Methods and kits for detecting cerebrospinal fluid in a sample

Abstract

The present invention 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 (PGDS). The present invention provides assays for the analysis of PGDS indicating the presence or absence of CSF in a sample.

Description

[0001] The present invention 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 (PGDS). The present invention provides assays for the analysis of PGDS indicating the presence or absence of CSF in a sample.[0002] Neural blockade is associated with many complications. Among the most feared is accidental, unrecognized penetration of nervous system compartments containing cerebrospinal fluid (CSF). If puncture into the CSF is not noted immediately, or if it is incorrectly diagnosed, subsequent drug administration may lead to paralysis or death. Despite widespread use during surgery, childbirth and pain relief, current methods to detect CSF during and after neural blockade are unreliable, costly and time-consuming.[0003] Patients undergoing epidural anesthesia and analgesia are at particular risk for needle puncture into the CSF. The epidural space is identifie...

AI Technical Summary

Benefits of technology

[0026] Experiments conducted during the course of development of the present invention demonstrate that PGDS is a reliable marker for CSF, and is less expensive and less time-consuming than conventional methods. The present invention provides novel methods and kits for rapid detection of CSF in samples obtained before, during and after neural blockade. Use of the present invention assures safer performance of neural blockade, and reduces the incidence and severity of life-threatening complications.

[1989]) to allow rapid and easy identification of monoclonal Fab fragments with the desired specificity for PGDS.

Problems solved by technology

Clinical, surgical and accidental events may cause CSF to breach its physiologic barriers.

The risk of dural puncture and entry into the CSF is particularly high in epidural anesthesia and analgesia.

A hole in the dura may allow CSF to leak into the epidural space causing severe headaches.

In patients with increased intracranial pressure, accidental dural puncture made while locating the epidural space risks cerebellar or tentorial herniation due to loss of CSF.

Other serious complications include permanent paralysis, cardiac arrest and death.

This may occur if the medication intended for the epidural space is mistakenly administered into the spinal fluid, causing sudden and profound hypotension, lower extremity paralysis, impaired ventilation and cardiac rhythm disorders.

However, at present there is no rapid and reliable method to evaluate the incidence of dural puncture and CSF leakage during procedures such as these, which are performed by the thousands every day.

Chemical analysis of fluid for glucose, protein, potassium or sodium is unreliable as a means of determining if the fluid is CSF.

Radiographic studies are only intermittently successful in demonstrating small or delayed CSF leaks, are cumbersome, costly, time consuming, and carry risks of exposure to radiation and to radioisotopic dyes.

However, the beta-2 transferrin assay requires the coordination of multiple acquisition and handling steps, is prohibitively time consuming for use during and after neural blockade (4 days), and is expensive ($300 / assay).

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