The present disclosure relates to diagnostic test devices that provide improved communication to a user of one or both of proper functioning of the test device and an analog test result that is provided by the test device. The diagnostic test devices particularly can include one or more sensors effective to indicate application of a sufficient volume of a test fluid and/or can include one or more light sources positioned to illuminate an analog test result for improved visibility and understanding of the analog test result.

Provided herein are urine-based lateral flow assays for the detection of the beta subunit of luteinizing hormone (LH), and methods of interpretation and digital quantification thereof. Such assays may be incorporated into ovulation test devices, e.g., for evaluating the onset and quality of ovulation. Also provided are diagnostic systems, and methods of using such devices and systems.

The present application relates to an antibody, kit, detection method, and sample analyzer for detecting thyroid stimulating hormone. Specifically, the present application relates to a monoclonal antibody or antigen-binding antibody fragment thereof that specifically binds to thyroid stimulating hormone (TSH), wherein the antibody can recognize TSH variant R55G and does not cross-react with an -subunit shared by human luteinizing hormone (LH), follicle stimulating hormone (FSH), human chorionic gonadotropin (hCG), and free glycoprotein hormones, and is particularly suitable for developing TSH detection kit with a functional sensitivity of 0.0015 IU/ml. The present application also relates to a thyroid stimulating hormone detection kit, detection method, and sample analyzer.

A device that includes a first portion, the first portion including at least one fluid channel; a fluid actuator; and an introducer; a second portion, the second portion including at least one well, the well containing at least one material, wherein one of the first or second portion is moveable with respect to the other, wherein the introducer is configured to obtain at least a portion of the material from the at least one well and deliver it to the fluid channel, and wherein the fluid actuator is configured to move at least a portion of the material in the fluid channel.

The present disclosure relates to an immunodiagnostic device for determining normal and abnormal pregnancy, and more particularly, to an immunodiagnostic device including a multi-binding anti-hCG monoclonal antibody that may recognize Intact hCG and cf hCG in common, wherein Intact hCG and cf hCG contained in the sample may be separately detected, including two detection lines and control lines, and the ratio of the color development intensity of cf hCG to the color development intensity of Intact hCG and cf hCG (the distribution ratio of cf hCG) may be numerically quantified to determine the number of weeks of pregnancy, normal pregnancy, and abnormal pregnancy including ectopic pregnancy and blighted ovum accurately and quickly.

An improved qualitative or semi-quantitative diagnostic test for low levels of any analyte, such as hCG, in a biological sample, such as urine. The test comprises of a test device containing reagents for the detection of the monitored analyte and an electronic reader that measures color development at a detection area of the device. The color development is converted to an electronic or digital signal. Improvements were made to the detection process to optimize the detection of a valid fluid front, increase the detection limit without compromising the reliability and accuracy of the test system, and improve the determination of test result validity.

A test device for detection and visual identification of a specific analyte in a liquid sample such as a bodily fluid is disclosed. The device includes a collection container, a test strip affixed to an interior surface of the collection container, and a removable protective strip adhered over the test strip. The protective strip is configured to be removed from contact with the test strip after the liquid sample has been collected in order to prevent unnecessary exposure and/or contamination of the test strip. In certain embodiments, the protective strip may be removed from the contact with the test strip when the collection container is in a sealed configuration. In other embodiments, the protective strip may be dissolvable when placed in contact with the desired liquid sample. An assay specific to the anticipated analyte may be provided on the test strip.

Methods are provided for determining the presence of an analyte present in a liquid sample involving: contacting the liquid sample with a predetermined amount of an analogue of the analyte and an excess of a first binding moiety, wherein the first binding moiety is capable of binding each of the analyte and the analogue independently; contacting the mixture with a second binding moiety; and determining the level of a signal indicative of the presence of the analogue-first binding moiety complex bound to the second binding moiety, wherein if the level of the signal determined is lower than the level of a maximum signal determined when no analyte is present, then analyte is present in the sample. Corresponding kits are also provided.

Provided is a testing device, including: a porous flow path member in which a flow path for flowing a sample is formed; and a resin layer provided at one position or a plurality of positions over the flow path member, wherein a reagent reactive with the sample is provided as a solid phase over a surface of the resin layer facing the flow path member.

An improved qualitative or semi-quantitative diagnostic test for low levels of any analyte, such as hCG, in a biological sample, such as urine. The test comprises of a test device containing reagents for the detection of the monitored analyte and an electronic reader that measures color development at a detection area of the device. The color development is converted to an electronic or digital signal. Improvements were made to the detection process to optimize the detection of a valid fluid front, increase the detection limit without compromising the reliability and accuracy of the test system, and improve the determination of test result validity.