US 11,867,693 B2
Semi-quantitative lateral-flow immunoassay for the detection of CSF leaks
Daniel Takashi Kamei, Monterey Park, CA (US); Maie A. St. John, Los Angeles, CA (US); Zachary D. Taylor, Los Angeles, CA (US); Daniel William Bradbury, Los Angeles, CA (US); and Ashley Elizabeth Kita, Los Angeles, CA (US)
Assigned to The Regents of the University of California, Oakland, CA (US)
Filed by The Regents of the University of California, Oakland, CA (US)
Filed on Nov. 18, 2021, as Appl. No. 17/530,336.
Application 17/530,336 is a continuation of application No. 16/498,312, granted, now 11,209,427, previously published as PCT/US2018/024392, filed on Mar. 26, 2018.
Claims priority of provisional application 62/477,230, filed on Mar. 27, 2017.
Prior Publication US 2022/0146507 A1, May 12, 2022
Int. Cl. G01N 33/543 (2006.01); B01L 3/00 (2006.01)
CPC G01N 33/54386 (2013.01) [B01L 3/5023 (2013.01); B01L 2400/0406 (2013.01); G01N 2333/99 (2013.01)] 19 Claims
OG exemplary drawing
 
1. A lateral flow device for the semi-quantitative detection of a cerebrospinal fluid (CSF) leak using a nasal drip or otologic sample, said device comprising:
a porous substrate;
a sample addition zone disposed on or in said porous substrate;
a detection zone disposed on or in said porous substrate where said detection zone comprises at least a first test line (T1) and a second test line (T2) each test line comprising binding moieties that bind a complex formed between beta-trace protein (βTP) and an indicator attached to a βTP binding molecule;
wherein said porous substrate defines a flow path through which a sample applied to the sample addition zone flows under capillary action away from said sample addition zone into said detection zone; and
wherein when a nasal drip sample diluted 300 fold with phosphate buffered saline is applied to said device:
said first test line (T1) and said second test line (T2) are configured so that either no test line signal or just a signal at the first test line (T1) is detectable when βTP concentration in a sample applied to said device is lower than the βTP level indicative of a CSF leak; and
said second test line (T2) is configured so that a signal is detectable at said second test line when βTP concentration in a sample applied to said device is greater than the βTP level indicative of a CSF leak.