Covid-19NCT05213897
Clinical Performance Evaluation of SARS-CoV-2 (COVID-19) Antigen Assay in Point of Care Settings
An observational study of Covid-19, run by Freedom For All Diagnostics at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the performance of Freedom For All Diagnostics, Inc.'s colloidal gold immune technology SARS-CoV-2 Antigen investigational assay when compared to a high-sensitivity Emergency Use Authorization (EUA) SARS-CoV-2 RT-PCR assay. Read more about this study
- Who is it for?
- Ages 2 to 94 years
- Conditions the study is for
- Covid-19
- What is being tested?
- SARS-CoV-2 Antigen Assay
- Type of treatment
- Medical device
- How many people
- 232 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2022to 1 Jun 2022
- 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 2 to 94 years
- All sexes
- Child, Adult, Older adult
Study population: Patients experiencing symptoms and presenting for testing of Covid-19.
Who may be able to join
- Subject suspected of having COVID-19 infection and within 7 days of symptom onset. This will include at least one of the following:
- Fever or chills
- Cough
- Shortness of breath or difficulty breathing
- Fatigue
- Muscle or body aches
Show all 13Show fewer
- Headache
- New loss of taste or smell
- Sore throat
- Congestion or runny nose
- In addition to the above primary symptoms, the Subject might also report nausea, vomiting and/or diarrhea, but these symptoms alone are not sufficient to include the Subject in the study.
- Subject is willing to provide consent/assent.
- Subject is willing to have two (2) nasopharyngeal swabs collected for the study and in the event of inconclusive results, be willing to return to the site to have two (2) more nasopharyngeal swabs
Who cannot join
- To be enrolled in the study, each Subject must not meet:
- Subject unable or unwilling to provide informed consent/assent.
- Subject tested positive for SARS-CoV-2 within the past 3 months.
- Subject has already participated in this study.
- Subject is a vulnerable population and deemed inappropriate for study by site Principal Investigator and/or IRB.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Performance Evaluation of SARS-CoV-2 Antigen Assay in Point of Care Settings
The purpose of this study is to evaluate the performance of Freedom For All Diagnostics, Inc.'s colloidal gold immune technology SARS-CoV-2 Antigen investigational assay when compared to a high-sensitivity Emergency Use Authorization (EUA) SARS-CoV-2 RT-PCR assay. The study will evaluate the accuracy in the intended use environment of the SARS-CoV-2 antigen assay when testing is conducted in a CLIA-waived setting (e.g., a physician's office or clinic) by non-laboratory personnel serving in a healthcare facility or setting.
Read the detailed description
The objective of this study is to demonstrate that non-laboratory personnel can accurately perform the SARS-CoV-2 Antigen assay in the intended use environment using nasopharyngeal samples by demonstrating that the assay can achieve a ≥ 80% sensitivity when it is compared to the results of a high sensitivity EUA SARSCoV-2 RT-PCR assay using nasopharyngeal samples. This study is designed as a prospective, blinded study to evaluate the sensitivity and specificity of the SARS-CoV-2 Antigen Assay when non-laboratory personnel conduct testing on Subjects presenting with symptoms of COVID-19.
A minimum of 30 positive and 30 negative samples are required in order to meet EUA submission guidelines. Enrollment will continue until both minimum requirements have been achieved.
- Conditions
- Covid-19
- Being tested
- SARS-CoV-2 Antigen Assay
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 Antigen AssayDevice
To demonstrate that non-laboratory personnel can accurately perform the SARS-CoV-2 Antigen assay in the intended use environment using nasopharyngeal samples by demonstrating that the assay can achieve a ≥ 80% sensitivity and specificity when it is compared to the results of a high sensitivity EUA SARSCoV-2 RT-PCR assay using nasopharyngeal samples.
