Abstract: Provided herein is a novel breath test for assessing hepatic function. The test involves administration of a labeled methionine or methionine metabolite to a subject and measurement of the expired label.

Abstract: An improved method for detecting even low titer HLA antibodies in proposed organ transplant recipients employs flow cytometry crossmatching (FCXM) on pronase-treated B-cells and T-cells of the donor. Two-color FCXM is preferably employed. The peripheral blood lymphocytes, after pronase digestion, are maintained under conditions to suppress Fcy R receptor regeneration, combined with sera of the proposed transplant recipient, and tested against control sera, using fluorescent reporting complexing agents. Use of pronase digested lymphocytes permits the assay to distinguish between normal or irrelevant IgG B cell binding and immunologically important HLA antibody binding.

Abstract: Dense microspheres can be extracted and purified to substantial homogeneity from mammalian brain tissue, and used in the screening of therapies for potential effectiveness in impeding the formation of amyloid fibrils associated with Alzheimer's disease and other forms of cerebral amyloidosis. Compounds that, at in-tissue concentrations of 10.sup.-5 M or less, inhibit amyloid formation in a test animal injected intracerebrally with dense microspheres are particularly useful in inhibiting treating cerebral amyloidosis.

Abstract: The invention relates to the DNAs of papillomaviruses, and more particularly to the probes derived from these papillomaviruses, as well as procedures for their implementation in the in vitro diagnosis of papillomavirus infections.

Abstract: The invention addresses new photo-activatable biotin derivatives having the formula I ##STR1## wherein R=?(CH.sub.2).sub.n --O.sub.m !.sub.q --?(CH.sub.2).sub.r --O.sub.s !.sub.t --(CH.sub.2).sub.pwith n,r=2,3; m,s=0,1; q+t=1-4; p=1-4,wherein the sum of all CH.sub.2 groups does not exceed 10and wherein R1 as a single or multiple substituent is hydrogen, C.sub.1 -C.sub.5 alkyl, NH.sub.2, COOH, F, Cl, or Br.and their preparation, their use to inactivate streptavidin, the use of the inactivated streptavidin to reduce interference in immunoassays.

Abstract: Bites from Amblyomma americanum, a hard tick, have been associated with a Lyme disease-like illness in the southeastern and south-central United States. Present in 2% of ticks collected in four states were uncultivable spirochetes. Through use of the polymerase chain reaction, partial sequences of the flagellin and 16s rRNA genes of microorganisms from Texas and New Jersey were obtained. The sequences showed that the spirochete was a Borrelia sp. but distinct from other known members of this genus, including B. burgdorferi, the agent of Lyme disease. Species-specific differences in the sequences of the flagellin protein, the flagellin gene and the 16s rRNA gene between the new Borrelia species and previously known species provide compositions and methods for assay for determining the presence of this new spirochete, or for providing evidence of past or present infection by this spirochete in animal reservoirs and humans.

Abstract: The present invention relates to compositions and methods for neutralizing lipopolysaccharide, and treatment of gram-negative sepsis based thereon. Accordingly, the invention is directed to a composition of homogeneous particles comprising phospholipids and a lipid exchange protein, such as phospholipid transfer protein or LPS binding protein. The lipid exchange protein is characterized by being capable of faciliting an exchange of lipopolysaccharide into the particles. In a specific embodiment, exemplified herein, the lipid particles are high density lipoprotein particles comprising apolipoprotein A-I (apo A-I), a phospholipid, and cholesterol or a lipid bilayer binding derivative thereof. In a specific example, the phospholipid is phosphatidylcholine (PC). In a specific example, the ratio of phosphatidylcholine: cholesterol: apolipoprotein A-I is approximately 80:4:1.

Abstract: A conjugate consisting of a sequence of the analyte and an antibody against one of the antibodies used in the test can be employed, in aqueous solution and in precisely known quantity, as a stable calibrator in a sandwich immunoassay for detecting the analyte.

Abstract: A method for predicting the presence of deep vein thrombosis in a patient comprises measuring the concentration of soluble tumor necrosis factor receptor-1 in the venous blood of the patient and comparing it to an established baseline concentration. A concentration in the patients venous blood higher than the established baseline concentration is predictive of the presence of deep vein thrombosis.

