Abstract: Various aspects of the system and methods described herein rely upon the operation of lateral flow assays specially configured to evaluate a bodily fluid for at least the presence or absence of pregnanediol glucuronide at a threshold selected from the range inclusive of 1 ?g/mL-10 ?g/mL. The results from the lateral flow assays are optionally interpreted in association with an application operating upon a mobile device or a system for the collection, interpretation and storage of results. The interpretations are useful in accordance with facilitating diagnoses and treatments associated with medical conditions related to the generated interpretations of the lateral flow assays.

Abstract: The subject application relates to methods for treating a placental syndrome, wherein relaxin is administered during the late secretory/luteal (LS) phase of the menstrual cycle in women who have a propensity for developing the placental syndrome. In certain embodiments, administration of relaxin continues beyond the LS phase and into pregnancy.

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.

Abstract: The present invention is directed to methods for predicting a pregnant woman's risk of developing early-onset preeclampsia or late-onset preeclampsia. The methods are based on measuring one or more metabolites obtained from a pregnant woman's bodily fluid, such as blood or urine, which were found to be predictive of early-onset preeclampsia and late-onset preeclampsia.

Abstract: A device adapted to determine an analyte concentration of a fluid sample using a test sensor. The device comprises a display adapted to display information to a user. The device further comprises at least one user-interface mechanism adapted to allow the user to interact with the device. The device further comprises a body portion including at least one opening formed therein, the at least one opening being of sufficient size to receive the test sensor. The device further comprises a memory adapted to store a plurality of stored analyte concentrations. The device further comprises a processing feature adapted to inhibit the stored analyte concentrations from being displayed on the display.

Abstract: The present invention relates to a quantitative assay device and a method for the determination of an analyte, based on a test strip, which contains a porous test membrane allowing for capillary flow of the analyte and complexes of the analyte, a porous upstream membrane in fluid connection with the test membrane and a porous downstream membrane in fluid connection with the test membrane, wherein the test membrane contains two bands having deposited on there high and low concentrations of different calibrator agents and a test band capable of reacting with conjugated analyte complexes giving rise to a measurable signal.

Abstract: The present invention provides a method for determining the gender of a fetus by assaying the sex hormones, evaluating the overall reducing/oxidizing (redox) activity, and/or evaluating the radical scavenging capacity of the maternal urine or other body fluid. The method can be used to determine fetal gender at any time point during the entire pregnancy. The body fluid may be processed before assaying. Processing may involve aging the body fluid, or purification of various fractions.

Abstract: The present invention provides a method of predicting pregnancy outcome in a subject by determining the amount of an early pregnancy associated molecular isoform of hCG in a sample. The present invention further provides a method for determining the amount of early pregnancy associated molecular isoforms of human chorionic gonadotropin (hCG) in a sample. The present invention also provides a diagnostic kit for determining the amount of early pregnancy associated hCG in a sample. The present invention additionally provides an antibody which specifically binds to an early pregnancy associated molecular isoform of human chorionic gonadotropin. Finally, the present invention provides methods for detecting trophoblast or non-trophoblast malignancy in a sample.

Abstract: A device adapted to determine an analyte concentration of a fluid sample using a test sensor. The device comprises a display adapted to display information to a user. The device further comprises at least one user-interface mechanism adapted to allow the user to interact with the device. The device further comprises a body portion including at least one opening formed therein, the at least one opening being of sufficient size to receive the test sensor. The device further comprises a memory adapted to store a plurality of stored analyte concentrations. The device further comprises a processing feature adapted to inhibit the stored analyte concentrations from being displayed on the display.

Abstract: A method and kit for determining whether an animal is not pregnant, or is pregnant following a breeding. The level of expression of a pregnancy induced protein is determined in an animal for which pregnancy status information is desired and the level is compared to that of the level in animals that are not pregnant.

