Lateral Flow Immunoassay Controls
AssigneeAlere 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.
Claims19
In combination with a lateral flow analysis device of the type wherein a test strip having a sample application area, a test results zone, a control zone and optionally a reagent zone, is provided for detecting an analyte by well known immunological or chemical techniques, the analyte suspected of being present in a liquid sample, wherein the analyte is a drug, a hormone, an antibody, an etiological agent, a bacterium, a virus, or a portion thereof, or an antibody specific for that drug, and wherein the analyte is indicative of an etiological or disease state, the improvement which comprises at least one detectable dye indicator located in the control zone or optionally adjacent to the control zone and capable of being moved through said test strip by the capillary flow of an applied liquid sample, the movement of said at least one detectable dye indicator being indicative of the movement of at least a portion of the sample through the test result zone and optionally the completion of the assay.
A procedural control for lateral flow analytical test devices for detecting an analyte suspected of being present in a sample, the procedural control comprising:
- a. a test strip;
- b. a control zone;
- and
- c. a control detection means.
An analytical lateral flow test device for detecting an analyte suspected of being present in a liquid sample having a test strip, and analyte detection means, a test result zone and a control means, the control means comprising:
- a. a first dye indicator having a first color and a second dye indicator having a second color, said first and second dye indicators being applied to the same application location on the test strip and said applied first and second dye indicators appearing to the user as a color other than the color of said second dye indicator.
Dependencies are inferred from the claim text.