SeroNeg RAdx4 Profile

Serum

3 mL

1.5 mL (Note: This volume does not allow for repeat testing.)

Red-top tube or gel-barrier tube

SeroNeg RAdx4 is a diagnostic and prognostic panel for Rheumatoid Arthritis designed to complement traditional RF and Anti-CCP testing.

This profile, consisting of 14-3-3 eta protein, Anti-CEP1 (citrullinated alphaenolase 1) Ab, Anti-Sa (citrullinated vimentin) Ab, and the novel Anti-CarP (carbamylated protein) Ab, enhances the diagnosis of established or early RA (especially in individuals seronegative for RF and Anti-CCP Ab) and may also help predict disease severity.

Decrease in 14-3-3 eta and/or Anti-Sa Ab with treatment is associated with less radiographic progression. The presence of Anti-CEP1 and Anti-CCP Antibodies suggests the imminent progression of pre-clinical RA into clinical RA. Anti-CarP may predict the development of RA independently of Anti-CCP and may be present years before the onset of symptoms in RA. Anti-CarP may confer a 10% incremental benefit in identify early RA and is associated with more active disease and higher risk of developing joint erosions.

This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.

Enzyme-linked immunosorbent assay (ELISA)