SARS-CoV-2 InfectionWHONCT05618561
EuGeni Rapid Antigen Test for the Qualitative Detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Causing COVID19 Disease in Compliance With the World Health Organization (WHO)
An observational study of SARS-CoV-2 Infection, run by AnteoTech Ltd at 5 sites in 3 countries.
Trial summary
Rapid antigen detection (RAD) tests are used to perform rapid diagnosis of SARS-CoV-2 infection based on a qualitative approach. RAD tests detect the viral antigen by the immobilized coated SARS-CoV-2 antibody placed on the device. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- EuGeni SARS-CoV-2 Antigen Rapid Diagnostic Test
- How many people
- 599 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 26 Jul 2022to 2 Nov 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The entire population over 12 years of age that met the inclusion criteria and none of the exclusion criteria. Positive subjects must present COVID19 symptoms. In the case of negative subjects, one part must be hospitalized (for any reason) and the other part must have respiratory symptoms.
Who may be able to join
- Specimens from subjects over 12 years old agreeing to participate in the study and with a legal representative able to provide informed consent, OR;
- Specimens from subjects over 18 years old able to provide informed consent.
- Specimens collected with nasopharyngeal swabs, OR;
- Combined nasal mid-turbinate and throat specimen collection.
Who cannot join
- Specimens and testing methods that are not deemed to be in line with gold-standard RT-PCR standards.
- Specimens stored for over 2 hours at 2-8 ºC temperature between collection and testing with EuGeni SARS-CoV-2 Ag RDT.
- Specimens stored for over 5 days at -20ºC between collection and testing with RT-PCR.
- Specimens stored for over 24h at 4ºC between collection and testing with RT-PCR.
- Contamination and/or deterioration of the specimen which, in the opinion of the investigator, may affect its handling and/or analysis.
- The subject is deemed unsuitable to participate in the study by the investigator.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Spain3 sites
Hospital Universitario de A Coruña (CHUAC)
A Coruña, Galicia, 15006
Centro de Salud Fuentes Norte
Zaragoza, Aragon, 50002
Centro de Salud Torre Ramona
Zaragoza, Aragon, 50013
About this study
Official title: EuGeni SARS-CoV-2 Antigen Rapid Diagnostic Test Clinical Performance Study
Rapid antigen detection (RAD) tests are used to perform rapid diagnosis of SARS-CoV-2 infection based on a qualitative approach. RAD tests detect the viral antigen by the immobilized coated SARS-CoV-2 antibody placed on the device. The results of these tests are available in a short time, reducing the workload in diagnostic hospitals and laboratories and improving the turn-around time.
EuGeni SARS-CoV-2 Antigen Rapid Diagnostic Test is an in vitro Diagnostic (IVD) medical device intended to be used for the qualitative detection of SARS-CoV-2 nucleocapsid antigen. The result from this IVD test identifies the presence or absence of the SARS-CoV-2 antigen as an aid for the diagnosis of COVID-19 infection.
Read the detailed description
The EuGeni SARS-CoV-2 Antigen (Ag) Rapid Detection Test (RDT) is a test strip based on lateral flow technology which utilizes nanoparticles, doped with europium, as the fluorescence reporter system. The test strip is housed in a cassette which is read by the EuGeni AX-2X-S Reader, a portable instrument that reads EuGeni fluorescent lateral flow tests.
The test line contains an immobilized monoclonal mouse antibody to capture SARS-CoV-2 antigen and the control line contains an immobilized control anti-mouse antibody.
The test sample is added to the sample well of the test cassette and then reconstitutes the dried europium nanoparticle antibody conjugate from the conjugate pad. The sample flows along the test strip by capillary action.
If the sample contains SARS-CoV-2 antigen, it binds to the antibody-labelled europium nanoparticle. When the sample flows past the test line, the europium bound antigen is captured by the second anti-SARS-CoV-2 antibody immobilized on the test line. A fluorescent signal detected by the EuGeni AX-2X-S Reader at this test line indicates that the specimen is SARS-CoV-2 antigen Positive.
If the sample does not contain SARS-CoV-2 antigen, the europium-labelled anti-antigen antibody will not bind to the test line. This indicates that the specimen is SARS-CoV-2 antigen Negative.
