Abstract: A lateral-flow assay device includes a substrate having a sample addition zone and a wash addition zone downstream thereof along a fluid flow path through which a sample flows. The fluid flow path is configured to receive a wash fluid in the wash addition zone. A hydrophilic surface is arranged in the wash addition zone. Flow constriction(s) are spaced apart from the fluid flow path and arranged to define, with the hydrophilic surface, a reservoir configured to retain the wash fluid by formation of a meniscus between the hydrophilic surface and the flow constriction(s). The fluid flow path draws the wash fluid from the reservoir by capillary pressure. Apparatus for analyzing a fluidic sample and methods of displacing a fluidic sample in a fluid flow path of an assay device are also described.

Abstract: An electronic device for reading diagnostic test results and collecting subject data for inclusion in a local chain of evidence database and for transferring and receiving data from remote databases.

Abstract: A concentration agent for microorganisms is provided that contains both lanthanum and carbonate. Additionally, articles that include the concentration agent and methods of concentrating a microorganism using the concentration agent are provided.

Abstract: The present invention provides novel methods of magnetically labeling a bacterial cell by contacting the call with an affinity ligand and subsequently contacting the cell with a magnetic agent, where the affinity ligand and magnetic agent include bioorthogonally reactive groups that can react with each other to form a covalent bond. Compounds, compositions, kits and applications of the method are also described.

Abstract: A device for detecting at least one analyte generally comprises (i) a support having a chamber for receiving a biological fluid therein, wherein said chamber is an elongate chamber having a length axis; (ii) a carrier or agitator in said elongate chamber, said carrier or agitator having opposite end portions and a side portion, the carrier or agitator dimensioned to travel in said chamber along said length axis and/or permit said liquid sample to flow in the chamber therearound, either (or both) thereby agitating the liquid sample; and (iii) at least one anti-analyte antibody coupled to either the carrier and/or the chamber side wall. Methods of using the device are also described.

Abstract: The invention relates to the area of health-beneficial preparations and production methods thereof, in particular to the use of thermally pre-treated Lactobacillus preparations having specific bonding capacity for Streptococcus mutans for caries prophylaxis. The invention further relates to the Lactobacillus preparations and thermal pasteurization.

Abstract: The present invention encompasses methods, assays and kits for the detection of pathogenic bacteria in a patient and for the differential diagnosis of pulmonary diseases associated with pathogenic bacteria from pulmonary diseases not associated with pathogenic bacteria.

Abstract: Methods for detecting in a sample the presence of an antibody to a conjugate of an antigen associated with a first carrier by a first association are disclosed. The method comprises contacting a conjugate of the antigen associated with a second carrier by a second association with said sample under conditions that allow binding of the antibody to the antigen; and introducing an agent to detect the presence of the antibody bound to said antigen. The first association and the second association are covalent associations and the first association is different from the second association. Also provided are kits, multiwell plates and conjugates that are useful in the method and further uses of the method. Also provided is a method of releasing a batch of a vaccine comprising a conjugate of an antigen associated with a first carrier by a first association and antibodies useful in this method.

Abstract: The present invention relates to moving microorganisms to a surface, where they are grown in the presence and absence of antimicrobials, and by monitoring the growth of the microorganisms over time in the two conditions, their susceptibility to the antimicrobials can be determined. The microorganisms can be moved to the surface through electrophoresis, centrifugation or filtration. When the movement involves electrophoresis, the presence of oxidizing and reducing reagents lowers the voltage at which electrophoretic force can be generated and allows a broader range of means by which the target can be detected. Monitoring can comprise optical detection, and most conveniently includes the detection of individual microorganisms. The microorganisms can be stained in order to give information about their response to antimicrobials.

Abstract: The present invention provides a rapid, highly sensitive and specific enzyme-linked immunosorbent assay (ELISA), referred to as N-Assay, a device, and a kit, for detection and identification of microorganisms in a sample, in thirty minutes or less, with little or no interference from non-target microorganisms. The present invention also provides for simultaneous determination of antimicrobial susceptibility of microorganism in the N-Assay.

Abstract: The present disclosure relates to devices and methods for rapidly detecting streptococcus bacteria. An illustrative device includes a first elongate handle connected to a first edible portion and a second elongate handle connected to a second edible portion. The first and second elongate handles are connected by a banding material. The first and second edible portions are inserted into the mouth of an individual for receiving a saliva sample.

