COVID-19NCT06734741
Prospective Clinical Evaluation of COVID/Flu Detect™ Rapid Self-Test in Symptomatic Subjects for Non-Prescription Over-the-Counter (OTC) Use
An observational study of COVID-19 and Influenza A, run by InBios International, Inc. at 10 sites in United States.
Trial summary
The goal of this study is to evaluate the performance of the COVID/Flu Detect™ Rapid Self-Test when used in a home-like setting by lay users. The COVID/Flu Detect™ Rapid Self-Test is an investigational device intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein… Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- COVID-19, Influenza A, Influenza B
- What is being tested?
- COVID/Flu Detect™ Rapid Self-Test
- How many people
- 899 participants
- Where
- 10 sitesUnited States
- Study dates
- 26 Dec 2024to 19 May 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will be selected from at least three geographically diverse sites in the United States.
Who may be able to join
- Subjects must be at least 18 years of age, or at least 2 years of age and accompanied by parent or legal guardian.
- Subjects must be willing and able to give informed consent or assent (as age-appropriate).
- Subjects must be able to read/speak English (or Spanish at specific sites) if subject is an adult, minor aged 14 years or older, or parent/guardian of a child subject aged 2 through 13 years.
- Subjects must be currently exhibiting at least two of the following symptoms consistent with possible SARS-CoV-2 or influenza infection: fever or feeling feverish (in absence of documented fever), chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, nasal congestion or runny nose, nausea or vomiting, and/or diarrhea. Subjects must be within 5 days of symptoms onset at enrollment (the day that symptoms start is day 0).
Who cannot join
- Subject was previously enrolled in this study.
- Subject has undergone a nasal wash or nasal aspirate procedure on day of enrollment.
- Subject has an active nosebleed.
- Subject has received results of an influenza or COVID-19 test within the previous 5 days.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Cahaba Research
Birmingham, Alabama, 35242
ASR, LLC
Boise, Idaho, 83702
Medicus Health Research Group Inc
Miami, Florida, 33135
Eastside Research Associates
Midland, Texas, 79707
Ichan School of Medicine at Mount Sinai, Department of Emergency Medicine
New York, New York, 10029
ERA Health Research
Odessa, Texas, 79762
Barnes-Jewish Hospital
St Louis, Missouri, 63110
St. Louis Children's Hospital
St Louis, Missouri, 63110
Washington University School of Medicine
St Louis, Missouri, 63110
CHEAR Center LLC.
The Bronx, New York, 10455
About this study
The goal of this study is to evaluate the performance of the COVID/Flu Detect™ Rapid Self-Test when used in a home-like setting by lay users. The COVID/Flu Detect™ Rapid Self-Test is an investigational device intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens in nasal swab samples. Participants who are aged two (2) years and older and have symptoms of respiratory illness consistent with SARS-CoV-2 and influenza infection may be enrolled. Participants will use the COVID/Flu Detect™ Rapid Self-Test to self-collect, self-test, and interpret the results. Participants will have a nasal swab sample collected by a healthcare provider for comparator testing by PCR tests for SARS-CoV-2, influenza A, and influenza B. Researchers will compare the results of the COVID/Flu Detect™ Rapid Self-Test obtained by the participants to results from the PCR comparator tests to evaluate performance.
Read the detailed description
This study will be a multi-site, all-comers, clinical trial assessing the positive percent agreement (PPA) and negative percent agreement (NPA) of the COVID/Flu Detect™ Rapid Self-Test, an investigational qualitative lateral flow immunoassay intended for non-prescription over-the-counter (OTC) use. Participants who are aged 2 years and older and meet the eligibility criteria will be enrolled for testing on the COVID/Flu Detect™ Rapid Self-Test and for comparator testing on (1) an FDA-cleared or emergency use authorized (EUA) SARS-CoV-2 RT-PCR test, (2) an FDA-cleared influenza A RT-PCR test, and (3) an FDA-cleared influenza B RT-PCR test.
After obtaining informed consent, participants' age, sex, days post-symptom onset, signs and symptoms of respiratory illness, comorbidities, any medications taken or administered, influenza/COVID-19 vaccination history, race/ethnicity, socioeconomic status, and educational background will be collected. Next, two (2) anterior nasal swab samples will be collected from each participant, with at least a 15-minute normalization period between swab sample collections. One (1) of the nasal swab samples will be collected by a healthcare provider (HCP) from the participant. This nasal swab sample will be sent for comparator testing. The other nasal swab sample will be self-collected or collected by the participant's parent or legal guardian. Adults (participants aged 18 years or older) and older children (participants aged 14-17 years) will self-collect a nasal swab sample by swabbing both nostrils and will test the swab sample themselves on the COVID/Flu Detect™ Rapid Self-Test. For child participants aged 2-13 years, parents or legal guardians will collect a nasal swab sample from their child by swabbing both nostrils and will test the swab sample on behalf of their child on the COVID/Flu Detect™ Rapid Self-Test. The order of collection of the two nasal swab samples will be randomized. A third nasal swab sample may be collected by the participant or the participant's parent, if the first COVID/Flu Detect™ Rapid Self-Test result is invalid. Study staff will observe participants while they self-collect their nasal swab sample and perform the COVID/Flu Detect™ Rapid Self-Test, but participants will not be given any assistance or guidance on these procedures by the study staff.
- Conditions
- COVID-19, Influenza A, Influenza B
- Being tested
- COVID/Flu Detect™ Rapid Self-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.
COVID/Flu Detect™ Rapid Self-TestDiagnostic test
The COVID/Flu Detect™ Rapid Self-Test is an investigational qualitative lateral flow immunoassay designed for the detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens in nasal swab samples. It is intended for non-prescription over-the-counter (OTC) use.
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive percent agreement (PPA) and negative percent agreement (NPA) of the COVID/Flu Detect™ Rapid Self-Test
The primary objective of the study is to evaluate the positive percent agreement (PPA) and negative percent agreement (NPA) of the COVID/Flu Detect™ Rapid Self-Test for SARS-CoV-2, influenza A, and influenza B when used in a home-like setting by symptomatic lay users who are within five (5) days of symptoms onset compared to RT-PCR comparator tests for SARS-CoV-2, influenza A, and influenza B. The comparator tests will include an emergency use authorized (EUA) or FDA-cleared SARS-CoV-2 RT-PCR test and an FDA-cleared influenza A and B RT-PCR test.
Measured: Participant samples will be tested on the COVID/Flu Detect™ Rapid Self-Test on the day of enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start26 Dec 2024
- Primary completion19 May 2025
- Study completion19 May 2025
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
- 899 participants (actual)
Sponsor and investigators
- Lead sponsor
- InBios International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734741
- Sponsor's protocol ID
- COVID-FLU-OTC 2024
- Other IDs
- W81XWH-20-F-0253
- Status last verified
- May 2025
- First submitted
- 10 Dec 2024
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Evaluation of COVID/Flu Detect™ Rapid Self-Test in Symptomatic Subjects for Non-Prescription Over-the-Counter (OTC) Use
- ClinicalTrials.gov ID
- NCT06734741
- Acronym / sponsor ID
- COVID-FLU-OTC 2024
- Conditions
- COVID-19, Influenza A, Influenza B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 899 participants (actual)
- Lead sponsor
- InBios International, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Dec 2024 (actual)
- Primary completion
- 19 May 2025 (actual)
- Study completion
- 19 May 2025 (actual)
- First posted
- 16 Dec 2024 (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 goal of this study is to evaluate the performance of the COVID/Flu Detect™ Rapid Self-Test when used in a home-like setting by lay users. The COVID/Flu Detect™ Rapid Self-Test is an investigational device intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens in nasal swab samples. Participants who are aged two (2) years and older and have symptoms of respiratory illness consistent with SARS-CoV-2 and influenza infection may be enrolled. Participants will use the COVID/Flu Detect™ Rapid Self-Test to self-collect, self-test, and interpret the results. Participants will have a nasal swab sample collected by a healthcare provider for comparator testing by PCR tests for SARS-CoV-2, influenza A, and influenza B. Researchers will compare the results of the COVID/Flu Detect™ Rapid Self-Test obtained by the participants to results from the PCR comparator tests to evaluate performance.
Detailed description
This study will be a multi-site, all-comers, clinical trial assessing the positive percent agreement (PPA) and negative percent agreement (NPA) of the COVID/Flu Detect™ Rapid Self-Test, an investigational qualitative lateral flow immunoassay intended for non-prescription over-the-counter (OTC) use. Participants who are aged 2 years and older and meet the eligibility criteria will be enrolled for testing on the COVID/Flu Detect™ Rapid Self-Test and for comparator testing on (1) an FDA-cleared or emergency use authorized (EUA) SARS-CoV-2 RT-PCR test, (2) an FDA-cleared influenza A RT-PCR test, and (3) an FDA-cleared influenza B RT-PCR test.