Abstract: Methods and systems to collect a sample of bodily fluid from a patient using an integrated needle and test strip assembly are provided. In this novel assembly, the test strip and needle form one unit that captures the sample of blood or interstitial fluid from the patient once the apparatus is pressed to the skin. The hollow aspiration needle includes more than one opening at a distal end, each opening coming into contact with the bodily fluid when disposed within a cutaneous or subcutaneous layer of the patient's skin. The disclosed test strip includes at least one reaction site for testing analyte concentrations and a means for linking to many commercially available test strip meters to provide readout of the analyte concentration. The sample may be captured by capillary flow, by an integrated aspirator, or by a differential vacuum device resident on the test strip meter.

Abstract: A method of determining the phase of an estrous cycle that a mammal is in at a given time that a biological sample is obtained from the mammal is provided. The biological sample obtained from the mammal is combined with a flavonol and an anthocyanin and/or iodine on, or which had been stored on and subsequently removed from, a silane-based surface to provide a color response. The estrus phase of the estrous cycle has a corresponding color response that is distinguishable from the color response of each other phase of the estrous cycle to an unaided human eye. The corresponding color response is correlated to the estrus phase of the estrous cycle.

Abstract: This disclosure relates to methods of predicting and diagnosing preeclampsia and eclampsia in pregnant subjects. These methods include detecting a decrease of soluble c-kit in a sample obtained from the pregnant subject. A significantly reduced concentration of soluble c-kit in the sample as compared to a gestational age-adjusted control indicates that the pregnant subject will develop or has preeclampsia or eclampsia.

Abstract: The present invention relates to an assay device and a method for using such for the quantitative determination of an analyte, based on a test strip, which contains a porous test membrane allowing for capillary flow of the analyte and complexes of the analyte, a porous upstream membrane in fluid connection with the test membrane and a porous downstream membrane in fluid connection with the test membrane, wherein the test membrane contains a test site having immobilized thereon a ligand capable of reacting with the analyte and binding such to the test site, and two standard band sites having immobilized thereon known high and low concentrations of a calibrator agent capable of reacting with a label conjugate and binding such to the standard sites, wherein the upstream membrane has a site for the application of a sample to be analyzed, and has a site downstream from the sample application site for depositing label conjugates capable of reacting with the analyte and label conjugates capable of reacting with the

Abstract: The present invention related to a pregnancy test device that can selectively detect hyperglycosylated human chorionic gonadotropin (hCG-H) in a liquid sample. The sample can be deposited on a proximal portion of the device for transport to a distal portion of the device. The device can include a release medium formed of a first material and including a detectable label thereon and a capture medium, including a capture site, in fluid communication with the release medium and formed of a second, different material. At least one of the release medium and the capture medium includes a binding member that exhibits a moderate to high affinity for hCG-H and is selectively or preferentially reactive with hCG-H.

Abstract: A method of determining the phase of an estrous cycle that a mammal is in at a given time that a biological sample is obtained from the mammal is provided. The biological sample obtained from the mammal is combined with at least one flavonoid pigment that reacts with the biological sample on a hydrophobic surface to provide a color response. The estrus phase of the estrous cycle has a corresponding color response that is distinguishable from the color response of each other phase of the estrous cycle to an unaided human eye. The corresponding color response is correlated to the estrus phase of the estrous cycle.

Abstract: Disclosed are an antigen protein of black-lip pearl oyster egg extract, an antibody specific thereto, and a method of quantitative assessment of the reproductive effort of black-lip pearl oyster using the antibody. The method accomplishes quantitative assessment of reproductive effort of black-lip pearl oysters easily and accurately. In addition, the method provides important information for the study of life cycles of black-lip pearl oysters, and allows efficient management of black-lip pearl oysters.

Abstract: A device adapted to determine an analyte concentration of a fluid sample using a test sensor. The device comprises a display adapted to display information to a user. The device further comprises at least one user-interface mechanism adapted to allow the user to interact with the device. The device further comprises a body portion including at least one opening formed therein, the at least one opening being of sufficient size to receive the test sensor. The device further comprises a memory adapted to store a plurality of stored analyte concentrations. The device further comprises a processing feature adapted to inhibit the stored analyte concentrations from being displayed on the display.

