SeroNeg RAdx4 Profile

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 RA Profile with Reflex to SeroNeg RAdx4 is a novel profile for rheumatoid arthritis that if negative for traditional markers, RF and anti-CCP, reflexes to four novel markers (anti-MCV, anti-CEP-1, anti-Sa, anti-CarP) that comprise the SeroNeg RAdx4 profile, which is designed to enhance diagnosis of RA and early RA as well as predict disease severity. 

If anti-MCV and/or anti-Sa positivity is present, the disappearance or decrease of these antibodies with treatment is associated with less radiographic progression. In pre-clinical RA, positivity of anti-CEP-1 along with anti-CCP antibodies significantly raises the risk of imminently developing 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 identifying early RA and is associated with more active disease and higher risk of developing joint erosions.