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

NCT05596032 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 440

Last updated 2023-05-03

No results posted yet for this study

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

Sponsors & Collaborators

  • Abionic SA

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-23
Primary Completion
2023-01-27
Completion
2023-02-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05596032 on ClinicalTrials.gov