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

E: AXD.axis-shield@alere.com

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