Abstract: The invention concerns soluble and antigenic HTLV p24 variants that can be fused to chaperones and their use in diagnostic applications such as immunoassays for detecting antibodies against HTLV-I or HTLV-II in an isolated biological sample. In particular, the invention relates to a soluble HTLV-I or HTLV-II p24 antigen comprising either the N- or the C-terminal domain of p24 and lacking the other domain. Moreover, the invention covers recombinant DNA molecules encoding these HTLV-I and -II fusion antigens as well as their recombinant production using expression vectors and host cells transformed with such expression vectors. In addition, the invention focuses on compositions of these HTLV p24 antigens with HTLV gp21 antigen and on an immunoassay method for detection of HTLV antibodies using the antigens of the invention. Also the use of HTLV p24 antigens in an in vitro diagnostic assay as well as a reagent kit for detection of anti-HTLV-antibodies comprising said HTLV antigens is encompassed.

Abstract: A biological process indicator is provided for validating a treatment process in which the amount or activity of a contaminant in a sample is reduced. The indicator comprises a thermostable kinase covalently linked to a biological component, with the proviso that the biological component is not an antibody. Methods of preparing the indicator, and methods of using the indicator, are also provided.

Abstract: A system and method is provided for analyzing a glucose state. A method may include identifying a target glucose state and an initial glucose state. The method may include calculating a target return path for a transition from the initial glucose state to the target glucose state. The target return path may comprise at least one intermediate glucose state associated with the transition from the initial glucose state to the target glucose state. The target return path may be calculated based on a hazard associated with the at least one intermediate glucose state of the target return path.

Abstract: The invention provides miniaturized lateral flow chromatographic and lateral flow chromatographic microarray devices (LFM). The miniaturization of lateral flow nucleic acid detection achieved by the present invention offers reduced reagent use, femtomole sensitivity, excellent linear dynamic range, and rapid detection. Moreover, the small feature sizes of capture oligonucleotides renders the potential information capacity of the platform comparable to more traditional spotted fluorescence microarrays as well as improving sensitivity. The LFM devices exemplified herein enable analytes to be detected within 10 seconds from the time of sample introduction to the LFM device. Sample volumes may be as low as about 10 microliters, significantly reducing assay costs and ameliorating reagent storage logistics. Additionally, the miniaturization of lateral flow opens the door to highly multiplexed assays, allowing many proteins or nucleic acids to be detected in a single assay.

Abstract: Methods for preparing a biological sample for testing by Maldi where such methods are selected based on sample parameters. Maldi scores are obtained for a range of sample parameters (e.g. McFarland, dispense volume and number of dispenses). From the data, sample preparation parameters can be selected for a biological sample being prepared for Maldi testing. One sample preparation strategy uses multiple dispenses of sample with an intervening drying step, which yields more accurate Maldi scores, particularly for samples at the low range of McFarland values (e.g. below about 2).

Abstract: The cMethDNA method of the present invention is a novel modification of the QM-MSP method (U.S. Pat. No. 8,062,849), specifically intended to quantitatively detect tumor DNA (or other circulating DNAs) in fluids such as serum or plasma at the lowest copy number yet reported. Unique compared to any other PCR-based assay, a small number of copies of a synthetic polynucleotide standard (STDgene) is added to an aliquot of patient serum with standards for a plurality of genes of interest (TARGETgene). Once total DNA is purified PCR is performed wherein the STDgene and the TARGETgene are co-amplified with the same external primer set, and the amplicons present in a dilution of the first PCR reaction are subjected to real time PCR, and quantified for each gene. Methods of making the STDgene standards and the use of the cMethDNA methods and kits containing the same are disclosed.

Abstract: The method is for quantification of purity of sub-visible particle samples. A sample to be analyzed is place in an electron microscope to obtain an electron microscopy image of the sample. The sample contains objects. The objects that have sizes being different from a size range of primary particles and sizes being within the size range of primary particles are enhanced. The objects are detected as being primary particles or debris. The detected primary particles are excluded from the objects so that the objects contain debris but no primary particles. A first total area (T1) of the detected debris is measured. A second total area (T2) of the detected primary particles is measured.

