SARS-CoV2 InfectionSETCOVNCT04889365
COVID-19 Antigen Rapid Test Kit
An observational study of SARS-CoV2 Infection, run by Polish Society of Disaster Medicine at 1 site in Poland.
Trial summary
The SG Diagnostics COVID-19 Antigen Rapid Test Kit (Colloidal Gold-Based) is a single-use test kit intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. This test is intended for use with self-collected nasal swab samples in individuals who are suspected of COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV2 Infection
- What is being tested?
- SG Diagnostics COVID-19 Antigen Rapid Test Kit and Polymerase chain reaction (PCR) test
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 11 May 2021to 10 Jul 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Volunteers with or without COVID-19 symptoms
Who may be able to join
- Adult (aged ≥ 18 years) volunteers
Who cannot join
- Children (aged < 18years)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of SG Diagnostics COVID-19 Antigen Rapid Test Kit for Self-testing as a Method for Reduction SARS-CoV-2
The SG Diagnostics COVID-19 Antigen Rapid Test Kit (Colloidal Gold-Based) is a single-use test kit intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. This test is intended for use with self-collected nasal swab samples in individuals who are suspected of COVID-19. This test utilizes a lateral flow immunoassay technology for the qualitative detection of spike and nucleocapsid protein antigens of SARS-CoV-2 in individuals with known or suspected COVID-19.
- Conditions
- SARS-CoV2 Infection
- Being tested
- SG Diagnostics COVID-19 Antigen Rapid Test Kit, Polymerase chain reaction (PCR) test
- Keywords
- SARS-CoV-2, COVID-19, symptoms, test
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SG Diagnostics COVID-19 Antigen Rapid Test KitDiagnostic test
SG Diagnostics COVID-19 Antigen Rapid Test Kit (self-use)
Polymerase chain reaction (PCR) testDiagnostic test
Professional collection of a second swab sample, for confirmation by PCR
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 positive, asymptomatic | COVID-19 positive, asymptomatic (i.e. no current symptoms of COVID-19, confirmed PCR positive for COVID-19) Receives: Diagnostic Test: SG Diagnostics COVID-19 Antigen Rapid Test Kit; Diagnostic Test: Polymerase chain reaction (PCR) test | |
| COVID-19 positive, symptomatic | COVID-19 positive, symptomatic (i.e. current symptoms of COVID-19, confirmed PCR positive for COVID-19) Receives: Diagnostic Test: SG Diagnostics COVID-19 Antigen Rapid Test Kit; Diagnostic Test: Polymerase chain reaction (PCR) test | |
| COVID-19 negative | COVID-19 negative (i.e. no current or previous symptoms of COVID-19, confirmed PCR negative for COVID-19) Receives: Diagnostic Test: SG Diagnostics COVID-19 Antigen Rapid Test Kit; Diagnostic Test: Polymerase chain reaction (PCR) test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of SG Diagnostics COVID-19 Antigen Rapid Test Kit
Sensitivity of SG Diagnostics COVID-19 Antigen Rapid Test Kit (self-use)
Measured: within 1 day
Specificity of SG Diagnostics COVID-19 Antigen Rapid Test Kit
Specificity of SG Diagnostics COVID-19 Antigen Rapid Test Kit (self-use)
Measured: within 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start11 May 2021
- Primary completion30 Jun 2021 (estimated)
- Study completion10 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV2 InfectionStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Polish Society of Disaster Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889365
- Sponsor's protocol ID
- PTMK_2021_01
- Acronym
- SETCOV
- Status last verified
- May 2021
- First submitted
- 10 May 2021
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of SG Diagnostics COVID-19 Antigen Rapid Test Kit for Self-testing as a Method for Reduction SARS-CoV-2
- ClinicalTrials.gov ID
- NCT04889365
- Acronym / sponsor ID
- SETCOV / PTMK_2021_01
- Conditions
- SARS-CoV2 Infection
- Keywords
- SARS-CoV-2, COVID-19, symptoms, test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Polish Society of Disaster MedicineUniversity, hospital or other
- Study start
- 11 May 2021 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 10 Jul 2021 (estimated)
- First posted
- 17 May 2021 (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 SG Diagnostics COVID-19 Antigen Rapid Test Kit (Colloidal Gold-Based) is a single-use test kit intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. This test is intended for use with self-collected nasal swab samples in individuals who are suspected of COVID-19. This test utilizes a lateral flow immunoassay technology for the qualitative detection of spike and nucleocapsid protein antigens of SARS-CoV-2 in individuals with known or suspected COVID-19.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COVID-19 positive, asymptomatic | – | Diagnostic Test: SG Diagnostics COVID-19 Antigen Rapid Test Kit, Diagnostic Test: Polymerase chain reaction (PCR) testCOVID-19 positive, asymptomatic (i.e. no current symptoms of COVID-19, confirmed PCR positive for COVID-19) |
| COVID-19 positive, symptomatic | – | Diagnostic Test: SG Diagnostics COVID-19 Antigen Rapid Test Kit, Diagnostic Test: Polymerase chain reaction (PCR) testCOVID-19 positive, symptomatic (i.e. current symptoms of COVID-19, confirmed PCR positive for COVID-19) |
| COVID-19 negative | – | Diagnostic Test: SG Diagnostics COVID-19 Antigen Rapid Test Kit, Diagnostic Test: Polymerase chain reaction (PCR) testCOVID-19 negative (i.e. no current or previous symptoms of COVID-19, confirmed PCR negative for COVID-19) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers with or without COVID-19 symptoms
Key inclusion criteria (1 listed)
- Adult (aged ≥ 18 years) volunteers
Key exclusion criteria (1 listed)
- Children (aged < 18years)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SG Diagnostics COVID-19 Antigen Rapid Test KitSG Diagnostics COVID-19 Antigen Rapid Test Kit (self-use) | Diagnostic test | COVID-19 negative, COVID-19 positive, asymptomatic, COVID-19 positive, symptomatic |
| Polymerase chain reaction (PCR) testProfessional collection of a second swab sample, for confirmation by PCR | Diagnostic test | COVID-19 negative, COVID-19 positive, asymptomatic, COVID-19 positive, symptomatic |
Primary outcome
Sensitivity of SG Diagnostics COVID-19 Antigen Rapid Test Kit
Time frame: within 1 day
Sensitivity of SG Diagnostics COVID-19 Antigen Rapid Test Kit (self-use)
Specificity of SG Diagnostics COVID-19 Antigen Rapid Test Kit
Time frame: within 1 day
Specificity of SG Diagnostics COVID-19 Antigen Rapid Test Kit (self-use)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV2 Infection, run by Polish Society of Disaster Medicine at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 17 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
Results are not available in the source record.
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?
Sensitivity of SG Diagnostics COVID-19 Antigen Rapid Test Kit (time frame: within 1 day). The study lists 2 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 17 May 2021.