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)

Study Overview
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Brief Summary
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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
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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.

Official Title
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EuGeni SARS-CoV-2 Antigen Rapid Diagnostic Test Clinical Performance Study

Conditions
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SARS-CoV-2 Infection

Intervention / Treatment
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* Diagnostic Test: EuGeni SARS-CoV-2 Antigen Rapid Diagnostic Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nasopharyngeal specimen collection arm<br>Specimens collected in nasopharyngeal form from positive subjects with symptoms and negative subjects hospitalized and negative subjects with respiratory symptoms. | Diagnostic Test: EuGeni SARS-CoV-2 Antigen Rapid Diagnostic Test<br>* 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.<br>|
| Combined nasal mid-turbinate and throat specimen collection arm<br>Specimens collected in combined nasal mid-turbinate form from positive subjects with symptoms and negative subjects hospitalized and negative subjects with respiratory symptoms. | Diagnostic Test: EuGeni SARS-CoV-2 Antigen Rapid Diagnostic Test<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Through study completion, an average of 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Through study completion, an average of 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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covid19