Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05897515
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2023-06-07
Brief Title:
LIAISON NES Influenza FLU AB Coronavirus Disease 2019 COVID-19 Clinical Agreement in Australia
Sponsor:
DiaSorin Molecular LLC
Organization:
DiaSorin Molecular LLC
Study Overview
Official Title:
LIAISON NES Flu AB COVID-19 Clinical Agreement in Australia
Status:
COMPLETED
Status Verified Date:
2024-04
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 DiaSorin Molecular LIAISON NES FLU AB COVID-19 real-time polymerase chain reaction RT-PCR assay is intended for use on the DiaSorin LIAISON NES instrument for the in-vitro qualitative detection and differentiation of nucleic acid from influenza A influenza B and SARS-CoV-2 virus from dry nasal swabs NS from human patients with signs and symptoms during the acute phase of respiratory tract infection in conjunction with clinical and epidemiological risk factors
The LIAISON NES FLU AB COVID-19 assay is intended for use as an aid in the differential diagnosis of influenza A influenza B and SARS-CoV-2 infection in a professional laboratory setting
Negative results do not preclude influenza A influenza B or SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions The assay is not intended to detect the presence of the influenza C virus
The LIAISON NES FLU AB COVID-19 assay is intended for use as an aid in the differential diagnosis of influenza A influenza B and SARS-CoV-2 infection in a professional laboratory setting
Negative results do not preclude influenza A influenza B or SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions The assay is not intended to detect the presence of the influenza C virus
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?:
False
Is an FDA AA801 Violation?:
None