After obtaining informed consent, participants' age, sex, days post-symptom onset, signs and symptoms of respiratory illness, comorbidities, any medications taken or administered, influenza/COVID-19 vaccination history, race/ethnicity, socioeconomic status, and educational background will be collected. Next, two (2) anterior nasal swab samples will be collected from each participant, with at least a 15-minute normalization period between swab sample collections. One (1) of the nasal swab samples will be collected by a healthcare provider (HCP) from the participant. This nasal swab sample will be sent for comparator testing. The other nasal swab sample will be self-collected or collected by the participant's parent or legal guardian. Adults (participants aged 18 years or older) and older children (participants aged 14-17 years) will self-collect a nasal swab sample by swabbing both nostrils and will test the swab sample themselves on the COVID/Flu Detect™ Rapid Self-Test. For child participants aged 2-13 years, parents or legal guardians will collect a nasal swab sample from their child by swabbing both nostrils and will test the swab sample on behalf of their child on the COVID/Flu Detect™ Rapid Self-Test. The order of collection of the two nasal swab samples will be randomized. A third nasal swab sample may be collected by the participant or the participant's parent, if the first COVID/Flu Detect™ Rapid Self-Test result is invalid. Study staff will observe participants while they self-collect their nasal swab sample and perform the COVID/Flu Detect™ Rapid Self-Test, but participants will not be given any assistance or guidance on these procedures by the study staff.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will be selected from at least three geographically diverse sites in the United States.
Key inclusion criteria (4 listed)
- Subjects must be at least 18 years of age, or at least 2 years of age and accompanied by parent or legal guardian.
- Subjects must be willing and able to give informed consent or assent (as age-appropriate).
- Subjects must be able to read/speak English (or Spanish at specific sites) if subject is an adult, minor aged 14 years or older, or parent/guardian of a child subject aged 2 through 13 years.
- Subjects must be currently exhibiting at least two of the following symptoms consistent with possible SARS-CoV-2 or influenza infection: fever or feeling feverish (in absence of documented fever), chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, nasal congestion or runny nose, nausea or vomiting, and/or diarrhea. Subjects must be within 5 days of symptoms onset at enrollment (the day that symptoms start is day 0).
Key exclusion criteria (4 listed)
- Subject was previously enrolled in this study.
- Subject has undergone a nasal wash or nasal aspirate procedure on day of enrollment.
- Subject has an active nosebleed.
- Subject has received results of an influenza or COVID-19 test within the previous 5 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 |
|---|---|---|
| COVID/Flu Detect™ Rapid Self-TestThe COVID/Flu Detect™ Rapid Self-Test is an investigational qualitative lateral flow immunoassay designed for the detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens in nasal swab samples. It is intended for non-prescription over-the-counter (OTC) use. | Diagnostic test | – |
Primary outcome
Positive percent agreement (PPA) and negative percent agreement (NPA) of the COVID/Flu Detect™ Rapid Self-Test
Time frame: Participant samples will be tested on the COVID/Flu Detect™ Rapid Self-Test on the day of enrollment.
The primary objective of the study is to evaluate the positive percent agreement (PPA) and negative percent agreement (NPA) of the COVID/Flu Detect™ Rapid Self-Test for SARS-CoV-2, influenza A, and influenza B when used in a home-like setting by symptomatic lay users who are within five (5) days of symptoms onset compared to RT-PCR comparator tests for SARS-CoV-2, influenza A, and influenza B. The comparator tests will include an emergency use authorized (EUA) or FDA-cleared SARS-CoV-2 RT-PCR test and an FDA-cleared influenza A and B RT-PCR test.
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 22 May 2025.
- 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.
10 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 and Influenza A, run by InBios International, Inc. at 10 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 4 inclusion and 4 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 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
Positive percent agreement (PPA) and negative percent agreement (NPA) of the COVID/Flu Detect™ Rapid Self-Test (time frame: Participant samples will be tested on the COVID/Flu Detect™ Rapid Self-Test on the day of enrollment.). 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 22 May 2025.