Abstract: The present invention related to a pregnancy test device that can selectively detect hyperglycosylated human chorionic gonadotropin (hCG-H) in a liquid sample. The sample can be deposited on a proximal portion of the device for transport to a distal portion of the device. The device can include a release medium formed of a first material and including a detectable label thereon and a capture medium, including a capture site, in fluid communication with the release medium and formed of a second, different material. At least one of the release medium and the capture medium includes a binding member that exhibits a moderate to high affinity for hCG-H and is selectively or preferentially reactive with hCG-H.

Abstract: Plasma samples of ovarian and breast cancer patients were used to search for markers of cancer, using two-dimensional gel electrophoresis and MALDI TOF mass spectrometry. Truncated forms of cytosolic serine hydroxymethyl transferase (cSHMT), T-box transcription factor 3 (Tbx3) and utrophin were aberrantly expressed in samples from cancer patients, as compared to samples from noncancer cases. Aberrant expression of proteins was validated by immunoblotting of plasma samples with specific antibodies to cSHMT, Tbx3 and utrophin. A cohort of 79 breast and 39 ovarian cancer patients, and 31 individuals who were either healthy or had noncancerous conditions was studied. We observed increased expression of truncated cSHMT, Tbx3 and utrophin in plasma samples obtained from patients at early stages of disease. The results indicate that cSHMT, Tbx3, utrophin and truncated forms thereof can be used as components of multiparameter monitoring of ovarian and breast cancer.

Abstract: This invention discloses using SPR technology to simultaneously and qualitatively detect the presence of respiratory tract viruses-related immunological markers in a serum sample, which can be used for the diagnosis of respiratory tract infections. It also discloses an efficient formula to make a mixed SAM that can greatly enhance the immobilization ability of the metal surface in SPR based techniques, which is good for the immobilization of representative antigens used to detect the respective respiratory tract viruses-related immunological markers (antibodies) in blood for the diagnosis of respiratory tract infections.

Abstract: A method of determining the phase of an estrous cycle that a mammal is in at a given time that a biological sample is obtained from the mammal is provided. The biological sample obtained from the mammal is combined with at least one flavonoid pigment that reacts with the biological sample on a hydrophobic surface to provide a color response. The estrus phase of the estrous cycle has a corresponding color response that is distinguishable from the color response of each other phase of the estrous cycle to an unaided human eye. The corresponding color response is correlated to the estrus phase of the estrous cycle.

Abstract: This invention discloses using SPR technology to simultaneously and quantitatively measure the concentrations of different sex hormones in a serum sample, which can be used to evaluate different clinical situations. It also discloses an efficient formula to make a mixed SAM that can greatly enhance the immobilization ability of the metal surface in SPR based techniques, which is good for the immobilization of relevant antibodies used for the detection of representative sex hormones in a serum sample.

Abstract: The present invention related to a pregnancy test device that can selectively detect hyperglycosylated human chorionic gonadotropin (hCG-H) in a liquid sample. The sample can be deposited on a proximal portion of the device for transport to a distal portion of the device. The device can include a release medium formed of a first material and including a detectable label thereon and a capture medium, including a capture site, in fluid communication with the release medium and formed of a second, different material. At least one of the release medium and the capture medium includes a binding member that exhibits a moderate to high affinity for hCG-H and is selectively or preferentially reactive with hCG-H.

Abstract: It has been surprisingly found that ZAP-70 expression, both at the protein and mRNA levels, is indicative of clinical subgroups of CLL/SLL patients. In particular, high ZAP-70 expression is indicative of Ig-unmutated CLL/SLL. Methods are provided for discriminating between clinical subgroups of CLL/SLL, by determining whether subjects overexpress ZAP-70 mRNA or protein.

Abstract: A method for detecting the onset of ovulation in a female mammal is provided. The method includes contacting mouth air of the female mammal with an arylmethane test chromogen in an amount effective to undergo a rapid and detectable color change in the presence of one or more volatile sulfur compounds. The color of the test chromogen is compared to a control color that corresponds to a pre-ovulatory sulfur content. The difference in color between the test chromogen and the control color is correlated to the onset of ovulation.

