US 12,138,624 B2
Devices and methods for molecular diagnostic testing
Boris Andreyev, Foster City, CA (US); Keith E. Moravick, Mountain View, CA (US); Brian Ciopyk, Santa Clara, CA (US); Victor Briones, Gilroy, CA (US); Gregory Loney, Los Altos, CA (US); Adam De La Zerda, Los Altos, CA (US); Jesus Ching, Saratoga, CA (US); Steven Chu, Menlo Park, CA (US); David Swenson, Santa Clara, CA (US); Helen Huang, San Pablo, CA (US); and Colin Kelly, Brooklyn, NY (US)
Assigned to Visby Medical, Inc., San Jose, CA (US)
Filed by Visby Medical, Inc., San Jose, CA (US)
Filed on Oct. 22, 2021, as Appl. No. 17/508,560.
Application 17/508,560 is a division of application No. 15/999,820, filed on Aug. 23, 2018, granted, now 11,167,285.
Application 15/474,083 is a division of application No. 14/984,573, filed on Dec. 30, 2015, granted, now 9,623,415, issued on Apr. 18, 2017.
Application 15/999,820 is a continuation of application No. 15/474,083, filed on Mar. 30, 2017, granted, now 10,124,334, issued on Nov. 13, 2018.
Claims priority of provisional application 62/213,291, filed on Sep. 2, 2015.
Claims priority of provisional application 62/098,769, filed on Dec. 31, 2014.
Prior Publication US 2022/0055032 A1, Feb. 24, 2022
Int. Cl. B01L 7/00 (2006.01); B01L 3/00 (2006.01)
CPC B01L 3/502715 (2013.01) [B01L 3/5029 (2013.01); B01L 7/52 (2013.01); B01L 7/525 (2013.01); B01L 3/5027 (2013.01); B01L 3/527 (2013.01); B01L 2200/025 (2013.01); B01L 2200/028 (2013.01); B01L 2200/0647 (2013.01); B01L 2200/0684 (2013.01); B01L 2200/0689 (2013.01); B01L 2200/10 (2013.01); B01L 2300/0627 (2013.01); B01L 2300/0654 (2013.01); B01L 2300/0672 (2013.01); B01L 2300/0681 (2013.01); B01L 2300/0867 (2013.01); B01L 2300/0883 (2013.01); B01L 2300/18 (2013.01); B01L 2300/1822 (2013.01); B01L 2300/1844 (2013.01); B01L 2400/0457 (2013.01); B01L 2400/0478 (2013.01); B01L 2400/0487 (2013.01); B01L 2400/0605 (2013.01); B01L 2400/0611 (2013.01); B01L 2400/0644 (2013.01)] 19 Claims
OG exemplary drawing
 
1. A method of detecting a target nucleic acid using a molecular diagnostic test device, comprising:
coupling the molecular diagnostic test device to a power source;
conveying, via a sample input opening, a biological sample into the molecular diagnostic test device, the molecular diagnostic test device comprising a flow path within which the biological sample is received via the sample input opening, a reaction volume within the flow path, a detection volume within the flow path, a control module, a fluid pump, and a heater;
actuating the molecular diagnostic test device to cause the molecular diagnostic test device to:
provide power from the power source to the heater;
provide power from the power source to the fluid pump;
regulate, via the control module, the power to the fluid pump to cause a movable member of the fluid pump to move in a first direction to produce a flow rate of the biological sample within the flow path;
regulate, via the control module, the power from the power source to the heater based on a temperature set point to amplify, within the reaction volume, the target nucleic acid within the biological sample to produce a target amplicon;
cause the movable member of the fluid pump to move in a second direction to produce a flow of a reagent within the detection volume, the reagent formulated to produce a signal indicating a presence of the target amplicon within the biological sample; and
react, within the detection volume, each of the target amplicon and the reagent; and
reading a result associated with the signal,
wherein the molecular diagnostic test device is a stand-alone molecular diagnostic test device that does not use any external instrument to amplify the target nucleic acid and react each of the target amplicon and the reagent.