Covid19NCT04733170
Clinical Performance Evaluation of KnowNow SARS-CoV-2 Test for the Detection of COVID-19 Antigen
An observational study of Covid19, run by Vatic Ltd..
Trial summary
This is an international, multicentre, non-interventional, observational study to assess the clinical diagnostic performance of a rapid, point of care (POC) COVID-19 (SARS-CoV-2) antigen In vitro diagnostic (IVD), The KnowNow SARS-CoV-2 Rapid Antigen Test, using saliva samples when compared to reverse transcription… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- KnowNow SARS-CoV-2 Rapid Antigen Test
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2021to 31 Aug 2021
- 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: Male or female aged 18 years or over (or age of adult consent in some states within the United States) with suspected COVID -19 infection.
Who may be able to join
- Male or female aged 18 years or over (or age of adult consent in some states within the United States).
- Suspected COVID-19 infection and / or presenting with at least 1 recognised symptom Fever or chills. ie: Cough. Shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat
- Be willing and able to comply with study procedures.
- Be able to give written informed consent.
Who cannot join
- Inability to give written informed consent.
- Vaccinated against SARS-CoV-2
- Adults unable to undertake the requirements of the nasopharyngeal or saliva sample collection for physical or psychological reasons
- Subjects with other significant disease, condition, or at the Clinician's discretion.
Trial locations and contacts
No sites are listed yet.
Laurie Comeau, BSc (Hons) contact
About this study
This is an international, multicentre, non-interventional, observational study to assess the clinical diagnostic performance of a rapid, point of care (POC) COVID-19 (SARS-CoV-2) antigen In vitro diagnostic (IVD), The KnowNow SARS-CoV-2 Rapid Antigen Test, using saliva samples when compared to reverse transcription polymerase chain reaction (RT-PCR) as the standard detection of COVID-19 infection.
Read the detailed description
The KnowNow SARS-CoV-2 Rapid Antigen Test which uses saliva and is a lateral flow diagnostic device that can detect the SARS-CoV-2 specific Antigens that are present on the surface of the virus. The KnowNow test is an affordable, user friendly, and point of care device that can be mass produced as part of a multipronged strategy to address the global COVID-19 pandemic.
A saliva sample is collected from someone with suspected COVID-19 and mixed with a running buffer. The mixture is added to the sample pad of the KnowNow test, from where it migrates through the lateral flow strip. If COVID-19 Antigens are present, they bind to capture proteins on a test line and are made visible by secondary reagents within the device. The test result is visually assessed after 15-30 minutes and provides a binary positive (two lines) or negative (one line) result. Levels of COVID-19 Antigen differ dependent on disease progression. A visible test line (marked T) indicates the presence of COVID-19 Antigen in sufficient quantity in the collected sample to be detected. The appearance of the control line (marked C) confirms that the test has been performed correctly.
- Conditions
- Covid19
- Being tested
- KnowNow SARS-CoV-2 Rapid Antigen 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.
KnowNow SARS-CoV-2 Rapid Antigen TestDiagnostic test
KnowNow SARS-CoV-2 Rapid Antigen Test for the detection of Covid-19 in saliva, as compared to high sensitivity reverse transcription polymerase chain reaction (RT-PCR) of nasopharyngeal swabs as the reference test method
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess clinical diagnostic performance of the KnowNow SARS-CoV-2 Rapid Antigen Test
This includes determination of the sensitivity/positive percent agreement (PPA), specificity/negative percent agreement (NPA), positive predicted value (PPV) and negative predictive value (NPV).
Measured: 6 months
Secondary outcomes (2)
Efficacy to assess the test compared to the reference test method
- Calculated Sensitivity/PPA, Specificity/NPA, PPV and NPV of the KnowNow SARS-CoV-2 Rapid Antigen Test compared to RT-PCR as SOT in individuals with and without COVID-19 symptoms.
- Calculated Sensitivity/PPA, Specificity/NPA, PPV and NPV of the KnowNow SARS-CoV-2 Rapid Antigen Test compared to RT-PCR as the reference method in individuals with and without COVID-19 symptoms.
- Calculated Sensitivity/PPA between the KnowNow SARS-CoV-2 Rapid Antigen Test and RT-PCR tests stratified using cycle threshold (CT) values.
