Evaluation of a new multi-parallel line immunoassay for systemic sclerosis-associated antibodies in an Asian population

Abstract

Objectives. To compare the SSc-line immunoassay (LIA) with conventional techniques of antibody detection, to evaluate its diagnostic utility and to describe clinical associations of antibodies in Asian SSc patients. Methods. Stored sera from patients with SSc (n = 68), SLE (n = 49), OA (n = 41) and normal controls (NCs, n = 32) were evaluated. Cohen's κ and Bland-Altman plots were used to evaluate agreement. Results. There was good agreement between LIA and ELISA for anti-Scl-70 (κ = 0.97), anti-CENPA (κ = 0.83), anti-CENPB (κ = 0.96) and anti-PmScl100 (κ = 1.00) (5.48-8.22% of values outside the 95% limits of agreement using Bland-Altman plots), and between LIA and IIF for anti-CENPA (κ = 0.81) and anti-CENPB (κ = 0.77) (P