Abstract: Methods for the diagnosis and evaluation of stroke and stroke sub-type employ a variety of bio-markers including cellular fibronectin (c-Fn) assembled as a panel for stoke diagnosis and evaluation. Methods are disclosed for selecting markers and correlating their combined levels with a clinical outcome of interest. In various aspects the methods permit early detection and differentiation of stroke subtypes, determination of the prognosis of a patient presenting stroke symptoms, and identification of a patient at risk for early hematoma growth and/or malignant massive cerebral artery infarction. The disclosed methods provide rapid, sensitive and specific assays to greatly increase the number of patients that can receive beneficial stroke treatment and therapy, and to reduce the human and economic costs associated with incorrect stroke diagnosis.

Abstract: A one-step diagnostic device for simultaneously detecting and distinguishing between a normal pregnancy and an ectopic pregnancy and methods for preparing the device are disclosed. Utilizing the device and principles of the present invention, normal pregnancy and ectopic pregnancy can be rapidly and accurately determined at an early stage by immunologically detecting the morphological differences between human chorionic gonadotropin (hCG) and modified forms thereof, which are secreted into the body fluid of a pregnant female.

Abstract: A pregnancy test device aids a woman in determining whether or not she is pregnant. The pregnancy test device includes a molded body, having a series of apertures and a display window; a sample pad, disposed within the molded body for receiving a urine sample, said sample pad treated to detect the presence of human chorionic gonadotropin or its ?-subunit, and exposed through the series of apertures in the molded body; a membrane, operatively connected to the sample pad, to display the results of the pregnancy test, and said membrane positioned to be viewed through the display window of the molded body; and gold, disposed between the sample pad and the membrane.

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: 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 is about a method for the prenatal diagnosis of preterm delivery, fetal infection, and fetal damage, and diagnostic reagent system and diagnostic kit for the diagnosis. The method, diagnostic reagent system, and kit are based on the finding that the level of MMP-8 in the amniotic fluid is significantly higher when the pregnant woman is at risk for preterm delivery, intrauterine infection, and fetal damage. The diagnostic reagent system and kit can be applied to patients with or without clinical signs of preterm labor or premature rupture of fetal membranes. With its superiority in sensitivity and specificity as well as its less invasiveness compared to the conventional method of measuring fetal blood cytokine levels, this diagnostic reagent system and kit is very useful in the prenatal diagnosis of preterm delivery, fetal infection, and fetal damage.

Abstract: A fluidic waveguide comprising a container and a fluid that fills said container, wherein said fluid has a refractive index greater than the refractive index of the wall of said container and wherein said fluid can act as a waveguide for electromagnetic radiation when contacted therewith is disclosed. A corresponding fluidic lightguide along with devices that function as composite waveguides and lightguides are described. Assays utilizing this waveguide for biochemical, chemical, and other kinds of analyzes are also disclosed.

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: A polysaccharide coated carrier having a coating of at least two successive layers of polysaccharide. The first polysaccharide layer spontaneously associates with a second polysaccharide layer and, optionally, the carrier. Each successive layer of polysaccharide spontaneously associates with a preceding layer. Spontaneous association occurs due to the presence of oppositely charged functional groups on each layer of polysaccharide or due to a spontaneous reaction between the functional groups the layers. The carrier may be any surface such as a tube, microtitration plate, bead, particle or the like and is suitable for use in diagnostic or therapeutic methods.

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: 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, compositions and kits are disclosed. The methods are directed to determining the presence of one or more analytes in a sample suspected of containing any one of a plurality of the analytes. A combination is provided comprising in a medium (i) the sample, (ii) a binding partner for each of the analytes, (iii) for each of the analytes, a first reagent comprising a member of a signal producing system, a ligand and an analyte analog, and (iv) a second reagent comprising a binding partner for the ligand. The binding of the binding partner for the ligand is affected by the presence of an analyte and alters the amount of signal produced by the member of the signal producing system. The signal thus is modulated if one or more of the analytes are present in the sample. The amount of the signal is determined and is related to the presence of one or more of the analytes in the sample. The method may be homogeneous or heterogeneous.

Abstract: A method for detecting a substance, comprising developing a developing liquid through a test region up to a reference region, and a detection device for use therein, wherein the reference region comprises a metal compound other than an alkali metal salt, and the developing liquid that reaches the reference region contains a label that can be accumulated in the reference region. The label is preferably a colored particle, and is preferably bound to an antibody or an antigen.

