Semi-quantitative lateral-flow immunoassay for the detection of CSF leaks

    公开(公告)号:US11867693B2

    公开(公告)日:2024-01-09

    申请号:US17530336

    申请日:2021-11-18

    CPC classification number: G01N33/54386 B01L3/5023 B01L2400/0406 G01N2333/99

    Abstract: Devices and methods are provided for the detection of CSF in a biological sample. In certain embodiments the device is a lateral flow 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 said first test line (T1) and said second test line (T2) are is 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.

    SEMI-QUANTITATIVE LATERAL-FLOW IMMUNOASSAY FOR THE DETECTION OF CSF LEAKS

    公开(公告)号:US20220146507A1

    公开(公告)日:2022-05-12

    申请号:US17530336

    申请日:2021-11-18

    Abstract: Devices and methods are provided for the detection of CSF in a biological sample. In certain embodiments the device is a lateral flow 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 said first test line (T1) and said second test line (T2) are is 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.

    SEMI-QUANTITATIVE LATERAL-FLOW IMMUNOASSAY FOR THE DETECTION OF CSF LEAKS

    公开(公告)号:US20200033336A1

    公开(公告)日:2020-01-30

    申请号:US16498312

    申请日:2018-03-26

    Abstract: Devices and methods are provided for the detection of CSF in a biological sample. In certain embodiments the device is a lateral flow 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 (betaTP) and an indicator attached to a betaTP 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.

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