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Completed

NCT Number: NCT01667172

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

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

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Key information

Conditions

Healthy and Acutely Ill Children & Adults

Age range

1 month–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huisartspraktijken, Leuven, Vlaams-Brabant, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • children and adults not understanding Dutch language

Treatment and study plan

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

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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. 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.

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 17, 2012
Registry last updated
Aug 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.