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

Study Overview
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Brief Summary
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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: Are the POC CRP devices technically accurate? Do the measured values agree with CRP values measured at the clinical laboratory? 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

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

Conditions
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Healthy and Acutely Ill Children & Adults

Intervention / Treatment
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* Device: Point-of-Care C Reactive Protein measurement on capillary blood


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children: aged 1 month to 14 years adults: aged 18-65 years Exclusion Criteria: children and adults not understanding Dutch language

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: point-of-care test for CRP<br> | Device: Point-of-Care C Reactive Protein measurement on capillary blood<br>* capillary blood fingerstick method to determine C Reactive Protein level in the blood<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| technical accuracy | 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 | 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 | 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 | 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 |