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NCT05596032 Clinical Trial

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

COVID-19 Clinical Trial

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®

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05596032
Other study ID # AB-COV-003
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 23, 2022
Est. completion date February 1, 2023

Study information
Verified date May 2023
Source Abionic SA
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 440
Est. completion date February 1, 2023
Est. primary completion date January 27, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Italy A.O Mauriziano di Torino Torino

Sponsors (1)
Lead Sponsor Collaborator
Abionic SA

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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