Abstract: Improved methods for the detection and quantitation of a target nucleic acid in a sample using a non-extending helper oligonucleotide are described. The methods include contacting nucleic acids in a sample with amplification reagents including one or more primers, one or more non-extending helper oligonucleotides, and one or more probes. The non-extending helper oligonucleotide facilitates and increases the target nucleic acid accessibility of one or more of the primers, result in greater accumulation of amplicon production, thereby increasing the efficiency and sensitivity of the amplification assay, including amplification assays for Hepatitis C Virus (HCV), for example, HCV Genotype 5. Kits, articles of manufacture, and reaction mixtures are also provided.

Abstract: A composition for treating cancerous cells in a subject having an immune system includes a virus in the Yatapoxvirus genus having at least one mutation. In one embodiment, the mutation results in suppressed expression of a TNF binding protein by the virus. In another embodiment, the mutation results in suppressed expression of thymidine kinase (“TK”) by the virus. In another embodiment, the mutation arms the virus with a transgene to express a bacterial flagellin. The mutations can be present singly or in combination. Additional aspects include a method of treating cancerous cells with a composition as described herein, and a method of delivering at least one gene to cancerous cells in a subject.

Abstract: A composition having nucleic acid polymerase activity, which comprises an active nucleic acid polymerase and an excess amount of a non-functional mutant nucleic acid polymerase protein, wherein the non-functional mutant nucleic acid polymerase protein stabilizes the active nucleic acid polymerase against loss of polymerase activity.

Abstract: Disclosed herein are compositions and methods for accurately estimating the absorbed dose of radiation indicated by a subject based on the expression pattern of a panel of radiation-modulated (RM) genes at various time points following exposure of the subject to ionizing radiation.

Abstract: The present invention relates to a diagnostic method for the detection of small quantities of amniotic fluid in the vagina. More specifically, the invention relates to the detection of PAMG-1 in the vagina using anti-PAMG-1 antibodies.

Abstract: Metapneumovirus (MPV) F proteins stabilized in a prefusion conformation, nucleic acid molecules and vectors encoding these proteins, and methods of their use and production are disclosed. In several embodiments, the MPV F proteins and/or nucleic acid molecules can be used to generate an immune response to MPV in a subject. In additional embodiments, the therapeutically effective amount of the MPV F ectodomain trimers and/or nucleic acid molecules can be administered to a subject in a method of treating or preventing MPV infection.

Abstract: Synthetic FMD peptide immunogens and compositions containing the same are disclosed. Methods for detecting, treating, and preventing an FMD infection in an animal using the synthetic FMD peptide immunogens are also disclosed. In a specific embodiment, a peptide-based emergency vaccine and formulations thereof against Foot and Mouth Disease is described. Various vaccine formulations contain a mixture of peptides derived from FMDV VP1 protein; each peptide containing a B cell FMDV neutralizing/receptor binding epitope sequence linked to an artificial Th epitope to enhance the immunogenicity of each peptide. Disclosed vaccine formulations containing viral immunogens can optionally be supplemented with a mixture of peptides representing the FMDV endogenous Th epitopes derived from FMDV proteins, homologues and functional analogues thereof.

Abstract: An exemplary embodiment describes a method for detection of bacteria and fungi in a sample of biological material, wherein the DNA contained in the sample of biological material is subjected to amplification in multiplex real-time PCR, with the use of primers specific for bacteria in the first stage and primers specific for fungi, and in the second stage, the resulting DNA is amplified using primers and probes differentiating fungi into a group of mold fungi and yeast fungi and bacteria into Gram-positive and Gram-negative bacteria. Another exemplary embodiment refers to oligonucleotide primers for the detection of bacteria and fungi by PCR and a kit for simultaneous detection of bacteria and fungi.

Abstract: Provided is a method for producing non-enveloped viral particles, comprising a step for obtaining a fraction containing non-enveloped viral particles by removing precipitates which are produced in a step for adding a substance which reduces the solubility of proteins under acidic conditions and/or a substance which precipitates under acidic conditions to a neutral or basic sample containing non-enveloped viral particles, and acidifying the sample after the addition of the substance.

Abstract: Cellular targets on cancer cells have been identified that can be used with targeted molecular imaging to detect the cancer cells in vivo. Non-invasive methods for detecting cancer cells, such as metastasized cancer cells, are therefore provided. Also provided are compositions and kits for use in the disclosed methods.

Abstract: The present invention provides monoclonal antibodies that bind to the Middle East Respiratory Syndrome-Coronavirus (MERS-CoV) spike protein, and methods of use. In various embodiments of the invention, the antibodies are fully human antibodies that bind to MERS-CoV spike protein. In some embodiments, the antibodies of the invention are useful for inhibiting or neutralizing MERS-CoV activity, thus providing a means of treating or preventing MERS infection in humans. In some embodiments, the invention provides for a combination of one or more antibodies that bind to the MERS-CoV spike protein for use in treating MERS infection. In certain embodiments, the one or more antibodies bind to distinct non-competing epitopes comprised in the receptor binding domain of the MERS-CoV spike protein.

Abstract: The invention relates to diagnostics, namely to a reagent kit, a rapid method and a device for detecting the fact of chronic, ischemia-linked brain pathology. A special feature of the invention is the use of an immunoactive hybrid peptide produced as a product of two fragments of the NMDA neuroreceptor subunits. A device is described that allows quick and convenient testing of autoantibodies in the patient's blood that recognize the hybrid peptide. The method of detection of autoantibodies is based on the principle of lateral flow immunochromatography. The invention can be used for prophylactic medical examination (screening of chronic ischemia-linked brain lesions), to detect decompensated chronic cerebral ischemia at the prehospital stage by general practitioners or neurologists, as well as in neurosurgery and sports medicine for diagnostics of delayed cerebral ischemia in persons with craniocerebral injury.

Abstract: A security tag can be used to identify or authenticate a substrate that has the security tag. The security tag includes a pattern of inimitable biological particles, a transparent adhesive layer, a substrate, and a transparent superstrate, where the pattern of inimitable biological particles is directly transferred from an organism to the transparent adhesive layer on the substrate, and where said biological particles are covered with the transparent superstrate, such that said inimitable biological particles are encapsulated between said substrate and said superstrate.

Abstract: The present invention provides an artificial tissue culture comprising a heterogeneous population of cells of at least two different tissue sections, wherein said tissue sections are in a three dimensional structure, method of generating such a tissue and kits suitable for said method or maintain a three dimensional tissue culture.

Abstract: A combination of active agents selected from a FoxM1 enhancer, an Id1 enhancer, and a JNK3 inhibitor and the uses thereof in promoting cardiomyocyte proliferation and treating heart diseases in a subject in need of the treatment.

Abstract: Disclosed herein are chimeric antigen receptor effector cells (CAR-ECs) and CAR-EC switches. The switchable CAR-ECs are generally T cells. The one or more chimeric antigen receptors may recognize a peptidic antigen on the CAR-EC switch. The CAR-ECs and switches may be used for the treatment of a condition in a subject in need thereof.

Abstract: A method is described for the detection of at least two of cytokeratins 8, 18 and 19 in a sample. It is practiced by contacting the sample with a solid phase having a first antibody with specificity for cytokeratin 8 , a second antibody with specificity for cytokeratin 18 and, optionally, a third antibody with specificity for a first epitope of cytokeratin 19 bound to it and allowing cytokeratins in the sample to bind to the bound antibodies to form complexes. The complexes are then contacted with a first labelled antibody with specificity for a dimer of cytokeratin 8 and 18 and optionally a second labelled antibody with specificity for a second epitope of cytokeratin 19 and allowing the labelled antibodies to bind to the complexes. The labelled antibodies bound to the complexes are then detected. A method for quantitative determination of soluble fragments of at least two of cytokeratin 8, 18 and 19 in a sample and a kit are also described.

Abstract: The present invention relates to a method for detecting or quantifying Human Immunodeficiency Virus-2 (HIV-2) nucleic acids in a biological sample, comprising: a) performing a real-time polymerase chain reaction (PCR) or a real-time reverse transcriptase polymerase chain reaction (RT-PCR) on nucleic acids of the biological sample with: (i) at least 4 primers respectively comprising or consisting of: sequence SEQ ID NO: 1 or a sequence having at least 90% identity to SEQ ID NO 1, and sequence SEQ ID NO: 2 or a sequence having at least 90% identity to SEQ ID NO: 2, and sequence SEQ ID NO: 4 or a sequence having at least 90% identity to SEQ ID NO: 4, and sequence SEQ ID NO: 5 or a sequence having at least 90% identity to SEQ ID NO: 5, and (ii) at least 2 labelled probes respectively comprising or consisting of: sequence SEQ ID NO: 3, a sequence complementary to SEQ ID NO: 3, or a sequence having at least 90% identity to SEQ ID NO: 3 or the complementary thereof, and sequence SEQ ID NO: 6, a sequence complemen

Abstract: The invention generally relates to methods for indicating whether an assay for isolating targets is properly isolating and detecting targets. Methods of the invention involve obtaining a sample suspected of a containing target, introducing a detectable marker into the sample, conducting an assay using magnet particles to isolate the detectable marker and the target if it is present in the sample, determining the presence or absence of the target; and confirming that the assay functioned properly by determining presence or absence of the detectable marker.

Abstract: The present invention provides a method for detecting the presence or absence of a guanine-abasic site, the method being a process for detecting guanine opposite at least one abasic sites generated in a double-stranded DNA, comprising: (1) step 1 of site-selectively cleaving at least one abasic sites in a double-stranded DNA using an enzyme; (2) step 2 of modifying the amino group at position 2 of guanine opposite the abasic sites using a modifier; and (3) step 3 of performing polymerase chain reaction on the modified double-stranded DNA obtained by conducting step 1 and step 2, which serves as a template, to search for the presence or absence of an amplification product, the sequence of steps 1 and 2 being not limited to the order presented.

Abstract: This disclosure describes a cell genetically modified to detect ribosome inhibition in the cell and methods involving such a cell. Generally, the genetically-modified cell includes an aminoglycoside-sensitive orthogonal 16S rRNA (O-16S) coding region bearing a mutated anti-Shine-Dalgarno (O-ASD) sequence, a repressor/operator system, and a polynucleotide encoding a detectable reporter under transcriptional control of the repressor/operator system. The repressor/operator system includes a coding region that encodes a transcriptional regulator and having an orthogonal SD (O-SD) sequence complementary to the 16S rRNA O-ASD sequence. The operator sequence, which is repressable by the transcriptional regulator, is operably linked to the polynucleotide encoding a detectable reporter.

Abstract: An identification method, for determining whether a sample of an unknown composition is a sample of a known composition to which a known amount of a SERS-active taggant compound has been added, includes the steps of: obtaining a sample of the unknown composition; adding to the composition a plurality of SERS particles to form a mixture, each SERS particle including:—a core including a nanoparticle having a plasmonic surface,—a SERS-active internal standard compound adjacent the plasmonic surface and,—a shell, the shell encapsulating the core and the SERS-active internal standard compound; obtaining a SERS spectrum from the mixture; and comparing the SERS response ratio SATC:SAISC from the SERS spectral response of the SERS-active taggant compound and the SERS spectral response of the SERS-active internal standard compound in the unknown composition with the SERS response ratio SATC:SAISC from the known composition.

Abstract: Provided is an inspection kit that proper inspection can be performed even if a tester drips a remainder of sample. The inspection kit includes: a reagent device having a sample-dripping part, the reagent device being capable of making a sample dripped on the sample-dripping part flow in a first direction from an upstream side toward a downstream side; and a case surrounding the reagent device. A liquid-absorbing part is provided with a portion near the sample-dripping part of the case, the liquid-absorbing part guiding, according to capillary action, the remainder of the sample in a second direction differing from the first direction.

