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

Catholic University (KU) of Leuven

Status: Completed

Conditions: Healthy and Acutely Ill Children & Adults

Treatments: Device: Point-of-Care C Reactive Protein measurement on capillary blood

Study type: Interventional

Funder types: Other

Identifiers

NCT01667172

S54271

Details and patient eligibility

About

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

Enrollment: 300 patients

Sex: All

Ages: 1 month to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• children and adults not understanding Dutch language

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind

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300 participants in 1 patient group

point-of-care test for CRP

Other group

Treatment:

Device: Point-of-Care C Reactive Protein measurement on capillary blood