The sample continues to flow along the strip and when it passes over the control line, antibody-labelled europium nanoparticles are captured by the immobilized anti-mouse antibody. The control line must be detected by the EuGeni AX-2X-S Reader for the test to be valid. If the control line is not detected, the test is considered invalid and must be repeated using another test cassette.
- Conditions
- SARS-CoV-2 Infection
- Being tested
- EuGeni SARS-CoV-2 Antigen Rapid Diagnostic Test
- Keywords
- covid19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EuGeni SARS-CoV-2 Antigen Rapid Diagnostic TestDiagnostic test
Subjects have two swabs taken for analysis, one (combined or nasopharyngeal) with the kit under investigation and the other (by standard of care) for analysis with PCRl.
| Study group | Role | What they receive |
|---|---|---|
| Nasopharyngeal specimen collection arm | Specimens collected in nasopharyngeal form from positive subjects with symptoms and negative subjects hospitalized and negative subjects with respiratory symptoms. Receives: Diagnostic Test: EuGeni SARS-CoV-2 Antigen Rapid Diagnostic Test | |
| Combined nasal mid-turbinate and throat specimen collection arm | Specimens collected in combined nasal mid-turbinate form from positive subjects with symptoms and negative subjects hospitalized and negative subjects with respiratory symptoms. Receives: Diagnostic Test: EuGeni SARS-CoV-2 Antigen Rapid Diagnostic Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic sensitivity and specificity in terms of true positive results and true negative results between the kit under investigation and the gold-standard PCR
Number of true positives and true negatives in terms of sensitivity and specificity (accuracy) by contrasting the result obtained with the investigational kit and the gold-standard PCR result.
Measured: Through study completion, an average of 4 months
Secondary outcomes (1)
The sensitivity and the specificity values between the two collection methods, nasal and nasopharyngeal.
To compare the sensitivity and specificity value translated as true positives and true negatives between the investigational kit and PCR between the two sample collection methods, nasal and nasopharyngeal.
Measured: Through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start26 Jul 2022
- Primary completion25 Aug 2022
- Study completion2 Nov 2022
Why it stopped: High number of false negatives
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies 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
- 599 participants (actual)
Sponsor and investigators
- Lead sponsor
- AnteoTech Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- M. Antonia Sánchez Calavera, Principal investigator, C.S. Fuentes Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618561
- Sponsor's protocol ID
- CT013
- Acronym
- WHO
- Status last verified
- Dec 2024
- First submitted
- 10 Nov 2022
- Last updated
- 6 Dec 2024
- 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 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EuGeni SARS-CoV-2 Antigen Rapid Diagnostic Test Clinical Performance Study
- ClinicalTrials.gov ID
- NCT05618561
- Acronym / sponsor ID
- WHO / CT013
- Conditions
- SARS-CoV-2 Infection
- Keywords
- covid19
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: High number of false negatives
- Enrolment
- 599 participants (actual)
- Lead sponsor
- AnteoTech LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Jul 2022 (actual)
- Primary completion
- 25 Aug 2022 (actual)
- Study completion
- 2 Nov 2022 (actual)
- First posted
- 16 Nov 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.
Rapid antigen detection (RAD) tests are used to perform rapid diagnosis of SARS-CoV-2 infection based on a qualitative approach. RAD tests detect the viral antigen by the immobilized coated SARS-CoV-2 antibody placed on the device. The results of these tests are available in a short time, reducing the workload in diagnostic hospitals and laboratories and improving the turn-around time.
EuGeni SARS-CoV-2 Antigen Rapid Diagnostic Test is an in vitro Diagnostic (IVD) medical device intended to be used for the qualitative detection of SARS-CoV-2 nucleocapsid antigen. The result from this IVD test identifies the presence or absence of the SARS-CoV-2 antigen as an aid for the diagnosis of COVID-19 infection.
Detailed description
The EuGeni SARS-CoV-2 Antigen (Ag) Rapid Detection Test (RDT) is a test strip based on lateral flow technology which utilizes nanoparticles, doped with europium, as the fluorescence reporter system. The test strip is housed in a cassette which is read by the EuGeni AX-2X-S Reader, a portable instrument that reads EuGeni fluorescent lateral flow tests.
The test line contains an immobilized monoclonal mouse antibody to capture SARS-CoV-2 antigen and the control line contains an immobilized control anti-mouse antibody.
