Abstract: A computer system for generating code for use in processing patient test data from point of care devices. The computer system comprises object definition storage storing a plurality of definition objects, each definition object defining a generic function to be performed in response to an output of a point of care device; instantiation data storage storing instantiation data for use in instantiating definition objects as processing objects for specific functions to be performed in response to outputs from specific point of care devices; and a code generating processor for generating code for at least one processing object to perform at least one specific processing function to process an output from a point of care device by accessing at least one definition object in the object definition storage and the instantiation data in the instantiation data storage to instantiate the at least one definition object using instantiation data for the point of care device.

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 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 invention discloses a method of prenatal diagnosis comprising the step of isolating exosomes from an isolated fluid, wherein the exosomes are identified by biomarker detection. Furthermore, the invention discloses the isolation of exosomes from an isolated fluid and the use of a biomarker, particularly CD24 to isolate exosomes from an isolated fluid.

Abstract: The present invention provides methods and kits for assessing the state of oocyte maturation in a female mammal based on the level of PAPP-A found in the female's bodily fluid sample.

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: 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: Briefly described, embodiments of this disclosure include ligand-regulable transactivation systems, methods of producing ligand-regulable transactivation systems, methods of using ligand-regulable transactivation systems, reporter polynucleotides, method of producing reporter polynucleotides, activator fusion proteins, methods of producing activator fusion proteins, methods of regulating gene expression in vitro and in vivo for gene therapy, methods of screening estrogen receptor modulators with therapeutic treatments (e.g., anticancer, antiosteoporosis, and hormone replacement treatments), method of screening compounds (e.g., drugs and environmental pollutants) for the estrogenic effect, methods of evaluating the estrogen receptor pathway under different pathological conditions are provided, and the like.

Abstract: This invention generally relates to methods, apparatus, and computer program code for antenatal screening for chromosomal abnormalities, in particular Down's Syndrome. A method of determining a likelihood of a fetus carried by a pregnant mother having a chromosomal abnormality, a first biological, parameter being suitable for screening said fetus for said chromosomal abnormality, the method comprising: receiving first data from a first stage of pregnancy of said mother, said first data comprising data representing a first value of said first biological parameter; receiving second data from a second, later stage of said pregnancy, said second data comprising data representing a second value of said first biological parameter; and determining likelihood data from said first and second data, said likelihood data representing the likelihood of said fetus having a chromosomal abnormality.

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: 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: 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: Disclosed are an immunoassay device which comprises a labeled substance dotting portion and a specimen dotting portion provided thereon, and an immunoassay method using the device.

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: 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: A method and test device for differentiating between states of an analyte that can exist in different forms, such as follicle stimulating hormone (FSH). The method or test device uses a pair of specific binding agents, especially monoclonal antibodies, in two assays for the same analyte. The assays, applied to contemporaneous samples, differ from one another in format, one being a two step assay and the other being one step. A novel pair of anti-FSH monoclonal antibodies that can be used together in two such assays to differentiate pre-menopausal and post-menopausal FSH samples is disclosed.

Abstract: A method of testing an animal for pregnancy or sex identification comprising the steps of first, providing a first vessel containing a liquid and having a removable surface wherein said removable surface is at least partially coated with an antibody and then introducing a bodily fluid from the female animal into said first vessel so that said bodily fluid contacts the liquid and then manipulating the first vessel so that the liquid contacts the antibody. Then, a second vessel containing a reporter hormone solution is provided and the removable surface from the first vessel is displaced to the second vessel and manipulating the second vessel so that the reporter hormone solution contacts the removable surface. Then, a third vessel containing an indicating solution which has an appearance which is related to the amount of the reporter hormone contacted is provided, and the removable surface is displaced from the second vessel to the third vessel.

Abstract: A chromatographic lateral-flow assay system for rapid, high sensitivity method of detecting low levels of ligands in body fluids, with few false positives and few false negatives. The lateral-flow assay may have a membrane strip in ribbon form, which increases detection on the order of 2 to 10 fold over the conventional chromatographic specific binding assay techniques by placing a dried or lyophilized conjugate in colloidal spheres opposite side of the lateral flow membrane strip. A chromatographic specific binding assay strip device, comprising: a laminate strip having a first side and an opposite second side; a conjugate pad or membrane disposed on said first side of said laminate; a sample receiving pad or membrane strip and reservoir pad or membrane disposed on said second side of said laminate; and a detection pad or membrane strip disposed between the sample pad or membrane and the reservoir pad or membrane on said second side of said laminate.

