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Clinical Chemistry Anti-CCPAnti-CCP testing in your chemistry workflow
Anti-CCP and the Clinician
Testing for anti-CCP antibodies can provide the clinician with a number of important
benefits:
• Anti-CCP antibodies are highly specific for RA3
• Anti-CCP antibodies can be present many years before visit to clinician4
• In patients with undifferentiated RA the presence of anti-CCP antibodies can
predict subsequent development to RA5,6
• Strong association between anti-CCP antibody levels and subsequent development
of more severe disease (erosive)7,8
• Patients who are CCP+/RF+ or CCP+/RF- have a higher chance of developing
erosive disease than those who are CCP-/RF- or CCP-/RF+9
• Evidence that CCP-positive patients respond better to disease modifying
anti-rheumatic drugs DMARDs than do CCP-negative patient groups10
In summary, although the clinical features of both CCP-positive and CCP-negative
RA are often similar, there is evidence to suggest that CCP-positive RA is more
strongly associated with poor outcome than CCP-negative RA.
Rheumatoid Arthritis – It’s Never too Early to Test
Rheumatoid Arthritis (RA) is a common, systemic autoimmune disease affecting
between 0.5-1% of the adult population. It is characterised by inflammation of the
synovial joints which can lead to progressive joint destruction and consequent
impairment in quality of life. Early intervention is vital in preventing irreversible joint
damage and it is therefore important to diagnose RA as early as possible.1 Antibodies
to citrullinated proteins/peptides (ACPAs) are reported to be strongly associated with
the progression of RA.
In the routine clinical setting, ACPAs have mostly been detected using the anti-cyclic
citrullinated peptide test (anti-CCP).2
Healthy RA
Clinical Chemistry Anti-CCP
Anti-CCP antibodies have
traditionally been measured by
heterogeneous immunoassay –
either time-consuming ELISA
tests or on closed mainframe
immunoassay analysers.
The Axis-Shield Clinical
Chemistry Anti-CCP assay
provides a quick and accurate
method for use on most clinical
chemistry platforms.
Assay Performance
• Excellent concordance with clinical classification
• High specificity for RA
• Equivalent performance to established immunoassay methods
Specimen Total No. of No. of % %Catagory Positives Negatives Sensitivity Specificity
RA 196 134 62 68.4 -
All non-RA 351 14 337 - 96.0
Other disease states 156 9 147 - 94.2
Healthy asymptomatic 195 5 190 - 97.4
For the first time, anti-CCP testing can now be consolidated into your
routine chemistry workflow.
Instrument Protocol
Simple assay protocol for easy use on most clinical chemistry platforms:
200µL R1
7µL
Sample
Add
50µL R2
Mix Incubate
5mins at
37˚C
Read
1 at
800nm
Read at
800nm
Mix and
Incubate
5mins at
37˚C
Mix Read
2 at
700nm
Axis-Shield Clinical Chemistry Anti-CCP Assay
• Applicable to many different clinical chemistry analysers
• Simple direct assay with two reagents and three steps
• Consolidate with acute phase reactants and other serology markers into your routine
chemistry workflow
Axis-Shield
The Technology Park
Dundee DD2 1XA
Scotland UK
T: +44 (0)1382 422000
F: +44 (0)1382 422088
www.axis-shield.com
CC
CC
P-V
2 1
0/1
6
Method Latex Immunoturbidimetry
Kit Components 2 liquid stable reagents
Instrument Protocol 2-reagent protocol
Sample Type K2EDTA, LiHep, NaHep plasma or serum
Sample Volume 7 µL
Time to first result 10 minutes
Reagent and Calibration ≥5 days calibration stability, depending on instrument
Stability
Analytical Performance Repeatability ≤5%
Robust to interference from endogenous substances including
Rheumatoid Factor
Distributed by:
Product Information
Ordering Information
Product Part No. Description
Clinical Chemistry Anti-CCP Reagent Kit FHCCP100 2 liquid-stable reagents
(typical 100 tests dependent on platform) 24mL Reagent 1, 7.6mL Reagent 2
Clinical Chemistry Anti-CCP Control Kit FHCCP200 2-level controls, Low and High
1mL each
Clinical Chemistry Anti-CCP Calibrator Kit FHCCP300 5-level calibrators, 0 to 200 U/mL*
1mL each
References
1. Landewe RB, 2003; Arthritis Rhuem; 48:46-53, 2. Van Venrooij et al, 2008; Ann NY Acad Sci;1143:268-285 3. Pruijn G et al,2010; Arthritis Res Ther;12:203 4. Rantappa-Dahlqvist S et al, 2003; Arthritis Rheum;48:2741-2749 5. van Gaalen FA et al, 2004; Arthritis Rheum;50:709-715
6. Van der Helm-van Mil AH et al, 2007; Arthritis Rheum;56:433-440 7. Turesson C et al, 2007; Ann Rheum Dis;66:59-64 8. Machold KP et al;2007;Rheumatology(Oxford);46:342-349 9. van der Linden MP et al, 2009; Arthritis Rheum;60:2232-2241 10. Visser K etal, 2008; Ann Rheum Dis;67:1194-1195
* lot dependent