Abstract: A sampling assembly for simultaneously testing a liquid biological sample for a plurality of hormones and method thereof are described. A sampling membrane includes a dry porous carrier having a proximal end narrower than a distal end and forming a unidirectional liquid flow channel. The distal end includes a plurality of tines arranged and separated by substantially regular spacing. Each tine defines a dye zone including a dye-tagged antigen-specific antibody at a distal end. The sampling membrane further defines a set of focusing recesses along each side of the unidirectional flow channel end and a set of dispersal recesses between and adjacent to each tine. A plurality of test strips each include a dry porous carrier communicatively attached to the distal end of one such tine. Each test strip forms a unidirectional liquid flow channel and includes a testing zone comprising an antigen-specific antibody located distally from the dye zone.

Abstract: The instant invention involves the use of a combination of preparatory steps in conjunction with mass spectroscopy and time-of-flight detection procedures to maximize the diversity of biopolymers which are verifiable within a particular sample. The cohort of biopolymers verified within such a sample is then viewed with reference to their ability to evidence at least one particular disease state; thereby enabling a diagnostician to gain the ability to characterize either the presence or absence of at least one disease state relative to recognition of the presence and/or the absence of the biopolymer, predict disease risk assessment, and develop therapeutic avenues against the disease.

Abstract: Disclosed is a method of diagnosing the chances of pregnancy and the diagnostic kit for the method. In the present invention, follicular fluid is retrieved from the women who attended the in vitro fertilization program and matrix metalloproteinase activity is measured. According to the present invention, the chance of pregnancy in the group with low matrix metalloproteinase-9 activity is zero whereas in the group with high matrix metalloproteinase-9 activity, the chances are 50-60%. Therefore it is possible to predict the chances of pregnancy in assisted reproduction technology by measuring the degree of matrix metalloproteinase-9 expression by using the method and kit of the present invention enhancing the efficiency of assisted reproduction technology.

Abstract: Methods, compositions and kits are disclosed. The methods are directed to determining the presence of one or more analytes in a sample suspected of containing any one of a plurality of the analytes. A combination is provided comprising in a medium (i) the sample, (ii) a binding partner for each of the analytes, (iii) for each of the analytes, a first reagent comprising a member of a signal producing system, a ligand and an analyte analog, and (iv) a second reagent comprising a binding partner for the ligand. The binding of the binding partner for the ligand is affected by the presence of an analyte and alters the amount of signal produced by the member of the signal producing system. The signal thus is modulated if one or more of the analytes are present in the sample. The amount of the signal is determined and is related to the presence of one or more of the analytes in the sample. The method may be homogeneous or heterogeneous.

Abstract: The invention provides a method for the early detection of pregnancy failure, spontaneous abortion or premature birth by determinations of complement regulatory protein levels. A kit for use in rapid identification of these pregnancy complications is also provided.

Abstract: The instant invention involves the use of a combination of preparatory steps in conjunction with mass spectroscopy and time-of-flight detection procedures to maximize the diversity of biopolymers which are verifiable within a particular sample. The cohort of biopolymers verified within such a sample is then viewed with reference to their ability to evidence at least one particular disease state; thereby enabling a diagnostician to gain the ability to characterize either the presence or absence of at least one disease state relative to recognition of the presence and/or the absence of the biopolymer.

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: Systems and methods for medical diagnosis or risk assessment for a patient are provided. These systems and methods are designed to be employed at the point of care, such as in emergency rooms and operating rooms, or in any situation in which a rapid and accurate result is desired. The systems and methods process patient data, particularly data from point of care diagnostic tests or assays, including immunoassays, electrocardiograms, X-rays and other such tests, and provide an indication of a medical condition or risk or absence thereof. The systems include an instrument for reading or evaluating the test data and software for converting the data into diagnostic or risk assessment information.

Abstract: Disclosed is a method of reducing the conductivity/charge of a layer of group III-V semiconductor doped with Sn. The method includes the steps of: forming an region of SiO2 on the semiconductor layer; annealing at least the semiconductor layer and the region of SiO2 at a temperature sufficiently high to cause atoms of the Sn dopant to leach from the semiconductor layer into the region of SiO2; and removing the region of SiO2 after the annealing step is performed. The method can be used, for example, during the manufacture of HEMT, PHEMT, MESFET and HBT devices.

Abstract: A method for measuring low levels of a substance in a sample includes the formation of a rotor from paramagnetic particles in a substantially uniform magnetic field. The rotor is rotated by rotating the substantially uniform magnetic field. A portion of the substance in a sample is bound to the paramagnetic particles, and a signal having a time-varying component is detected. The signal is then processed using a lock-in amplifier with a reference signal having a frequency twice that of the rotation of the magnetic field. This improves the signal-to-noise ratio of the time-varying component of the signal.

Abstract: The invention provides methods for detecting a labeled sample molecule bound to an immobilized probe by electrochemiluminescence. The method comprises providing a multiplexed molecular analysis system comprising a reaction chamber comprising a reaction substrate comprising a plurality of biosites, each biosite comprising a plurality of similar capture probes attached to the reaction substrate, the reactions substrate comprising an embedded conductive material connected to an electrical source and providing a sample comprising a plurality of molecules labeled with a electrochemiluminescent label; adding a solution comprising this sample to the reaction chamber; applying a voltage from the electrical source to the conductive material after sufficient time has passed for a labeled molecule to bind to a capture probe, thereby inducing an electrochemical event within the electrochemiluminescent label that releases a detectable amount of electromagnetic energy; and, detecting the released electromagnetic energy.

Abstract: The invention concerns the identification of proteomes of biological fluids and their use in determining the state of maternal/fetal conditions, including maternal conditions of fetal origin, chromosomal aneuploidies, and fetal diseases associated with fetal growth and maturation. In particular, the invention concerns the identification of the proteome of amniotic fluid (multiple proteins representing the composition of amniotic fluid) and the correlation of characteristic changes in the normal proteome with various pathologic maternal/fetal conditions, such as intra-amniotic infection, or chromosomal defects.

Abstract: Disclosed is a method of diagnosing the chances of pregnancy and the diagnostic kit for the method. In the present invention, follicular fluid is retrieved from the women who attended the in vitro fertilization program and MMP activity is measured. According to the present invention, the chance of pregnancy in the group with low MMP-9 activity is zero whereas in the group with high MMP-9 activity, the chances are 50-60%. Therefore it is possible to predict the chances of pregnancy in ART by measuring the degree of MMP-9 expression by using the method and kit of the present invention enhancing the efficiency of ART.

Abstract: A method of and a kit for diagnosing spontaneous abortion involves assessing in a human the presence and/or concentration of antibodies to platelet activating factor (PAF) in a sample of body fluid of the human.

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 of diagnosing infertility in a mammal that include detecting the presence and level of a &bgr;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 &bgr;3 integrin subunit expression with infertility are provided. Diagnostic kits useful in the practice of the methods of the invention are also provided.

Abstract: Disclosed is a method for determining the fertility of mammals, in particular of humans, wherein a body or organ fluid is taken from a mammal, the afamin content is determined in this body or organ fluid, and the determined afamin content is compared with a reference value so as to determine the fertility, the use of afamin for determining the fertility of mammals, as well as a kit for carrying out this method.

Abstract: The invention relates to the medicine and can be used for the prophylaxis and diagnostics of a number of disorders in human organism and also for the revealing of some states accompanied by the changes in the content of diagnostically important metabolites in biological liquids. The object of the invention is to make a basically new sanitary means providing an additional function—testing for the purpose of an organism state analysis—along with his designated purpose and intended for daily use for the patients. The widely used sanitary hygienic article such as pampers or feminine hygienic napkin is provided with the special functional diagnostic means. The functional diagnostic means according to the invention comprises at least one chemical reagent disposed so that it can react with biological liquids secreted by an organism with the following comparison of the change in the content of reference (diagnostically significant) metabolites in liquid biological samples.

Abstract: Methods for diagnosing risk of miscarriage and/or premature birth, foetal abnormalities, cancer (e.g. prostate cancer) and inflammatory disease (e.g. rheumatoid arthritis) are disclosed which involve determining abnormal levels of macrophage inhibitory cytokine-1 (MIC-1) in a body sample or, otherwise, determining the presence of a MIC-1 variant protein. Also disclosed are methods for reducing the risk of miscarriage and/or premature birth in pregnant subjects, and methods for treatment of inflammatory disease and/or cancer.

