Diagnostic detection device
AssigneeChurch & Dwight Co., Inc.
InventorsAlbert R. Nazareth, Shang Li
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Abstract
The invention comprises a device for detecting an analyte in a liquid sample deposited on a first portion of the device for transport to a second portion of the device that is in fluid contact with the first portion. In specific embodiments, the device is a pregnancy test device, which detects human chorionic gonadotropin (hCG) as an indicator of pregnancy. Devices with improved clinical sensitivity are provided which are capable of detecting all clinically relevant hCG isoforms.
Claims29
A device for detecting human chorionic gonadotropin (hCG) isoforms in a liquid sample, wherein the device comprises a substrate comprising a release medium formed of a first material and a capture medium formed of a second, different material, the substrate having deposited thereon:
- i) a first antibody that recognizes all clinically relevant hCG isoforms;
- ii) a second antibody that is specific for an epitope unique to hCG beta core fragment (hCG-βcf) isoform or specific for an epitope common to both hCG-βcf and hCG beta subunit (hCG-β);
- and
- iii) a third antibody that binds multiple hCG isoforms but not the hCG-βcf isoform,
- wherein one of the following conditions is met:
- a) said first antibody is conjugated with a detectable label;
- or b) both of said second antibody and said third antibody are conjugated with one or more detectable labels;
- and
- wherein the capture medium of the substrate includes one or more capture sites configured for capture of one or more of the hCG isoforms in the liquid sample.
Dependencies are inferred from the claim text.