Selected as an Oral Presentation at the
2023 Congress of Neurological Surgeons Annual Meeting, September 9-13 in Washington, D.C.

Point-of-Care Cerebrospinal Fluid (CSF) Leak Detection


Patent-pending CSF Leak Detection Assay with Clinical Validation Available for License

Point-of-Care Cerebrospinal Fluid (CSF) Leak Detection


Patent-pending CSF Leak Detection Assay with Clinical Validation Available for License

Clinical Problem

  • Undiagnosed CSF leakage can lead to serious pathologies including meningitis, abscess & pneumocephalus


  • Current testing can take days to obtain results, delaying life-saving treatment

Solution

  • Rapid POC lateral flow assay that detects Beta-2 Transferrin to identify CSF Leaks in fluid samples


  • Hook-effect based lateral flow assay allows for detection of Beta-2 Transferrin in minutes


  • POC CSF leak detection can enable life-saving treatment for CSF leaks

Clinical Sample Validation with 100% Sensitivity/Specificity

Clinical Sample Validation with 100% Sensitivity
/Specificity

Hook-Effect
Technology

  • LFA with two conjugates: a gold nanoshell-anti-TF antibody conjugate (conjugate 1) and a gold nanoshell-lectin conjugate (conjugate 2).


  • Conjugate release occurs and a chromatographic sandwich forms in two detection zones to yield a detectable dark line: Test line 1 (T1) where anti-TF antibodies are embedded form a sandwich reaction with analyte (TF) and with conjugate 1 and test line 2 (T2) where embedded serum glycoproteins react with conjugate 2.


  • A control line with anti-mouse IgG antibody is embedded to form a reaction with conjugate 1.


  • We availed the well-known hook effect as both T1 and T2 detection zone development is inhibited by the saturation of binding sites of the conjugates and embedded material.

Clinical Sample Validation of CSF Leak Detection

  • 18 clinical samples of either CSF or postoperative drain fluid (serum) were tested


  • There were 7 CSF samples and 11 serum samples


  • Successful discrimination between positive clinical CSF samples from negative samples in all cases.

CFS Detection

Serum Detection

WO2023/278113: Assay for Rapid Detection of Cerebrospinal Fluid Leaks

US20230015102: Assay for Rapid Detection of Cerebrospinal Fluid Leaks


Contact: Michael Bielski: mbielski@devtechpartners.com

WO2023/278113:

Assay for Rapid Detection of Cerebrospinal Fluid Leaks


US20230015102:

Assay for Rapid Detection of Cerebrospinal Fluid Leaks


Contact:

Michael Bielski mbielski@devtechpartners.com

WO2023/278113: Assay for Rapid Detection of Cerebrospinal Fluid Leaks

US20230015102: Assay for Rapid Detection of Cerebrospinal Fluid Leaks


Contact:

Michael Bielski

mbielski@devtechpartners.com