Abstract: This invention is about a method for the prenatal diagnosis of preterm delivery, fetal infection, and fetal damage, and diagnostic reagent system and diagnostic kit for the diagnosis. The method, diagnostic reagent system, and kit are based on the finding that the level of MMP-8 in the amniotic fluid is significantly higher when the pregnant woman is at risk for preterm delivery, intrauterine infection, and fetal damage. The diagnostic reagent system and kit can be applied to the patients without, as well as with, clinical signs of preterm labor or premature rupture of fetal membranes. With the superiority in sensitivity and specificity as well as its less invasiveness compared to the conventional method of measuring fetal blood cytokine levels, this diagnostic reagent system and kit is very useful in the prenatal diagnosis of preterm delivery, fetal infection, and fetal damage.

Abstract: Approaches are described for separating plasma from whole blood samples and include the use of magnetically attractable particles associated with an agglutinating agent. The magnetically attractable particles bind the cellular components in a whole blood sample. Application of a magnetic field gradient to a container with the blood sample and the magnetically attractable particles draws the particles to the surface of the container near the source of the magnetic field gradient. The plasma can be removed and stored or used for monitoring or detecting analytes in the plasma.

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: A method of determining the probability of an in vitro fertilization (IVF) or embryo transfer (ET) method being successful is disclosed. Relaxin can be measured directly in the serum or indirectly by culturing granulosa lutein cells extracted from the patient as part of an IVF/ET procedure. A method of enhancing the rate of a successful pregnancy resulting from an IVF/ET procedure is also disclosed whereby relaxin is administered and/or endogenous relaxin levels are enhanced by varying convention IVF/ET procedures.

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 immobilised 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: 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: 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: A method for diagnosis of pre-eclampsia is disclosed, which comprises measuring the hormone inhibin A in a biological sample such as maternal serum. The method allows non-invasive, early diagnosis and can be used to predict the onset of secondary symptoms.

Abstract: A one-step diagnostic device for simultaneously detecting and distinguishing between a normal pregnancy and an ectopic pregnancy and methods for preparing the device are disclosed. Utilizing the device and principles of the present invention, normal pregnancy and ectopic pregnancy can be rapidly and accurately determined at an early stage by immunologically detecting the morphological differences between human chorionic gonadotropin (hCG) and modified forms thereof, which are secreted into the body fluid of a pregnant female.

Abstract: Provided herein are two 1-8 family gene interferon tau inducible genes, bovine 1-8U and bovine Leu-13, and methods of detecting the same to determine bovine pregnancy.

Abstract: A testing apparatus 10 having an absorbent matrix 12, including a membrane 14 which contains a plurality of counter-ions 16. Chromionophore (or fluorionophore)s 18 and affinophores 22 compete to carry ions into the membrane 14 and neutralize the charge of the counter-ions 16. Biological recognition molecules 42 bind to a portion of the affinophores 22 and prevent them from entering the membrane 14, thereby allowing more chromionophore (or fluorionophore)s 18 to enter the membrane 14. The portion of affinophores 22 bound to the biological recognition molecules 42 is inversely proportional to the amount or concentration of analyte 40 occurring within the solution or medium 30. The result of this is that the color of the membrane-covered matrix changes in a manner related to the concentration of the analyte. One application of this apparatus is a strip test for prediction of ovulation.

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: Novel diagnostic/monitoring methods are provided using cadherin-11 expression by endometrial tissue as indicator of ability to establish or maintain a viable pregnancy.

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: Method for specific detection of one or more analytes in a sample. The method includes specifically associating any one or more analytes in the sample with a scattered-light detectable particle, illuminating any particle associated with the analytes with light under conditions which produce scattered light from the particle and in which light scattered from one or more particles can be detected by a human eye with less than 500 times magnification and without electronic amplification. The method also includes detecting the light scattered by any such particles under those conditions as a measure of the presence of the analytes.

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 OX-40 antigen is characterized and claimed together with variants and derivatives thereof. Also described are binding agents for the antigen and the use of these in diagnosis and therapy. Examples of such use include a method for the selective depletion of activated CD4+ T-cells in vivo by using immunotoxins comprising an OX-40 antibody conjugated to a toxic molecule (such as Ricin-A chain). The administration of these specific immunotoxins is used therapeutically to deplete autoimmune reactive CD4+ T-cells which have been implicated in diseases including Multiple Sclerosis, Rheumatoid Arthritis, Sarcoidosis, and Autoimmune Uveitis as well as inflammatory bowel disease and graft-versus-host disease. This type of therapy is also beneficial for eradicating CD4+ T-cell lymphomas and alloreactive CD4+ T-cells involved with a transplantation reaction. The use of the human form of the OX-40 antibody will also help in the early diagnosis of all the diseases mentioned above.

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.