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: Decision-support systems, such as neural networks, for assessing the risk of delivery within a predetermined time or the likelihood of preterm delivery are 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: Methods are provided for developing medical diagnostic tests using decision-support systems, such as neural networks. Patient data or information, typically patient history or clinical data, are analyzed by the decision-support systems to identify important or relevant variables and decision-support systems are trained on the patient data. Patient data are augmented by biochemical test data, or results, where available, to refine performance. The resulting decision-support systems are employed to evaluate specific observation values and test results, to guide the development of biochemical or other diagnostic tests, too assess a course of treatment, to identify new diagnostic tests and disease markers, to identify useful therapies, and to provide the decision-support functionality for the test.

Abstract: Methods are provided for developing medical diagnostic tests using decision-support systems, such as neural networks. Patient data or information, typically patient history or clinical data, are analyzed by the decision-support systems to identify important or relevant variables and decision-support systems are trained on the patient data. Patient data are augmented by biochemical test data, or results, where available, to refine performance. The resulting decision-support systems are employed to evaluate specific observation values and test results, to guide the development of biochemical or other diagnostic tests, too assess a course of treatment, to identify new diagnostic tests and disease markers, to identify useful therapies, and to provide the decision-support functionality for the test.

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: 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: The present invention provides an early, biochemical indication of increased risk of impending preterm delivery. The method comprises obtaining a cervicovaginal secretion sample from a pregnant patient after week 12 of gestation and determining the level of a local inflammatory product protein in the sample. The presence of an elevated level of the selected protein in the sample indicates an increased risk of delivery. The test is a screening assay that can detect women at risk of imminent delivery, as early as two to three weeks prior to delivery.

Abstract: A reflective biograting consists of an optically flat layer of a transparent composition such as silicon dioxide having a first and second surface, alternating zones of active and inactive binding reagent on the first surface, and a reflective metal layer having a thickness of at least above 1000 .ANG.. The reflective metal layer can be supported on an optically flat surface of a wafer, and the reflective metal can be aluminum, silver, gold, chromium, nickel, titanium or platinum coating on a polished wafer. Preferably, the silicon dioxide layer is formed either by direct sputtering of silicon dioxide or by coating an alkali metal silicate solution on the surface of the reflective metal, optionally containing an aminoalkylsilane and a water-soluble hydroxylated polymer such as a dextran. Alternatively, the reflective support comprises one or more reflective layer units, each reflective layer unit comprising an optically flat layer of silicon, and preferably polysilicon, on a layer of silicon dioxide.

Abstract: The present invention provides an early, biochemical indication of increased risk of impending delivery. The method is particularly useful to identify those pregnant women who are at increased risk for preterm delivery and can also be used to identify those women at risk for a post-date delivery. The method comprises obtaining a cervicovaginal secretion sample from a pregnant patient after week 12 of gestation and determining the level of total fibronectin in the sample. The presence of an elevated fibronectin level in the sample indicates an increased risk of delivery. The test detects greater than 80% of women who deliver prematurely, as early as two to three weeks prior to delivery.

Abstract: This invention relates to methods, reagents and kits for detection of normal or ectopic pregnancy, the termination of pregnancy, or increased risk of preterm labor and rupture of membranes. Each embodiment involves sampling from the vaginal cavity, and determining the presence or absence of a specific analyte in the test sample. Sandwich or competition assay procedures can be used. Reagents and reagent kits for the above assays are included. The kit contains anti-(fetal fibronectin) antibody and an anti-fibronectin antibody.

Abstract: A method for determining ectopic pregnancy in pregnant persons comprises obtaining a test sample; and determining the absence of a fetal restricted antigen in the sample. The sample is obtained from the vaginal cavity in the vicinity of the cervical canal or the cervical os. One fetal restricted antigen is fetal fibronectin. In one embodiment of this invention, the sample is contacted with an insoluble support to which anti-(fetal restricted antigen) antibody is adhered, and the fetal restricted antigen binding to the support is determined. Alternatively, a class of substances of which the fetal restricted antigen is a member is captured with a general binding antibody such as an anti-(fibronectin) antibody; an anti-(fetal restricted antigen) antibody such as anti-(fetal fibronectin) antibody is bound to the support; and the absence of binding with fetal restricted antigen is determined. Competition or sandwich assay procedures can be used. Reagents and reagent kits are also included.

