Lateral flow immunoassay controls
AssigneeInverness Medical Switzerland GmbH
InventorsHuiyan Guo, Min Wang, Tao Shang, Hui-Kang Chen, Fei Gao
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Abstract
Rapid lateral flow immunoassays have an extensive history of use in both the clinical and home settings. These devices are used to test for a variety of analytes, such as drugs of abuse, hormones, proteins, urine or plasma components and the like. The present invention provides an improved procedural control that indicates to the test user that at least a portion of the applied sample has passed through the test result zone of the test strip, and optionally that the test is complete and the test results may be read.
Claims11
An analytical test device for detecting an analyte suspected of being present in an applied liquid sample, the device comprising:
- a. a test strip having a control results zone and a test result zone;
- b. an analyte detection means comprising multiple colored particles configured to participate in a sandwich assay or a competitive assay for the analyte, the particles being disposed in a dry state along the test strip;
- and
- c. a control detection means, wherein the control detection means allows a user to determine that at least a portion of liquid sample applied to the device has moved through said test result zone and the completion of the assay, the control detection means comprising at least a first detectable dye reagent and a second detectable dye reagents disposed along the test strip;
- wherein the first detectable dye reagent is mobilizable by the applied liquid sample and the movement of the first detectable reagent in, into or out of the control results zone indicates that at least a portion of a liquid sample applied to the device has moved through said test result zone and the completion of the assay, and wherein the second detectable dye reagent is not substantially mobilizable by the applied liquid sample.
Dependencies are inferred from the claim text.