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

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.

Completed

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Key information

Conditions

COVID-19 COVID-19 Pandemic Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

A.O Mauriziano di Torino

Torino, 10126, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Sponsors and collaborators

Lead sponsor

Abionic SA

Industry

Registry information

Official study 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®

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Oct 27, 2022
Registry last updated: May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed