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®

Abionic SA1 site in 1 country440 target enrollmentOctober 23, 2022

ConditionsCOVID-19 COVID-19 Pandemic

Overview

Phase: N/A
Intervention: Not specified
Conditions: COVID-19
Sponsor: Abionic SA
Enrollment: 440
Locations: 1
Primary Endpoint: Diagnostic performance of the IVD CAPSULE COVID-19-NP antigenic test
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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:

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.
show ≥ 98% specificity.

Registry

clinicaltrials.gov

Start Date

October 23, 2022

End Date

February 1, 2023

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Abionic SA

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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

Time Frame: 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.