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

NCT ID: NCT05596032

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 440 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-23
• Study Completion Date: 2023-02-01

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.

2. show ≥ 98% specificity.

Conditions

COVID-19; COVID-19 Pandemic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abionic SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

A.O Mauriziano di Torino

Torino, , Italy

Countries

Italy

Other Identifiers

AB-COV-003

Identifier Type: -

Identifier Source: org_study_id