Device and methods for the immunological identification of cerebrospinal fluid
The present disclosure relates to detection of the presence or absence of cerebrospinal fluid (CSF) in a sample by the detection of one or more antigens that are enriched in CSF compared to their levels in other bodily fluids. The devices and methods are suitable for the detection of the presence or absence of cerebrospinal fluid in samples of mixed bodily fluids from a wide variety of human populations crossing ethnicity, age, gender, health status and genetic variability.
1. A device for detection of the presence or absence of cerebrospinal fluid in a sample, comprising
a sample application region,
a sample labeling region comprising a first antibody to a CSF-enriched protein, wherein the first antibody is conjugated to a mobile particle;
a sample detection region comprising a second antibody to the CSF-enriched protein, wherein the second antibody is fixed to the sample detection region,
wherein the presence of a detectable band in the sample detection region indicates the presence of cerebrospinal fluid in the sample, wherein the CSF-enriched protein is selected from the group consisting of SEQ ID NO:2, SEQ ID NO: 5, SEQ ID NO: 7 and SEQ ID NO: 8.
2. The device of claim 1 , wherein the device further comprises additional two to ten different antibodies that each specifically binds a different CSF-enriched protein.
3. The device of claim 2 , wherein the device provides a single combined result, or the device provides an individual result for each antibody.
4. The device of claim 2 , wherein each antibody is employed at a subthreshold level.
5. The device of claim 1 , wherein the device further comprises additional four to ten different antibodies that each specifically binds a different CSF-enriched protein, and wherein a positive test does not require binding to all antibodies.
6. The device of claim 1 , further comprising quantitating the level of CSF-enriched protein in the sample.
7. A method for detecting the presence or absence of CSF in a sample, comprising
contacting the sample with the device of claim 1 , and
detecting binding partner-CSF-enriched protein complexes if present, wherein the presence of detectable complexes indicates the presence of CSF in the sample.
8. The method of claim 7 , further comprising quantitating the amount of the CSF-enriched protein in the sample.
9. The method of claim 7 , wherein detecting comprises an in situ immunoassay.
10. The method of claim 7 , wherein the sample is tissue, blood, serum, plasma, urine, nasal and ear effluents, saliva, sweat, or tears.
11. The method of claim 7 , wherein the sample is from an individual suspected of having a brain injury.
12. The method of claim 7 , wherein the device further comprises additional two to ten different antibodies that each specifically binds a different CSF-enriched protein.
13. The method of claim 12 , wherein each antibody is employed at a subthreshold level.
14. The method of claim 7 , wherein the device further comprises additional four to ten different antibodies that each specifically binds a different CSF-enriched protein, and wherein a positive test does not require binding to all antibodies.