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

Not Applicable

Completed

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

• Registration Number: NCT01667172
• Lead Sponsor: KU Leuven

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-08
• Study First Submitted: 2012-08-14
• Study First Submitted QC: 2012-08-15
• Last Update Submitted: 2012-08-15
• Study First Posted: 2012-08-17
• Last Update Posted: 2012-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

• children and adults not understanding Dutch language

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
point-of-care test for CRP	Point-of-Care C Reactive Protein measurement on capillary blood	-

Primary Outcome Measures

Name	Time	Method
technical accuracy	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

Name	Time	Method
User-friendliness	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	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	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.

Trial Locations

Locations (3)

UZ Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium

Huisartspraktijken; 🇧🇪 Leuven, Vlaams-Brabant, Belgium

Medisch Centrum voor Huisartsen; 🇧🇪 Leuven, Vlaams-Brabant, Belgium