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

Completed

• Conditions: COVID-19 Pandemic; COVID-19

• Registration Number: NCT05596032
• Lead Sponsor: Abionic SA

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-21
• Study Start: 2022-10-23
• Study First Submitted QC: 2022-10-25
• Study First Posted: 2022-10-27
• Primary Completion: 2023-01-27
• Study Completion: 2023-02-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-01
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 440

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

A.O Mauriziano di Torino; 🇮🇹 Torino, Italy