Abstract: In alternative embodiments, the invention provides vaccines, pharmaceutical compounds and formulations for diagnosing, preventing, treating or ameliorating Group A Streptococcus (GAS), Group C Streptococcus (GCS), or Group A Streptococcus (GGS), infections, or other pathogenic Streptococcus infections. In alternative embodiments, the invention provides compositions such as diagnostic tests, assays, immunoassays and test strips, and methods, for detecting or diagnosing the presence of a Streptococcal infection, e.g., Group A Streptococcus (GAS), Group C Streptococcus (GCS), or Group A Streptococcus (GGS), infections, or other pathogenic Streptococcus infections.

Abstract: Described herein is a method and a device for expediting delivery of an agent to a damaged bacterial cell. In one embodiment, the methods and devices are useful for screening candidate antibiotics. In another embodiment, the methods and devices described herein are used to determine susceptibility of bacteria to an antibiotic. The methods also provide a method for determining an appropriate antibiotic to treat an individual having a bacterial infection.

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: Disclosed is a new and emerging serotype of Streptococcus pneumoniae designated serotype 6C, and assays and monoclonal antibodies useful in identifying same. Also disclosed is a novel pneumococcal polysaccharide with the repeating unit {2) glucose 1 (1?3) glucose 2 (1?3) rhamnose (1?3) ribitol (5?phosphate}. This new serotype may be included in pneumococcal vaccines.

Abstract: Disclosed are methods of identifying an individual having a predisposition to the development of a cardiovascular disease, and administering a suitable prophylactic agent to the identified individual to prevent disease. Methods of screening and identifying agents that inhibit bacterial collagen binding protein (CBP)-mediated cell invasion are also disclosed.

Abstract: The invention is directed to aptamers, methods and kits comprising same for detecting Streptococcus pyogenes. The method of screening a subject for Streptococcus pyogenes involves obtaining a body sample from the subject; contacting the sample or a bacterial culture of the sample with an aptamer or a panel of aptamers specific to S. pyogenes; and detecting the presence or absence of S. pyogenes in the sample or the bacterial culture, wherein binding of the aptamer is indicative of the presence of S. pyogenes.

Abstract: This invention provides an isolated nucleic acid encoding a polypeptide comprising amino acid sequences of a streptococcal matrix adhesion E (EmaE) polypeptide. Antibodies to the EmaE polypeptide and immunogenic fragments thereof are also provided. This invention provides pharmaceutical compositions, immunogenic compositions, vaccines, and diagnostic and therapeutic methods of use of the isolated polypeptide, antibodies thereto, and nucleic acids.

Abstract: The present invention includes methods and devices for preventing interfering substances from affecting the accuracy of a lateral flow immunoassay. In preferred embodiments, a test strip includes a capturing zone that includes at least one mobile capturing reagent that separates at least one interfering substance from the analyte. The capturing zone is preferably located upstream of the sample application zone. In some embodiments, the reagent/conjugate zone is also located upstream of the sample application zone. The capturing zone may be located upstream, downstream, or overlapping with the reagent/conjugate zone in these embodiments. In other preferred embodiments, one or more mobile capturing reagents are included in the elution medium/running buffer. In yet other embodiments, the capturing reagent is incorporated into a sample collection device of a sample collection system, preferably separate from the chromatographic test strip. A lysis zone is also included in some preferred embodiments.

Abstract: A method of providing protection against pneumococcal infection in a subject is disclosed. The method includes steps of administering to the subject a composition that includes combination of three recombinant pneumococcal neuraminidases: NanA, NanB, and NanC of S. pneumoniae strains CGSP14, wherein administration of the recombinant pneumococcal neuraminidases elicits an immune response to S. pneumoniae, and treats the subject. In one embodiment, the method further includes a step of adding adjuvants to enhance the immune response. The method also includes a step of using passive antibodies, wherein said passive antibodies are anti-neuraminidase antibodies generated from neuraminidases-immunized humanized animals: NanA, NanB, and NanC. Meanwhile, this invention also provides a method for the molecular diagnosis of pneumococcal infection.

Abstract: Assays for detecting anti-streptococcal antibodies in biological samples using one or more streptococcal antigens are described herein. Various combinations of antigens may be used in the assays. For example, one or more of Ply, PhtD, PhtE, LytB and PcpA may be utilized. Additional streptococcal antigens may also be used. The assays may also be used in combination with assays that detect streptococcal nucleic acids.

