Human Immunodeficiency Virus Fingerprick Study
Research type
Research Study
Full title
Validation of the use of capillary blood collected by fingerprick for the detection of Human Immunodeficiency Virus (HIV-1) RNA on the GeneXpert molecular diagnostic system
IRAS ID
208516
Contact name
Sarah Fidler
Contact email
Sponsor organisation
Imperial College London and Imperial College Healthcare NHS Trust
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
People living with HIV undergo regular HIV viral load testing. This test measures the amount of HIV in a body fluid and typically is measured in the blood. An HIV clinic uses the results of this and other tests to monitor health and helps inform decisions about treatment, and if a patient is on treatment, confirms whether treatment is working.
Current HIV viral load tests are performed in a laboratory and require blood to be taken from a vein via needle stick, which some individuals find invasive and uncomfortable. One additional drawback to the current testing method is the turnaround time for the result to come back and can be up to 1-2 weeks. Not only may individuals be anxious to get their HIV viral load results back, clinical decisions may also be delayed.
Having a reliable point of care (POC) HIV viral load test with a faster turnaround time would improve acceptability to patients and improve clinical care by offering same-day results of HIV viral load.
A new type of POC HIV viral load test has been developed using blood inserted into a cartridge and analysed in a machine which can be operated in the clinic, thus eliminating the need for blood to be sent to a laboratory off-site. Results can be processed within 110 minutes. This new type of POC HIV viral load test has been approved in the EU for use from venous blood but has not yet been tested and compared for use from a finger prick (capillary) blood sample.
Therefore we would like to validate this test and assess whether POC HIV viral load test results obtained with finger prick (capillary) blood match those obtained from venous blood from HIV positive individuals both on and off antiretroviral therapy.REC name
London - Westminster Research Ethics Committee
REC reference
16/LO/1238
Date of REC Opinion
8 Jul 2016
REC opinion
Favourable Opinion