Measured: 6 months
Usability Questionnaire to evaluate the use of the test with 2 saliva collection methods
Evaluation of the 2 saliva collection methods by a patient questionnaire with responses recorded by a healthcare provider. responses are on a numerical scale graded 1 to 9. 1 = 'hard' to 9 which is 'easy'.
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 posted1 Feb 2021
- Study start15 Feb 2021 (estimated)
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vatic Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alex Sheppard, BA, Study director, Vatic Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733170
- Sponsor's protocol ID
- VATIC-0101
- Status last verified
- Jan 2021
- First submitted
- 22 Jan 2021
- Last updated
- 25 Feb 2021
- 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 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance Evaluation of KnowNow SARS-CoV-2 Test for the Detection of COVID-19 Antigen
- ClinicalTrials.gov ID
- NCT04733170
- Acronym / sponsor ID
- VATIC-0101
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Vatic Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Feb 2021 (estimated)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 1 Feb 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.
This is an international, multicentre, non-interventional, observational study to assess the clinical diagnostic performance of a rapid, point of care (POC) COVID-19 (SARS-CoV-2) antigen In vitro diagnostic (IVD), The KnowNow SARS-CoV-2 Rapid Antigen Test, using saliva samples when compared to reverse transcription polymerase chain reaction (RT-PCR) as the standard detection of COVID-19 infection.
Detailed description
The KnowNow SARS-CoV-2 Rapid Antigen Test which uses saliva and is a lateral flow diagnostic device that can detect the SARS-CoV-2 specific Antigens that are present on the surface of the virus. The KnowNow test is an affordable, user friendly, and point of care device that can be mass produced as part of a multipronged strategy to address the global COVID-19 pandemic.
A saliva sample is collected from someone with suspected COVID-19 and mixed with a running buffer. The mixture is added to the sample pad of the KnowNow test, from where it migrates through the lateral flow strip. If COVID-19 Antigens are present, they bind to capture proteins on a test line and are made visible by secondary reagents within the device. The test result is visually assessed after 15-30 minutes and provides a binary positive (two lines) or negative (one line) result. Levels of COVID-19 Antigen differ dependent on disease progression. A visible test line (marked T) indicates the presence of COVID-19 Antigen in sufficient quantity in the collected sample to be detected. The appearance of the control line (marked C) confirms that the test has been performed correctly.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female aged 18 years or over (or age of adult consent in some states within the United States) with suspected COVID -19 infection.
Key inclusion criteria (4 listed)
- Male or female aged 18 years or over (or age of adult consent in some states within the United States).
- Suspected COVID-19 infection and / or presenting with at least 1 recognised symptom Fever or chills. ie: Cough. Shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat
- Be willing and able to comply with study procedures.
- Be able to give written informed consent.
Key exclusion criteria (4 listed)
- Inability to give written informed consent.
- Vaccinated against SARS-CoV-2
- Adults unable to undertake the requirements of the nasopharyngeal or saliva sample collection for physical or psychological reasons
- Subjects with other significant disease, condition, or at the Clinician's discretion.
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 |
|---|---|---|
| KnowNow SARS-CoV-2 Rapid Antigen TestKnowNow SARS-CoV-2 Rapid Antigen Test for the detection of Covid-19 in saliva, as compared to high sensitivity reverse transcription polymerase chain reaction (RT-PCR) of nasopharyngeal swabs as the reference test method | Diagnostic test | – |
Primary outcome
Assess clinical diagnostic performance of the KnowNow SARS-CoV-2 Rapid Antigen Test
Time frame: 6 months
This includes determination of the sensitivity/positive percent agreement (PPA), specificity/negative percent agreement (NPA), positive predicted value (PPV) and negative predictive value (NPV).
2 secondary outcomes
Efficacy to assess the test compared to the reference test method
Time frame: 6 months
Usability Questionnaire to evaluate the use of the test with 2 saliva collection methods
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- 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.
Laurie Comeau, BSc (Hons) contact
Alex Sheppard, BA study director
Vatic Ltd.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Vatic Ltd..
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: status not confirmed, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Andrea Goodyer, BSc (Hons) (07930277125, andrea.goodyer@clinicallyconnected.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess clinical diagnostic performance of the KnowNow SARS-CoV-2 Rapid Antigen Test (time frame: 6 months). 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 25 Feb 2021.