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US 12,405,278 B2Granted
Saturation binding ratiometric assay
AssigneeLumiraDx UK Ltd.
InventorsVictor Manneh, Sergei Svarovsky
Life of this patent
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Abstract
Methods, devices, and reagents are described for performing ratiometric assays for hemoglobin A1c. The methods involve a direct ratio determination between Hb A1c and normalized total hemoglobin utilizing a saturating amount of hemoglobin so that Hb A1c binds proportionately to a substrate. In some applications, the assay utilizes a proximity label system for signal generation and/or labeled magnetic beads. The methods can be configured as homogeneous or heterogeneous assays.
Claims13
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.
3 more elements
Dependencies are inferred from the claim text.