US 2013/0203183 A1 · ASSAY DEVICE

Abstract

An assay device for performing an assay on a liquid sample using a detection conjugate capable of binding to an antigen and containing a label. The device includes a substrate surface having a sample addition zone, a reaction zone and an absorbing zone, the zones being connected by at least one fluid passage, wherein the device has a first functionality verifying feature located between the sample addition zone and the reaction zone, and a second functionality verifying feature located within the absorbing zone. Both functionality verifying features are capable of undergoing a detectable change when contacted by the sample, in which the assay device further includes at least one alignment verification zone. There is further provided a kit of parts and a method of conducting an assay.

Claims8

Dependent claims

A method of conducting an assay, comprising:

verifying the alignment of an assay device in a reader using at least one alignment verification zone;
adding a sample and detecting at least one reaction between the sample and one or more reagents using a device having at least one fluid passage, a sample addition zone and an absorbing zone, said reagents including a detection conjugate capable of binding to an antigen and containing a label;
determining the presence of the label in a first area downstream from the sample addition zone in which the absence of signal or an insufficient signal is taken as an indication of error, said method further comprising a calibration step, wherein the amount of at least one label, pre-dispensed in a zone for calibration on the assay device, separate from the fluid passage, is determined and the amount compared to a preset value.

Dependencies are inferred from the claim text.

Assay device

Life of this patent

Assay device

Life of this patent

Abstract

Claims8