Abstract: The present invention provides a method of predicting pregnancy outcome in a subject by determining the amount of an early pregnancy associated molecular isoform of hCG in a sample. The present invention further provides a method for determining the amount of early pregnancy associated molecular isoforms of human chorionic gonadotropin (hCG) in a sample. The present invention also provides a diagnostic kit for determining the amount of early pregnancy associated hCG in a sample. The present invention additionally provides an antibody which specifically binds to an early pregnancy associated molecular isoform of human chorionic gonadotropin. Finally, the present invention provides methods for detecting trophoblast or non-trophoblast malignancy in a sample.

Abstract: The invention relates to a diagnostic method for detecting susceptibility to delivery, and to a test kit for this purpose. A low, but higher than baseline level concentration of Insulin-like Growth Factor Binding Protein 1 (IGFBP-1), which is due to leakage from decidual cells, is detected by an immunological assay in a vaginal secretion sample.

Abstract: The present invention relates to a method for detecting an optimal time for embryo implantation in mammals, particularly humans. In particular, the invention relates to a method for determining the optimal time for implantation of an embryo in a mammalian endometrium comprising detecting the levels of an endocannabinoid in the early, mid and late stage of the menstrual cycle in a subject.

Abstract: This invention provides methods and compositions for testing for pregnancy and non-pregnancy in ungulates and non-hoofed ruminates. The tests provided by this invention are useful during a time that coincides with the estrus cycle during which breeding occurs or the first estrus cycle after breeding of a non-pregnant animal. The tests provided by this invention are useful in estrus and ovulation synchronization programs, with pregnancy testing useful at a time allowing for resynchronization of non-pregnant animals within the first estrus cycle. The tests provided by this invention assay for the presence, absence, or level of a selected IFN-?-induced protein in a sample from a female animal. The tests of this invention are useful for testing cells, blood, plasma, serum, cells, milk, nasal secretions, ocular secretions, vaginal secretions, urine, and saliva samples. The tests provided by this invention are immunoassays.

Abstract: Methods are provided for the diagnosis and treatment of patients with increased risk of preeclampsia. The methods involve measuring levels of TGF-?3, receptors of cytokines of the TG? family, or HIF-1?.

Abstract: The present invention concerns methods of identifying extra-uterine (or ectopic) pregnancies and involves the screening of samples for the presence of certain molecules now known to be markers of extra-uterine pregnancies. The present invention provides a method for identifying an ectopic pregnancy, said method comprising the steps of: (a) providing a sample from a subject; (b) identifying a level of one or more of: (i) inhibin/activin BETA b subunit gene (ii) activin B (iii) cysteine-rich secretory protein 3 (CRISP-3); and/or (iv) carboxypeptidase-B1 (CPB1) (v) SLP1 (vi) elafin (vii) prolactin in the sample, wherein the level of inhibin/activin BETA b subunit gene, activin B, CRISP-3, SLP1, elafin, prolactin and/or CPB1 is associated with, or indicative of, an ectopic pregnancy.

Abstract: Methods and kits are provided for diagnosing, monitoring, or predicting the conditions of pre-eclampsia, fetal chromosomal aneuploidy, and pre-term labor in a pregnant woman, as well as for detecting pregnancy in a woman, by quantitatively measuring in the maternal blood the amount of one or more mRNA species encoding human chorionic gonadotropin ? subunit (hCG-?), human placental lactogen (hPL), human corticotropin releasing hormone (hCRH), KiSS-1 metastasis-suppressor (KISS1), tissue factor pathway inhibitor 2 (TPFI2), placenta-specific 1 (PLAC1), or glyceraldehyde-3-phosphate dehydrogenase (GAPDH), and comparing the amount of the mRNA species with a standard control.

Abstract: The present invention relates to methods of inducing ovulation in a female host comprising the administration of a non-polypeptide cyclic adenosine monophosphate (cAMP) level modulator to the female host. In another aspect, the invention provides for specific administration of the phosphodiesterase inhibitor prior to the luteal phase of the host's ovulatory cycle. Preferred non-polypeptide cAMP level modulators include phosphodiesterase inhibitors, particularly inhibitors of phosphodiesterase 4 isoforms.

Abstract: The present invention provides methods and compositions related to biomarker profiles for each trimester of pregnancy. The present invention also provides methods for identifying patients at risk of developing a complication of pregnancy, such as preeclampsia. In further embodiments, the present invention relates to methods for the diagnosis of patients with preeclampsia.

