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.