COVID-19CV009NCT05605769
Evaluation of the Performance of Rapid Diagnostics for SARS-CoV-2 Self-testing in the Hands of Untrained
An observational study of COVID-19, run by Foundation for Innovative New Diagnostics, Switzerland at 2 sites in 2 countries.
Trial summary
The aim of this study is to independently evaluate the usability and performance of rapid assays detecting SARS-CoV-2 antigen(s) and intended for self-testing. For this, the results of the test performed and interpreted by an untrained lay user will be compared to the results obtained by a trained healthcare… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- How many people
- 3,266 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 13 Jul 2022to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants from general population who are able to read the local language and have no prior experience with covid self-specimen collection and testing. For Phase II, (less than 18 years) old suspected to be infected with SARS-CoV-2 (as per national or WHO guidelines) presenting at the testing site(s) will be invited to participate. Participants will come from the following countries: Georgia, South Africa, Uganda and Peru
Phase 1 Inclusion Criteria:
- 18 years of age
- Able to speak and read local language depending on site of recruitment
- Provided voluntary written consent to participate in this stud
Phase 11 inclusion Criteria:
- 18 years of age
- Able to speak and read local language depending on site of recruitment
- Suspected to have COVID-19 (as per WHO or national guidelines).
- SYMPTOMATIC group)
- Contacts of confirmed cases of COVID-19
- Individuals residing or working in an area with high risk of transmission of virus
- Individuals residing or travelling to an area with community transmission
- Individuals working in any health care setting, including within health facilities or within the community
- Written consent
- Provided the required number of specimens suitable for testing. Exclusion criteria
- Participated in Phase I or Phase II of the study
- Prior medical or clinical laboratory training
- Prior experience with self-testing for SARS-CoV-2
- Hemodynamic instability as determined by the treating physician
- unable to cooperate with respiratory sample collection or on oxygen therapy
- Recent history of excessive nose bleeds
- Any condition which, in the opinion of the investigator feels unable to participate in the study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Evaluation of the Performance of Rapid Diagnostics for SARS-CoV-2 Self-testing in the Hands of Untrained Users
The aim of this study is to independently evaluate the usability and performance of rapid assays detecting SARS-CoV-2 antigen(s) and intended for self-testing. For this, the results of the test performed and interpreted by an untrained lay user will be compared to the results obtained by a trained healthcare professional using the same test kit, and, separately, to the current gold standard for testing, RT-PCR detecting SARS-CoV-2 RNA
Read the detailed description
The COVID-19 pandemic has rapidly spread across the globe. As 03 March 2022, there are approximately 438 517 285 confirmed cases worldwide. Recent surge of new infections globally due to omicron variant led to significant increase of testing demand. Although rapid diagnostic tests (RDT) detecting SARS-CoV-2 antigens are now authorized in most countries and contribute substantially to expanding of testing capacity, shortage of healthcare resources is an important barrier to further scale up. Self-testing has been widely used in many high-income countries as an additional tool to provide convenient and timely access to testing. A number of self-tests detecting SARS-CoV-2 have been authorized by stringent regulatory authorities (SRA) such as US Food and Drug Administration (FDA), CE-IVD, Health Canada, Therapeutics Goods Administration (TGA) under an Emergency Use Authorization (EUA). In low- and middle-income countries (LMIC) self-testing for SARS-CoV-2 has not yet been widely adopted. Data on self-test use in LMIC are still very limited and the performance of SARS-CoV-2 self-test assays was not evaluated in LMIC settings. Additionally, the price for self-test kits is often prohibitive to its wide use in low resource settings. In 2021, FIND, the Diagnostic Alliance, through an open request for proposal (RFP) has identified several manufacturers of affordable and easy-to-use self-testing assays for SARS-CoV-2 antigen detection in nasal swabs and saliva specimens. FIND and [NAME OF THE PARTNER] aim to evaluate these novel affordable self-testing solutions in LMIC settings in a 2-phase study
- Conditions
- COVID-19
- Keywords
- Covid 19 self- testing, lay users
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the SARS-CoV-2 self-tests label comprehension by the intended users by assessing the extent to which the users understand the information in the self-test labelling
Proportion of study participants that correctly comprehend key messages from packaging and labelling measured by the proportion of participants providing correct responses to a self-administered semi-structured question
Measured: 4 weeks
To determine the ability of the intended users to correctly interpret testing results by evaluating the correctness of user's interpretation of contrived results
Percentage of the agreement between the pre-defined results of contrived self-testing devices and their interpretation by study participants
Measured: 4 weeks
Phase 11 Outcomes
- Proportion of participants that performed the self-testing procedure correctly and usability index of each testing step (Proportion of participants that performed each step correctly); documented errors and difficulties faced at each self-testing step
Measured: 6weeks
Secondary outcomes (2)
To evaluate the usability in specific subgroups defined based on demographic characteristics such as age and education level
Proportion of participants that correctly comprehend key messages from packaging and labelling, performed the self-testing procedure and interpreted the results correctly in specific subgroups defined based on age and educational level. Documented errors and difficulties at each self-testing step in these subgroups