Abstract: The present invention relates to newly identified open reading frames comprised within the genomic nucleotide sequence of Streptococcus pneumoniae, wherein the open reading frames encode polypeptides that are surface localized on Streptococcus pneumoniae. Thus, the invention relates to Streptococcus pneumoniae open reading frames that encode polypeptides encoded by the Streptococcus pneumoniae open reading frames, vectors comprising open reading frame sequences and cells or animals transformed with these vectors. The invention relates also to methods of detecting these nucleic acids or polypeptides and kits for diagnosing Streptococcus pneumoniae infection. The invention finally relates to pharmaceutical compositions, in particular immunogenic compositions, for the prevention and/or treatment of bacterial infection, in particular infections with Streptococcus pneumoniae.

Abstract: The present invention relates to processes for the rapid detection, semi-quantification and quantification of live microorganisms in solutions or suspensions using immunomagnetic particles, without requiring pre-enrichment through culture of the microorganism. The invention also relates to kits for carrying out said processes and to the quantification of the microorganisms detected by means of automated biosensor equipment.

Abstract: The disclosure relates to the detection of analytes (e.g., biological pathogens such as bacteria or viruses) using a conductive polymer label. The disclosed detection system utilizing the conductive polymer label generally involves the formation of an analyte conjugate between the target analyte and a conductive polymer moiety conjugated to the target analyte. The conductive polymer portion of the analyte conjugate is electrically activated to form an electrically activated analyte conjugate having an increased electrical conductivity relative to the analyte conjugate as originally formed. The electrically activated analyte conjugate can then be detected by any suitable means, such as by conductimetric or electrochemical detection.

Abstract: The present invention discloses methods for detecting the presence of a complex between a first reagent and a second reagent in solution. In particular, the invention provides methods for qualitative or quantitative detection of an analyte or its specific binding partner in complex biological samples. The invention further discloses algorithms using summary rate changes at selected wavelengths in the absorbance spectra of colloidal metal-labeled analytes or specific binding partners to identify intermolecular interactions between the analyte and its binding partner.

Abstract: The present invention relates to antibodies, binding portions thereof, or probes that bind specifically to glucosyltransferase enzymes, and uses of these agents for detecting glucosyltransferase enzyme(s) in a sample and for diagnosing predisposition of a human child to early childhood caries. The present invention also relates to a kit for detecting a glucosyltransferase enzyme in an oral sample from an animal.

Abstract: The invention described herein provides methods for the detection of target particles, such as pathogens, soluble antigens, nucleic acids, toxins, chemicals, plant pathogens, blood borne pathogens, bacteria, viruses and the like. Also described is an emittor cell comprising a receptor, wherein the receptor can be an antibody or an Fc receptor, and an emittor molecule for the detection of a target particle in a sample wherein the target particle to be detected is bound by one or more receptors on the emittor cell. Also provided are optoelectronic sensor devices for detecting a target particle in a sample, including in a plurality of samples.

Abstract: Compositions and methods for eliciting an immune response against Streptococcus pneumoniae are described. More particularly, the present disclosure relates to immunogenic PcpA polypeptides, including fragments of PcpA and variants thereof, and nucleic acids that encode the polypeptides. The present disclosure further relates to methods of making and using the immunogenic polypeptides. Further provided is a method of diagnosing pneumococcal infection (e.g., pneumonia) in a subject by obtaining a biological sample from the subject and detecting one or more pneumococcal antigens that are selectively expressed during invasion (e.g., PcpA or fragments thereof).

Abstract: The present invention is directed to methods for extracting markers from biological samples, and to systems, devices, kits and reagents for use in such methods. The invention is also to methods, kits, reagents and compositions for measuring a plurality of different organism types in a sample. One of the specific advantages of the present invention is the ability to simultaneously extract more than one microorganism or viral particle marker in one volume from a single sample containing a complex biological matrix.

Abstract: The invention provides methods, devices and kits for rapid detection and identification of one or more live target microorganisms in a liquid sample or grown on plates containing nutrient media. The invention includes mixing one or more target microorganisms with one or more aptamers and/or one or more antibodies, each conjugated to a reporter compound and specific for a first site on one or more target microorganisms to form a mixture. The mixture is placed on a permeable membrane having immobilized thereon one or more aptamers linked to an amine compound, and/or one or more antibodies, each specific for a second site on one or more target microorganisms or a site on the aptamer conjugate and/or antibody conjugate. A detection solution is added to the membrane and detection and identification of one or more target microorganisms is achieved in about one hour or less.

