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