COVID-19, COVID-19 Pandemic
Conditions
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: 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.
Interventions
None listed
Sponsors
Abionic SA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic performance of the IVD CAPSULE COVID-19-NP antigenic test | 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. |
Countries
Italy
Outcome results
None listed