Abstract: Provided are methods, test devices, and diagnostic kits for predicting, assessing, and diagnosing the risk of a disease using salivary analysis. The methods comprise providing a whole (unfractionated) saliva sample from a subject; contacting an aliquot of the saliva with two or more lectins under conditions that allow the two or more lectins to bind to a lectin-binding component of the saliva; detecting the amount of bound lectin; and comparing the amount of bound lectin to the amount known to bind a saliva sample from a control patient, to predict the risk of a disease in the subject. Also provided are methods for reducing the risk of a disease and a method for assessing the risk of the disease at a defined level.

Abstract: The invention herein generally relates to kits and methods for detecting the presence of a bacterium in a subject, for example, methicillin resistant S. aureus.

Abstract: Methods and devices are provided for the rapid and specific detection of target microorganisms, cells, and the like. In one embodiment, the methods involve contacting a target microorganism (e.g., in a sample) with a permeabilization reagent that selectively permeabilizes or lyses the microorganism; contacting the selectively permeabilized microorganism with a detection reagent that is taken into the selectively permeabilized organism or that contacts metabolites or enzymes released by the selectively permeabilized microorganism, where the detection reagent produces a signal in the presence of said metabolites or enzymes; and detecting a signal produced by the detection reagent in the presence of the metabolites or enzymes wherein the strength of the signal indicates the presence and/or amount of the target microorganism in the sample.

Abstract: Described are Streptococcus suis infections in pigs, vaccines directed against those infections and tests for diagnosing S. suis infections. Provided is an isolated or recombinant nucleic acid encoding a capsular gene cluster of S. suis or a gene or gene fragment derived therefrom. Further provided is a nucleic acid probe or primer allowing species or serotype-specific detection of S. suis. Also provided is a Streptococcus suis antigen and vaccine derived therefrom.

Abstract: The present invention provides a test medium comprising a test microorganism, an indicator and a metal in ionized form, wherein the valence of said metal is at least 2 and the concentration of said metal is between 0.001 M and 1 M. Furthermore, there is provided a method for the determination of the presence of an antibiotic characterized in that a metal salt is added to said test medium and/or to said sample of fluid. Finally, there is provided a kit suitable for the determination of an antibiotic in a fluid.

Abstract: The present invention describes novel fluorescent compounds analogous to alkyl phospholipids, containing highly photostable fluorescent groups in the structure thereof and emitting in the visible spectrum wavelength zone. Said compounds are easily introduced to microorganisms, enabling the detection and identification of these organisms by means of fluorescence microscopy. The novel fluorescent compounds can also diagnose, rapidly and easily, the presence of pathogenic microorganisms characterised in that they are resistant to treatment with alkyl phospholipids.

Abstract: Provided herein are imaging methods for detecting, diagnosing and imaging pathogenic bacteria or a pathophysiological condition associated therewith using fluorogenic substrates for bacterial enzymes. Fluorescent, luminescent or colorimetric signals emitted by substrates or enzyme products in the presence of the bacteria are compared to controls to detect and locate the pathogenic bacteria. Provided is a method for screening therapeutic agents to treat the pathophysiological conditions by measuring a signal emitted from the fluorogenic substrates or products in the presence and absence of the potential therapeutic agent. In addition, a diagnostic method for detecting a mycobacterial infection in a subject by contacting biological samples with a fluorogenic substrate and imaging for signals emitted from a mycobacterial beta-lactamase product.

Abstract: Protein antigens from Streptococcus pneumoniae are disclosed, together with nucleic acid sequences encoding them. Their use in vaccines and in screening methods is also described.

Abstract: The present invention relates to a modified polypeptide with a biological activity to lyse cell walls of bacteria, wherein the polypeptide has no caspase, clostripain, enterokinase, factor Xa, granzyme B, staphylococcus peptidase I (V8 Protease), plasmin, streptopain, bacillolysin and/or thrombin cleavage site. The invention further relates to nucleic acids with a sequence encoding a polypeptide according to the present invention.

Abstract: The present invention discloses methods for detecting the presence of a complex between a first reagent and a second reagent in solution. In particular, the invention provides methods for qualitative or quantitative detection of an analyte or its specific binding partner in complex biological samples. The invention further discloses algorithms using summary rate changes at selected wavelengths in the absorbance spectra of colloidal metal-labeled analytes or specific binding partners to identify intermolecular interactions between the analyte and its binding partner.

Abstract: Provided are methods, test devices, and diagnostic kits for predicting, assessing, and diagnosing the risk of a disease using salivary analysis. The methods comprise providing a whole (unfractionated) saliva sample from a subject; contacting an aliquot of the saliva with two or more lectins under conditions that allow the two or more lectins to bind to a lectin-binding component of the saliva; detecting the amount of bound lectin; and comparing the amount of bound lectin to the amount known to bind a saliva sample from a control patient, to predict the risk of a disease in the subject. Also provided are methods for reducing the risk of a disease and a method for assessing the risk of the disease at a defined level.

