Diagnostic device for distinguishing between normal and ectopic pregnancy and method for preparing the same
AssigneeHumasis Co., Ltd.
InventorsJin-Dong Chang, Jung-Hak Cha, Jung-Hyun Nam
Life of this patent
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Abstract
A one-step diagnostic device for simultaneously detecting and distinguishing between a normal pregnancy and an ectopic pregnancy and methods for preparing the device are disclosed. Utilizing the device and principles of the present invention, normal pregnancy and ectopic pregnancy can be rapidly and accurately determined at an early stage by immunologically detecting the morphological differences between human chorionic gonadotropin (hCG) and modified forms thereof, which are secreted into the body fluid of a pregnant female.
Claims14
A pregnancy diagnosis device based on the immuno-chromatography, comprising an antibody-bound membrane and an antibody-bound colored particulate pad, wherein an antibody is comprised of a combination of an anti-α-hCG monoclonal antibody, an anti-β-hCG monoclonal antibody, an anti-I-hCG monoclonal antibody and an anti-modified hCG monoclonal antibody.
A pregnancy diagnosis device comprising an ectopic pregnancy line, a normal pregnancy line, and a test completion line, wherein
- when a specimen from a non-pregnant female is tested, only the test completion line is turned visually observable;
- when a specimen from a female with a normal pregnancy is tested, the test completion line, the ectopic pregnancy line and the normal pregnancy line are turned visually observable with equal intensities;
- and
- when a specimen from a female with an ectopic pregnancy is tested, only the test completion line and the ectopic pregnancy line are turned visually observable, or alternatively the test completion line, the ectopic pregnancy line, and the normal pregnancy line are turned visually observable with the intensity of the normal pregnancy line being distinctively low.
Dependencies are inferred from the claim text.