WüRDT

Overview
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A prospective performance assessment from 12 November 2020 to 30 June 2023 at a single centre tertiary care hospital determining the sensitivity and specificity (primary endpoints) of RDTs from three manufacturers (NADAL®, Panbio™, MEDsan®) compared to RT-qPCR as reference standard among patients, accompanying persons and staff.

Sponsor: University Hospital Würzburg

SEEK ID: https://ldh.uk-wuerzburg.imise.uni-leipzig.de/projects/7

Public web page: Not specified

NFDI4Health PIs: No PIs for this Trial Project

Trial Project start date: 12th Nov 2020

Trial Project end date: 30th Jun 2023

Extended Metadata (Nfdi4Health MDS 3.3)

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Id of the project(*) : 29339

Resource classification(*)

Type of the resource(*) : Study

Title(s)/name(s) of the Project

Title/name(*) : SARS-CoV-2 antigen rapid detection tests: test performance during the COVID-19 pandemic
Language of the title/name(*) : English

Acronym(s) of the Project

Acronym(*) : WüRDT
Language of the acronym(*) : German

Acronym(*) : WüRDT
Language of the acronym(*) : English

Description(s) of the Project

Description(*) : A prospective performance assessment from 12 November 2020 to 30 June 2023 at a single centre tertiary care hospital determining the sensitivity and specificity (primary endpoints) of RDTs from three manufacturers (NADAL®, Panbio™, MEDsan®) compared to RT-qPCR as reference standard among patients, accompanying persons and staff.
Language of the description(*) : English

Keyword(s) describing the Project

Keyword(*) : Not specified

Contributor(s) of the Project

Is it a personal or organisational contribution?(*) : Organisational
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Sponsor (primary)
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Universitätsklinikum Würzburg
Details about the contributing person(s)
Contributor type(*) : Not specified
Given name(*) : Not specified
Family name(s)(*) : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : Not specified
Phone number : Not specified
Organisation(s) associated with the contributor
Name(*) : Not specified
Address : Not specified
Web page : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified

Is it a personal or organisational contribution?(*) : Personal
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Not specified
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Not specified
Details about the contributing person(s)
Contributor type(*) : Principal investigator
Given name(*) : Manuel
Family name(s)(*) : Krone
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : krone_m@ukw.de
Phone number : Not specified
Organisation(s) associated with the contributor
Name(*) : Not specified
Address : Not specified
Web page : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Identifier(*) : Not specified
Scheme(*) : Not specified
Name(*) : Not specified
Address : Not specified
Web page : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Identifier(*) : Not specified
Scheme(*) : Not specified

Alternative identifiers

Type of the registry(*) : Not specified
Identifier(*) : Not specified

Characteristics of the Project

Is it an interventional or non-interventional Project? : Non-interventional
Specification of the type of the Project
Interventional Project type : []
Non-interventional Project type : Longitudinal
Primary health condition(s) or disease(s) considered in the Project
Primary health condition or disease name(*) : Acute respiratory infections
Terminology/classification(*) : SNOMED CT
Code of the health condition or disease : 195647007
Groups of diseases or conditions(*)
Which groups of diseases or conditions were the data collected on? : Certain infectious or parasitic diseases (I)
On which diseases or conditions were the data collected? : []
Collects mortality data? : Not specified
Administrative information about the Project
Status of the ethics committee approval : Request for approval submitted, exempt granted
Overall Project status : Completed: Recruitment, data collection, and data quality management completed normally
Participants enrolled by invitation? : Not specified
Start date : Not specified
End date : Not specified
Mono- or multicentric? : Not specified
Number of centers : Not specified
One or more data providers? : Not specified
Number of data providers : Not specified
Primary subject(*) : Person
Eligibility criteria for Project participants
Eligibility criteria: Minimum age
Minimum eligible age(*) : 18
Unit of age(*) : Years
Eligibility criteria: Maximum age
Maximum eligible age(*) : 99
Unit of age(*) : Years
Eligible gender : []
Inclusion criteria : Not specified
Exclusion criteria : Not specified
Population of the Project(*)
Coverage : Regional
Country(ies) : Germany
Region(s) and/or city(ies) : Not specified
Interventions of the Project
Name of the intervention(*) : Not specified
Type of the intervention : Not specified
Additional information about the intervention : Not specified
Name(s) of the arm(s) associated with the given intervention : Not specified
Exposures of the Project
Name of the exposure : Not specified
Type of the exposure : Not specified
Additional information about the exposure : Not specified
Name(s) of the group(s) associated with the given exposure : Not specified
Outcome measures in the Project
Name of the outcome measure(*) : Not specified
Description of the outcome measure : Not specified
Type of the outcome measure : Not specified
Time point(s) of assessment : Not specified
Additional information about the Project : Not specified
Additional assessments/measurements in the Project : []
Data sharing strategy of the Project(*)
Is it planned to share the data?(*) : Yes, there is a plan to make data available
Supporting documents available in addition to the data : []
When and for how long will the data be available? : Not specified
Criteria for data access : Not specified
Additional information about data sharing : Not specified
DataSHIELD/Opal infrastructure available? : Not specified
Link to data request application : Not specified
Web page with additional information about data sharing : Not specified
Record linkage possible? : false
Non-interventional aspects of the Project
Temporal design : []
Target follow-up duration of the Project
Target follow-up duration(*) : Not specified
Unit of time(*) : Not specified
Number of follow-ups conducted : Not specified
Biosamples retained in a biorepository : []
Specific types of retained biosamples : Not specified
Interventional aspects of the Project
Numerical phase : Not specified
Masking of intervention(s) assignment
Masking implemented? : Not specified
Who is masked? : []
Additional information about masking : Not specified
Type of allocation of participants to an arm : Not specified
Off-label use of a drug product : Not specified

WüRDT

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