HPValidate
Research type
Research Study
Full title
Clinical Validation of hrHPV test system using self-collected vaginal samples in NHS England commissioned laboratories providing cervical screening services.
IRAS ID
286052
Contact name
Ann-Marie Wright
Contact email
Sponsor organisation
UKHSA
Duration of Study in the UK
0 years, 6 months, 31 days
Research summary
An evaluation of self-sampling as a primary screening offer is being planned within the Cervical Screening Programme (CSP). A process is required to validate a self-sampling device(s) to directly capture exfoliated cells for testing in combination with a hrHPV test currently validated and accepted in the cervical screening programme. The validation aims to test the accuracy of detecting human papillomavirus (HPV) on vaginal self-samples when compared with samples taken by a clinician in a clinical environment. It will involve using a self-sampling device either CE marked for use in the home environment or for use in a clinical setting.
Participants will be recruited from colposcopy units because they need to showing a persistent HPV infection. This will test for sensitivity of the self-sample device. Participants will also be recruited from primary care and this will test for specificity of the self-sample device.
The result of the samples will be analysed and recommendations made as to the accuracy of self-sampling test systems and if they could be used safely to clinically manage participants in the programme. In addition permission will be sought to keep excess aliquots of both clinician samples and self-samples in a storage for future validation purposes. The validation aims to recruit approx. 2000 participants.
Participants will also be asked to complete a questionnaire based on their experience of using the self-sample device. The results of which will help inform the choice of test carried forward forward.
REC name
London - Stanmore Research Ethics Committee
REC reference
20/LO/1009
Date of REC Opinion
27 Oct 2020
REC opinion
Further Information Favourable Opinion