Anti-nuclear antibody detection and diagnostics for systemic and non-systemic autoimmune disorders

Abstract

Provided are compositions that contain mammalian cells for use in detecting antibodies. The mammalian cells are modified such that they do not contain LEDGF protein. The mammalian cells are immobilized on a solid substrate. The compositions can also contain mammalian cells that contain the LEDGF protein. Methods for using the cell compositions in diagnostic approaches are included, as are kits for performing diagnostic tests.

1 - 9 . (canceled) 
     
     
         10 . A method for determining whether a biological sample comprises antibodies that bind to LEDGF protein (anti-LEDGF Abs), the method comprising:
 i) exposing the biological sample to mammalian cells that are modified such that they do not comprise LEDGF protein (LEDGF− cells),   ii) exposing the biological sample to mammalian cells that comprise the LEDGF protein (LEDGF+ cells), and   iii) comparing the amount of anti-LEDGF Abs bound to the LEDGF− cells to the amount of anti-LEDGF Abs bound to the LEDGF+ cells,   wherein determining a greater amount of anti-LEDGF Abs bound to the LEDGF+ cells relative to the amount of anti-LEDGF Abs bound to the LEDGF− cells is indicative that the biological sample comprised the anti-LEDGF Abs, and   wherein the same or less anti-LEDGF Abs bound to the LEDGF+ cells relative to the amount of anti-LEDGF Abs bound to the LEDGF− cells is indicative that the biological sample did not comprise the anti-LEDGF Abs.   
     
     
         11 . The method of  claim 10  wherein the LEDGF− cells are killed and permeabilized and are immobilized on a solid substrate. 
     
     
         12 . The method of  claim 11 , wherein the LEDGF+ cells are killed and permeabilized, and are immobilized on the same solid substrate as the LEDGF− cells, or are immobilized on a distinct solid substrate. 
     
     
         13 . The method of  claim 12 , wherein the determining the amount of anti-LEDGF Abs is performed using an indirect immunofluorescence (IIF) assay. 
     
     
         14 . The method of  claim 10 , wherein a chromosome in the LEDGF− cells comprises a Cas9 DNA coding sequence, or a DNA sequence encoding a clustered regularly interspaced short palindromic repeats (CRISPR) guide RNA targeted to a DNA sequence encoding the LEDGF protein, or a combination thereof. 
     
     
         15 . The method of  claim 12 , wherein the LEDGF− and LEGDF+ cells are the same mammalian cell type. 
     
     
         16 - 20 . (canceled)