Analytical and clinical evaluation of new automated chemiluminescent immunoassays for the detection of IgG and IgM anti-Bartonella henselae antibodies

Abstract

Serological diagnosis of Bartonella henselae infection mainly rely on microscopic immunofluorescence assays (IFA), which are however time-consuming and poorly standardized. The aim of the study was to assess the use of the new fully automated VirClia® chemiluminescent immunoassays for the detection of IgG and IgM anti-B. henselae antibodies. Eighty-one patients with a well-defined B. henselae infection as well as 80 patients with an alternative disease were included. The VirClia® IgG antibody assay showed a sensitivity of 79.0% and a specificity of 93.8% for the diagnosis of B. henselae infection. For the VirClia® IgM assay, results were more conflicting with a sensitivity of 42.0% and a specificity of 98.2% to predict IFA IgM results. In 11 additional patients with uninterpretable IFA due to autoimmune antibodies, VirClia® assays were able to deliver valuable quantitative results. The VirClia® IgG assay shows good analytical and clinical performances and could be easily integrated in the diagnostic workflow of B. henselae infection.