Ignite Creation Date:
2024-05-06 @ 10:35 AM
Last Modification Date:
2024-10-26 @ 12:32 PM
Study NCT ID:
NCT03299283
Status:
UNKNOWN
Last Update Posted:
2019-01-15
First Post:
2017-07-18
Brief Title:
Specimen Collection and Transport Workflow Evaluations for CLIA-waived Molecular Testing
Sponsor:
BioFire Diagnostics LLC
Organization:
BioFire Diagnostics LLC
Study Overview
Official Title:
Specimen Collection and Transport Workflow Evaluations for CLIA-waived Molecular Testing
Status:
UNKNOWN
Status Verified Date:
2019-01
Last Known Status:
ENROLLING_BY_INVITATION
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 this study is two-fold In the first phase the goal is to characterize the stability of respiratory nasal swab nasopharyngeal swab and throat swab NS NPS TS and stool raw stool and rectal swab specimens collected using various standard medically established procedures with and without transport media and tested at various time points and under different temperature conditions and also to look at variation between repeat sampling events The intention is for these data to support decisions made by BioFire regarding the appropriate specimen type and handling guidelines for future tests In the second phase of the study collection and transport conditions identified in Phase 1 will be used to collect specimens for pilot performance evaluations of a new molecular diagnostic test
Detailed Description:
This evaluation will be initiated at several sites in the US In the first phase of the study multiple specimens will be collected from each subject and tested using various pre-analytical techniques Current BioFire FilmArray test panels will be used to assay each specimen and evaluate the multiple variables repeat sampling native specimen stability or other post-collection variables In the second phase of the study only two specimens will be collected from each subject one for testing with the new test using handling procedures identified in Phase 1 and another for testing with the reference method Up to 2000 subjects will be enrolled across all sites in each phase up to 4000 subjects total Enrollment is expected to last approximately 18 months to cover both phases of the study All specimens and subject data will be de-identified and coded Prior to study initiation each participating site will have the necessary Institutional Review Board IRB reviews Specimens in both phases will be tested at the study site using various BioFire test platforms and cartridges
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None