Apparatus and methods for steroid hormone testing

Abstract

An immuno-chromatographic detection device for detecting an analyte in sample, such as estrogen in a urine or saliva sample, the device comprising (a) a binding membrane having immobilized thereon (i) an test antibody against said analyte in at least one detection region, and (ii) a control antibody against a control antigen known to be present in the sample in a control region, (b) a sample membrane located at a first end of the binding membrane for receiving the sample, wherein the sample membrane is in chromatographic connection with the binding membrane, and (c) a label membrane containing (iii) a labeled antigen that is capable of binding to the test antibody and upon binding with the test antibody exhibits an observable change at the at least one detection region, and (iv) a labeled control antigen that is capable of binding to the control antibody and upon binding with the control antibody exhibits an observable change at the control region, wherein the sample membrane is separated from the label membrane by a waterproof membrane which is removable to allow the sample membrane and label membrane to be connected chromatographically. Also provided are kits comprising the device, method for detecting the analyte, and methods for manufacturing the device and kit.

Dependencies are inferred from the claim text.