Abstract: Disclosed herein is a composition for ultrasensitive bioassay applications. The composition includes a plurality of dispersible, nanoparticles having a size less than 500 nm. The nanoparticles contain a metal catalyst or a metal catalyst precursor. The nanoparticles are conjugated to at least one biospecific binding reactant that is selectively reactive with a target analyte. The composition includes a dispersing medium. A method and a kit for conducting bioassays are described.

Abstract: A method of detecting a biomarker in one embodiment includes identifying a quantity of biomolecule types in a sample, exposing the sample to a plurality of test sites, wherein the number of test sites in the plurality of test sites is equal to or greater than the identified quantity of biomolecule types, establishing, for each of the plurality of test sites, a respective test environment, wherein the test environment for each of the plurality of test sites is different from the test environment for each of the other of the plurality of test sites, obtaining a detection signal associated with each of the plurality of test sites, and determining the concentration of one of the biomolecule types based upon the obtained detection signals.

Abstract: A lateral test flow arrangement for a test molecule is disclosed, comprising: a test strip for transporting an analyte away from a sampling region and towards an absorbing region, the test strip having therein and remote from the sampling region, a test region for functionalization with a molecule which binds to the test molecule or to a conjugate of the test molecule; a sensing test capacitor having electrodes extending across the test strip at least partially aligned with the test region and being physically isolated therefrom; a reference test capacitor having electrodes extending across the test strip and being physically isolated therefrom; and an electronic circuit configured to measure a time-dependant capacitance difference between the sensing test capacitor and the reference test capacitor. A method for carrying out that lateral flow tests is also disclosed, as are test systems and in particular pregnancy test systems.

Abstract: Various embodiments are drawn to systems and methods for detecting an analyte of interest in a sample including an optical sensor, a capture probe attached to a surface of the optical sensor wherein the capture probe is capable of binding to the analyte to form a duplex or complex, and an antibody capable of binding to the analyte, duplex, or complex. In several embodiments, systems and methods further include a particle attached to the antibody or capable of binding to the antibody. In several embodiments, systems and methods for analyte detection feature one or more of the following: high detection sensitivity and specificity, scalability and multiplex capacity, ability to analyze large analytes, and ability to detect or measure multiple individual binding events in real-time.

Abstract: Herewith disclosed is a sample analyzer comprising: a measurement section configured to perform a measurement on a sample and generate a measurement value according to the concentration of an analyte in the sample; a memory storing a calibration curve; an analysis section; an output section; and an instruction receiver. When the instruction receiver receives an instruction to perform a diluting measurement on a calibration sample, the measurement section dilutes the calibration sample by a predetermined ratio and performs a measurement on the diluted calibration sample, and the analysis section determines the concentration of the analyte in the diluted calibration sample by applying a measurement value obtained from the diluted calibration sample to the calibration curve. Information generated based on the determined concentration and the known concentration is output.

Abstract: A molecular net formed as a branched pseudorandom copolymer including two broad classes of subunits: capture agents and linking agents. The subunits self-assemble to form a structure capable of binding to predetermined targets. The binding can then be detected.

Abstract: A lateral flow assay detects and differentiates between viral and bacterial infections. A combined point of care diagnostic device tests markers for viral infection and markers for bacterial infection, to effectively assist in the rapid differentiation of viral and bacterial infections. In one preferred embodiment, the bacterial marker is CRP. In another preferred embodiment, the viral marker is MxA. In some embodiments, it is unnecessary to lyse the cells in the sample prior to applying it to the device.

Abstract: Biological activity in holding pens in a micro-fluidic device can be assayed by placing in the holding pens capture objects that bind a particular material of interest produced by the biological activity. The biological material of interest that binds to each capture object can then be assessed, either in the micro-fluidic device or after exporting the capture object from the micro-fluidic device. The assessment can be utilized to characterize the biological activity in each holding pen. The biological activity can be production of the biological material of interest. Thus, the biological activity can correspond to or arise from one or more biological cells. Biological cells within a holding pen can be clonal cell colonies. The biological activity of each clonal cell colony can be assayed while maintaining the clonal status of each colony.

Abstract: A problem to be solved by the present invention is to provide an immunochromatographic test strip and a detection method using immunochromatography avoiding aggregation of colloidal gold conjugates while red blood cells in whole blood are agglutinated and then separated and removed in the case of using polybrene as a blood-agglutinating agent and the colloidal gold conjugates as a detection reagent. To solve the problem, the present inventers reviewed a past reagent configuration itself from a completely different viewpoint rather than selecting type and amount of polyanions and, as a result of extensive study on each element, the inventers surprisingly found that aggregation of colloidal gold can be suppressed by using a certain buffer solution without using neutralization by polyanions.

Abstract: A method for performing an assay on a liquid sample for the detection of one or more analytes of interest in an assay device having a flow path which includes a sample zone and detection zone thereon includes: dispensing the sample onto the sample zone; combining the sample and a reagent, wherein the sample and reagent may be combined prior to addition of the sample to the sample zone or on the assay device, flowing the combined sample/reagent by capillary action into and through the detection zone having capture elements bound thereto, wherein a signal at least partially representative of the presence or concentration of analyte(s) is produced and detected; determining a reaction time or reaction volume; and determining the concentration of the analyte by using both the detected signal and the reaction time or reaction volume.

