Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-25 @ 7:22 PM
Study NCT ID:
NCT05596032
Status:
COMPLETED
Last Update Posted:
2023-05-03
First Post:
2022-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Study to Validate the Diagnostic Performance of IVD CAPSULE COVID-19-NP Test for the Detection of SARS-CoV-2
Sponsor:
Abionic SA
Organization:
Study Overview
Official 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®
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: