Abstract: A test strip, a device incorporating the test strip and a method for use of the test strip within the device detecting an analyte in a solution or bodily fluid are disclosed. The test strip was three zones, a reaction zone coated with a substance that binds the analyte, a sample zone with a region for addition of the sample of solution or fluid, and a detection region zone with a region coated with detection reagent. An absorbent pad underlies the reaction zone. The reaction zone is a small membrane and is physically in contact on its upper surface with both the sample zone and the detection zone. The test strip is incorporated into a device which includes a sample collection/transferring device, a housing for holding the test strip, and a container for holding solvent solutions at both outer ends of the test strip such that the solvent solutions can come into contact with the outer ends of the test strip when pressure is applied to the ends.

Abstract: This invention provides a device and method for preparing a plasma enriched sample for use in an immunoassay strip. All parts that contact blood or a blood fraction remain in a container and prevent contamination from used blood. In one embodiment a sampling device collects blood and enters the container. A plasma enriched sample fills a plasma receptor which in turn is transferred to an immunoassay strip. Plasma is washed out of the strip by an aqueous solution. In another embodiment the sampling device doubles as a plasma separator. The invention allows sensitive and safe immunoassays to be performed on whole blood samples outside of the normal clinical laboratory setting.