Ratiometric immunoassay method and blood testing device

摘要

The invention is to devices and methods for rapid determination of analytes in liquid samples. The devices and methods incorporate a sample dilution feature and multiple immunosensors for performing a ratiometric immunoassay on a first analyte and a second analyte, for example, hemoglobin and hemoglobin A1c or albumin and glycosylated albumin. The devices are preferably capable of being used in the point-of-care diagnostic field.

主权项

1. A cartridge for performing a ratiometric assay in a blood sample, comprising:
a sample holding chamber oriented between a sample entry port and a sample isolation unit and having a diluent introduction port disposed therebetween for introduction of a diluent into the sample holding chamber, wherein a volume within the sample holding chamber between the diluent introduction port and the sample isolation unit defines a metered volume of a sample for analysis; a diluent conduit oriented between a diluent entry port and the diluent introduction port and having an air introduction port disposed therebetween for introduction of air into the diluent conduit, wherein a volume within the diluent conduit between the air introduction port and the diluent introduction port defines a metered volume of the diluent for mixing with the metered volume of the sample to create a diluted sample with a predetermined dilution ratio; an analysis conduit in fluid communication with the sample isolation unit, the analysis conduit including a sensing region comprising a first sensor comprising an immunosensor for a first analyte, and a second sensor comprising an immunosensor for a second analyte; and a pump for introducing the diluent from the diluent conduit into the sample holding chamber, and for moving said diluted sample into the sensing region.