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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| point-of-care test for CRP | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Point-of-Care C Reactive Protein measurement on capillary blood | Device | capillary blood fingerstick method to determine C Reactive Protein level in the blood |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huisartspraktijken | Leuven | Vlaams-Brabant | 3000 | Belgium | ||
| Medisch Centrum voor Huisartsen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21653621 | Background | Van den Bruel A, Thompson MJ, Haj-Hassan T, Stevens R, Moll H, Lakhanpaul M, Mant D. Diagnostic value of laboratory tests in identifying serious infections in febrile children: systematic review. BMJ. 2011 Jun 8;342:d3082. doi: 10.1136/bmj.d3082. | |
| 20132979 | Background | Van den Bruel A, Haj-Hassan T, Thompson M, Buntinx F, Mant D; European Research Network on Recognising Serious Infection investigators. Diagnostic value of clinical features at presentation to identify serious infection in children in developed countries: a systematic review. Lancet. 2010 Mar 6;375(9717):834-45. doi: 10.1016/S0140-6736(09)62000-6. Epub 2010 Feb 2. |
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| 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 |
| Leuven |
| Vlaams-Brabant |
| 3000 |
| Belgium |
| UZ Leuven | Leuven | Vlaams-Brabant | 3000 | Belgium |