COVID-19NCT05610449
Assessing Performance of the Testing Done Simple Covid 19 Antigen Test
An observational study of COVID-19, run by Testing Done Simple at 2 sites in United States.
Trial summary
This study will measure the sensitivity and specificity of the Testing Done Simple severe acute respiratory syndrome (SARS) CoV-2 antigen test in subjects with suspected Covid-19 that present throughout several urgent care clinics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Testing Done Simple SARS CoV-2 Antigen Test
- How many people
- 171 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Nov 2022to 29 Mar 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
- No healthy volunteers
- Adult, Older adult
Study population: The cohorts consist of a symptomatic group of patients with Covid related symptoms and an asymptomatic group of patients that may have been exposed to Covid through another person
Who may be able to join
- Subject was given a SARS CoV 2 PCR test for any of the following 4 reasons:
- Subject has Covid like symptoms that started within past (7) days
- Subject has been exposed to another individual with a known Covid diagnosis or probable Covid diagnosis
- Subject needs Covid test done for travel, school, work, etc
- Subject works in a high risk environment
- Subject can provide a nasal swab sample
Show all 9Show fewer
- Subject is at least 18 years of age
- Subject was given a SARS CoV 2 PCR test on same day participating this study
- Subject provides informed consent
Who cannot join
- Subject is less than 18 years of age
- Subject does not provide consent
- Subject's Covid 19 related symptom(s) started greater than 7 days from visit
- Asymptomatic subjects whom have had symptom(s) within past (14) days
- Signs of local infection in the area of the face
- Subject was not given a SARS CoV 2 PCR test on same day as study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Nao Medical Urgent Care-Astoria
Queens, New York, 11105
Nao Medical Urgent Care-Jackson Heights
Queens, New York, 11372
About this study
This study will measure the sensitivity and specificity of the Testing Done Simple severe acute respiratory syndrome (SARS) CoV-2 antigen test in subjects with suspected Covid-19 that present throughout several urgent care clinics. The antigen test performance will be compared to a real-time polymerase chain reaction (RT-PCR) test.
Read the detailed description
The Testing Done Simple antigen test is a lateral flow immunoassay that detects the presence of the SARS CoV-2 nucleoprotein and is primarily intended for use in an at home setting. The antigen test will be compared to a traditional RT-PCR tested nasal swab specimens. The purpose of study is to measure the performance of the Testing Done Simple test via sensitivity and specificity when compared to the gold-standard RT-PCR test. The test will be administered in symptomatic and asymptomatic subjects and participants will report the days that has passed since their symptom onset. The RT-PCR test will be performed prior to the Testing Done Simple test.
- Conditions
- COVID-19
- Being tested
- Testing Done Simple SARS CoV-2 Antigen Test
- Keywords
- Antigen test, Test, Diagnosis
- Medical subject headings
- COVID-19, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testing Done Simple SARS CoV-2 Antigen TestDiagnostic test
Collections of specimens from subjects presenting with Covid-19 like symptoms or known/suspected exposure to SARS CoV-2 via nasal swabs administered by trained medical personnel.
| Study group | Role | What they receive |
|---|---|---|
| Testing Done Simple Antigen test in Symptomatic Subjects (Nasal swab) | Not described Receives: Diagnostic Test: Testing Done Simple SARS CoV-2 Antigen Test | |
| Testing Done Simple Antigen test in Asymptomatic Subjects (Nasal swab) | Not described Receives: Diagnostic Test: Testing Done Simple SARS CoV-2 Antigen Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Sensitivity (True Positive Rate) of Testing Done Simple Antigen Test compared to RT-PCR
Measured: 15 minutes
Specificity
Specificity (True Negative Rate) of Testing Done Simple Antigen Test compared to RT-PCR
Measured: 15 minutes
Secondary outcomes (1)
Sensitivity in Relation to the Time Since Symptom Onset in Symptomatic subjects
Sensitivity of Testing Done Simple Antigen Test according to the days of symptom onset in symptomatic subjects
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start4 Nov 2022
- Primary completion17 Feb 2023
- Study completion29 Mar 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
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Testing Done Simple
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nao Medical Urgent Care
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610449
- Sponsor's protocol ID
- 7113211
- Status last verified
- May 2023
- First submitted
- 7 Nov 2022
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Performance of the Testing Done Simple Covid 19 Antigen Test
- ClinicalTrials.gov ID
- NCT05610449
- Acronym / sponsor ID
- 7113211
- Conditions
- COVID-19
- Keywords
- Antigen test, Test, Diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Testing Done SimpleIndustry (pharma, biotech, devices)
- Collaborators
- Nao Medical Urgent Care
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 17 Feb 2023 (actual)
- Study completion
- 29 Mar 2023 (actual)
- First posted
- 9 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.