Abstract: A problem to be solved by the present invention is to provide an immunochromatographic test strip and a detection method using immunochromatography avoiding aggregation of colloidal gold conjugates while red blood cells in whole blood are agglutinated and then separated and removed in the case of using polybrene as a blood-agglutinating agent and the colloidal gold conjugates as a detection reagent. To solve the problem, the present inventers reviewed a past reagent configuration itself from a completely different viewpoint rather than selecting type and amount of polyanions and, as a result of extensive study on each element, the inventers surprisingly found that aggregation of colloidal gold can be suppressed by using a certain buffer solution without using neutralization by polyanions.

Abstract: Provided herein are methods, systems, and devices for detecting and/or identifying one or more specific microorganisms in a culture sample. Indicator particles, such as surface enhanced Raman spectroscopy (SERS)-active nanoparticles, each having associated therewith one or more specific binding members having an affinity for the one or more microorganisms of interest, can form a complex with specific microorganisms in the culture sample. Further, agitating magnetic capture particles also having associated therewith one or more specific binding members having an affinity for the one or more microorganisms of interest can be used to capture the microorganism-indicator particle complex and concentrate the complex in a localized area of an assay vessel for subsequent detection and identification. The complex can be dispersed, pelleted, and redispersed so that the culture sample can be retested a number of times during incubation so as to allow for real-time monitoring of the culture sample.

Abstract: Embodiments of the invention relate generally to devices and methods for pumping and controlling the flow of a fluid. More particularly, embodiments of the invention relate to capacitive pumping and flow control devices and methods. In one embodiment, the invention provides a pump system having an inlet valve, an outlet valve, and a chamber between and in communication with each of the inlet valve and the outlet valve, the chamber having at least one elastic surface, wherein the chamber will dilate in response to a fluid exerting a pressure on the elastic surface, contain a quantity of the fluid when so dilated, and discharge the quantity of the fluid through the opened outlet valve.

Abstract: Systems and methods are described for isolation, separation and detection of a molecular species using a low resource device for processing of samples. Methods include isolation, separation and detection of whole cells.

Abstract: Disclosed herein are methods and devices for detecting the presence of an analyte of interest. A biosensor device can include a reaction chamber and an electrochemical detection chamber. The reaction chamber can include at least one immobilized binding site and a probe conjugate adapted to bind to at least one of the target analyte and the immobilized binding site while the detection chamber can include electrodes for detecting an electrochemical reaction. If present, the target analyte in the fluid sample results in a change in the amount of probe conjugate bound in the reaction chamber, which can be detected electrochemically in the detection chamber.

Abstract: Embodiments disclosed herein relate to a sensor comprising an on-board control system and a testing system. The on-board system can determine viability of the control system or the testing system. Also disclosed are methods of using such a sensor.

Abstract: Disclosed is a method for determining a quantitative estimate of the length of time since conception in a female mammalian subject, the method comprising: a) providing a liquid sample suspected of containing hCG; b) measuring, by means of an assay or assay device, an analyte measurement signal, whose value is dependent upon the level of hCG; c) comparing the measured signal value to an analyte threshold, wherein said analyte threshold corresponds to a time since conception; d) providing an quantitative estimate of the length of time since conception based upon the comparison in step (c).

Abstract: A method for analyzing a metalloprotein and/or the interaction with its environment comprising the following steps: (a) Providing a medium that enhances the detection of the electromagnetic cross-section signal of metalloproteins, (b) Incorporating a metalloprotein to analyse into said medium, (c) Contacting said medium with electromagnetic radiation, (d) Obtaining the electromagnetic cross-section spectrum of said metalloprotein, (e) Determining from said electromagnetic cross-section spectrum at least one parameter related to one or several analytes of interest.

Abstract: Acceleration and automation of immunohistochemical staining are achieved as follows: an automatic electric field immunohistochemical staining apparatus is configured to provided with a sample mounting unit, a solution supply unit, an electric field stifling unit, and a washing unit; the sample mounting unit on which a glass substrate with a tissue specimen fixed thereto is mounted and the electric field stirring unit that includes an upper electrode are operated in coordination to activate an antigen in the tissue specimen; the sample mounting unit and the solution supply unit containing various solutions are operated in coordination to supply a primary-antibody-containing solution to the tissue specimen; the sample mounting unit and the electric field stirring unit are operated in coordination to perform an antigen-antibody reaction of the antigen in the tissue specimen and a primary antibody; and the electric field stirring unit and the washing unit are operated in coordination.

Abstract: The present invention provides an apparatus for retaining solid state reagents and/or for processing sample for a diagnostic test, where the apparatus avoids liquid “hang-up” that would otherwise result in loss of sample or fluid volume during sample transfer. The invention further provides diagnostic methods that employ the apparatus, so as to provide sensitive and accurate analyte detection.