US 12,268,371 B2
Device and method for saliva-based analyte testing
Serhat Pala, San Diego, CA (US)
Assigned to Clinical Reference Laboratory, Inc., Lenexa, KS (US)
Appl. No. 17/421,296
Filed by Clinical Reference Laboratory Inc., Lenexa, KS (US)
PCT Filed Jan. 10, 2020, PCT No. PCT/US2020/013222
§ 371(c)(1), (2) Date Jul. 7, 2021,
PCT Pub. No. WO2020/146826, PCT Pub. Date Jul. 16, 2020.
Claims priority of provisional application 62/879,437, filed on Jul. 27, 2019.
Claims priority of provisional application 62/791,012, filed on Jan. 10, 2019.
Prior Publication US 2022/0117588 A1, Apr. 21, 2022
Int. Cl. A61B 10/00 (2006.01); B01L 3/00 (2006.01); G01N 1/18 (2006.01)
CPC A61B 10/0051 (2013.01) [A61B 10/0096 (2013.01); B01L 3/5023 (2013.01); G01N 1/18 (2013.01); A61B 2010/0003 (2013.01); B01L 2200/0689 (2013.01); B01L 2300/044 (2013.01); B01L 2300/0672 (2013.01); B01L 2300/0825 (2013.01); B01L 2300/0864 (2013.01); B01L 2400/0683 (2013.01)] 19 Claims
OG exemplary drawing
 
1. A multi-chamber saliva collection device (10), comprising:
a container (11) including:
a well (12) extending within a volume of the container from a proximal end (13) to a distal end (14),
a bifurcating element (15) disposed adjacent to the well at the distal end,
a first chamber (16 a) coupled to the bifurcating element at a first fluid-aperture (17 a), and
a second chamber (16 b) coupled to the bifurcating element at a second fluid-aperture (17 b),
a volume between each of: the well, the first fluid-aperture and the second fluid-aperture collectively defining a fluid communication channel (18);
wherein the container is adapted to receive saliva (SA) upon extraction from a collection-swab (19), and communicate said saliva through the fluid communication channel into each of the first and second chambers;
characterized in that the multi-chamber saliva collection device further comprises:
an amount of DNA preservation buffer (20) contained within a buffer-containing cavity (21);
the buffer-containing cavity being configured to selectively release the DNA preservation buffer for mixing with an aliquot of the saliva in at least one of the first and second chambers;
wherein the multi-chamber saliva collection device is configured to segregate the saliva into at least two aliquots for use in performing an instant analyte test and a subsequent DNA confirmation;
wherein a wall of the first chamber includes a lateral flow immunochromatographic diagnostic assembly (24) that is coupled to the first chamber and is in fluid communication with the first chamber and segregated from the second chamber by a trigger-element, the lateral flow immunochromatographic diagnostic assembly being configured to receive an effective amount of the saliva from the first chamber for completing a lateral flow immunochromatographic diagnostic test and displaying results thereof.