Validation of a new immunoenzymatic method to detect antibodies to RNA polymerase III in systemic sclerosis

Clinical and Experimental Rheumatology

R. Tozzoli¹  G. Valesini¹  A. Tincani¹  R. Salvini¹  G. Morozzi¹  V. Riccieri¹  O. De Pit๠ A. Bardoni¹  A. Ruffatti¹  V. Codullo¹  G. Deleonardi¹    Forum Interdisciplinare per la Ricerca sulle Malattie Autoimmuni (F.I.R.M.A.) study group.¹ 

关键词: Systemic sclerosis;    autoantibodies;    anti-RNA polymerases antibodies.;   

DOI  :  

学科分类：医学（综合）

来源: Pacini Editore SpA

【 摘 要 】

OBJECTIVES: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.METHODS: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.RESULTS: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; p < 0.0001). 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.CONCLUSIONS: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.

【 授权许可】

Unknown