Abstract: The present invention provides methods for identifying and/or enriching fetal cells from maternal blood, using as fetal cell markers the antibodies that the mother produces against paternally inherited fetal antigens. The fetal cell-maternal antibody complexes are identified and isolated using labelled agents that bind to the maternal antibodies. The present invention also provides fetal cells, isolated by use of said maternal antibodies, as a source of fetal DNA for prenatal genetic diagnosis of the fetus.

Abstract: The solution covered by the invention contains 0.5 to 9.0% by mass of hydrate salt of chloride anion Cl+ with a chemical element of bivalent kation of cobalt or copper, magnesium, manganese, zinc, calcium or a monovalent kation of sodium, potassium; 0.5 to 10.5% by volume of oxalic acid, formic acid, acetic acid, butyric acid, citric acid, lactic acid, hydrofluoric acid, boric acid, tartaric acid; 0.2 to 8.0% by mass of casein and 80.5 to 98.5% by volume of water. The overall pH of the solution is 0.8 to 3.5%.

Abstract: This invention provides bovine pregnancy test methods and devices. The test is also suitable for other ruminant and/or ungulate animals. Antigens from Group A (early pregnancy antigens), and/or Group B (mid-pregnancy antigens), and Group C (early, mid- and late pregnancy antigens) are detected in a fluid from the animal, and pregnancy is reliably determined. The pregnancy assays of this invention are preferably carried out using immunoassay devices which provide immediate results in the field.

Abstract: The present invention relates to a novel method of determining the existence of a normal pregnancy which has a high likelihood of culminating in a term pregnancy, by measuring hyperglycosylated hCG in a pregnant woman and comparing the concentration of measured hyperglycosylated hCG with a predetermined value. A measurement of hyperglycosylated hCG above the predetermined value, for example, about 13 ng/ml, is evidence of a high likelihood of a normal pregnancy. A measurement below the predetermined value is evidence of an abnormal pregnancy (ectopic pregnancy or miscarriage). Further analysis of the patient in the event that the measurement falls below the predetermined value is made by intravaginal or abdominal ultrasound to determine whether or not the pregnancy is ectopic or will likely result in a spontaneous abortion (miscarriage).

Abstract: A test kit for determining the presence of one or more analytes in a fluid sample, including an assay device together with a reading device which engages with the assay device and wherein precisely located engagement of the assay device with the reading device is essential for accurate reading of the assay result, where precisely located engagement of the assay device with the reading device causes a ‘lock-and-key’ interaction between the assay device and reading initiation means of the reading device. Preferably the reading initiation means includes switch actuating means including at least one fixed projecting portion and at least one displaceable projecting portion, and a contact portion of the assay device casing includes a recess shaped to accommodate the fixed projecting portion of the switch actuating means but not the displaceable projecting portion.

Abstract: The invention provides improved assays for detection of pregnancy. In the assays, pregnancy associated glycoproteins are analyzed in conjunction with progesterone analysis. The techniques of the invention overcome limitations in the prior art by reducing the rate of false positive results. The assays provided by the invention can be implemented to increase the efficiency of commercial animal breeding programs.

Abstract: A method for predicting pregnancy outcome includes measuring blood levels of hCG-hg and progesterone in a pregnant woman, determining a rate of change of progesterone levels from the blood measurements, determining at least a qualitative direction of change of hCG-hg levels from the blood measurements, comparing the determined rate of change of progesterone levels with a pre-established reference value, and determining at least a qualitative likelihood of a term pregnancy and a failed pregnancy for the woman from the qualitative direction of change of hCG-hg levels and the determined rate of change of progesterone levels relative to the pre-established reference value. The rate of change of progesterone is determined by formula as a number of days for progesterone to double.

Abstract: An immunoassay device has a housing defining a first opening for receiving a solution and a second opening through which a liquid sample is deposited, a strip of sorbent material having a test site with immobilized antigen or antibody for the ligand to be tested, and a filter for filtering the sample. The filter is located at the second opening and directly above the test site. The sorbent material defines a horizontal flow path in the housing for the solution from the first opening to the test site. In use, the sample is first applied via the filter to the test site, and then, after the ligand has been captured, a buffer added through the first opening is used to cause a secondary specific binder conjugated to a marker to migrate horizontally by capillary action to the test site where it can bind to the already captured ligand. This immunoassay offer several advantages over the traditional chromatographic immunoassays.

