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)

NCT05618561 | Terminated

• 1 other identifier: CT013
• Study Type: observational
• Target: 599
• Locations: 3 countries
• Sites: 5

Brief 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. 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.

Conditions

SARS-CoV-2 Infection

Keywords

covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The sensitivity and the specificity values between the two collection methods, nasal and nasopharyngeal.

  Through study completion, an average of 4 months

Study Arms (2)

Nasopharyngeal specimen collection arm

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

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.

Diagnostic Test: EuGeni SARS-CoV-2 Antigen Rapid Diagnostic Test

Interventions

EuGeni SARS-CoV-2 Antigen Rapid Diagnostic Test DIAGNOSTIC_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.

Combined nasal mid-turbinate and throat specimen collection arm; Nasopharyngeal specimen collection arm

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AnteoTech Ltd: lead

Study Sites (5)

Institut Virion

Split, 21213, Croatia

Location

Laiko General Hospital

Athens, 115 27, Greece

Location

Centro de Salud Fuentes Norte

Zaragoza, Aragon, 50002, Spain

Location

Centro de Salud Torre Ramona

Zaragoza, Aragon, 50013, Spain

Location

Hospital Universitario de A Coruña (CHUAC)

A Coruña, Galicia, 15006, Spain

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• M. Antonia Sánchez Calavera

  C.S. Fuentes Norte

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: November 16, 2022
• Study Start: July 26, 2022
• Primary Completion: August 25, 2022
• Study Completion: November 2, 2022
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1); ES (3); GR (1)