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 Printable version |
Evaluation of analytical and diagnostic performances of the anti-cyclic citrullinated peptides (anti-CCP) automated assay on Elecsys
® analyzer |
Annales de Biologie Clinique. Volume 67, Number 4, 405-10, juillet-aout 2009, article original
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 Résumé
Article gratuit
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Author(s) : C Chenevier-Gobeaux, C Simonneau, OG Ekindjian, B Weill, C Goulvestre |
Summary : Anti-cyclic citrullinated peptides (anti-CCP) are highly characteristics of rheumatoid arthritis (RA). Since 2006, anti-CCP assays have been included in both French and European recommendations. We have evaluated the analytical and clinical performances of the anti-CCP assay on the Elecsys
® analyzer (Roche Diagnostics). Two plasma pools (target values: 17.2 and 363.0 U/mL) and two quality controls (target values: 24.5 and 157.0 U/mL) were tested\; we also analyzed three hundred plasma samples from healthy subjects (n \= 86) and diseased patients (presenting with RA, non rheumatoid disorders, or undifferentiated arthritis: n \= 214). Analytical performances (intra- and inter-assay precisions) and clinical performances (ROC analysis and method comparison) were evaluated. Elecsys
® assay was compared to Immunoscan RA
® assay using contingency tables. Intra- and inter–assay precisions showed coefficients of variation less than 5%. ROC analysis showed an area under the curve at 0.886. Considering the value of 17 U/mL as the optimal cut-off, we found sensibility and specificity at 75% and 95%, respectively. Comparison of the Elecsys
® anti-CCP assay with the Immunoscan RA
® assay showed an overall agreement of 98,3%. We conclude that the the Elecsys
® anti-CCP assay displayed a high precision and clinical performances comparable to that of the efficient anti-CCP assay Immunoscan RA
®. |
Keywords : anti-cyclic citrullinated peptides, Elecsys, immunoassay, rheumatoid arthritis |
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