Covid-19 TestingNCT04926779
Study Utilizing BIOZEK COVID-19 Antigen Rapid Test
A study testing Biozek Covid-19 Antigen Rapid Test (Saliva) in people with Covid-19 Testing, run by Mach-E B.V. at 2 sites in United States.
Trial summary
This is a research study to evaluate the Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test (Saliva) and BIOZEK COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) on samples that are self-collected; and to perform analysis to compare results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19 Testing
- What is being tested?
- Biozek Covid-19 Antigen Rapid Test (Saliva)
- How many people
- 185 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 May 2021to 4 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Subjects must be ≥18 years of age and have had an RT-PCR test performed prior to enrollment.
- Subjects must be able to understand and willingly sign a written informed consent. Additionally, participants need to meet at least 1 of the criteria listed below:
- Currently experiencing symptoms of COVID-19.
- Be clinically diagnosed or suspected to have COVID-19.
- Recent past (3 weeks) exhibited symptoms of COVID-19.
- Be capable of performing a self-collection of a nasopharyngeal sample with use of nasal swab kit.
- Be capable of performing a self-collection of an oral fluid sample with use of oral fluid collection kit.
- Interacted with a COVID-19 positive individual.
Who cannot join
- Subjects who meet any of the following exclusion criteria may not be enrolled in this study:
- Cannot perform self-collection of a nasopharyngeal sample with use of nasal swab kit.
- Cannot perform self-collection of an oral fluid sample with use of oral fluid collection kit.
- Have a deviated nasal septum.
- Cognitively impaired individuals resulting in the inability to provide informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mobile Covid Services LLC
Flushing, New York, 11354
Quality Research and Invention LLC
Southampton, New York, 11968
About this study
Official title: Open Label, Single-Center Study Utilizing BIOZEK COVID-19 Antigen Rapid Test: Comparison of Biozek COVID-19 Antigen Rapid Test Results Performed on Self-collected Samples by the Subjects, to Results of COVID-19 RT-PCR as a Standard of Care
This is a research study to evaluate the Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test (Saliva) and BIOZEK COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) on samples that are self-collected; and to perform analysis to compare results. In addition, to obtain RT-PCR test results, performed prior to enrollment, and compare all three results.
- Conditions
- Covid-19 Testing
- Being tested
- Biozek Covid-19 Antigen Rapid Test (Saliva)
- Keywords
- Covid-19, Antigen, Rapid, Test
- Medical subject headings
- COVID-19, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biozek Covid-19 Antigen Rapid Test (Saliva)Diagnostic test
Also called Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab)
Self-collection of nasopharyngeal and saliva samples and self test performance - Biozek Covid-19 Antigen Rapid Test (Saliva) and Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab). Both procedures are supervised by trained study personnel.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Saliva)
The Biozek Antigen Rapid Tests performed by subjects on the self-collected, oral fluid samples . Sensitivity was calculated using (TP/TP+FN)*100% formula.
Specificity was calculated using (TN/TN+FP)*100% formula.
Measured: 6 months
Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab)
The Biozek Antigen Rapid Tests performed by subjects on the self-collected, nasopharyngeal samples . Sensitivity was calculated using (TP/TP+FN)*100% formula.
Specificity was calculated using (TN/TN+FP)*100% formula.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start24 May 2021
- Primary completion4 Nov 2022
- Study completion4 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Covid-19 TestingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mach-E B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926779
- Sponsor's protocol ID
- Biozek-ARTC-US/002/4-12-2021
- Status last verified
- Dec 2023
- First submitted
- 11 Jun 2021
- Last updated
- 20 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Single-Center Study Utilizing BIOZEK COVID-19 Antigen Rapid Test: Comparison of Biozek COVID-19 Antigen Rapid Test Results Performed on Self-collected Samples by the Subjects, to Results of COVID-19 RT-PCR as a Standard of Care
- ClinicalTrials.gov ID
- NCT04926779
- Acronym / sponsor ID
- Biozek-ARTC-US/002/4-12-2021
- Conditions
- Covid-19 Testing
- Keywords
- Covid-19, Antigen, Rapid, Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Mach-E B.V.Industry (pharma, biotech, devices)
- Study start
- 24 May 2021 (actual)
- Primary completion
- 4 Nov 2022 (actual)
- Study completion
- 4 Nov 2022 (actual)
- First posted
- 15 Jun 2021 (actual)
- Results
- Posted 20 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a research study to evaluate the Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test (Saliva) and BIOZEK COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) on samples that are self-collected; and to perform analysis to compare results. In addition, to obtain RT-PCR test results, performed prior to enrollment, and compare all three results.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must be ≥18 years of age and have had an RT-PCR test performed prior to enrollment.
- Subjects must be able to understand and willingly sign a written informed consent. Additionally, participants need to meet at least 1 of the criteria listed below:
Key exclusion criteria (5 listed)
- Subjects who meet any of the following exclusion criteria may not be enrolled in this study:
- Cannot perform self-collection of a nasopharyngeal sample with use of nasal swab kit.
- Cannot perform self-collection of an oral fluid sample with use of oral fluid collection kit.
- Have a deviated nasal septum.
- Cognitively impaired individuals resulting in the inability to provide informed consent
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 |
|---|---|---|
| Biozek Covid-19 Antigen Rapid Test (Saliva)Also: Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab)Self-collection of nasopharyngeal and saliva samples and self test performance - Biozek Covid-19 Antigen Rapid Test (Saliva) and Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab). Both procedures are supervised by trained study personnel. | Diagnostic test | – |
Primary outcome
Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Saliva)
Time frame: 6 months
The Biozek Antigen Rapid Tests performed by subjects on the self-collected, oral fluid samples . Sensitivity was calculated using (TP/TP+FN)*100% formula. Specificity was calculated using (TN/TN+FP)*100% formula.
Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab)
Time frame: 6 months
The Biozek Antigen Rapid Tests performed by subjects on the self-collected, nasopharyngeal samples . Sensitivity was calculated using (TP/TP+FN)*100% formula. Specificity was calculated using (TN/TN+FP)*100% formula.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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?
A study testing Biozek Covid-19 Antigen Rapid Test (Saliva) in people with Covid-19 Testing, run by Mach-E B.V. 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 8 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 20 Dec 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?
Yes. Results are posted in the registry (first posted 20 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 and Specificity of Biozek Covid-19 Antigen Rapid Test (Saliva) (time frame: 6 months). 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 20 Dec 2023.