Echinococcosis is a kind of parasitic disease shared by humans and animals. The aim of this study was to establish a new detection method for echinococcosis screening using magnetic bead-based chemiluminescence immunoassay (CLIA). A magnetic bead-based CLIA to determine anti-echinococcosis IgG antibodies was optimized and established. The sensitivity, accuracy, precision and recovery rate were evaluated using the national reference serum, and the reference interval, specificity and comparison assays were performed using the clinical negative/positive echinococcosis serum samples. This study established a new CLIA to determine anti-echinococcosis IgG antibodies. The sensitivity of this CLIA method was higher than that of the registered ELISA kit and the national standard, the conformance rate of the negative/positive references was 100% (8/8), the CVs of the sensitivity reference were all below 5%, and the CVs of the precision reference were 5.7%. There was no obvious cross-reactivity with the common parasitic disease-positive serum and serum interferents. Clinical sample testing found that the cutoff value of this CLIA was 5537.15 (RLU), and there was no significant difference between the CLIA method and the registered ELISA kit. This study established a fully automated CLIA method with high sensitivity, specificity, accuracy, precision, recovery rate, and satisfactory clinical testing performance, which may provide a new choice for echinococcosis screening.
Keywords: Chemiluminescence immunoassay; Detection method; Echinococcosis; IgG; Magnetic beads.
Copyright © 2023. Published by Elsevier B.V.