1. Can I join the UniCoV study if I've had COVID-19?
If you have had COVID-19 three or more months ago, you can join the study. If you had COVID-19 less than three months ago, then you cannot join the study.
2. Is the UniCoV study open to both vaccinated and unvaccinated people?
Yes. Vaccinated, partially vaccinated and unvaccinated people can join the study if they have no symptoms. Individuals with symptoms are recommended to follow the routine clinical pathway and make contact with their GP.
3. What happens next if I agree to join this study?
If you decide to join as a volunteer, you will be asked to read the Participant Information Leaflet and Consent Form and complete and sign the Consent Form.
4. What will happen to the samples I give?
Volunteers will be provided with clear instructions on how to provide high-quality samples by way of a video. https://youtu.be/AZwd15I5bKU
The saliva and nasal swab samples collected will be tested for the presence of SARS-CoV-2 using different testing methods – Saliva PCR, Saliva LAMP, and/or Lateral Flow Antigen Test.
We would like to collect a nasopharyngeal swab sample from you on one occasion. This would be used for comparisons between different testing methods. Nasopharyngeal swab samples will be taken by trained personnel using HSE protocols.
5. Will my details be kept confidential?
Yes. Best ethical and legal practices will be followed to ensure that all your information will be handled in confidence. Your personal details will never be released and your samples will be anonymised and kept in secure locations. Your samples will be labelled with a unique sample study number. Access to your personal details will only be available to clinical staff on this project. De-personalised, anonymised data about your sample will be stored in a secure electronic archive (hard drive). You will not be identified personally in any report or publication arising from the analysis of your samples and/or data.
6. What are the disadvantages of joining the research study?
You will encounter no significant risks or disadvantages from contributing saliva or nasal swab samples to this research study. The nasopharyngeal swab might feel uncomfortable. However, there is a possibility that testing of the samples may generate a positive result. If that happens a member of the research team will contact you by telephone and/or email to inform you. You will be provided with instructions on how to make an appointment to get a SARS-CoV-2 test in an official clinical HSE testing centre.
7. Can I know the results obtained from my study samples?
The result of your rapid antigen test will be visible to you on the test cartridge. The result of your saliva test will be emailed to you 24 hours after dropping off the sample, if the sample is dropped off on Monday and Thursday before 11 am. In the event that your sample yields a positive indication for SARS-CoV-2, we can assist in arranging for an official SARS- CoV-2 test conducted in an official clinical HSE testing centre (where this is available under the latest Guidelines) and advised to follow the latest HSE Guidelines.
8. Are there any payments and what happens if an invention is made using my sample/data?
Your donated samples and related information are given as an absolute gift, i.e. without receiving payment and without conditions, even in the event of your incapacity or death.
9. What if I no longer want to be in the research study?
You are free to withdraw from participation in the research study at any time without giving a reason. If you choose to withdraw, you can either (1) ask us to stop further contact with you but allow us to continue accessing your existing samples for the COVID-19 research study, or (2) you can ask us to also stop further use of your data and destroy your remaining samples. Any research already done with your data and samples cannot be undone.
10. Who can I contact if I lost or need more supplies?
If you need more supplies, contact your local Research Team via email firstname.lastname@example.org.
11. How do I withdraw from the study?
You can withdraw from the study at any stage. Contact the local UniCoV research team at the email address email@example.com to discuss your withdrawal.
12. If I miss the deadline to submit my saliva samples, should I still drop them off?
If it is Monday and you have taken your samples, but you missed the allocated time for drop off, yes, please proceed to drop off. However, there is no guarantee your Monday sample with be processed. Make sure you resume the normal schedule on Thursday.
13. If I forget to perform my rapid nasal swab test on the designated day, what should I do?
We would like you to take the rapid nasal swab test on the designated days, Monday and Thursday. It is important that both tests, rapid nasal swab test and saliva test are performed at the same time. This allows us to have 'matched' samples and compare the performance of both tests. However, we are all human and if you miss the designated day e.g. Monday, you may take it on Tuesday or Wednesday on this week ONLY. Please ensure to upload your results via the website. It is important you resume your normal schedule on Thursday taking both tests.
14. If I skip submitting one saliva sample, should I carry on and continue to follow the schedule to submit the next one?
We would like you to take the saliva test on the designated days, Monday and Thursday. It is important that both tests rapid nasal swab test and saliva test are performed at the same time on the same day. This allows us to have 'matched' samples and compare the performance of both tests. However, we are all human and if you miss the designated day e.g. Monday, you may take it on Tuesday or Wednesday on this week ONLY. Please ensure to upload your results via the website. It is important you resume your normal schedule on Thursday taking both tests.
15. If my rapid nasal swab test shows a positive result, what should I do?
If your rapid nasal swab test shows a positive result, you should follow the instructions as per the instructional video and HSE guidelines and click the link provided to contact the UniCoV Clinical team.
a) Upload your results via the Test Result page
b) Ensure that you upload a photograph of the result as well as ticking the appropriate box 'positive' 'negative' or 'indeterminate'
c) Follow the HSE guidelines and the research team will be in touch with you regarding the next steps. This will include advising you to restrict your movements and organising a test appointment for the HSE nasopharyngeal swab test which is the gold standard PCR test
d) Contact your local research team at firstname.lastname@example.org to arrange optimal collection of the saliva sample
16. How sensitive and specific are the UniCoV rapid nasal swab tests? Are false positives and false negatives possible?
The sensitivity of a test measures the chance of getting a false-positive result. This is measured in a percentage. For the rapid nasal swab test kits in UniCoV, there is a 99% chance that a test shows a positive result when it is positive.