Abstract: The invention provides a method for determining the presence of products of conception in a sample derived from the uterus during a D&C, or a therapeutic or spontaneous abortion, and comprises determining the presence in the sample of a fetal restricted antigen, which is found in products of conception but not found in significant amounts in maternal plasma or serum. Since the fetal restricted antigen is not present in significant quantities in maternal plasma or serum, the methods of this invention are reliable even when the sample is contaminated with maternal blood. One fetal restricted antigen is fetal fibronectin.In one embodiment of this invention, the sample is contacted with an insoluble support to which anti-(fetal restricted antigen) antibody is adhered, and the fetal restricted antigen binding to the support is determined.

Abstract: A method for determining normal intrauterine pregnancy during the first 20 weeks of pregnancy comprises obtaining a test sample; and determining the presence of a fetal restricted antigen in the sample. The test sample is removed the vaginal cavity in the vicinity of the cervical canal and/or the cervical os. One fetal restricted antigen is fetal fibronectin.In one embodiment of this invention, the test sample is contacted with an insoluble support to which anti-(fetal restricted antigen) antibody is adhered, and the fetal restricted antigen binding to the support is determined. Alternatively, the test sample is contacted with an insoluble support to which is adhered an antibody which binds a class of substances including the fetal restricted antigen; and the fetal restricted antigen binding to the support is determined. Reagents and reagent kits are also included.

Abstract: Novel adenocarcinoma binding human monoclonal antibody binds preferentially with ADCA antigens and is useful in diagnostic and imaging methods for identifying and locating adenocarcinoma cells, and in therapeutic methods to reduce the reproduction of adenocarcinoma cells. The novel ADCA antigen is useful in methods for diagnosing the presence of adenocarcinoma. The antigen, antibodies, hybridoma, reagents, therapeutic agents and methods of use are aspects of the invention.

Abstract: A method for determining increased risk of labor and fetal membrane rupture after week 20 of pregnancy comprises obtaining a secretion sample from the vaginal cavity; and determining the presence of a fetal restricted antigen in the sample. The sample can be removed from anywhere in the vaginal cavity, but is preferably removed from the posterior fornix or and/or cervical os. One fetal restricted antigen is fetal fibronectin. In one embodiment of this invention, the sample is contacted with an insoluble support to which anti-(fetal restricted antigen) antibody is adhered, and the fetal restricted antigen binding to the support is determined. Alternatively, the class of substances of which the fetal restricted antigen is a member is captured with a general binding antibody (such as anti-human fibronectin antibody), anti-(fetal restricted antigen) antibody (such as anti-fetal fibronectin antibody) is conjugated with the support, and binding with fetal restricted antigen is determined.

Abstract: The assay of the subject invention uses DNA sequences as probes in a nucleic acid hybridization diffraction assay, to detect specific DNA sequences in a sample. Diffraction assay methodologies are applied to determine the presence and amount of analyte.This invention involves a discovery in the areas of supporting surfaces for a biogrid or biograting which provide greatly reduced non-specific hybridization and binding. A preferred process of this invention involves manufacturing a biograting for use in a light diffraction assay, and comprises adhering a uniform layer of hybridizing reagent comprising a nucleotide sequence on a smooth, solid surface and exposing the surface to UV radiation through a shadow mask with a diffraction grating pattern of lines to selectively deactivate the hybridizing reagent, leaving a biological diffraction grating design of lines of active hybridizing reagent.

Abstract: Preeclampisa, pregnancy induced hypertension (PIH) and eclampsia are determined by identifying the presence of an endothelial cell marker in a sample of blood, plasma or serum of a pregnant woman using a sandwich or competition immunoassay. Cellular fibronectin marker in a sample is determined by binding with an anti-(cellular fibronectin) antibody. Reagents for these methods are also an aspect of the invention.