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Clinical Chemistry 53: 498-504, 2007. First published January 26, 2007; 10.1373/clinchem.2006.078063
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(Clinical Chemistry. 2007;53:498-504.)
© 2007 American Association for Clinical Chemistry, Inc.

Evidence-Based Laboratory Medicine and Test Utilization

Technical and Diagnostic Performance of 6 Assays for the Measurement of Citrullinated Protein/Peptide Antibodies in the Diagnosis of Rheumatoid Arthritis

Dries Coenen1, Patrick Verschueren2, René Westhovens2 and Xavier Bossuyt1,a

Departments of1 Laboratory Medicine & Immunology and 2 Rheumatology, University Hospital Leuven, Belgium.

aAddress correspondence to this author at: Department of Laboratory Medicine, Immunology, University Hospital Leuven, Herestraat 49, B-3000 Leuven, Belgium. Fax 0032-16-347931; e-mail xavier.bossuyt{at}uz.kuleuven.ac.be

Background: Several anticitrullinated protein/peptide antibodies (ACPA) assays have been reported to be of diagnostic value for rheumatoid arthritis (RA). We evaluated the technical performance and diagnostic accuracy of 6 ELISAs for the detection of antibodies to citrullinated protein/peptide antigens.

Methods: ACPA were determined in 298 serum samples using 6 commercially available ACPA assays. One hundred two samples were from RA patients, including patients with early and established RA, and 196 were from controls, including patients with psoriatic arthritis, connective tissue diseases, organ-specific autoimmune diseases, and a group of consecutive patients for whom a rheumatologist ordered anticyclic citrullinated peptide (CCP) antibodies. The ELISA reagent sets under study were Citrullinated Protein Antibodies (Genesis), Anti-MCV (Orgentec), Immunoscan RA (Euro-Diagnostica), Anti-CCP IgG ELISA (Euroimmun), EliATM CCP (Phadia), and Quanta LiteTM CCP3 IgG ELISA (Inova). Technical performance (imprecision, linearity, correlation, and agreement) and diagnostic accuracy (sensitivity and specificity) were compared.

Results: Variable technical performance was noted among the different ACPA assays, with some assays displaying poor reproducibility and bad linearity. ACPA results were well correlated among assays with the same antigen specificity, but the numerical values reported for each assay differed widely. Using cutoff values proposed by the manufacturer, diagnostic sensitivities ranged between 69.6% and 77.5% and specificities between 87.8% and 96.4%. The areas under the ROC curves were comparable among the different assays.

Conclusions: Overall diagnostic performance of ACPA assays is comparable among the different assays, but standardization is needed. For some assays, analytical characteristics could be improved.




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