Clinical evaluation of cobas core anti-dsDNA EIA quant

✍ Scribed by Concepción González; Paloma Guevara; Belén García-Berrocal; José Alejandro Navajo; José Manuel González-Buitrago

• Publisher: John Wiley and Sons
• Year: 2004
• Tongue: English
• Weight: 104 KB
• Volume: 18
• Category: Article
• ISSN: 0887-8013
• DOI: 10.1002/jcla.20023

✦ Synopsis

Abstract

The measurement of antibodies to double‐stranded DNA (anti‐dsDNA) is a useful tool for the diagnosis and monitoring of patients with connective tissue diseases, particularly systemic lupus erythematosus (SLE). The aim of the present study was to compare a new enzyme‐linked immunosorbent assay (ELISA) for the measurement of anti‐dsDNA antibodies, which uses purified double‐stranded plasmid DNA as the antigen (anti‐dsDNA EIA Quant; Roche Diagnostics, Mannheim, Germany), with an established ELISA. The clinical usefulness of this new ELISA was also assessed. We measured anti‐dsDNA antibodies in 398 serum samples that were divided into four groups: 1) routine samples sent to our laboratory for an antinuclear antibody (ANA) test (n=229), 2) samples from blood donors (n=74), 3) samples from patients with SLE (n=48), and 4) samples from patients with other autoimmune diseases (n=47). The methods used were the Cobas Core Anti‐dsDNA EIA Quant (Roche Diagnostics, Mannheim, Germany) and the Anti‐dsDNA test (Gull Diagnostics, Bois d'Arcy, France). We obtained a kappa index and Spearman correlation coefficient in the comparative study, and sensitivity, specificity, predictive values, and likelihood ratios in the clinical study. The results obtained show a good agreement between the two methods in both the qualitative results (κ=0.91) and the quantitative data (r=0.854). The best accuracy, predictive values, likelihood ratios, and correlation with active disease were obtained with the Roche anti‐dsDNA assay. J. Clin. Lab. Anal. 18:200–205, 2004. © 2004 Wiley‐Liss, Inc.