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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01667172

Enrollment

300

Registered

2012-08-17

Start date

2012-04-30

Completion date

2012-06-30

Last updated

2012-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy and Acutely Ill Children & Adults

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

Interventions

DEVICEPoint-of-Care C Reactive Protein measurement on capillary blood

capillary blood fingerstick method to determine C Reactive Protein level in the blood

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

1 Months to 65 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* children and adults not understanding Dutch language

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026