Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-01-06 @ 9:55 PM
Study NCT ID:
NCT03248960
Status:
COMPLETED
Last Update Posted:
2018-02-01
First Post:
2017-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ellume.Lab Flu A+B Test and iTreat Flu A+B Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction.
Sponsor:
Ellume Pty Ltd
Organization:
Study Overview
Official Title:
A Prospective Multi-Centre Study of the Ellume.Lab Flu A+B Test and iTreat Flu A+B Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction.
Status:
COMPLETED
Status Verified Date:
2018-01
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 primary purpose of this study is to validate the sensitivity and specificity of the iTreat Flu A+B Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to viral culture.
The secondary aims are to:
Validate the sensitivity and specificity of the iTreat Flu A+B Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).
Evaluate the correct interpretation of the iTreat Flu A+B Test by subjects with influenza-like symptoms.
Evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the iTreat Flu A+B Test.
Evaluate the operators' satisfaction with the ease of use of the ellume.lab Flu A+B Test.
The secondary aims are to:
Validate the sensitivity and specificity of the iTreat Flu A+B Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).
Evaluate the correct interpretation of the iTreat Flu A+B Test by subjects with influenza-like symptoms.
Evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the iTreat Flu A+B Test.
Evaluate the operators' satisfaction with the ease of use of the ellume.lab Flu A+B Test.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: