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

August 15, 2012 updated by: Jan Verbakel, KU Leuven

Study of Technical Accuracy and Userfriendliness of Two Point-of-care C Reactive Protein Devices

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • UZ Leuven
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Huisartspraktijken
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Medisch Centrum voor Huisartsen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • children and adults not understanding Dutch language

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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.
3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

August 14, 2012

First Submitted That Met QC Criteria

August 15, 2012

First Posted (Estimate)

August 17, 2012

Study Record Updates

Last Update Posted (Estimate)

August 17, 2012

Last Update Submitted That Met QC Criteria

August 15, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • S54271

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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