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

Abionic

Status: Completed

Conditions: COVID-19; COVID-19 Pandemic

Study type: Observational

Funder types: Industry

Identifiers

NCT05596032

AB-COV-003

Details and patient eligibility

About

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.

Enrollment: 440 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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