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: An analytical test device incorporating a dry porous carrier to which a liquid sample, eg. urine, suspected of containing an analyte such as HCG or LH can be applied indirectly, the device also incorporating a labelled specific binding reagent which is freely mobile in the porous carrier when in the moist state, and an unlabelled specific binding reagent which is permanently immobilized in a detection zone on the carrier material, the labelled and unlabelled specific binding reagents being capable of participating in either a sandwich reaction or a competition reaction in the presence of the analyte, in which prior to the application to the device of a liquid sample suspected of containing the analyte, the labelled specific binding reagent is retained in the dry state in a macroporous body, eg.

Abstract: A chromatographic assay device for the analysis of an analyte in a liquid sample has a proximal sample application zone and a distal test zone. The test zone contains a first ligand capable of binding with the analyte to form an analyte-ligand complex. The device also includes a spatially distinct reservoir containing a labeled reagent capable of binding to the analyte-ligand complex; an absorbent sink which is positioned to be capable of drawing the contents of the spatially distinct reservoir through the test zone; and structures for contacting the spatially distinct reservoir with the chromatographic medium so that the labeled reagent migrates from the reservoir to the absorbent sink, and thereby through the test zone to determine the presence or absence of the analyte. The device is used in a method for detecting analyte.

Abstract: This invention relates to a biospecific assay method, in which microparticles coated with the bioaffinity reactant A binding the analyte to be assayed; the sample to be analyzed, and the labelled bioaffinity reactant B are mixed. After the binding reaction the signal strength from the labelled bioaffinity reactant B bound to the microparticles is quantitated for the determination of the concentration of the analyte in the sample. According to the invention, such an amount of sample and microparticles is used in the assay that after binding of the analyte of the sample to the said amount of microparticles, each individual microparticle will emit such a signal strength as to allow the measurement of the analyte concentration over the whole range of typical analyte concentrations, and the signal strength from each microparticle is measured separately.

Abstract: The present invention provides antibodies which specifically bind early conception factor, which can be found in body fluids of animals including but not limited to the cow, cat, dog, horse, human, sheep, and pig. The invention provides methods for detecting conception or the absence of conception in an animal, the latter being recognized by the absence of early conception factor in a suitable body fluid collected from the animal. Apparati for detecting early conception factor in a body fluid from an animal comprising the antibodies which specifically bind early conception factor are also provided.

Abstract: The invention provides a hapten derivatized with a crosslinker at the nitrogen of the 8?-carboxamide of 2-oxo-3-hydroxy LSD. The invention also provides an immunogen comprising the aforementioned hapten coupled to an antigenicity-conferring carrier material; a conjugate comprising the aforementioned hapten coupled to a labelling agent, as well as, antibodies raised against the aforementioned immunogen and capable of binding with at least the 3-hydroxy-2-pyrrolidone structural epitope of 2-oxo-3-hydroxy LSD.

Abstract: An analytical test device useful for example in pregnancy testing, comprises a hollow casing (500) constructed of moisture-impervious solid material, such as plastics materials, containing a dry porous carrier (510) which communicates indirectly with the exterior of the casing via a bibulous sample receiving member (506) which protrudes from the casing such that a liquid test sample can be applied to the receiving member and permeate therefrom to the porous carrier, the carrier containing in a first zone a labelled specific binding reagent is freely mobile within the porous carrier when in the moist state, and in a second zone spatially distinct from the first zone unlabelled specific binding reagent for the same analyte which unlabelled reagent is permanently immobilised on the carrier material and is therefore not mobile in the moist state, the two zones being arranged such that liquid sample applied to the porous carrier can permeate via the first zone into the second zone, and the device incorporating mea

Abstract: Methods of diagnosing infertility in a mammal that include detecting the presence and level of a ?3 integrin subunit in an endometrium sample of a mammal at a plurality of stages of the endometrial cycle and correlating delayed appearance or a reduced level of ?3 integrin subunit expression with infertility are provided. Diagnostic kits useful in the practice of the methods of the invention are also provided.

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: An analytical test device useful for example in pregnancy testing, comprises a hollow casing (500) constructed of moisture-impervious solid material, such as; plastics materials, containing a dry porous carrier (510) which communicates indirectly with the exterior of the casing via a bibulous sample receiving member (506) which protrudes from the casing such that a liquid test sample can be applied to the receiving member and permeate therefrom to the porous carrier, the carrier containing in a first zone a labelled specific binding reagent is freely mobile within the porous carrier when in the moist state, and in a second zone spatially distinct from the first zone unlabelled specific binding reagent for the same analyte which unlabelled reagent is permanently immobilised on the carrier material and is therefore not mobile in the moist state, the two zones being arranged such that liquid sample applied to the porous carrier can permeate via the first zone into the second zone, and the device incorporating me

Abstract: The present invention provides antibodies which specifically bind early conception factor, which can be found in body fluids of animals including but not limited to the cow, cat, dog, horse, human, sheep, and pig. The invention provides methods for detecting conception or the absence of conception in an animal, the latter being recognized by the absence of early conception factor in a suitable body fluid collected from the animal. Apparati for detecting early conception factor in a body fluid from an animal comprising the antibodies which specifically bind early conception factor are also provided.

