The present invention relates to a test kit for performing an
assay to detect and measure at least one
autoantibody molecule in a subject developing type 1 diabetes (T1D). The invention more specifically relates to a
recombinant antigen molecule fused to a bioluminescent reporter
protein to detect an
autoantibody molecule against a self-
antigen. Said self-
antigen is preferably expressed by pancreatic
islet beta cells and include
insulin,
proinsulin,
Glutamate decarboxylase 65,
islet antigen 2, and
Zinc transporter 8. More specifically, the present invention relates to an
assay comprising a set of at least three
recombinant antigen molecules in a single composition, the antigen molecules being selected from the
list comprising recombinant human
Glutamate decarboxylase 65, recombinant human
islet antigen 2, recombinant human
Zinc transporter 8, recombinant
human insulin, and recombinant human
proinsulin. The invention further relates to methods for determining the presence and / or level of at least one
autoantibody molecule in a sample from a human subject developing T1D using said
recombinant antigen molecules. According to the invention, the presence, absence, or amount of one or more autoantibody molecules against said self-antigens is determined with a
luciferase immune
precipitation system (LIPS)
assay or a modified version of a LIPS assay, i.e., a
solid phase capture LIPS (scLIPS) assay.