-What are the testcharacteristics of an anti-CCP2 quicktest (sensitivity, specificity, positive and negative predictive value, kappa statististics) using capillary or venous blood compared to the golden standard, the anti-CCP2 Elisa in serum?-What…
ID
Source
Brief title
Condition
- Synovial and bursal disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Results from the anti-CCP2 quicktest with capillary and venous blood are
compared to each other and to the anti-CCP2 elisa in serum using dichotomeous
and trichotomeous distributions (negatief, weakly positive and positive (3*3
table) or positive and negative (2*2) table). Testcharacteristics are decribed
using sensitivity, specificity, positive and negative predictive value.
Secondary outcome
Pragmatic aspects including needed time, feasability and the percentage of
failed tests are described qualitatively and quantitatively.
Background summary
Recently a new diagnostic test for Rheumatoid Arthritis has been developed -
the anti-CCP2 test - which is as sensitive (60%) but more specific for RA (95%)
compared to rheumatoid factor. The additional value of anti-CCP2 has been
established in prospective studies.
The presence of anti-CCP antibodies is measured using an Elisa, which takes a
few days. If a quicktest for anti-CCP2 was available, this could decrease delay
of diagnosis and treatment. Recently a 5 minute anti-CCP2 test has been
developed that can be used on capillary or venous blood.
Study objective
-What are the testcharacteristics of an anti-CCP2 quicktest (sensitivity,
specificity, positive and negative predictive value, kappa statististics) using
capillary or venous blood compared to the golden standard, the anti-CCP2 Elisa
in serum?
-What are pragmatic aspects of this test, including average needed time,
percentage number of failed tests, feasability.
Study design
Two anti-CCP2 quicktests will be done on RA patients at their home or at the
outpatient clinic. Both venous blood and capillary blood will be drawn. Results
for each test are noted as well as pragmatic aspect and baseline, medication
and RA related data.
Study burden and risks
The Burdon for the patient include sampling of venous blood and capillary blood
("finger prick") and providing some baseline data. Time required is once 10
minutes and there are no associated risks bu a bruise from the venous blood
sampling. The anti-CCP2 status is already known for all patients, so they do
not receive new disease information.
Hengstdal 3
6522JV
Nederland
Hengstdal 3
6522JV
Nederland
Listed location countries
Age
Inclusion criteria
Rheumatoid arthritis
informed consent given
Aerea of Nijmegen
Previous Anti-CCP2 status determined
Exclusion criteria
none
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL13564.091.06 |