Diagnostic accuracy of immunoassays for the detection of antibodies to citrullinated proteins.

Anticitrullinated protein/peptide antibodies (ACPA) are highly specific for rheumatoid arthritis (RA). They can be found early in the disease course and are associated with more severe joint destruction and disease activity. In the last 4 years, important progress has been made in the detection and identification of ACPA, improving antigenic composition and epitope recognition. Consequently, many ACPA-ELISA kits have been developed by several manufacturers and are now commercially available. However, albeit their widespread use in clinical laboratories, the use of some kits has not been accompanied by a clinical validation nor by a comparative evaluation of their diagnostic accuracy. In addition, full automation of ACPA assays featuring ease of use, rapid response, and high productivity is just beginning to appear on the market and also deserves clinical and analytical validation. This review will consider the most relevant characteristics of the ACPA-ELISA assays and will describe the results of a comparative study performed with all the currently available second- and third-generation commercial methods.