Abstract: Methods for detecting receptivity of mammalian endometrium to embryo implantation comprising obtaining a sample of the endometrium, contacting the endometrium with a monoclonal antibody for &bgr;3 and detecting &bgr;3 in the endometrium. The invention also provides for methods of diagnosing infertility in a mammal and methods of detecting the window of embryo implantation in endometrium. Methods of in vitro fertilization, methods of preventing embryo implantation and a method of monitoring endometrial maturation are also within the scope of the present invention. The present invention is also directed to contraceptives. Diagnostic kits useful in the practice of the methods of the invention are also provided.

Abstract: An increased risk of a fetal chromosomal abnormality, for example, fetal Down syndrome can be detected by separating or discriminating &agr;-fetoproteins present in the body fluid of a pregnant woman, and measuring the proportion of one or more of the &agr;-fetoproteins which have a specific sugar chain structure, relative to the total &agr;-fetoproteins.

Abstract: The efficiency and accuracy of one-step lateral flow assays can be improved by employing more efficient binding between participants in labeling and capture. Thus, in addition to analyte/anti-analyte interactions, specific binding is achieved through members of an irrelevant specific binding pair. Also included within the invention is a format wherein unlabeled competitor for analyte serves as a gatekeeper in the capture zone, competing with analyte for labeled anti-analyte, which analyte will be captured in a detecting portion of a capture zone.

Abstract: This invention relates to a method of predicting pregnancy, particularly, in a cow, the method comprising taking a milk sample from the cow in which a milk progesterone concentration of >3 ng ml−1 by Day 4 post insemination is indicative that the animal is pregnant. The invention also relates to methods of improving pregnancy success by timely supply of progesterone or a functional equivalent thereof (progestagen); to methods of assessing suitability for progesterone replacement therapy; and to methods of embryo transfer.

Abstract: A method of screening for fetal Down's syndrome is described. Screening marker levels are measured. These may be measurements of a biochemical marker in a maternal sample or measurements of a marker from an ultrasound scan. The marker levels are used to calculate a risk of Down's syndrome. Instead of using markers from a single stage of pregnancy, the method uses markers from two or more different stages of pregnancy, typically one being in the first and another being in second trimester. The method may be automated.

Abstract: The present invention relates to male infertility, and in particular to assays for predicting fertility in animals including human and bovines. In some embodiments, semen samples are evaluated by measuring the amount of ubiquitin in the sample, and in particular by measuring the extent of ubiquitination spermatozoa. Increased levels of ubiquitination in a sample are correlated with lower fertility. Ubiquitination may be assayed by several methods, including immunocytochemical measurement, ELISA, and flow cytometry.

Abstract: A chromatographic assay or test device for detection and/or determination of an analyte in a test sample, comprises a base member, and a chromatographic medium located in or on said base member, the base member being provided with a receptacle to receive an applicator having the sample applied thereto, and the applicator being movable when located in said receptacle between a first position in which the applicator is out of fluid contact with the chromatographic medium, and a second position in which the applicator is in fluid contact with the chromatographic medium so as to apply a sample on the applicator to the chromatographic medium. In an alternative aspect, the test device comprises a base member, and a second member, at least one of the base member and the second member including a chromatographic medium, and the second member being slidably movable with respect to the base member from a first position to a second position.

Abstract: In qualitative or quantitative assays which employ a test device comprising a test strip pretreated for detection of a specified target analyte dissolved in a liquid medium, the presence of solid, semisolid and/or colloidal materials in the liquid medium may interfere with the assay results. The present invention involves collecting the sample from a flowing or quiescent pool of liquid also containing solid, semisolid or colloidal material with a swab comprised of a handle and a mass of fibrous material or foamed, open cell material which, when immersed in and thoroughly wetted by the liquid, entraps solid, semisolid and/or colloidal material and delivers only the liquid to the sample receiving zone of the test strip.

Abstract: There are provided methods for assaying biological specimens for one or more of leptin, prorenin or renin in order to provide predictive information about the likelihood of a woman carrying a Downs Syndrome affected fetus.