| Study group | Role | What they receive |
|---|---|---|
| 30 subjects testing positive for Covid-19 | 30 subjects testing positive for Covid-19 using the proprietary SARS-CoV-2 Antigen Assay Receives: Device: SARS-CoV-2 Antigen Assay | |
| 30 subjects testing negative for Covid-19 | 30 subjects testing negative for Covid-19 using the proprietary SARS-CoV-2 Antigen Assay Receives: Device: SARS-CoV-2 Antigen Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assay Sensitivity - 80% (versus the EUA SARS-CoV-2 RT-PCR assay)
SARS-CoV-2 Antigen investigational assay shall have an observed sensitivity of at least 80% when the EUA SARS-CoV-2 RT-PCR assay for nasopharyngeal swabs is used as a reference method.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start27 Jan 2022
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
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
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Freedom For All Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CSSi Life Sciences
- Responsible party
- Sponsor
- Investigators
- Steven Geller, MD, Principal investigator, Centennial Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213897
- Sponsor's protocol ID
- FFA-CV19_1006
- Status last verified
- Jun 2022
- First submitted
- 25 Jan 2022
- Last updated
- 2 Jun 2022
- 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 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance Evaluation of SARS-CoV-2 Antigen Assay in Point of Care Settings
- ClinicalTrials.gov ID
- NCT05213897
- Acronym / sponsor ID
- FFA-CV19_1006
- Conditions
- Covid-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Freedom For All DiagnosticsIndustry (pharma, biotech, devices)
- Collaborators
- CSSi Life Sciences
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 28 Jan 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 purpose of this study is to evaluate the performance of Freedom For All Diagnostics, Inc.'s colloidal gold immune technology SARS-CoV-2 Antigen investigational assay when compared to a high-sensitivity Emergency Use Authorization (EUA) SARS-CoV-2 RT-PCR assay. The study will evaluate the accuracy in the intended use environment of the SARS-CoV-2 antigen assay when testing is conducted in a CLIA-waived setting (e.g., a physician's office or clinic) by non-laboratory personnel serving in a healthcare facility or setting.
Detailed description
The objective of this study is to demonstrate that non-laboratory personnel can accurately perform the SARS-CoV-2 Antigen assay in the intended use environment using nasopharyngeal samples by demonstrating that the assay can achieve a ≥ 80% sensitivity when it is compared to the results of a high sensitivity EUA SARSCoV-2 RT-PCR assay using nasopharyngeal samples. This study is designed as a prospective, blinded study to evaluate the sensitivity and specificity of the SARS-CoV-2 Antigen Assay when non-laboratory personnel conduct testing on Subjects presenting with symptoms of COVID-19.
A minimum of 30 positive and 30 negative samples are required in order to meet EUA submission guidelines. Enrollment will continue until both minimum requirements have been achieved.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30 subjects testing positive for Covid-19 | – | Device: SARS-CoV-2 Antigen Assay30 subjects testing positive for Covid-19 using the proprietary SARS-CoV-2 Antigen Assay |
| 30 subjects testing negative for Covid-19 | – | Device: SARS-CoV-2 Antigen Assay30 subjects testing negative for Covid-19 using the proprietary SARS-CoV-2 Antigen Assay |
Who may qualify
- Ages
- 2 to 94 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients experiencing symptoms and presenting for testing of Covid-19.
Key inclusion criteria (13 listed)
- Subject suspected of having COVID-19 infection and within 7 days of symptom onset. This will include at least one of the following:
- In addition to the above primary symptoms, the Subject might also report nausea, vomiting and/or diarrhea, but these symptoms alone are not sufficient to include the Subject in the study.
- Subject is willing to provide consent/assent.
- Subject is willing to have two (2) nasopharyngeal swabs collected for the study and in the event of inconclusive results, be willing to return to the site to have two (2) more nasopharyngeal swabs
Key exclusion criteria (5 listed)
- Subject unable or unwilling to provide informed consent/assent.
- Subject tested positive for SARS-CoV-2 within the past 3 months.
- Subject has already participated in this study.
- Subject is a vulnerable population and deemed inappropriate for study by site Principal Investigator and/or IRB.
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 |
|---|---|---|
| SARS-CoV-2 Antigen AssayTo demonstrate that non-laboratory personnel can accurately perform the SARS-CoV-2 Antigen assay in the intended use environment using nasopharyngeal samples by demonstrating that the assay can achieve a ≥ 80% sensitivity and specificity when it is compared to the results of a high sensitivity EUA SARSCoV-2 RT-PCR assay using nasopharyngeal samples. | Device | 30 subjects testing negative for Covid-19, 30 subjects testing positive for Covid-19 |
Primary outcome
Assay Sensitivity - 80% (versus the EUA SARS-CoV-2 RT-PCR assay)
Time frame: 48 hours
SARS-CoV-2 Antigen investigational assay shall have an observed sensitivity of at least 80% when the EUA SARS-CoV-2 RT-PCR assay for nasopharyngeal swabs is used as a reference method.
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 2 Jun 2022.
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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.
Steven Geller, MD principal investigator
Centennial Medical Group
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 Covid-19, run by Freedom For All Diagnostics at 1 site 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 13 inclusion and 5 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 2 Jun 2022. 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 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?
Assay Sensitivity - 80% (versus the EUA SARS-CoV-2 RT-PCR assay) (time frame: 48 hours). 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 2 Jun 2022.