A multi-center, randomized, double-blind and controlled study of BP180NC16a enzyme-linked immu-nosorbent assay (BP180NC16a-ELISA) in the diagnosis of bullous pemphigoid

Abstract

Objective To evaluate the sensitivity and specificity of BP180NC16a-ELISA in the diagnosis of bullous pemphigoid (BP). Methods A multi-center, randomized, double-blind, parallel-controlled study was conducted. Sera were collected from 106 patients with clinically confirmed active BP and 106 control subjects including patients with non-BP bullous diseases, scleroderma, psoriasis or systemic lupus erythematosus,late pregnant women and healthy blood donors. BP180NC16a-ELISA was performed on these sera. The IgG antibody levels measured by ELISA kit were compared with those measured by indirect immunofluorescence (IIF) test. Results Of the 106 BP sera, 81 were positive for BP180NC16a-ELISA with a sensitivity of 76.4%,83 for ⅡF test with a sensitivity of 78.3%. Among the 106 control serum samples, 95 were negative for BP180NC16A-ELISA with a specificity of 89.6%, and 102 for ⅡF test with a specificity of 96.2%. There was no significant difference between the two tests in dignostic sensitivity and specificity for BP (both P ＞ 0.05).Conclusion BP180NC16A-ELISA may serve as an adjuvant tool for the diagnosis of BP. Key words: Pemphigoid, bullous; Immunologic tests; Diagnosis; BP180