This study will measure the sensitivity and specificity of the Testing Done Simple severe acute respiratory syndrome (SARS) CoV-2 antigen test in subjects with suspected Covid-19 that present throughout several urgent care clinics. The antigen test performance will be compared to a real-time polymerase chain reaction (RT-PCR) test.
Detailed description
The Testing Done Simple antigen test is a lateral flow immunoassay that detects the presence of the SARS CoV-2 nucleoprotein and is primarily intended for use in an at home setting. The antigen test will be compared to a traditional RT-PCR tested nasal swab specimens. The purpose of study is to measure the performance of the Testing Done Simple test via sensitivity and specificity when compared to the gold-standard RT-PCR test. The test will be administered in symptomatic and asymptomatic subjects and participants will report the days that has passed since their symptom onset. The RT-PCR test will be performed prior to the Testing Done Simple test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testing Done Simple Antigen test in Symptomatic Subjects (Nasal swab) | – | Diagnostic Test: Testing Done Simple SARS CoV-2 Antigen Test |
| Testing Done Simple Antigen test in Asymptomatic Subjects (Nasal swab) | – | Diagnostic Test: Testing Done Simple SARS CoV-2 Antigen Test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The cohorts consist of a symptomatic group of patients with Covid related symptoms and an asymptomatic group of patients that may have been exposed to Covid through another person
Key inclusion criteria (9 listed)
- Subject was given a SARS CoV 2 PCR test for any of the following 4 reasons:
- Subject can provide a nasal swab sample
- Subject is at least 18 years of age
- Subject was given a SARS CoV 2 PCR test on same day participating this study
- Subject provides informed consent
Key exclusion criteria (6 listed)
- Subject is less than 18 years of age
- Subject does not provide consent
- Subject's Covid 19 related symptom(s) started greater than 7 days from visit
- Asymptomatic subjects whom have had symptom(s) within past (14) days
- Signs of local infection in the area of the face
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 |
|---|---|---|
| Testing Done Simple SARS CoV-2 Antigen TestCollections of specimens from subjects presenting with Covid-19 like symptoms or known/suspected exposure to SARS CoV-2 via nasal swabs administered by trained medical personnel. | Diagnostic test | Testing Done Simple Antigen test in Asymptomatic Subjects (Nasal swab), Testing Done Simple Antigen test in Symptomatic Subjects (Nasal swab) |
Primary outcome
Sensitivity
Time frame: 15 minutes
Sensitivity (True Positive Rate) of Testing Done Simple Antigen Test compared to RT-PCR
Specificity
Time frame: 15 minutes
Specificity (True Negative Rate) of Testing Done Simple Antigen Test compared to RT-PCR
1 secondary outcome
Sensitivity in Relation to the Time Since Symptom Onset in Symptomatic subjects
Time frame: 15 minutes
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 15 May 2023.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Testing Done Simple at 2 sites in United States.
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 9 inclusion and 6 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: finished, as of the sponsor's last update on 15 May 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 United States. 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?
Sensitivity (time frame: 15 minutes). 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 15 May 2023; AzTrials last refreshed its copy on 6 Nov 2026.