US 12,405,278 B2
Saturation binding ratiometric assay
Victor Manneh, Encinitas, CA (US); and Sergei Svarovsky, San Diego, CA (US)
Assigned to LumiraDx UK Ltd., London (GB)
Filed by LumiraDx UK Ltd., London (GB)
Filed on Sep. 13, 2023, as Appl. No. 18/466,519.
Application 18/466,519 is a continuation of application No. 17/409,279, filed on Aug. 23, 2021, granted, now 11,802,881.
Application 17/409,279 is a continuation of application No. 16/293,628, filed on Mar. 5, 2019, abandoned.
Prior Publication US 2024/0219408 A1, Jul. 4, 2024
Int. Cl. G01N 33/72 (2006.01); G01N 33/543 (2006.01)
CPC G01N 33/723 (2013.01) [G01N 33/543 (2013.01); G01N 33/54326 (2013.01); G01N 2333/805 (2013.01)] 13 Claims
OG exemplary drawing
 
1. An assay cartridge for determining an amount of glycated hemoglobin (HbA1c) in a blood sample, the assay cartridge comprising:
a) a channel, and (i) one or more zones, (ii) one or more chambers, or (iii) both;
b) an anti-hemoglobin (anti-Hb) first binding agent specific for binding to hemoglobin A (HbA), including un-glycated hemoglobin A (HbA0) and HbA1c, the first binding agent bound to a magnetic particle or a fluorescently labelled particle, the first binding agent disposed in the (i) channel, (ii) at least one of the one or more zones, or (iii) at least one of the one or more chambers;
c) an anti-HbA1c second binding agent that is (i) specific for binding to HbA1c that is bound to the first binding agent, (ii) bound to the other of the magnetic particle or fluorescently labelled particle, and (iii) disposed in the channel, the at least one of the one or more zones, or the at least one of the one or more chambers;
wherein the first binding agent comprises an antibody that binds within amino acid residues 3-30 or 7-25 of the beta subunit of HbA0 and HbA1c; and
wherein binding of hemoglobin to the first binding agent causes an amino terminal end of a hemoglobin beta chain of the hemoglobin to become exposed.