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Technical Accuracy and Userfriendliness of Two Point-of-care C Reactive Protein Devices in Comparison With Laboratory CRP Testing.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01667172
First Posted: August 17, 2012
Last Update Posted: August 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jan Verbakel, Katholieke Universiteit Leuven
  Purpose

Study to test technical accuracy and userfriendliness of two Point-of-care C Reactive Protein devices (POC CRP devices) in comparison with laboratory CRP testing on children and adults.

Research questions:

  1. Are the POC CRP devices technically accurate? Do the measured values agree with CRP values measured at the clinical laboratory?
  2. Are the 2 POC CRP devices equivalent ? 2.1. Are the 2 POC CRP devices equally reliable? 2.1.1. Comparison of 2 measurements in the same patient on 1 device (inter-observer-variability) 2.1.2. Comparison of 2 measurements in the same patient on 2 identical devices (inter-device-variability) 2.2. Are the 2 Point-of-Care CRP devices equally userfriendly in a general practice surgery? (userfriendliness

Condition Intervention
Healthy and Acutely Ill Children & Adults Device: Point-of-Care C Reactive Protein measurement on capillary blood

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Diagnostic
Official Title: Study of Technical Accuracy and Userfriendliness of Two Point-of-care C Reactive Protein Devices

Further study details as provided by Jan Verbakel, Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • technical accuracy [ Time Frame: 3 months ]
    correlation obtained between the results from the Point-of-care C Reactive Protein devices and the results from the laboratory


Secondary Outcome Measures:
  • User-friendliness [ Time Frame: 3 months ]
    evaluation of the userfriendliness by General Practitioners at 5 practices, on a five point Likert-scale scoring these criteria: device start-up, test duration, sample size, test characteristics, calibration, measuring range, handling of test tubes, filling of the capillary, placing the test cartridge, test recording and additional material usage. The median results are compared between both devices qualitatively.

  • Inter-device variability [ Time Frame: 3 months ]
    The inter-device-variability (by 1 physician) was tested on 10 patients in one General Practice surgery each on two different Point-of-Care devices of the same brand.

  • Inter-observer variability [ Time Frame: 3 months ]
    The inter-observer variability (by two physicians) was tested on 10 patients in one GP surgery on two different Point-of-care devices of the same brand.


Enrollment: 300
Study Start Date: April 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
point-of-care test for CRP Device: Point-of-Care C Reactive Protein measurement on capillary blood
capillary blood fingerstick method to determine C Reactive Protein level in the blood

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • children: aged 1 month to 14 years
  • adults: aged 18-65 years

Exclusion Criteria:

  • children and adults not understanding Dutch language
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01667172


Locations
Belgium
Huisartspraktijken
Leuven, Vlaams-Brabant, Belgium, 3000
Medisch Centrum voor Huisartsen
Leuven, Vlaams-Brabant, Belgium, 3000
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Katholieke Universiteit Leuven