Prospective Study to Validate the Diagnostic Performance of IVD CAPSULE COVID-19-NP Test for the Detection of SARS-CoV-2

May 1, 2023 updated by: Abionic SA

Prospective Field Study to Validate the Diagnostic Performance of the IVD CAPSULE COVID-19-NP Test for the Detection of SARS-CoV-2 on abioSCOPE®

The purpose of the study is to conduct a prospective evaluation of the diagnostic performance of the IVD CAPSULE COVID-19-NP test for antigenic determination of SARS-CoV-2 virus on the abioSCOPE® instrument.

The objective of the clinical study is to demonstrate that the IVD CAPSULE COVID-19-NP test:

  1. shows sensitivity:

    • ≥ 80% when testing unselected symptomatic participants within the first seven days of symptom onset or asymptomatic participants when diagnosis is confirmed by RT-PCR; Or
    • ≥ 90% for subjects with Ct ≤ 25.
  2. show ≥ 98% specificity.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

440

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Torino, Italy, 10126
        • A.O Mauriziano di Torino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The study population includes unselected participants*, symptomatic, asymptomatic having had close contact with positive patients, and asymptomatic with no known exposure to SARS-CoV-2.

Description

Inclusion Criteria:

  • provide valid informed consent before taking the tests;
  • in the case of symptomatic patients, be tested within the first seven days after the onset of symptoms.
  • Male or female, aged equal to or older than 18 years of age.

Exclusion Criteria:

  • Symptomatic participants who take the test after seven days after the onset of symptoms are excluded from the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance of the IVD CAPSULE COVID-19-NP antigenic test
Time Frame: through study completion, an average of 1 month
The purpose of this work is to carry out a prospective evaluation of the diagnostic performance of the IVD CAPSULE COVID-19-NP test for the antigenic determination of the SARS-CoV-2 virus on the abioSCOPE instrument.
through study completion, an average of 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abionic SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2022

Primary Completion (Actual)

January 27, 2023

Study Completion (Actual)

February 1, 2023

Study Registration Dates

First Submitted

October 21, 2022

First Submitted That Met QC Criteria

October 25, 2022

First Posted (Actual)

October 27, 2022

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

May 1, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AB-COV-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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