Abstract: A fertility determining system employing hormone level measuring apparatus on selected days in a menstrual cycle to determine the levels of analytes, i.e., estrone-3-glucuronide (“E3G”) and luteinizing hormone (“LH”), in early morning urine. The fertility/infertility signalling algorithm relies upon data characterizing the user earlier in that menstrual cycle, and also upon her analyte pattern in past recent cycles. At a point in a menstrual cycle which is user-dependent, the early morning E3G urine level is compared against the lower E3G level earlier in the cycle. The beginning of the fertile period is signalled when a sufficient E3G increase occurs. The end of the fertile period (and, correspondingly, the reestablishment of a period requiring no contraception) is signalled a period after the LH surge. In the absence of an LH surge in any subject, the end of the fertile phase is signalled a period of time following the peak of the E3G urinary metabolite of estradiol.

Abstract: The present invention relates to a method for determining the condition of a biological fluid by recording the IR spectrum of a sample of the biological fluid. To this end, the biological fluid can be examined in its native form. The method of the invention is usable, for example, for detecting pathological conditions in organisms.

Abstract: The present invention relates to methods of inducing ovulation in a female host comprising the administration of a non-polypeptide cyclic adenosine monophosphate (cAMP) level modulator to female host. In another aspect, the invention provides for specific administration of the phosphodiesterase inhibitor prior to the luteal phase of the host's ovulatory cycle. Preferred non-polypeptide cAMP level modulator include phosphodiesterase inhibitors, particularly inhibitors of phosphodiesterase 4 isoforms.

Abstract: A system and method for tracking and informing about a physical, emotional, or physiological cycle, such as a menstrual cycle, includes at least one definition entry and at least one date indicator. Each definition entry defines indicia such as color to represent a stage of a physical, emotional, or physiological cycle. Each date indicator includes a date section and a tracking section corresponding to each date section. The date section of the date indicator indicates at least one date, wherein the tracking section is capable of being marked so as to indicate indicia corresponding to a definition entry to signify the stage of the physical, emotional, or physiological cycle for each date. According to one embodiment, the date indicators are arranged according to phases of the moon to allow correlation of a user's cycle to the lunar cycle.

Abstract: Disclosed is a lateral flow quantitative assay method which can measure one or more analyte species at the same time, with high sensitivity. Also, the present invention relates to a strip which can measure one or more analyte species at the same time, with high sensitivity and a package in which the strip is integrated with a laser-induced surface fluorescence detector. The present invention can quantify multiple analytes with a minimum detection limit of pg/ml. Therefore, the present invention provides an advantage capable of quantifying a plurality of analytes at the same time using a simple lateral flow assay strip.

Abstract: The invention concerns a device for determining an analyte in a liquid sample, comprising: a) a gripping support (1); b) first capillary diffusing means (2) integral with the gripping support (1) comprising a downstream zone (2a) accessible to external observation; c) a set of predetermined reagents for detecting and/or quantifying the analyte; d) a member for collecting (4) the liquid sample mounted on the support (1). The invention is characterized in that the member for collecting (4) the liquid sample is mounted mobile or fixed on the support; second capillary diffusion means (41) extends from a zone collecting (41a) said sample, to a zone transferring (41b) the latter; and an upstream zone (2b) of said first capillary diffusion means (2) is arranged to be urged temporarily to constitute continuous capillary flow with the second diffusion means (41) transferring zone (41b), when the collecting member (4) is in the retracted position.

Abstract: A method of determining the presence of preeclampsia is provided wherein a determination is made as to whether there has been a substantial elevation in marinobufagenin which may be a blood-derived or urine-derived and if such elevation does exist concluding that preeclampsia does exist in a patient. The method may advantageously be practiced by employing urine, blood serum or blood plasma as the body specimen containing the protein in determining whether a patient has preeclampsia. The method may include subsequent therapeutic patient treatment. Related diagnostic apparatus is also provided.