Abstract: The invention relates to an automated method for high-throughput DNA sequencing from high density DNA arrays by (a) initiating a first sequencing reaction on a first high density DNA array; and imaging said first high density DNA array using a detector, and (b) initiating a first sequencing reaction on a second high density DNA array; and imaging said second high density DNA array using the detector, wherein the first sequencing reaction in (a) is initiated before the first sequencing reaction in (b) is initiated such that the sequencing reactions in (a) and (b) are staggered. By using asynchronous sequencing reactions and imaging two separate arrays using one detector, imaging can be carried out on one array while sequencing reactions are carried out on one the other, substrate, the other substrate is imaged, reducing the idle time of the imaging system.

Abstract: The present invention provides an immunoassay leading to the rapid and simultaneous detection of antibodies to a wide range of infectious pathogens in biological fluids of infected patients. This immunoassay involves the covalent and oriented coupling of fusion proteins comprising an AGT enzyme and a viral antigen on an identifiable solid support (e.g. fluorescent microspheres). The thus obtained antigen-coupled microspheres show enhanced capture of specific antibodies as compared to antigen-coupled microspheres produced by standard amine coupling procedures.

Abstract: Methods of using probes and probe sets for the detection of high grade dysplasia and carcinoma in cervical cells are described. Methods of the invention include hybridizing one or more chromosomal probes to a biological sample obtained from a subject and detecting the hybridization pattern of the chromosomal probes to the sample to determine whether the subject has high grade dysplasia or carcinoma. Methods of the invention also include preliminary screening the cells for a marker associated with a risk for cancer, and preferably involves screening for HPV infected cells by in situ hybridization using an HPV probe mixture.

Abstract: The present invention relates to a pretreatment method of a sample for detecting HBs antigen, which is a surface antigen of the hepatitis B virus, and a method for detecting HBs antigen utilizing the pretreatment method. The present invention also relates to a pretreatment reagent kit for detecting HBs antigen.

Abstract: The invention relates to compositions and methods for preventing or treating arenavirus related diseases and disorders through the administration to a subject in need thereof a live-attenuated virus (LAV), wherein the LAV is a codon deoptimized (CD) arenavirus.

Abstract: Anti-carbohydrate antibodies are detected by (a) contacting an array of oligomannose-serum albumin conjugates immobilized on a substrate with an antibody-containing serum sample under conditions wherein TM10 antibodies bind the oligomannose of the conjugates at at least micromolar affinity; and (b) detecting resultant binding of specific antibodies of the sample to the oligomannose of the conjugates, as indicative of the anti-carbohydrate antibodies.

Abstract: The present specification discloses recombinant nucleic acid constructs encoding an immunogenic multiepitope polypeptide comprising two or more polypeptides, recombinant nucleic acid constructs encoding at least two epitopes from two or more internal proteins of influenza virus, compositions comprising such recombinant nucleic acid constructs and methods of eliciting a T cell immune response against an influenza virus in a vertebrate using such recombinant nucleic acid constructs and compositions.

Abstract: This disclosure describes related novel methods for Recombinase-Polymerase Amplification (RPA) of a target DNA that exploit the properties of recombinase and related proteins, to invade double-stranded DNA with single stranded homologous DNA permitting sequence specific priming of DNA polymerase reactions. The disclosed methods have the advantage of not requiring thermocycling or thermophilic enzymes, thus offering easy and affordable implementation and portability relative to other amplification methods. Further disclosed are conditions to enable real-time monitoring of RPA reactions, methods to regulate RPA reactions using light and otherwise, methods to determine the nature of amplified species without a need for gel electrophoresis, methods to improve and optimize signal to noise ratios in RPA reactions, methods to optimize oligonucleotide primer function, methods to control carry-over contamination, and methods to employ sequence-specific third ‘specificity’ probes.

Abstract: Attenuated isolates of the Arkansas serotype of infectious bronchitis virus (IBV), including the IBV isolate ArkGA p60 deposited at the ATCC under Patent Designation PTA-123783, and compositions thereof are presented. Methods for administering the isolates or compositions as vaccines to the prevent virulent IBV infection in birds of the order Galliformes are also presented.

