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KMID : 0371620090240010007
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Journal of Wonkwang Medical Science
2009 Volume.24 No. 1 p.7 ~ p.13
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Evaluation for Analytic Performance of cobas Anti-Cyclic Citrullinated Peptide Antibody Assay
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Lee Koung-Sun
Park Do-Sim
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Abstract
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Background: Anti-cyclic citrullinated peptide(CCP) antibody is very useful test for diagnosis of rheumatoid arthritis(RA) because of its high specificity. However, the test has been developed for ELISA(enzyme-linked immunosorbent assay) method, it has a limitation to get a rapid result or deal with small number of tests. In this study we evaluated the analytical performance of cobas anti-CCP test(cobas), which has developed recently, has random accessibility and can be applied on automated immunochemical analyzer, to know appropriate clinical applications.
Methods: cobas(Roche Diagnostics GmBH Mannheim, Germany) was performed on automated immunochemical analyzer. The imprecision and linearity were evaluated using commercialized controls and pooled sera. Sixty serum samples(26 RA, 34 controls) were measured by cobas and ELISA method(DIASTAT; Axis-Shield Diagnostics, UK)to define the correlation, sensitivity, specificity, and agreement of both tests.
Results: cobas showed less than 5% of imprecision and its linearity was retained up to 639 U/mL. It showed good correlation with DIASTAT(R=0.90). The diagnostic sensitivity was 84.6% and specificity was 88.3%. The qualitative agreement with DIASTAT was 95.0%.
Conclusions: Automated cobas anti-CCP test showed acceptable analytical performance as a semi-quantitative test and high agreement rate with DIASTAT anti-CCP test. Considering random access capability and short analytical processing time of cobas anti-CCP assay, it will be useful in laboratories with small sample sizes and/or with a need of rapid turnaround time.
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KEYWORD
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Anti-cyclic citrullinated peptide antibody, Rheumatoid arthritis, Cobas, Automated Immunochemical Analyzer, Analytic Performance
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