PRETREATMENT OF A BIOLOGICAL SAMPLE FROM AN AUTOIMMUNE DISEASE SUBJECT

• US 20100015055A1
• Filed: 08/31/2009
• Published: 01/21/2010
• Est. Priority Date: 05/20/2005
• Status: Abandoned Application

• Current Assignee: Genentech, Inc. (Roche Holding AG)
• Original Assignee: Genentech, Inc. (Roche Holding AG)
• Inventors: Song, An, McCutcheon, Krista
• Application Number:
  US12/550,729
• Publication Number:
  US 20100015055A1
• Time in Patent Office: Days
• US Class Current: 424/9.100
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 37/02 Immunomodulators
• CPC Class Codes: A61P 37/06 Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: G01N 2800/101 Diffuse connective tissue disease, e.g. Sjögren, Wegener's granulomatosis
• CPC Class Codes: G01N 2800/24 Immunology or allergic disorders SLE G01N2800/104
• CPC Class Codes: G01N 33/564 for pre-existing immune complex or autoimmune disease , i.e. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, rheumatoid factors or complement components C1-C9
• CPC Class Codes: G01N 33/6854 Immunoglobulins
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
• CPC Class Codes: Y10S 435/962 Prevention or removal of interfering materials or reactants or other treatment to enhance results, e.g. determining or preventing nonspecific binding
• CPC Class Codes: Y10S 436/824 Immunological separation techniques
• CPC Class Codes: Y10S 436/825 Pretreatment for removal of interfering factors from sample
• CPC Class Codes: Y10T 436/255 including use of a solid sorbent, semipermeable membrane, or liquid extraction

Abstract

The present application describes a method for pretreating a biological sample from an autoimmune disease subject in order to avoid interference, especially where the sample is to be subjected to a cell-based biological activity assay, such as a neutralizing antibody assay.

Claims

1. A method of treating a subject with an autoimmune disease comprising:

(a) administering a therapeutic antibody or immunoadhesin to the subject to treat the autoimmune disease;

(b) obtaining a biological sample from the subject;

(c) affinity purifying immunoglobulins in the biological sample; and

(d) subjecting the purified immunoglobulins to a neutralizing antibody assay.

2. The method of claim 1 wherein the sample in step (b) comprises human serum.

3. The method of claim 1 wherein the autoimmune disease is rheumatoid arthritis, systemic lupus erythematosis (SLE) or Sjogren'"'"'s disease.

4. The method of claim 1 wherein the sample in step (b) comprises interference.

5. A diagnostic kit comprising:

(a) delipidation reagent;

(b) buffers for affinity purification of immunoglobulins; and

(c) instruction manual instructing the user of the diagnostic kit to practice a method of treating a biological sample from an autoimmune disease subject comprising;

(i) delipidating the sample;

(ii) affinity purifying immunoglobulins in the sample;

(iii) concentrating the purified immunoglobulins; and

(iv) subjecting the concentrated immunoglobulins to a cell-based biological activity assay.

6. The diagnostic kit of claim 5 further comprising any one or more of:

drug reference material, positive control neutralizing antibody, complement serum, assay diluent for cells, and cell labeling reagent.