Enzyme-linked immunosorbent assay (ELISA) screening test for detection of rheumatoid factor.

A new enzyme-linked immunosorbent assay (ELISA) screening test for total rheumatoid factor (RF) activity is described. Rabbit IgG was used as antigen and enzyme-conjugated monoclonal anti-kappa antibody as third layer. Of 183 samples measured for RF isotype levels, 60 were found to have one or more raised. In terms of raised isotypes the ELISA screening test had a sensitivity of 97% (58/60) while the Rheumaton had a sensitivity of only 75% (45/60). Nearly all discordant false-negative samples had only one RF isotype raised. The ELISA test gave 29% (53/183) and the Rheumaton 34% (63/183) false-positive results. Thus the ELISA test was more specific and sensitive for the detection of raised single RF isotypes than the Rheumaton and Rose-Waaler tests. Moreover, approximately 30% of RA patients were seronegative according to the conventional RF tests but only 8% in the new ELISA system.