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Publication Number
US-8759115-B2
Publication Date
2014-06-24
Expiration Date
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.
Core Innovation
The invention relates to an assay device for lateral-flow immunoassays. The assay device includes a substrate surface defining a sample addition zone, a reaction zone, and an absorbing zone connected by a fluid passage using capillary-flow projections substantially perpendicular to the substrate surface, and integrates functionality-verifying features that undergo a detectable change when the liquid sample contacts the assay device.
The invention further relates to conducting an assay method in which alignment of the assay device in a reader is verified using at least one alignment verification zone disposed on the assay device for correct positioning in a reader. After adding a sample, a detection conjugate capable of binding to an antigen and containing a label is used, and at least one reaction between the sample and one or more reagents is detected using the assay device zones including the fluid passage, sample addition zone, reaction zone, and absorbing zone.
The method determines the presence of the label in a first area downstream from the sample addition zone, where absence of signal or insufficient signal is taken as an indication of error. The invention additionally includes a calibration step in which the amount of at least one label pre-dispensed in a calibration zone separate from the fluid passage is determined and compared to a preset value, with label presence or absence in first and second read areas indicating proper initiation, fluid progression/sample-volume sufficiency, and assay/reader error handling with immediate user alerting.
Claims Coverage
Independent claim clm-00001 covers a method that combines 4 inventive features: reader alignment verification, zone-based detection using a labeled antigen-binding detection conjugate, error indication based on absence or insufficient signal in a downstream read area, and calibration using a pre-dispensed label in a separate calibration zone compared to a preset value.
Alignment verification using alignment verification zones
The method verifies the alignment of an assay device in a reader using at least one alignment verification zone disposed on the assay device.
Zone-based detection with a labeled antigen-binding detection conjugate
The method adds a sample and detects at least one reaction between the sample and one or more reagents using the assay device, the assay device having at least one fluid passage, a sample addition zone, a reaction zone and an absorbing zone, with the one or more reagents including a detection conjugate capable of binding to an antigen and containing a label.
Downstream label presence or insufficient signal as error indication
The method determines the presence of the label in a first area downstream from the sample addition zone, where the absence of signal or detection of an insufficient signal is taken as an indication of error.
Separate calibration using pre-dispensed label compared to a preset value
The method further comprises a calibration step in which 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 is compared to a preset value.
Overall, the claims cover an assay method that verifies reader alignment, performs zone-based detection using a labeled antigen-binding detection conjugate, flags errors when label is absent or insufficient in a downstream area, and performs calibration by determining a pre-dispensed label amount in a separate calibration zone and comparing it to a preset value.
Stated Advantages
Immediate user alerting.
Prompt to remove the assay device and attempt a new assay.
Calibration-based adjustment of analysis result.
Displaying a margin of error based on calibration.
Reader determination of detection conjugate passage over the reaction zone.
Reaction kinetics determined over a range of time.
Documented Applications
Lateral-flow immunoassays.
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