US 12,270,810 B2
QMAX assay and applications (II)
Stephen Y. Chou, Princeton, NJ (US); Wei Ding, East Windsor, NJ (US); Yufan Zhang, Monmouth Junction, NJ (US); and Ji Qi, Hillsborough, NJ (US)
Assigned to Essenlix Corporation, Monmouth Junction, NJ (US)
Appl. No. 16/484,035
Filed by Essenlix Corporation, Monmouth Junction, NJ (US)
PCT Filed Feb. 9, 2018, PCT No. PCT/US2018/017712
§ 371(c)(1), (2) Date Aug. 6, 2019,
PCT Pub. No. WO2018/148606, PCT Pub. Date Aug. 16, 2018.
Claims priority of provisional application 62/460,069, filed on Feb. 16, 2017.
Claims priority of provisional application 62/459,602, filed on Feb. 15, 2017.
Claims priority of provisional application 62/459,160, filed on Feb. 15, 2017.
Claims priority of provisional application 62/457,103, filed on Feb. 9, 2017.
Claims priority of provisional application 62/457,031, filed on Feb. 9, 2017.
Claims priority of provisional application 62/457,133, filed on Feb. 9, 2017.
Prior Publication US 2020/0103401 A1, Apr. 2, 2020
This patent is subject to a terminal disclaimer.
Int. Cl. G01N 33/543 (2006.01); B01L 3/00 (2006.01); G01N 1/31 (2006.01); G01N 33/49 (2006.01)
CPC G01N 33/54366 (2013.01) [B01L 3/502738 (2013.01); B01L 3/5088 (2013.01); G01N 1/312 (2013.01); G01N 33/492 (2013.01); B01L 2200/025 (2013.01); B01L 2200/12 (2013.01); B01L 2300/04 (2013.01); B01L 2300/0609 (2013.01)] 104 Claims
OG exemplary drawing
 
1. A method for an affinity binding assay comprising:
(a) providing a first plate, a second plate, and spacers, wherein:
(i) the first plate and second plate are movable relative to each other into different configurations, including an open configuration and a closed configuration;
(ii) each of the plates comprises an inner surface having a sample contact area for contacting a sample that contains or is suspected of containing a target analyte;
(iii) the first plate comprises, on its inner surface, a binding site that contains a binding agent capable of binding the target analyte;
(iv) the second plate comprises, on its inner surface, a storage site that contains a detection agent and a controlled release agent, wherein the controlled release agent is mixed with or coated on top of the detection agent;
(v) the spacers have a pillar shape and are fixed to the respective inner surface of one or both of the plates, at least one of the spacers is inside and fixed on the sample contact area of one or both of the plates, and the spacers have a predetermined inter-spacer distance;
(b) depositing the sample on the inner surface of at least one of the two plates when the two plates are in the open configuration, in which: the first and second plates are partially or entirely separated apart, and the spacing between the first and second plates is not regulated by the spacers;
(c) compressing at least part of the deposited sample by bringing the two plates into the closed configuration, in which: said at least part of the deposited sample is compressed into a layer sandwiched between the first and second plates and having a thickness of 200 microns or less, wherein the spacers inside the sample contact area contact the inner surfaces of both the first and second plates to regulate the thickness of the layer;
(d) releasing the detection agent into the layer through the controlled release agent, wherein the controlled release agent is capable of rendering the detection agent substantially released at a time point after the first and second plates are compressed into the closed configuration and the sample surface contacts the controlled release agent; and
(e) after step (d), incubating the assay for a time period no shorter than an average time for the detection agent to diffuse across the thickness of the layer,
(f) detecting the analyte in the layer using a detector and analyzing the target analyte in the layer,
wherein the detection agent and the binding agent are capable of binding either directly or indirectly to generate a signal indicative of the presence or quantity of the target analyte;
wherein in the direct binding, the detection agent competes with the target analyte and directly binds to the binding agent; and
wherein in the indirect binding, the binding agent and the detection agent bind to a different location of the target analyte.