Methods, Antibodies and Kits for Detecting Cerebrospinal Fluid in a Sample

• US 20080227113A1
• Filed: 04/14/2008
• Published: 09/18/2008
• Est. Priority Date: 04/09/2003
• Status: Active Grant

• Current Assignee: Stony Brook Anaesthesiology, University Faculty Practice Corporation
• Original Assignee: Srinivas N. Pentyala
• Inventors: Pentyala, Srinivas N.
• Granted Patent: US 8,003,765 B2
• Time in Patent Office: Days
• US Class Current: 435/7.1
• CPC Class Codes: C07K 16/40 against enzymes
• CPC Class Codes: C07K 2317/34 Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
• CPC Class Codes: C12Q 1/533 involving isomerase
• CPC Class Codes: G01N 2333/99 Isomerases (5.)

Abstract

The present disclosure relates to detection of the presence or absence of cerebrospinal fluid (CSF) in a sample, in particular to the analysis of the CSF protein lipocalin-type prostaglandin D2 synthase (L-PGDS). The present disclosure provides assays for the analysis of L-PGDS indicating the presence or absence of CSF in a sample.

Claims

1. An isolated monoclonal antibody that specifically binds to VQPNFQQDKFLGR (SEQ ID NO:

1).

2. The isolated monoclonal antibody of claim 1, wherein the monoclonal antibody is reactive with native L-PGDS.

3. A hybridoma producing the monoclonal antibody of claim 1.

4. The hybridoma of claim 3, corresponding to clone 12 (Deposit # ______) or clone 42 (Deposit # ______).

5. An immunoassay device suitable for detecting the presence or absence of cerebrospinal fluid in a sample suspected of containing cerebrospinal fluid, comprising:

a support comprising a first monoclonal antibody according to claim 1.

6. The immunoassay device of claim 5, wherein the support comprises:

a sample region comprising a mobile indicator suitable for binding L-PDGS in fluid communication with

a detection region comprising a fixed indicator suitable for binding to L-PDGS,

wherein the mobile indicator, the fixed indicator, or both, comprises the monoclonal antibody according to claim 1.

7. The immunoassay device of claim 6, further comprising a control region in fluid communication with the sample region and the detection region, wherein the control region comprises a positive control.

8. The immunoassay device of claim 5, wherein the support comprises:

a sample zone comprising the first monoclonal antibody according to claim 1, wherein the first monoclonal antibody is not fixed to the support;

a test zone comprising a second monoclonal or polyclonal antibody to lipocalin-type prostaglandin D2 synthase immobilized to the support; and

a control zone comprising a control antibody,

wherein the sample zone, the test zone and the control zone are in fluid communication.

9. A kit comprising

the monoclonal antibody of claim 1, and

instructions for determining whether the sample contains L-PGDS.

10. A method of detecting the presence of cerebrospinal fluid in a sample, comprising

contacting the sample with the monoclonal antibody of claim 1.

11. The method of claim 10, wherein the sample is from a subject suspected of cerebrospinal fluid leaks associated with head traum, cerebrospinal fluid leaks associated with concussion, bodily trauma with cerebrospinal fluid involvement, skull fractures with cerebrospinal fluid leak, cerebrospinal fluid leak following endoscopic endonasal surgery, cerebrospinal fluid leak following neurosurgery, cerebrospinal fluid leak following epidural catheter placement, spontaneous intracranial hypotension following cerebrospinal fluid leak, anthrax induced intracranial hypotension with cerebrospinal fluid leak, cerebrospinal fluid leak associated rhinnorhea, cerebrospinal fluid associated otorrhea, cerebrospinal fluid leak associated with hydrocephalus, cerebrospinal fluid leak associated intracranial neoplasms, or cerebrospinal fluid leak associated congenital neural malformations.