Abstract: This method for non-invasively, rapidly and simply distinguishing between allergies, viral infections and sinusitis involves testing nasal secretions, preferably with commercially available (Ames Division, Miles Laboratories, Inc., Elkhart, Ind. 46515; or from Boehringer Mannheim Corporation, Advanced Diagnostics, 9115 Hague Road, P.O. Box 50457, Indianapolis, Ind. 46250-0457) or novel, modified reagent test strips. The commercially available strips, also referred to as dipsticks, test for pH, protein, nitrite, glucose, ketone, white blood cell esterase, bilirubin and blood. In the method of this invention, a sample of a patient's nasal secretions is tested and, based on the pH, amount of protein, nitrite, esterase and a measure of eosinophil infiltration, it can quickly be determined if the patient is suffering from an allergy, from a viral infection or a bacterial infection. The method has the potential to supplant much more expensive and invasive clinical procedures.

Abstract: By measuring smooth muscle myosin heavy chain in the blood of a patient using an antibody to the smooth muscle myosin heavy chain, dissecting aortic aneurysm can be diagnosed very easily and rapidly without any special equipment.

Abstract: Use of an anti-cardiolipin antibody, anti-lipoprotein antibody or anti-.beta.2-glycoprotein I antibody together with an immobilized antibody thereof enables to accurately assay for a complex of .beta.2-glycoprotein I and an oxidized lipoprotein in a blood sample, according to a sandwich immunoassay. Thus, the oxidized lipoprotein in blood can be detected, whereby diagnosis of arteriosclerotic disease is enabled.

Abstract: The present invention provides methods of improving phenotypic defects that are caused by conformationally defective target proteins. The methods of the invention comprise exposing a cell that expresses a conformationally defective target protein with an amount of a protein stabilizing agent that is effective to improve the phenotypic defect. Nonlimiting examples of protein stabilizing agents include dimethylsulfoxide (DMSO), deuterated water, trimethylamine N-oxide (TMAO). Nonlimiting examples of defective target proteins to be treated include the cystic fibrosis transmembrane conductance regulator (CFTR) protein and prion proteins. In one embodiment, the invention provides methods for detecting protein stabilizing agents. In another embodiment, the invention provides methods for detecting cells and pathological conditions caused by improper folding and protein processing.

Abstract: Diagnostic methods are described for using the concentration of a cytokine present in serum or other biological fluids in order to predict the predisposition of an individual to post-trauma infectious and or inflammatory complications. Also described are diagnostic kits that are particularly suitable for use in such diagnosis.

Abstract: Method for treatment of a disease in a patient characterized by accumulation of .beta.-amyloid. The method includes identifying a patient potentially suffering from such a disease and contacting a neuron of the patient with a therapeutically effective amount of a tachykinin agonist. Methods for screening for compounds useful for treating such a disease are also disclosed.

Abstract: A method of diagnosing and determining the disease stage of a degenerative disease of the central nervous system associated with the impairment of integrative brain function is disclosed. The method includes the steps of (a) measuring a cytokine production level of peripheral mononuclear cells from a peripheral blood sample and (b) determining the disease stage by comparing the level determined in step (a) with a level generated by age-matched normal controls.

Abstract: Method for the determination of chlamydial or gram negative bacterial antigen comprising contacting a sample potentially containing extracted antigen with an optically active surface comprising an attachment layer, and a layer of non-specific protein.

Abstract: Methods for monitoring the progression of systemic lupus erythematosus (SLE) in a patient by detecting elevated levels of circulating ICAM-R wherein progression is indicated in an SLE patient whose circulating ICAM-R levels are increased as compared to normal individuals or individuals with in active SLE. Methods for the detection of an inflammatory disease state selected from the group consisting of rheumatoid arthritis, SLE, and Guillain-Barre syndrome and multiple sclerosis in a patient by detecting elevated levels of circulating ICAM-R wherein the presence of the inflammatory disease state is indicated in a patient whose circulating ICAM-R levels are increased as compared to normal healthy individuals. ICAM-R is also known as ICAM-3 and CDw50 in the art.

Abstract: The present invention relates to a culture of human olfactory neurons. The neurons may display a normal neuronal pathology or a pathology characteristic of a generalized central nervous system disease. The cultured neurons can be used for neurotoxicity tests, screening for therapeutic drugs and anti-viral agents, and diagnosing Alzheimer's disease.

Abstract: A method of identifying individuals who have, or who are at risk of developing, autoimmune neuropsychiatric disorders is disclosed. The invented method relies on detection of the B lymphocyte antigen, D8/17. The invented method can conveniently be carried out as a simple blood test.

Abstract: This invention pertains to a PT Assay Calibrator and a method of preparing a PT Assay Calibrator including a coagulation factor such as recombinant FVII or recombinant FVIIa that will allow preparation of PT calibration curves with values about 100% and which will give results analogous to those obtained using fresh normal plasma.

Abstract: This invention is based on the discovery that the type II TGF-.beta. receptor (RII) is a cancer suppressor gene which is genetically inactivated (mutated) in approximately 25% of colon cancers, including nearly all colon cancers of the class identified as mutator/microsatellite instability/RER. Methods are provided for detecting inactivation of RII for use in cancer diagnosis or prognosis.

Abstract: The present invention includes novel rubella assays employing a Rubella virus capture reagent and a solid phase material containing a reaction site comprising a polymeric cation substance. A test sample suspected of containing Rubella antibody may be contacted with the capture reagent to form a capture reagent/analyte complex. The complex is then contacted to the positively charged solid phase to attract, attach, and immobilize the capture reagent/analyte complex.

Abstract: The present invention is related to a rapid and reliable method for making chair-side diagnoses of periodontal diseases and especially for predicting the risk of progressing of the periodontal diseases. The diagnosis and prognosis are performed using an immunological test kit by which increased levels of neutrophil gelatinase-related lipocalin (NGAL) derived from polymorphonuclear neutrophilic leucocytes PMNs) is measured.

Abstract: Disclosed is a method for aiding in the diagnosis of merosin deficiency-type congenital muscular dystrophy (CMD). The method is based on the discovery of a previously unidentified form of CMD which is characterized by a substantial reduction in the levels of merosin in skeletal muscle tissue containing normal levels of dystrophin and dystrophin-associated proteins.

Abstract: The invention relates to a monoclonal antibody which forms an immunological complex with an epitope of an antigen belonging to normal human tau protein as well as abnormally phosphorylated human tau protein, with said tau protein being liable to be obtained from a brain homogenate, itself isolated from human cerebral cortex. The monoclonal antibodies of the invention can be used to detect tau and abnormally phosphorylated tau in brain extracts and in unconcentrated cerebrospinal fluid.

Abstract: The present invention comprises a simple way of identifying the tendency towards allergy or allergy already broken out, and showing the probability of allergy in a patient, by measuring the receptor expression of the phagocytic cells of peripheral blood. With a logistic regression model a combination of variables were found which best describe the probability of allergy. Thus the invention relates to a method for detecting allergy and a test kit for accomplishing the method. The invention also relates to a sensitive and specific logistic model for determining the probability of allergy.

Abstract: The present invention provides a method for treating the inflammatory response of an established colitis in a subject with inflammatory bowel disease (IBD), comprising administering to a subject diagnosed with an established colitis from an IBD an amount of an antibody to interleukin-12 effective in reducing the colitis-inducing effect of interleukin-12. Also provided is a method for screening a substance for its effectiveness in reducing the inflammatory response of an established colitis comprising obtaining an animal having an established colitis; administering the substance to an animal; and assaying the animal for an effect on interleukin-12 which results in the reduction of the inflammatory response of the colitis, an amount of reduction of the inflammatory response greater than the amount of reduction produced by the administration of antibodies against interferon-gamma or tumor necrosis factor-alpha indicating an effective substance.

Abstract: A method and kit are described that are useful in the diagnosis of amyotrophic lateral sclerosis or the evaluation of its progression. According to the method, a purified voltage-sensitive calcium channel complex is contacted with a biological fluid obtained from a person suspected of having, or known to have, amyotrophic lateral sclerosis. The voltage-sensitive calcium channel is of a type that ALS sera selectively reacts with. The reaction takes place for a time and under conditions sufficient for the calcium channel complex and anti-calcium channel complex antibodies that may be present in the biological fluid to form an antigen/antibody complex. The presence or absence of the antigen/antibody complex is then determined.

Abstract: Multiple methods for measuring the COUP-TF system, including: a method to measure the level of COUP-TF by combining antibodies with biological samples and measuring the resultant antibody/COUP-TF complex; the binding of COUP-TF to promoters by combining biological samples with COUP-TF binding oligonucleotides and measuring the resultant complex or gene synthesis; and a method to measure COUP-TF inducable promoters by combining native COUP-TF with nuclear extracts of biological samples and measuring the resultant complexes. The methods when applied to human biological samples can detect diabetes due to COUP-TF or promoter defects. In addition to the methods for measuring the COUP-TF system and associated diseases, there are also the polyclonal and monoclonal antibodies necessary for the methods. These bind to at least one immunoreactive site on COUP-TF. Furthermore, there is a DNA clone containing the genetic coding regions of the COUP-TF protein.

Abstract: The invention provides a method of diagnosing Alzheimer's disease in a human patient by measuring the amount of p33 present in a biological sample from a patient who may have Alzheimer's disease relative to the amount of p33 in a control sample from an unaffected human. Also included in the invention are diagnostic kits for Alzheimer's disease and methods of screening for effective therapeutics for Alzheimer's disease.

Abstract: This invention relates to identification of a new key marker namely 9-O-Acetylated sialoglycoconjugate with the help of a known 9-O acetylsialic acid binding lectin, Achatinin-H useful for the diagnosis of visceral leishmaniasis, by a rapid, accurate haemagglutination assay.

Abstract: Methods and materials are disclosed for the production of purified, active recombinant human neutrophil protease, PR-3, via activation of a pro-form herein referred to as proPR-3. Human PR-3 is useful for discovering inhibitors of excessive release of mature, active TNF.alpha.. Also disclosed are methods for the identification of inhibitors of the conversion of the pro-form of TNF.alpha. to its mature active form.

Abstract: Disclosed is the family of genes responsible for the neurodegenerative diseases, particularly Amyotrophic Lateral Sclerosis. Methods and compounds for the diagnosis, prevention, and therapy of the disease are also disclosed.

Abstract: Glutathione levels are determined using a glutathione surrogate in HIV-positive patients to evaluate survival longevity and determine appropriate treatment. Low glutathione levels indicate a need for a glutathione enhancing supplement and a more aggressive therapeutic regimen, as well as diminishing drugs which may result in the reduction of available glutathione.

Abstract: The present invention provides a more accurate risk assessment of antenatal screening results because the maternal age of the patient is considered in evaluating the results from various common screening markers, and especially the results from UE determinations.

Abstract: Soluble .beta.-amyloid peptide (.beta.AP) is measured in biological fluids at very low concentrations, typically in the range from 0.1 ng/ml to 10 ng/ml. The measurement of .beta.AP concentrations in animals or conditioned medium from cultured cells can be used for drug screening, where test compounds are administered to the animals or exposed to the cultured cells and the accumulation of .beta.AP in the animal or culture medium observed. It has been found that elevated levels of .beta.AP in body fluids, such as blood and cerebrospinal fluid, is associated with the presence of a .beta.AP-related condition in a patient, such as Alzheimer's Disease. Methods for diagnosing and monitoring .beta.AP-related conditions comprise measuring the levels of .beta.AP in such body fluids from a patient.

Abstract: An assay, and kit, for the quantitation of cardiac troponin I in human biological fluid is provided. The assay involves a sandwich assay employing an antibody specific for cardiac troponin I as one binding partner for cardiac troponin I and troponin C as the other binding partner for cardiac troponin I.

Abstract: The present invention provides for a method of detecting antipolymer antibodies, and a method for detecting silicone related disease, fibromyalgia, and chronic fatigue syndrome.

Abstract: The invention relates to in vitro detection of human pancreatitis-associated protein (hPAP) for the purpose of screening for cystic fibrosis. hPAP is quantitated in a biological sample, preferably blood, and a high value is indicative of pancreatic dysfunction. Immunoassays as rapid, reliable methods for hPAP quantitation are provided as are antibodies for use in the assays and hybridomas for production of monoclonal antibodies preferred for use in the assays.

Abstract: Disclosed is a method of diagnosing sepsis in a human infant. The method includes detecting an increase in the expression of leukocyte cell surface antigens in a blood sample from an infant at risk for developing sepsis.

