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Capillary blood sample results are compared to venous blood results
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Any client attending clinic for venous blood sampling | Experimental | Any client attending clinic for venous blood sampling for sexually transmitted disease diagnostics will also collect capillary blood using a finger prick |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIV diagnostic testing | Diagnostic Test | Finger-prick capillary blood will be tested alongside venous blood |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparative capillary and venous samples screening testing | 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 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Comparative capillary and venous samples confirmatory testing | 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 | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cressida Auckland | Contact | 01392 406459 | cressida.auckland@nhs.net | |
| Alison Kerridge | Contact | 01392 403055 | rduh.research-eastern@nhs.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Devon University Hospital NHS Foundation Trust | Exeter | Devon | EX2 5AD | United Kingdom |
No data will be shared
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 30, 2025 | |
| Reset | Aug 15, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 30, 2025 | Aug 15, 2025 |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D006509 | Hepatitis B |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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Comparative study of two collection methods for blood samples
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D018178 | Flaviviridae Infections |