Abstract: The present invention relates to a method for identifying the source of an amplicon, comprising: providing a plurality of pools of amplicons from different sources, wherein the amplicons from different sources are present in more than one pool, and wherein the amplicons in each pool are tagged with a unique pool-specific identifier; sequencing at least part of the amplicons that comprise the pool-specific identifiers; and assigning one or more of the amplicons to corresponding pools and/or sources using the pool-specific identifiers.

Abstract: This disclosure provides antibody-urease conjugates having therapeutic and diagnostic utility. More specifically, the disclosure relates to diagnostic and/or therapeutic conjugates that are prepared by conjugating one or more whole antibodies to urease.

Abstract: The invention belongs to the fields of medicine and immunology, particularly, the field of immunological diagnosis. In particular, the invention discloses a method for assessing whether a subject is at risk of developing human cytomegalovirus (HCMV) active infection and a kit therefore. The method comprises the steps of: (1) determining the level of an antibody against a HCMV protein in a body fluid sample from the subject; and (2) comparing the level with a predetermined reference value, wherein if the level is below the predetermined reference value, the subject is determined to be at risk of developing HCMV active infection. In addition, the invention also discloses a method for screening a candidate drug which is capable of improving the ability of a subject to resist human cytomegalovirus (HCMV) active infection, and a kit therefore.

Abstract: Methods of evaluating a cellular sample for latent cellular replication competent HIV-1 are provided. Aspects of the methods include contacting a cellular sample with an HIV-1 inducing compound to produce an activated cellular sample; and assessing plasma viral load in the activated cellular sample to evaluate the cellular sample for latent cellular replication competent HIV-1. Also provided are devices and kits that find use in practicing the methods.

Abstract: The instant disclosure provides norovirus binding aptamers, compositions comprising such aptamers, and methods of using and producing such aptamers. The aptamers are useful, for example, for detecting the presence of norovirus in test samples, for capturing and/or concentrating norovirus from test samples, for evaluating the efficacy of therapeutic agents in patients diagnosed with a norovirus infection, and for evaluating the efficacy of norovirus vaccines.

Abstract: Methods of increasing diversity in cytomegalovirus vaccines through the selection of cell type in which the virus is propagated, and the use of cytomegalovirus produced by those methods in the development of vaccine compositions, are disclosed. Vaccine compositions comprising CMV isolated from epithelial cells are also disclosed.

Abstract: The present invention discloses a method for terminal inactivation of pathogenic microorganisms, comprising the following steps of: a. vacuum freeze-drying a bio-product packaged in a container, feeding in a gas and sealing to obtain the end product and, b. performing inactivation by dry-heating. The method provided by the present invention can effectively inactivate non-lipid enveloped viruses, with excellent inactivation effects and short inactivation time particularly to parvoviruses, and thus overcome the deficiencies of the conventional terminal dry-heating inactivation methods.

Abstract: A compound having an antiviral activity for inhibiting release of an enveloped virus from a cell is disclosed, including methods of inhibiting release of an enveloped virus from a cell. The antiviral activity of the compound includes inhibiting formation of an associative complex or disrupting formation of an associative complex. The associative complex comprises an L-domain motif of the enveloped virus and at least one cellular polypeptide, or fragment thereof, capable of binding the L-domain motif of the enveloped virus.

Abstract: The present invention provides quenchers of excited state energy, probes and other conjugates comprising these quenchers, and methods of their use.

Abstract: This specification generally relates to non-radioactive methods of detecting nucleic acid polymerase activity and methods of detecting compounds that modulate nucleic acid polymerase activity. The activity may be measured in real-time using a real-time PCR instrument.

Abstract: Methods for enhancing the binding of oligonucleotide probes to DNA and RNA are disclosed. The methods make use of thermodynamic and kinetic effects to reduce probe mismatches and failure of complementary probes to bind to DNA and RNA templates. Mapping and sequencing of the probed DNA and RNA samples are contemplated herein.