Abstract: Methods for detecting pregnancy in a woman comprise screening a biological sample of the woman for pregnancy markers. The methods of the invention include chemiluminescent assays for the pregnancy markers. The methods of the invention also comprise utilizing at least two capture antibodies that specifically bind different epitopes of the pregnancy marker in one assay. The methods of the invention permit detection of pregnancy within about 7 days after ovulation or implantation.

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 is 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 subject invention pertains to methods and materials for accurately assessing the presence or absence of analytes of interest in samples, particularly in physiological samples. The subject invention involves utilizing a ligand binding domain (LBD) of a receptor to selectively capture the analyte target specific for that LBD. In one embodiment, the receptor is a protein or polypeptide. The ligand binding domain is allowed to react with a sample and the presence or amount of ligand (i.e., target analyte) bound by the LBD is determined. Suitable analytes include soluble analytes such as hormones, enzymes, lipoproteins, bacterial or viral antigens, immunoglobulines, lymphokines, cytokines, drugs, soluble cancer antigens, and the like. The methods of the present invention can be performed in both liquid-phase and solid-phase.

Abstract: There are provided methods for assaying biological specimens for one or more of leptin, prorenin or renin in order to provide predictive information about the likelihood of a woman carrying a Downs Syndrome affected fetus.

Abstract: Disclosed is a test cell and a method for detection of a preselected ligand in a liquid sample such as a body fluid. The test cell includes an elongate outer casing which houses an interior permeable material capable of transporting an aqueous solution and defining a sample inlet, a test volume, and a reservoir volume. The reservoir volume is disposed in a section of the test cell spaced apart from the inlet and is filled with sorbent material. The reservoir acts to receive liquid transported along a flow path defined by the permeable material and extending from the inlet and through the test volume. In the test volume is a test site which includes a first protein having a binding site specific to a first epitope of the ligand immobilized in fluid communication with the flow path. The test site can be observed through a window of the casing.

Abstract: A substance having an inhibitory effect on the production of human choriogonadotropin (hCG) is described, which comprises a protein isolated from human decidual cells with a preliminary amino acid analysis and a molecular weight of about 7,000 to about 10,000 daltons, and useful for use in inhibiting production of hCG in vivo or in vitro, may be measured as an indication of a cause of hCG inhibition, or used in the treatment of hCG-secreting tumors.

Abstract: The invention discloses a method for detecting and/or quantifying a hapten in a homogeneous phase, comprising the following steps: adding a known quantity of a hapten inhibitor complex to the solution containing the hapten to be detected and/or quantified; adding to the solution a quantity of antibodies corresponding to the quantity of the hapten/inhibitor complex; adding to the solution a type C &bgr;-lactamase having an active site for two substrates in antigenic competition in the said active site, the first substrate being a reporter substrate capable of being transformed into a detectable and/or quantifiable product, preferably by visible UV radiation measurement, the second substrate being the hapten/inhibitor complex acting on the hydrolysis rate of the reporter substrate; detecting and/or quantifying the concentration of the product resulting from the transformation of the reporter substrate, the Km constant of the reporter substrate being at least a hundred times higher than the Km constant of the ha

Abstract: A prenatal screening method for Down's syndrome involves assaying for hyperglycosylated gonadotropin in biological test samples such as urine, plasma or serum obtained from pregnant women. Hyperglycosylated gonadotropin comprises a variant population of chorionic gonadotropin, chorionic gonadotropin-free &bgr;-subunit, &bgr;-core fragment, and/or free &agr;-subunit exhibiting differences in the carbohydrate content from what is observed in samples obtained from pregnant women carrying normal fetuses. Qualitative or quantitative observation of differences in the carbohydrate content of the hyperglycosylated gonadotropin population from corresponding control samples containing a normal gonadotropin population, or direct observation of the variant species seen in Down's syndrome, indicates that the woman's fetus has Down's syndrome. Typical screens involve carbohydrate analyses, immunoassays, or combinations of these methods.

Abstract: The present invention provides a gender-indicating composition, and a method and kit for determining the gender of an unborn child. The gender-indicating composition includes thymol blue and can be in solid or solution form. The method of the invention includes a non-invasive colorimetric assay of a pregnant woman's urine. The kit includes a unit dose of the gender-indicating composition and, optionally, a color standard.

Abstract: A solid diagnostic device for the quantitative determination of substances of biological affinity in biological fluids is described. A process is also described in which the biological fluid is brought into contact with a specific functional sector of the device, the fluid migrates through several functional sectors situated beside one another and containing suitable reagent components, and one or more substances of biological affinity are detected in such functional sectors which contain, for each substance to be detected, at least one combination partner of biological affinity, attached to a solid phase.