COVID-19NCT05119530
POC Study to Evaluate the Performance of the AcuVid COVID-19 Rapid Antigen Saliva Test
An observational study of COVID-19, run by Therma Bright Inc at 1 site in United States.
Trial summary
The AcuVid COVID-19 Rapid Antigen Saliva Test is a lateral flow immunoassay to detect SARS-CoV-2 nucleocapsid antigens in human saliva specimens from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset, or from individuals without symptoms or other… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- AcuVid COVID-19 Rapid Antigen Saliva Test
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2021to Jan 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study population will come from individuals visiting COVID-19 testing Centers for the purpose of obtaining a COVID-19 RT-PCR test results. Individuals will be approached to determine eligibility and obtain consent after they have provided a NP swab sample for their COVID-19 RT-PCR test.
Who may be able to join
- Participant is willing to sign verbal informed consent form.
- Age ≥12 and parents or legal guardians must consent as required by law.
- Participant is attending COVID-19 testing centre to provide a nasopharyngeal swab sample.
- Participant is willing to provide a self-collected saliva sample.
Who cannot join
- Participant has previously tested positive for COVID-19 within the past 90 days.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Covid Clinic Inc.
Modesto, California, 95356
Hazel Flores, 909-462-4161
Matthew Abinante, MD
About this study
Official title: U.S. POC Study to Evaluate the Performance of the AcuVid COVID-19 Rapid Antigen Saliva Test
The AcuVid COVID-19 Rapid Antigen Saliva Test is a lateral flow immunoassay to detect SARS-CoV-2 nucleocapsid antigens in human saliva specimens from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect.
The AcuVid COVID-19 Rapid Antigen Saliva Test performance will be compared to a high sensitivity FDA EUA approved RT-PCR COVID-19 test. Nasopharyngeal (for RT-PCR) swab results will be collected from subjects by healthcare providers at CLIA Waived COVID-19 Testing Centers, and on the same day the subjects will also provide saliva samples which will be tested and interpreted by the healthcare providers.
This prospective, observational, study will test up to 300 participants to establish the performance characteristics of the AcuVid test on saliva specimens.
- Conditions
- COVID-19
- Being tested
- AcuVid COVID-19 Rapid Antigen Saliva 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.
AcuVid COVID-19 Rapid Antigen Saliva TestDiagnostic test
The AcuVid COVID-19 Rapid Antigen Saliva Test is a lateral flow immunoassay to detect SARS-CoV-2 nucleocapsid antigens in human saliva specimens
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish performance of AcuVid COVID-19 Rapid Antigen Saliva Test
To establish the performance characteristics of the AcuVid COVID-19 Rapid Antigen Saliva Test in a point-of-care (POC) CLIA Waived setting with lay users (no laboratory experience) testing a participant that has self-collected a saliva specimen. Clinical accuracy of the AcuVid Test will be compared to RT-PCR test results. Accuracy refers to the (PPA, positive percent agreement (sensitivity) and (NPA, negative percent agreement (specificity) between the results of the AcuVid Test and the comparator RT-PCR test.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start6 Dec 2021
- Primary completion31 Dec 2021 (estimated)
- Study completionJan 2022 (estimated)
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
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Therma Bright Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119530
- Sponsor's protocol ID
- TB20-03
- Status last verified
- Dec 2021
- First submitted
- 11 Nov 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- U.S. POC Study to Evaluate the Performance of the AcuVid COVID-19 Rapid Antigen Saliva Test
- ClinicalTrials.gov ID
- NCT05119530
- Acronym / sponsor ID
- TB20-03
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Therma Bright IncIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 15 Nov 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 AcuVid COVID-19 Rapid Antigen Saliva Test is a lateral flow immunoassay to detect SARS-CoV-2 nucleocapsid antigens in human saliva specimens from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect.
The AcuVid COVID-19 Rapid Antigen Saliva Test performance will be compared to a high sensitivity FDA EUA approved RT-PCR COVID-19 test. Nasopharyngeal (for RT-PCR) swab results will be collected from subjects by healthcare providers at CLIA Waived COVID-19 Testing Centers, and on the same day the subjects will also provide saliva samples which will be tested and interpreted by the healthcare providers.
This prospective, observational, study will test up to 300 participants to establish the performance characteristics of the AcuVid test on saliva specimens.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population will come from individuals visiting COVID-19 testing Centers for the purpose of obtaining a COVID-19 RT-PCR test results. Individuals will be approached to determine eligibility and obtain consent after they have provided a NP swab sample for their COVID-19 RT-PCR test.
Key inclusion criteria (4 listed)
- Participant is willing to sign verbal informed consent form.
- Age ≥12 and parents or legal guardians must consent as required by law.
- Participant is attending COVID-19 testing centre to provide a nasopharyngeal swab sample.
- Participant is willing to provide a self-collected saliva sample.
Key exclusion criteria (1 listed)
- Participant has previously tested positive for COVID-19 within the past 90 days.
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 |
|---|---|---|
| AcuVid COVID-19 Rapid Antigen Saliva TestThe AcuVid COVID-19 Rapid Antigen Saliva Test is a lateral flow immunoassay to detect SARS-CoV-2 nucleocapsid antigens in human saliva specimens | Diagnostic test | – |
Primary outcome
Establish performance of AcuVid COVID-19 Rapid Antigen Saliva Test
Time frame: 1 day
To establish the performance characteristics of the AcuVid COVID-19 Rapid Antigen Saliva Test in a point-of-care (POC) CLIA Waived setting with lay users (no laboratory experience) testing a participant that has self-collected a saliva specimen. Clinical accuracy of the AcuVid Test will be compared to RT-PCR test results. Accuracy refers to the (PPA, positive percent agreement (sensitivity) and (NPA, negative percent agreement (specificity) between the results of the AcuVid Test and the comparator RT-PCR test.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- 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.
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 Therma Bright Inc 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 4 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 11 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hazel Flores (909-462-4161, hazel@covidclinic.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish performance of AcuVid COVID-19 Rapid Antigen Saliva Test (time frame: 1 day). 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 Jan 2022.