Diagnostics Worldwide

Autoimmune Diagnostics

Advances in the Diagnosis of Rheumatoid Arthritis Staged Multimarker Concept

> Cost-efficient Screening for High-Titer RF

> High Specificity for Early RA Diagnosis by Detection of Anti-CCP

> Increased Sensitivity by Sequential Testing with RF, CCP and RA33

> Prognosis of Disease Outcome Allows Individually Tailored Therapies

Early Diagnosis of Rheumatoid Arthritis

Rheumatoid Arthritis (RA) is a chronic, progressive, systemic

autoimmune disease characterized by persistent joint

inflammation. If left untreated the disease leads to systemic

complications, irreversible joint damage and invalidity.

For effective treatment, an early diagnosis of RA is essential.

Serologic markers can detect early-stage RA, thereby con-

tributing to an improved outcome of RA therapy and reduc-

tion of the severity of joint damage.

Serologic RA Markers

Rheumatoid Factor (RF) was long the sole serologic indicator

for RA, showing a sensitivity of 60 to 80 % and a specificity

of 90 %. In recent years new prognostic and diagnostic mark-

ers have been identified. The greatest potential has been

observed for antibodies against cyclic citrullinated peptides

(Anti-CCP). Anti-CCP antibodies have a specificity for RA of

The Staged Multimarker Concept

High titer RF (> 50 IU/ml), Anti-CCP and Anti-RA33

can occur independently in early-stage RA and can even

precede the development of clinical manifestations.

The sequential determination of RF, Anti-CCP and Anti-RA33

is an efficient and cost-effective strategy for routine diag-

nosis of early RA.

Appropriate Early Treatment

Prevention of Progressive Joint Damage

ReducedInvalidity

ReducedMortality

Anti-RA33hnRNP-A2 Antibodies

mild prognosis

Anti-CCPcyclic citrullinated peptidesevere, erosive prognosis

RF 50 ≥ lU/mlRheumatoid Factor

severe, erosive prognosis

Diagnosis of Rheumatoid Arthritis

at least 98 % and a sensitivity that is comparable to that of

RF reaching 75 % in established RA. Another well-character-

ized marker is the autoantibody against hnRNP-A2 (Anti-

RA33). Anti-RA33 is detectable in one third of RA patients and

shows specificity similar to RF. Antibodies against RA33 are

associated with a less severe form of the disease.

High risk of developing RAHigh risk of developing erosive disease

Increased risk of developing RAGood prognosis

Anti-RA33

Decreased risk of developing RA

Adapted from reference 3

negative

negative

positive

positive

≥ 50 U/ml

Anti-CCP

Anti-RF

Suspicion of Rheumatoid Arthritis (RA)

Diagnostics WorldwideHUMAN Gesellschaft für Biochemica und Diagnostica mbH Max-Planck-Ring 21 · 65205 Wiesbaden · GermanyTel. +49 6122-9988-0 · Fax +49 6122-9988-100 · e-mail: human@human.de · www.human.de

Enzyme Immunoassays Cat. No.

IMTEC-RF Screen 96 Tests ITC60000

ELISA for the quantitative determination

of rheumatoid factors (Ig(GAM))

IMTEC-CCP-Antibodies 96 Tests ITC60021

ELISA for the quantitative determination

of Anti-CCP antibodies (IgG)

IMTEC-RA33-Antibodies 96 Tests ITC60015

ELISA for the quantitative determination

of Anti-RA33 antibodies (IgG)

With the IMTEC product line HUMAN offers the broadest

test portfolio for a complete up-to-date diagnosis of early

rheumatoid arthritis.

Enzyme Immunoassays Cat. No.

IMTEC-RF IgM 96 Tests ITC60003

ELISA for the quantitative determination

of rheumatoid factors (IgM)

IMTEC-RF IgG 96 Tests ITC60007

ELISA for the quantitative determination

of rheumatoid factors (IgG)

IMTEC-RF IgA 96 Tests ITC60010

ELISA for the quantitative determination

of rheumatoid factors (IgA)

9815

90/G

B/20

10-1

1 ©

201

0 H

uman

Gm

bH

References1. Lee & Schur, Ann Rheum Dis, 2003; 62: 870-874

2. Lindquist et al., Ann Rheum Dis, 2005; 64:196-201

3. Nell et al., Ann Rheum Dis, 2005; 64:1731-1736

4. Nielen et al., Arthritis & Rheumatism, 2004; 50:380-386

5. Pruijn et al., Current Rheum Reviews, 2005; 1:1-7

6. Rantapää-Dahlqvist et al., Arthritis & Rheumatism, 2003;

10:2741-2749

7. Sauerland et al., Ann N.Y. Acad Sci, 2005; 1050: 314-318

8. Van Gaalen et al., Arthritis, 2004; 50:709-715

9. Visser et al., Arthritis and Rheumatism 2002; 46:357-65

Diagnosis of Rheumatoid ArthritisIMTEC Product Line