Published:
Last updated:
Evaluation of the point of care CRP test
ID
NL-OMON45337
Source
ToetsingOnline
Brief title
Cobas b 101 CRP Performance Evaluation
Condition
- Ancillary infectious topics
Synonym
blood infection parameters, infection
Research involving
Human
Sponsors and support
Primary sponsor
:
Roche Diagnostic International Ltd.
Source(s) of monetary or material Support
:
Roche Diagnostics international Ltd.
Intervention
Keyword
:
CRP, diagnostic, point of care
Outcome measures
Primary outcome
Analytical performance, reliability and robustness
Secondary outcome
Interference
Background summary
In current medical practice, the CRP test is taken by venous sampling and
analysed in the laboratory. A new point of care CRP test is develloped that
needs onlt capillary blood sampling.
Study objective
Evaluation of the point of care CRP test
Study design
Diagnostic cohort study
Study burden and risks
Blood sampling at a single occation, including 2 fingerpricks and 1 venous
blood draw.
Public
Roche Diagnostic International Ltd.
Forrenstrasse 2
Rotkreuz CH6343
CH
Forrenstrasse 2
Rotkreuz CH6343
CH
Scientific
Roche Diagnostic International Ltd.
Forrenstrasse 2
Rotkreuz CH6343
CH
Forrenstrasse 2
Rotkreuz CH6343
CH
Listed location countries
Netherlands
Age
Adults (18-64 years)
Elderly (65 years and older)
Inclusion criteria
> 18 years of age
clinical patients with (known) raised CRP levels, and/or
patients who requier blood sampling within standard care
Exclusion criteria
contra-indication for blood drawing
pregnancy
breast feeding
Design
Study type
:
Observational invasive
Masking
:
Open (masking not used)
Control
:
Uncontrolled
Primary purpose
:
Diagnostic
Recruitment
NL
Recruitment status
:
Recruitment stopped
Start date (anticipated)
:
Enrollment
:
160
Type
:
Actual
Approved WMO
Date
:
Application type
:
First submission
Review commission
:
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL61250.100.17 |