Measured: 6 weeks
To evaluate diagnostic accuracy of SARS-CoV-2 self-tests in specific subgroups defined based on the presence of symptoms, RT-PCR Ct values, vaccination status
Point estimates of sensitivity and specificity of index test with 95% confidence intervals in specific subgroups defined based on presence of symptoms, RT-PCR Ct values, vaccination status
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start13 Jul 2022
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maia Alkhazashvili, MD, Principal investigator, Lugar CentreIsaac Ssewanyana, Phd, Principal investigator, Uganda National Laboratory ServicesMohhamed Majam, Msc, Principal investigator, Ezintsha Research CentreCesar Ugarte, Phd, Principal investigator, UPCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05605769
- Sponsor's protocol ID
- CV009
- Acronym
- CV009
- Status last verified
- Oct 2023
- First submitted
- 31 Oct 2022
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance of Rapid Diagnostics for SARS-CoV-2 Self-testing in the Hands of Untrained Users
- ClinicalTrials.gov ID
- NCT05605769
- Acronym / sponsor ID
- CV009 / CV009
- Conditions
- COVID-19
- Keywords
- Covid 19 self- testing, lay users
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,266 participants (actual)
- Lead sponsor
- Foundation for Innovative New Diagnostics, SwitzerlandUniversity, hospital or other
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 4 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to independently evaluate the usability and performance of rapid assays detecting SARS-CoV-2 antigen(s) and intended for self-testing. For this, the results of the test performed and interpreted by an untrained lay user will be compared to the results obtained by a trained healthcare professional using the same test kit, and, separately, to the current gold standard for testing, RT-PCR detecting SARS-CoV-2 RNA
Detailed description
The COVID-19 pandemic has rapidly spread across the globe. As 03 March 2022, there are approximately 438 517 285 confirmed cases worldwide. Recent surge of new infections globally due to omicron variant led to significant increase of testing demand. Although rapid diagnostic tests (RDT) detecting SARS-CoV-2 antigens are now authorized in most countries and contribute substantially to expanding of testing capacity, shortage of healthcare resources is an important barrier to further scale up. Self-testing has been widely used in many high-income countries as an additional tool to provide convenient and timely access to testing. A number of self-tests detecting SARS-CoV-2 have been authorized by stringent regulatory authorities (SRA) such as US Food and Drug Administration (FDA), CE-IVD, Health Canada, Therapeutics Goods Administration (TGA) under an Emergency Use Authorization (EUA). In low- and middle-income countries (LMIC) self-testing for SARS-CoV-2 has not yet been widely adopted. Data on self-test use in LMIC are still very limited and the performance of SARS-CoV-2 self-test assays was not evaluated in LMIC settings. Additionally, the price for self-test kits is often prohibitive to its wide use in low resource settings. In 2021, FIND, the Diagnostic Alliance, through an open request for proposal (RFP) has identified several manufacturers of affordable and easy-to-use self-testing assays for SARS-CoV-2 antigen detection in nasal swabs and saliva specimens. FIND and [NAME OF THE PARTNER] aim to evaluate these novel affordable self-testing solutions in LMIC settings in a 2-phase study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants from general population who are able to read the local language and have no prior experience with covid self-specimen collection and testing. For Phase II, (less than 18 years) old suspected to be infected with SARS-CoV-2 (as per national or WHO guidelines) presenting at the testing site(s) will be invited to participate. Participants will come from the following countries: Georgia, South Africa, Uganda and Peru
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the SARS-CoV-2 self-tests label comprehension by the intended users by assessing the extent to which the users understand the information in the self-test labelling
Time frame: 4 weeks
Proportion of study participants that correctly comprehend key messages from packaging and labelling measured by the proportion of participants providing correct responses to a self-administered semi-structured question
To determine the ability of the intended users to correctly interpret testing results by evaluating the correctness of user's interpretation of contrived results
Time frame: 4 weeks
Percentage of the agreement between the pre-defined results of contrived self-testing devices and their interpretation by study participants
Phase 11 Outcomes
Time frame: 6weeks
a. Proportion of participants that performed the self-testing procedure correctly and usability index of each testing step (Proportion of participants that performed each step correctly); documented errors and difficulties faced at each self-testing step
2 secondary outcomes
To evaluate the usability in specific subgroups defined based on demographic characteristics such as age and education level
Time frame: 6 weeks
To evaluate diagnostic accuracy of SARS-CoV-2 self-tests in specific subgroups defined based on the presence of symptoms, RT-PCR Ct values, vaccination status
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maia Alkhazashvili, MD principal investigator
Lugar Centre
Isaac Ssewanyana, Phd principal investigator
Uganda National Laboratory Services
Mohhamed Majam, Msc principal investigator
Ezintsha Research Centre
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Foundation for Innovative New Diagnostics, Switzerland at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the SARS-CoV-2 self-tests label comprehension by the intended users by assessing the extent to which the users understand the information in the self-test labelling (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.