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

Sponsor
Abionic SA (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05596032
Collaborator
(none)
440
Enrollment
1
Location
3.3
Anticipated Duration (Months)
132.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

  1. show ≥ 98% specificity.
Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    440 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    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®
    Actual Study Start Date :
    Oct 23, 2022
    Actual Primary Completion Date :
    Jan 27, 2023
    Anticipated Study Completion Date :
    Feb 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Diagnostic performance of the IVD CAPSULE COVID-19-NP antigenic test [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 A.O Mauriziano di Torino Torino Italy 10126

    Sponsors and Collaborators

    • Abionic SA

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abionic SA
    ClinicalTrials.gov Identifier:
    NCT05596032
    Other Study ID Numbers:
    • AB-COV-003
    First Posted:
    Oct 27, 2022
    Last Update Posted:
    Feb 1, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Feb 1, 2023