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

NCT05596032 | Completed

• 1 other identifier: AB-COV-003
• Study Type: observational
• Target: 440
• Locations: 1 country
• Sites: 1

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:

• ≥ 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.
• show ≥ 98% specificity.

Conditions

COVID-19; COVID-19 Pandemic

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance of the IVD CAPSULE COVID-19-NP antigenic test

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Abionic SA: lead

Study Sites (1)

A.O Mauriziano di Torino

Torino, 10126, Italy

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 Design

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

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: October 27, 2022
• Study Start: October 23, 2022
• Primary Completion: January 27, 2023
• Study Completion: February 1, 2023
• Last Updated: May 3, 2023

Record last verified: 2023-05

Locations

IT (1)