Methods, antibodies and kits for detecting cerebrospinal fluid in a sample
View Patent ↗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.
1. An isolated monoclonal antibody that specifically binds to VQPNFQPDKFLGC (SEQ ID NO:1), wherein the monoclonal antibody binds native lipocalin-type prostaglandin D2 synthase (L-PGDS).
2. A hybridoma producing the monoclonal antibody of claim 1 .
3. The hybridoma of claim 2 , selected from the group consisting of clone 12 (Deposit # PTA-11691) and clone 45 (Deposit # PTA-11692).
4. 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 .
5. The immunoassay device of claim 4 , 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 .
6. The immunoassay device of claim 5 , further comprising a control region in fluid communication with the sample region and the detection region, wherein the control region comprises a positive control.
7. The immunoassay device of claim 4 , 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.
8. A kit comprising
the monoclonal antibody of claim 1 , and
instructions for determining whether the sample contains L-PGDS.