Open AccessClinical evaluation of cobas core anti‐dsDNA EIA quant
Author(s) -
González Concepción,
Guevara Paloma,
GarcíaBerrocal Belén,
Alejandro Navajo José,
Manuel GonzálezBuitrago José
Publication year - 2004
Publication title -
journal of clinical laboratory analysis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.536
H-Index - 50
eISSN - 1098-2825
pISSN - 0887-8013
DOI - 10.1002/jcla.20023
Subject(s) - anti nuclear antibody , roche diagnostics , medicine , antibody , anti dsdna antibodies , kappa , lupus erythematosus , immunology , gastroenterology , autoantibody , mathematics , geometry
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.