Abstract: Methods for detecting abnormalities in prolactin daily rhythms of a subject are provided. Prolactin levels of a subject are compared to levels of healthy subjects and based on the comparison a determination is made of the adjustments necessary to normalize the subject's daily prolactin rhythm. Also provided are methods for normalizing a subject's daily prolactin rhythm.

Abstract: Human P450 IID6 cytochrome-derived peptide fragments, anti peptide anti fragment antibodies and applications thereof in the diagnosis of autoimmune hepatitis and more especially in the differential diagnosis between autoimmune hepatitis and other chronic viral forms of hepatitis, such as hepatitis C or B. Said human P450 cytochrome peptide fragment contains at least one P450 IID6 cytochrome immunodominant epitope and consists of an amino acid sequence comprising from 3 to 70 amino acids. Said peptide binds specifically with anti-LKM auto-anitbodies produced in autoimmune hepatitis.

Abstract: The present invention provides a method of detecting and diagnosing myocardial infarction which detects myocardial infarction by immunoassay using a monoclonal antibody having specific reactivity for human hepatocyte growth factor (HGF) as obtained by using human HGF as immunogen as well as a disganostic agent for myocardial infarction which comprises, as essential component thereof, the monoclonal antibody mentioned above. The method of the present invention makes it possible to detect and diagnose patients with myocardial infarction.

Abstract: The present invention is directed to diagnostic reagents for the detection of antibodies against the Epstein Barr Virus and a method for the detection of antibodies to the Epstein Barr Virus in a sample.The diagnostic reagents according to the invention comprise a combination of at least part of an Epstein Barr viral structural protein, preferably a Epstein Barr VCA-protein or an Epstein Barr MA protein, and at least part of an Epstein Barr EBNA protein. Preferably, the VCA-protein is VCA-p18 protein, the MA-protein is MA-gp350/220 protein and the EBNA-protein is EBNA-1 protein.It has been found that the combination of a VCA-protein or a MA-protein, and an EBNA protein, into a single diagnostic assay yields an EBV-antibody detection method with greater sensitivity and accuracy than current methods.

Abstract: The present invention relates to a sandwich immunoassay for rapidly and readily measuring N-peptide using two kinds of monoclonal antibodies recognizing different portions of the N-peptide. The method for measuring N-peptide or a precursor thereof includes the steps of: incubating a mixture containing a sample and a first monoclonal antibody recognizing a portion of N-peptide; adding a labelled second monoclonal antibody recognizing a portion of N-peptide to the mixture, followed by further incubation; and detecting the resulting antigen-antibody complex in the mixture. Alternatively, the method includes the steps of: incubating a mixture containing a sample, a first monoclonal antibody recognizing a portion of N-peptide, and a labelled second monoclonal antibody recognizing another portion of N-peptide; and detecting the resulting antigen-antibody complex.

Abstract: A method for identifying the presence of spontaneous ischemia in a subject comprised of obtaining biological samples from the subject at each of a plurality of time intervals within 18 hours of the onset of a symptom, measuring the amount of an angiogenic growth factor in the biological samples at each of the plurality of time intervals, and comparing the amounts of the angiogenic growth factor measured, wherein decreasing amounts of the angiogenic growth factor during the time intervals is indicative of spontaneous ischemia. Methods for identifying the presence of ischemia induced by an exercise or a pharmaceutical composition in a subject are also described.

Abstract: The present invention involves DNA encoding a mammalian Sp 17 protein, particularly human Sp17 protein, or antigenic peptides which are fragments thereof, along with said antigenic fragments. These proteins and peptides are useful as immunocontraceptive agents and/or for the diagnosis of autoimmune infertility. Avirulent host cells which express the antigenic proteins or peptides and which are useful as immunocontraceptive agents are also disclosed.

Abstract: The invention relates to a hybridoma cell line which produces a monoclonal antibody which cross reacts with both yeast and human fibrillarin. Diagnostic kits are also described. These are useful in diagnosing diseases such as scleroderma.

Abstract: The invention relates to a method for determining the extent of sepsis and/or an infection in a human or animal patient by detecting the amount of an antigen indicative of such infection. The amount of the antigen is detected in a patient blood derived test sample containing blood cell fractions.