A cross-sectional study comparing BIOCHIP Mosaic 7 and Multivariant ELISA in the serodiagnosis of IgG-mediated Autoimmune Blistering Disorders

Autoimmune blistering diseases (AIBD) are characterized by the presence of autoantibodies directed against the major structural proteins in skin and mucous membranes such as the desmosomes and hemidesmosomes. DIF microscopy is considered as the gold standard in the diagnosis of AIBD. However, DIF often provides limited information about the target antigens and the conventional serological diagnosis of IgG mediated AIBD is done by a multi-step approach based on initial indirect immunofluorescence (IIF) microscopy and subsequent individual antigen-specific assays by enzyme-linked immunosorbent assay (ELISA). This shows that the current diagnostic approach in IgG mediated AIBD is a multi-step process which is time consuming resulting in a significant time-lag before a precise diagnosis is made.

A single test that is simple, rapid and minimally invasive is the need of the hour in the diagnosis of IgG mediated AIBD. BIOCHIP is an indirect immunofluorescence technique for the rapid diagnosis of autoimmune blistering conditions. It provides the results of multiple individual tests on a single field. On the other hand, a recently developed multivariant profile ELISA is a single testing strategy where simultaneous processing of multiparametric antigen-specific testing for autoantibodies is possible in adjacent wells of a microplate.

Thus, we intend to undertake the present study as there is paucity of studies from India comparing these two techniques in the diagnosis of IgG mediated AIBD. All newly diagnosed cases of IgG mediated AIBDs, who meet the inclusion criteria will be recruited in the study. A detailed history and examination findings shall be entered in the predesigned proforma. Perilesional skin biopsy sample will be obtained for direct immunofluorescence (DIF) microscopy and serum sample will be obtained for BIOCHIP and multi-variant ELISA. The results obtained shall be compiled and analyzed using standard statistical methods.