1. Validation of a new immunoenzymatic method to detect antibodies to RNA polymerase III in systemic sclerosis
- Author
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Codullo, V., Morozzi, G., Bardoni, A., Salvini, R., Deleonardi, G., De Pita, O., Riccieri, Valeria, Ruffatti, A., Tincani, A., Tozzoli, R., Valesini, Guido, Montecucco, C., and Study Group Forum Interdisciplinare Per La Ricerca Sulle Malattie Autoimmuni, F. I. R. M. A.
- Subjects
Adult ,Aged, 80 and over ,anti-rna polymerases antibodies ,autoantibodies ,systemic sclerosis ,Scleroderma, Systemic ,RNA Polymerase III ,Reproducibility of Results ,Enzyme-Linked Immunosorbent Assay ,Middle Aged ,Sensitivity and Specificity ,Antibodies ,Italy ,ROC Curve ,Reference Values ,Humans ,Immunoprecipitation ,Aged - Abstract
To test the reliability of a new enzyme-linked immunosorbent assay (ELISA) to identify anti-RNA polymerase III (RNAP III) positive sera from Italian patients with Systemic Sclerosis (SSc) and other chronic inflammatory disorders.A comparison between the new ELISA for anti-RNAP III and the gold standard technique, immunoprecipitation (IP), was first performed on 106 SSc patients, 16 patients with other connective tissue diseases and 10 healthy subjects. A further ELISA evaluation was performed on 224 SSc patients, 120 subjects with other rheumatic or infectious diseases, and 81 healthy controls.Plotting ELISA and IP data in a Receiver Operator Characteristic curve, the ELISA cut-off value providing the best specificity (99.1%) and sensibility (100%) was 28 U/ml (AUC=0.999; p0.0001). Using this cut-off in the second analysis, anti-RNAP III positive results were found in 41 (18.3%) SSc patients, all negative for anticentromere or anti-topoisomerase I antibodies, while only 3 subjects tested positive among the 120 sera collected from other patients. All the healthy subjects were negative.This new ELISA for anti-RNAP III is highly accurate when a proper cut-off value is employed and represents a valid substitute to IP in a clinical setting.
- Published
- 2007