Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06289868
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-02-26
Brief Title:
Access Anti-HAV and Access Anti-HAV IgM Assays EU Clinical Trial Protocol HAV-EU-11-23
Sponsor:
Beckman Coulter Inc
Organization:
Beckman Coulter Inc
Study Overview
Official Title:
Evaluation of the Access Anti-HAV and Access Anti-HAV IgM Assays as an Aid in the Diagnosis of HAV Infection and for Detection of Anti-HAV After Vaccination EU Clinical Trial Protocol
Status:
RECRUITING
Status Verified Date:
2024-06
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 this study is to evaluate the clinical performance supporting that intended purpose of the Access anti-HAV as an aid in the laboratory diagnosis of HAV infection and for detection of anti-HAV after vaccination and of the Access anti-HAV IgM assay as an aid in the laboratory diagnosis of acute or recent HAV infection on the DxI 9000 Access Immunoassay Analyzer
This study will be used to obtain CE mark for both Access anti-HAV and anti- HAV IgM assays
This study will be used to obtain CE mark for both Access anti-HAV and anti- HAV IgM assays
Detailed Description:
The objective of this study is to determine the diagnostic accuracy of Access anti-HAV and Access anti-HAV IgM assays on the DxI 9000 Access Immunoassay Analyzer measured as clinical sensitivity and specificity
The testing will be performed using banked de-identified prospective and retrospective US leftover clinical samples and fully-anonymized retrospective known anti-HAV IgM positive patient samples procured from sample vendors
The testing will be performed using banked de-identified prospective and retrospective US leftover clinical samples and fully-anonymized retrospective known anti-HAV IgM positive patient samples procured from sample vendors
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HAV-EU-11-23 | OTHER | Beckman Coulter Inc | None |