Hepatitis B and Hepatitis C, HIV Infections, Syphilis Infection
Conditions
Brief summary
Capillary blood sample results are compared to venous blood results
Detailed description
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 the investigators to assess if results measured in samples taken using the two methods are similar. The investigators will recruit 40 participants for each collection device to this study. It is important to obtain a range of positive and negative results from the study participants, and from stored samples and quality control material.
Interventions
DIAGNOSTIC_TESTHIV diagnostic testing
Finger-prick capillary blood will be tested alongside venous blood
Sponsors
Royal Devon and Exeter NHS Foundation Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Comparative study of two collection methods for blood samples
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults * Able and willing to provide informed consent. * Already having a venous blood sample for clinical care
Exclusion criteria
* Failure to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparative capillary and venous samples screening testing | 1 year | To have sufficient parallel samples (capillary and venous) collected to demonstrate equivalence of the results of HIV, HBV, HCV and syphilis testing using the Roche Cobas e601 platform |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparative capillary and venous samples confirmatory testing | 1 year | To have sufficient parallel samples (capillary and venous) collected to demonstrate equivalence of the results of HIV, HBV, HCV and syphilis testing using other platforms and for viral load |
Countries
United Kingdom
Contacts
Primary ContactCressida Auckland
Backup ContactAlison Kerridge
Outcome results
None listed