US 12,105,099 B2
Methods and devices for quantitatively estimating syndecan-1
Richard Eng, Baltimore, MD (US); Cassandra Parent, Baltimore, MD (US); Amal Hayat, Baltimore, MD (US); Amanda Ruci, Baltimore, MD (US); Anvith Krishnan, Baltimore, MD (US); Feiyang Huang, Baltimore, MD (US); Eric Simon, Baltimore, MD (US); and Ellie Zhang, Baltimore, MD (US)
Assigned to DIOTEX DIAGNOSTICS, LLC, Oakland, MD (US)
Filed by Richard Eng, Baltimore, MD (US); Cassandra Parent, Baltimore, MD (US); Amal Hayat, Baltimore, MD (US); Amanda Ruci, Baltimore, MD (US); Anvith Krishnan, Baltimore, MD (US); Feiyang Huang, Baltimore, MD (US); Eric Simon, Baltimore, MD (US); and Ellie Zhang, Baltimore, MD (US)
Filed on Apr. 7, 2022, as Appl. No. 17/715,294.
Claims priority of provisional application 63/180,762, filed on Apr. 28, 2021.
Prior Publication US 2022/0349905 A1, Nov. 3, 2022
Int. Cl. G01N 33/53 (2006.01); G01N 33/543 (2006.01); G01N 33/553 (2006.01); G01N 33/68 (2006.01); B82Y 5/00 (2011.01); B82Y 40/00 (2011.01)
CPC G01N 33/6893 (2013.01) [G01N 33/54346 (2013.01); G01N 33/54388 (2021.08); G01N 33/553 (2013.01); B82Y 5/00 (2013.01); B82Y 40/00 (2013.01)] 10 Claims
 
1. A method for determining a quantitative estimate of syndecan-1 levels in a mammalian subject suspected of internal hemorrhaging, the method comprising:
a) applying a blood sample from the subject to a hand-held assay device capable of providing optical quantitation of the amount of syndecan-1 in the sample;
b) measuring, by means of said assay device, an analyte signal value correlated to a concentration of the syndecan-1 in the blood sample;
c) comparing the analyte signal value to a minimum threshold, wherein an analyte signal value less than the minimum threshold indicates that the subject is not internally hemorrhaging, and an analyte signal value above the minimum threshold indicates the subject is internally hemorrhaging,
wherein the assay device comprises:
a sample pad for receiving the blood sample,
a signal release pad fluidly connected to the sample pad and containing a signal member with binding specificity for syndecan-1 and configured to produce an optically detectable analyte signal when an amount of the signal member captured by the capture region correlates to a concentration of the syndecan-1 in the blood sample exceeding the minimum threshold, and
a capture region that is fluidly connected to the signal release pad and in which a capture reagent having binding specificity for syndecan-1 is immobilized.