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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 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 599

Last updated 2024-12-06

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

EuGeni SARS-CoV-2 Antigen Rapid 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.

Sponsors & Collaborators

  • AnteoTech Ltd

    lead INDUSTRY

Principal Investigators

  • M. Antonia Sánchez Calavera · C.S. Fuentes Norte

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-26
Primary Completion
2022-08-25
Completion
2022-11-02

Countries

  • Croatia
  • Greece
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05618561 on ClinicalTrials.gov