The test sample is added to the sample well of the test cassette and then reconstitutes the dried europium nanoparticle antibody conjugate from the conjugate pad. The sample flows along the test strip by capillary action.
If the sample contains SARS-CoV-2 antigen, it binds to the antibody-labelled europium nanoparticle. When the sample flows past the test line, the europium bound antigen is captured by the second anti-SARS-CoV-2 antibody immobilized on the test line. A fluorescent signal detected by the EuGeni AX-2X-S Reader at this test line indicates that the specimen is SARS-CoV-2 antigen Positive.
If the sample does not contain SARS-CoV-2 antigen, the europium-labelled anti-antigen antibody will not bind to the test line. This indicates that the specimen is SARS-CoV-2 antigen Negative.
The sample continues to flow along the strip and when it passes over the control line, antibody-labelled europium nanoparticles are captured by the immobilized anti-mouse antibody. The control line must be detected by the EuGeni AX-2X-S Reader for the test to be valid. If the control line is not detected, the test is considered invalid and must be repeated using another test cassette.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasopharyngeal specimen collection arm | – | Diagnostic Test: EuGeni SARS-CoV-2 Antigen Rapid Diagnostic TestSpecimens collected in nasopharyngeal form from positive subjects with symptoms and negative subjects hospitalized and negative subjects with respiratory symptoms. |
| Combined nasal mid-turbinate and throat specimen collection arm | – | Diagnostic Test: EuGeni SARS-CoV-2 Antigen Rapid Diagnostic TestSpecimens collected in combined nasal mid-turbinate form from positive subjects with symptoms and negative subjects hospitalized and negative subjects with respiratory symptoms. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The entire population over 12 years of age that met the inclusion criteria and none of the exclusion criteria. Positive subjects must present COVID19 symptoms. In the case of negative subjects, one part must be hospitalized (for any reason) and the other part must have respiratory symptoms.
Key inclusion criteria (4 listed)
- Specimens from subjects over 12 years old agreeing to participate in the study and with a legal representative able to provide informed consent, OR;
- Specimens from subjects over 18 years old able to provide informed consent.
- Specimens collected with nasopharyngeal swabs, OR;
- Combined nasal mid-turbinate and throat specimen collection.
Key exclusion criteria (6 listed)
- Specimens and testing methods that are not deemed to be in line with gold-standard RT-PCR standards.
- Specimens stored for over 2 hours at 2-8 ºC temperature between collection and testing with EuGeni SARS-CoV-2 Ag RDT.
- Specimens stored for over 5 days at -20ºC between collection and testing with RT-PCR.
- Specimens stored for over 24h at 4ºC between collection and testing with RT-PCR.
- Contamination and/or deterioration of the specimen which, in the opinion of the investigator, may affect its handling and/or analysis.
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 |
|---|---|---|
| EuGeni SARS-CoV-2 Antigen Rapid Diagnostic TestSubjects have two swabs taken for analysis, one (combined or nasopharyngeal) with the kit under investigation and the other (by standard of care) for analysis with PCRl. | Diagnostic test | Combined nasal mid-turbinate and throat specimen collection arm, Nasopharyngeal specimen collection arm |
Primary outcome
Diagnostic sensitivity and specificity in terms of true positive results and true negative results between the kit under investigation and the gold-standard PCR
Time frame: Through study completion, an average of 4 months
Number of true positives and true negatives in terms of sensitivity and specificity (accuracy) by contrasting the result obtained with the investigational kit and the gold-standard PCR result.
1 secondary outcome
The sensitivity and the specificity values between the two collection methods, nasal and nasopharyngeal.
Time frame: Through study completion, an average of 4 months
Results and safety
The study was stopped early (reason given: High number of false negatives). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- 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.
M. Antonia Sánchez Calavera principal investigator
C.S. Fuentes Norte
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2 Infection, run by AnteoTech Ltd at 5 sites in 3 countries.
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 6 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: stopped early, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain, Croatia, Greece. 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 was stopped early (reason given: High number of false negatives). Results are not available in the source record.
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?
Diagnostic sensitivity and specificity in terms of true positive results and true negative results between the kit under investigation and the gold-standard PCR (time frame: Through study completion, an average of 4 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 6 Dec 2024.