Described herein are methods, compositions, kits, and systems for detecting free and bound PlGF, and using detection of such species to distinguish between pregnant women with or without preeclampsia or related conditions.

The present application provides use of a CCDC157 gene and mutant genes thereof as molecular markers in diagnosis of male infertility diseases. Experiments have shown that the CCDC157-MIF515 mutant gene/protein causes male infertility, spermatogenesis disorder, sperm dysfunction, reduced sperm count, reduced sperm motility, abnormal sperm morphology, abnormal sperm head, etc. The CCDC157-MIF515 mutant gene/protein of the present application can be used as target genes for diagnosing male infertility. Meanwhile, the expression level of the CCDC157 of CCDC157 gene/protein is significantly reduced in NOA patients and SCOS patients, and the male infertility can be prevented and/or treated by increasing the activity and/or expression of the CCDC157 protein.

The present disclosure relates to devices and methods for identifying conditions in a human or animal body, such as pregnancy or ovulation. For example, the present disclosure relates to devices and methods for identifying pregnancy or ovulation, which devices and methods are adapted to mitigate the “hook effect”, thereby improving accuracy of the devices and methods.

The present invention includes a method for determining pre-term birth or an associated clinical condition or an increased risk of pre-term birth or an associated clinical condition based on the presence and/or increased amount of specific amnion and/or chorion cells in a blood sample from a pregnant woman.

A method for collection and dissemination of biologic data, comprising collecting at least one biologic sample by a testing device including thereon an alignment target and including a plurality of immunoassay test strips, wherein the at least one biologic sample contacts a sample pad on at least one of the plurality of immunoassay test strips, assigning correlative values as test results, wherein each test performed on the biologic sample is assigned a different correlative value, receiving the test results at a server disposed on a network, wherein the server has configured thereon a database, assigning a unique identification to the biologic sample, storing the unique identification in the database, storing the test results in the database in association with the unique identification of the biologic sample, and providing access to the database to healthcare organizations for analysis of the test results.

Disclosed herein are devices, systems, methods and kits for performing immunoassay tests on a sample. The immunoassay devices may be used in conjunction with diagnostic reader systems for obtaining a sensitive read-out of the immunoassay results. The immunoassay devices may be especially suited for the detection of at least a first analyte and a second analyte in a sample. The immunoassay devices and methods may utilize a competitive binding-like assay and a sandwich binding assay to detect analytes in a sample.

Embodiments are directed to methods of examining preimplantation factor (PIF) binding to a subject's circulating immune cells as a marker for immune dysregulation. Some embodiments are directed to methods of detecting a level of immune dysregulation sufficient to cause recurrent pregnancy loss (RPL), methods of detecting a level of immune dysfunction sufficient to cause endometriosis, and methods of detecting a level of immune dysfunction comprising administering an effective amount of PIF or an analog thereof, and examining its binding to circulating immune cells. Within those methods, an about twenty percent change in PIF binding to a subject's circulating immune cells indicates a level of immune dysfunction.

The present invention provides polymersomes comprising amphiphilic block-copolymers and their use to quantify ammonia in samples (e.g., body fluid samples). More particularly, it provides a polymersome comprising (a) a membrane, which comprises a block copolymer of poly(styrene) (PS) and poly(ethylene oxide) (PEO), wherein the PS/PEO molecular weight ratio is higher than 1.0 and lower than 4.0; and (b) a core which encloses an acid and at least one pH-sensitive dye. Compositions, strips and kits comprising the polymersomes are also provided along with methods of quantifying ammonia in a sample using the polymersomes, compositions and kit.

The present invention relates to a method of assessing a female’s risk of having polycystic ovary syndrome (PCOS), a kit for use in assessing a female’s risk of having PCOS, the use of a marker combination in the assessment of a female’s risk of having PCOS, a computer system for use in a method according to the present invention as well as a computer program and a computer-readable storage medium comprising instructions, which when executed by a computer, cause the computer to carry out the method of the present invention.

A method is taught for the accurate determination of the premature rupture of membranes (PROM), defined as spontaneous rupture of membranes before the onset of uterine contractions. More specifically, a lateral flow assay strip tests for at least two antigens to greatly limit or eliminate the possibility of false negatives. A built-in timer in the cassette holding the lateral flow assay further increases the accuracy of the test. A collection buffer vial with self-contained shipping and dropper caps and built-in stand is also taught.