Performance characteristics of three random access cyclic citrullinated peptide antibody assays.
BACKGROUND
Cyclic citrullinated peptide antibodies (CCP Ab) are useful biomarkers for the early detection and diagnosis of rheumatoid arthritis (RA).


METHODS
We evaluated the performance of 3 random access 2nd generation CCP Ab assays, the Abbott AxSYM and Architect analyzers and the Roche Modular Analytics E170 analyzer, for limit of detection (LOD), imprecision, results for samples from healthy subjects, analytic concordance, and interferences. Method comparison testing was performed using the AxSYM analyzer as the comparison method and a 3rd generation INOVA Quanta Lite ELISA assay was included.


RESULTS
LOD determinations met the manufacturers' claims. Total CVs ranged from 1.6% to 8.2%. Results from healthy subjects were generally much lower than the manufacturers' decision cutoffs. Comparison to the AxSYM assay resulted in overall concordance ranging from 82.1% to 98.3%. These assays were resistant to interference from hemolysis, icterus, lipemia and rheumatoid factor.


CONCLUSIONS
All 3 random access CCP Ab assays performed according to the manufacturers' claims and have the potential to improve workflow in clinical laboratories.
Wyness
Sara P
SP
ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, UT, USA.
La'ulu
Sonia L
SL
Hunsaker
Joshua J H
JJ
Tebo
Anne E
AE
Roberts
William L
WL
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015415:Biomarkers / Q000097:blood; D001774:Blood Chemical Analysis; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010456:Peptides, Cyclic / Q000097:blood*; D012016:Reference Values; D012680:Sensitivity and Specificity; D055815:Young Adult
D015415:Biomarkers; D010456:Peptides, Cyclic; C487763:cyclic citrullinated peptide