An ultra-rapid and highly-sensitive chemiluminescence immunoassay for the detection of thyroid stimulating hormone uses water-soluble CdTe QDs as a chemiluminescence reagent and PBS solution of KMnO.sub.4 with specific concentration and pH as an activator to construct a CdTe QDs/KMnO.sub.4 chemiluminescence system of nanoparticle luminescence; based on the semi-automatic test method, the ultra-fast and highly sensitive detection of TSH can reach the level of single molecule detection.

According to a first aspect of the invention, there is provided a device for estimation of an ovulation date, comprising a camera, configured to obtain colour data of successive FSH test strips and a processor, configured to evaluate the colour data obtained by the camera. The processor is configured to determine a concentration value of each successive FSH test strip based on the data of the camera and to output a signal, if the processor determines that a first FSH downward trend of the FSH test strip values is occurring in the successive FSH test strips.

One aspect of the invention provides a method of diagnosing and treating a subject presenting with a pregnancy of unknown location (PUL). The method includes: obtaining a parameter set including: a first -human chorionic gonadotropin (-hCG) value generated using a first sample from a subject; and a second -human chorionic gonadotropin (-hCG) value generated using a second sample from a subject, wherein the second sample is obtained between about 36 hours and about 72 hours after the first sample; providing the parameter set as an input to either a computer-implemented method as described herein or a computer executing the program instructions of a non-transitory computer readable medium as described herein; receiving a probability of ectopic pregnancy in the subject; and treating the subject based on the probability.

Genetic factors that regulate uterine development, endometrial function, and gonadotropin signaling are associated with increased time to conception. Newly discovered loci are shown to have a highly significant correlation with the phenotype. These newly discovered associations form the basis for methods of diagnosing and treating infertility. These loci are useful alone or in combination with other biomarkers and phenotypic markers to diagnose or assess the risk of an increased time to conception phenotype, and can help guide diagnosis and treatment while improving outcomes.

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.

The present invention relates to a target analyte detection composition based on a proximity proteolysis reaction and a target analyte detection method using same. More specifically, the present invention relates to a method for detecting a target analyte, the method comprising a step in which when a first binder and a second binder bind to the target analyte, hybridization is made between ssDNA linked to the first binder and ssDNA linked to a protease and between ssDNA linked to the second binder and ssDNA linked to a zymogen, whereby a signal generated by a proximity proteolysis reaction between the protease and the zymogen is detected.

A lateral flow assay test device providing a structure for the lateral flow assay reactions provides for a continuous flow path of bibulous material provided in separate but contiguous regions of the device in which the bibulous layers are in fluid contact with each other thereby providing flow control of the timing and speed of the assay reaction. Increased flow control results in increasing reliability of use, increasing sophistication of reactions and increases the range of molecules or diagnosis that can be identified. Such flow control can extend processing times and allow users or test givers to manually delay test processing providing enhanced test results.

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.

The present invention relates to a lateral flow membrane arrangement (1), comprising a microporous membrane layer (2) and a liquid-impermeable support layer (3), for lateral flow of a liquid through the microporous membrane layer (2), wherein the microporous membrane layer (2) is supported on the liquid-impermeable support layer (3) and has at least one detection zone (5) and at least one non-detection zone, wherein binding agents are immobilized in the at least one detection zone (5), the liquid-impermeable support layer (3) has at least one zone having a large thickness and at least one zone having a small thickness, the microporous membrane layer (2) is supported on the liquid-impermeable support layer (3) such that said at least one detection zone is provided above said at least one zone of the support layer having a large thickness and said at least one non-detection zone is provided above said at least one zone of the support layer having a small thickness, the zones are oriented in a direction orthogonally to the lateral flow direction (a) of said liquid, the detection zone (5) has a thickness (7) of 100 to 150 m over the entire width of the membrane, the non-detection zone has a thickness (8) of at most 300 m over the entire width of the membrane, and the lateral flow membrane arrangement (1) has a constant thickness (9), as well as to a lateral flow immunoassay device comprising said membrane arrangement (1).

Test devices to detect pregnancy in a human female subject are provided. In various embodiments, test devices include an assay means to measure the absolute or relative amount of hCG in a sample from the subject; an assay means to measure the absolute or relative amount of FSH in a sample from the subject; and an assay means to measure the absolute or relative amount of one or more progesterone metabolites in a sample from the subject.