US 12,247,250 B2
Point of need testing device and methods of use thereof
Chang Hee Kim, Waunakee, WI (US); Wendy A. Henderson, Bethesda, MD (US); Sarah K. Abey, Bethesda, MD (US); Nicolaas H. Fourie, Bethesda, MD (US); and Eric G. Ferguson, Bethesda, MD (US)
Assigned to GODX, INC, Madison, WI (US); and THE UNITED STATES OF AMERICA, AS REPRESENTED BY THE SECRETARY, DEPARTMENT OF HEALTH & HUMAN SERVICES, Bethesda, MD (US)
Filed by GODX, INC, Madison, WI (US); and THE UNITED STATES OF AMERICA, AS REPRESENTED BY THE SECRETARY, DEPARTMENT OF HEALTH & HUMAN SERVICES, Bethesda, MD (US)
Filed on Jul. 28, 2020, as Appl. No. 16/941,333.
Application 16/941,333 is a division of application No. 15/574,750, abandoned, previously published as PCT/US2016/032788, filed on May 16, 2016.
Claims priority of provisional application 62/162,668, filed on May 16, 2015.
Prior Publication US 2020/0354778 A1, Nov. 12, 2020
Int. Cl. C12Q 1/6834 (2018.01); B01L 3/00 (2006.01); C12Q 1/00 (2006.01); C12Q 1/6816 (2018.01); C12Q 1/6825 (2018.01); C12Q 1/6888 (2018.01); C12Q 1/689 (2018.01); C12Q 1/70 (2006.01); G01N 15/06 (2006.01); G01N 15/10 (2006.01); G01N 15/14 (2006.01); G01N 15/1433 (2024.01); G01N 33/487 (2006.01); G01N 15/075 (2024.01)
CPC C12Q 1/6834 (2013.01) [B01L 3/5023 (2013.01); C12Q 1/00 (2013.01); C12Q 1/6816 (2013.01); C12Q 1/6825 (2013.01); C12Q 1/6888 (2013.01); C12Q 1/689 (2013.01); C12Q 1/701 (2013.01); G01N 15/06 (2013.01); G01N 15/1023 (2024.01); G01N 15/1433 (2024.01); G01N 15/1484 (2013.01); G01N 33/487 (2013.01); B01L 2200/141 (2013.01); B01L 2300/069 (2013.01); B01L 2400/0406 (2013.01); G01N 15/075 (2024.01); G01N 2015/1006 (2013.01); Y02A 50/30 (2018.01)] 12 Claims
OG exemplary drawing
 
1. A method for detecting the presence of a microorganism or virus in a diluted stool sample from a subject, comprising:
(i) lysing cells within the diluted stool sample;
(ii) adding the lysed sample to a sample loading area of a point of need testing device, wherein said point of need testing device comprises: at least one lateral flow device, wherein said at least one lateral flow device comprises:
(a) a sample loading area positioned at one end of the lateral flow device, comprising a debris trapping material;
(b) an area comprising a detectably labelled probe specific for a target nucleic acid sequence from a microorganism or virus, wherein said detectably labelled probe is not bound to the lateral flow device and is capable of wicking across at least a portion of the lateral flow device;
(c) an area comprising a capture probe for the target nucleic acid sequence, wherein said capture probe for the target nucleic acid sequence is immobilized on the lateral flow device; and
(d) absorbent material, wherein the absorbent material wicks an aqueous sample across the lateral flow device when the aqueous sample is added to the sample loading area; and
(iii) detecting a trimolecular hybridization of: (1) the target nucleic acid sequence, (2) the detectably labelled probe specific for the target nucleic acid sequence, and (3) the capture probe for the target nucleic acid sequence,
wherein nucleic acids are not isolated or purified from the lysed sample.