HF Summative Research on Covid-19 Antibody Test Kit. V1
Research type
Research Study
Full title
Human Factors Summative Research Study Investigating the Usability of the Thriva Covid-19 Antibody Test Kit by Adolescents in the United Kingdom
IRAS ID
307079
Contact name
Leanne Verwey
Contact email
Sponsor organisation
Thriva Limited
Duration of Study in the UK
0 years, 0 months, 16 days
Research summary
This research is a usability (Human Factors) study. The intention is to explore the ease of use of a Covid-19 test kit by adolescents in the United Kingdom. The research participants will take part in the actual use of the Covid-19 test kit. Each participant will be given a test kit and asked to use the instructions provided to complete the task of taking a blood sample and packaging it ready for posting to the laboratory.
This is not a clinical study. The blood samples will be sent to the client’s laboratory and tested only in order to determine whether the samples are valid or void. The blood samples will be de-identifed and no data will be generated which is clinically relevant to the participants. This is a qualitative study involving observations of participants using the Covid-19 test kit.
There will be two sets of participants
16-17 year-olds. There will be 16 participants in this group. The participants will use the test kit on their own.
12-15 year-olds. There will be 30 participants in this group. 15 participants will use the Covid-19 test kit with adult supervision (parent or guardian) and 15 participants will have an adult (parent or guardian) lead the use of the Covid-19 test kit.
It is planned to conduct the study over 3 different locations: Birmingham, London and Dorset. The study will take place over a two-week period.
The participants will be observed throughout the study and the test team will intervene if necessary, in the event of unforeseen circumstances which could otherwise lead to harm to the participants or someone else present. Once the participant has completed the task the test team will ask questions about their experience using the Covid-19 test kit.REC name
South Central - Oxford A Research Ethics Committee
REC reference
21/SC/0390
Date of REC Opinion
8 Dec 2021
REC opinion
Further Information Favourable Opinion