Abstract: The invention relates to the field of diagnosis of and vaccination against Streptococcal infections and to the detection of virulence markers of Streptococci. The invention discloses a method for modulating virulence of a Streptococcus, the method comprising modifying a genomic fragment of Streptococcus wherein the genomic fragment comprises at least a functional part of a fragment identifiable by hybridization in Streptococcus suis to a nucleic acid or fragment thereof as shown in FIG. 5.

Abstract: The present invention relates to modifying rapid immunochromatographic (“ICT”) tests for the detection of characteristic carbohydrate antigens of bacteria that are known to be causative of otitis media and respiratory diseases in children under the age of approximately 12 years. The test modifications involve either (1) reducing the total amount of antibodies to the carbohydrate antigen employed in each test, (2) adding at least one fixed “scrub” line located just prior to the capture line in the sample flow path to the prepared ICT test strip to “scrub” out an identical amount of target antigen from all bodily fluid test samples obtained from both colonized but otherwise healthy children and diseased children, or (3) combinations of (1) and (2).

Abstract: The present invention relates to antigens, more particularly antigenS of Streptococcus pyogenes (also called group A Streptococcus (GAS)) bacterial pathogen which are useful as vaccine component for therapy and/or prophylaxis.

Abstract: The present invention relates to a method for assessing the likelihood of the presence or formation of fetal heart disease (such as HLHS) in a fetus. In this methodology, the mother, either before or during pregnancy, is tested for the presence of anti-strep antibodies. If positive, the fetus is evaluated and monitored for the presence of fetal heart disease; the fetus can be treated, if appropriate. In addition, either prior to pregnancy or during the first trimester, the mother can be treated to prevent the formation of such antibodies or to neutralize their presence or effect fetal heart tissue.

Abstract: Multiplexed lateral flow assays, related methods, and devices are disclosed which are capable of simultaneously detecting multiple analytes. The assays are preferably immunoassays and can be multiplexed spatially, spectrally, and both spatially and spectrally. Multiplexed assays are disclosed employing quantum dots for applications including the detection of human proteins and the monitoring of microorganisms relevant to water contamination. The multiplexed assays can employ one or more species of Surface Enhanced Raman Scattering nanoparticles, with one or more species having a unique Raman shift spectrum. The invention is widely adaptable to a variety of analytes such as biowarfare agents, human clinical markers, and other substances.

Abstract: The full-length nucleic acid sequence of the C1 bacteriophage is disclosed in the present application The specific regions of the C1 genome encoding the PlyC lysin have also been identified and sequenced. The invention relates to the pharmaceutical and diagnostic utility of these sequences and provides for development of pharmaceutical compositions for treating or preventing streptococcal infections in mammals, for compositions for decontamination of inanimate surfaces and for diagnosis of streptococcal infections.

Abstract: The present invention is directed to methods, assays and compositions for implementing such methods and assays for assessing efficacy of individual components in multi-component vaccines and for assessing efficacy of a vaccine against a pathogen. In one aspect, the method of assessing efficacy of a vaccine against a pathogen is a quick assay that tests for an activity correlated with efficacy such as binding in an ELISA rather than requiring the time and expense of an assay that detects actual bactericidal activity. In another aspect, the method for testing the efficacy of an individual component in a multi-component vaccine includes obtaining an immune sample from a subject inoculated with the multi-component vaccine; blocking the portion of the immune sample that recognizes the individual component such as by addition of the individual component, and testing the efficacy of the immune sample to respond to the pathogen.

Abstract: This application discloses a multivalent opsonophagocytosis assay that does not rely on counting of bacterial colonies to determine bacteria viability following opsonophagocytosis. Instead, the method uses a metabolic colorimetric indicator to determine if viable bacteria are present. Also disclosed are arrays that can be used to determine the viability of bacteria following opsonophagocytosis.

Abstract: An antibody for detection of microorganisms, a method of detection of microorganisms, and a reagent kit for detection of microorganisms, which is species specific for every species of microorganisms and with which all serototypes within the same species can be detected, are provided. Antibody to intracellular molecules with the same function in each type of microorganism, particular antibody to ribosomal protein, that is, ribosomal protein L7/L12, is made and antibody that reacts specifically with the microorganism in question is selected.