taken by patients from their own finger without requiring a healthcare professional to take a blood sample. Samples taken this way can be posted from home. This crucially avoids visits to the clinic or hospital to have blood samples taken. It would reduce the burden on healthcare professionals and is often preferred by patients. It is important to demonstrate that the results of an analysis performed on capillary blood samples are equivalent to the analysis of a standard venous sample.
This study aims to collect, in parallel to a standard venous blood sample, a capillary blood sample taken by the participant which is then added to specially designed filter paper (dried plasma spot sample) or other collection devices. Parallel analysis of paired samples will then allow us to assess if results measured in samples taken using the two methods are similar.
We will recruit 40 participants for each collection device to this study. We want to obtain a range of positive and negative results from the study participants and from stored samples and quality control material.Finger prick capillary blood samples offer a way that people can test themselves at home and be called into clinic when necessary to discuss test results. Patients already self-test for other samples such as swabs, and this has proved a popular and cost effective way to diagnose infection.
However, it is important that any new method of blood sampling is proven to have equivalence before tests are used to help guide medical decisions. We therefore need to assess whether a sample taken from a finger prick capillary sample gives the same results as a standard blood sample taken from a vein in the arm.REC name
London - Queen Square Research Ethics Committee
REC reference
24/LO/0080
Date of REC Opinion
2 Feb 2024
REC opinion
Favourable Opinion