Abstract: Disclosed is an invention in the field of conducting an immunoassay of 25(OH) vitamin D in blood or blood components, notably serum or plasma. The invention employs a perfluoro alkyl acid, or a salt thereof, to release 25(OH) vitamin D from vitamin D binding protein. Thereafter the binding protein comprising the 25-OH vitamin D is subjected to a competitive binding assay with a labeled vitamin D compound.

Abstract: An electrochemiluminescence method of detecting an analyte in a liquid sample and a corresponding analysis system. An analyte in a liquid sample is detected by first providing a receptacle containing a fluid comprising protein coated magnetic microparticles to a stirring unit. Stirring of the fluid is necessary since the density of the microparticles is usually higher than the density of the buffer fluid. Thus the microparticles tend to deposit on the bottom of the receptacle leading to an aggregation of the microparticles because of weak interactions. To obtain representative measurements a homogeneous distribution of the microparticles in the buffer fluid is necessary to ensure a constant concentration of microparticles for each analysis cycle. It is further necessary to provide disaggregation of the microparticles, which is also realized by stirring the fluid. Stirring is conducted with a rotational frequency that is adapted to the amount of fluid to be stirred.

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: The application describes methods for determining the particle number and/or molar mass of lipoprotein(a) subform(s) in a biological sample using enzyme linked immunosorbent assay (ELISA). The methods described herein significantly improve lipoprotein ELISA methods and devices capable of quantifying particle numbers and population mass of Lp(a) particles. This technology offers a method for the efficient and cost-effective measurement of specific Lp(a) in a rapid, low-cost format, rather than limited measurement of Lp(a) concentration in patient tissues. The ability to measure the particle number and/or molar mass of lipoprotein(a) subform(s) in a biological sample also provides a useful diagnostic tool for assessing cardiovascular risk in a subject.

Abstract: A test device for detection and visual identification of a specific analyte in a liquid sample such as a bodily fluid is disclosed. The device includes a collection container, a test strip affixed to an interior surface of the collection container, and a removable protective strip adhered over the test strip. The protective strip is configured to be removed from contact with the test strip after the liquid sample has been collected in order to prevent unnecessary exposure and/or contamination of the test strip. In certain embodiments, the protective strip may be removed from the contact with the test strip when the collection container is in a sealed configuration. In other embodiments, the protective strip may be dissolvable when placed in contact with the desired liquid sample. An assay specific to the anticipated analyte may be provided on the test strip.

Abstract: The present invention is directed to a novel method to multiplex long lifetime fluorescent dyes using time-resolved fluorescence (TRF) detection. A combination of spectral and temporal differences in fluorescence emission is used to enhance the ability to separate signals in an assay from multiple dyes. Multiplexed TRF detection apparatuses and systems configured for performing all or part of any of the methods disclosed herein are also provided, particularly apparatuses and systems incorporating cartridge-based multi-mode readers.

Abstract: Disclosed is a novel method for measuring haemagglutinin of an influenza virus, which can construct an assay system in a shorter period of time than a sandwich immunoassay method using two kinds of anti-haemagglutinin antibodies. The method for measuring haemagglutinin of an influenza virus is achieved by a sandwich immunoassay method comprising sandwiching the haemagglutinin between a lectin which binds to the haemagglutinin but does not bind to an antibody, and an anti-haemagglutinin antibody which undergoes antigen-antibody reaction with the haemagglutinin.

Abstract: A device and method for detecting bacteria in a sample can include an optically transparent substrate and a phage that is known to react with the bacteria being detected. The phage can be tagged with a fluorescent tag such as DAPI or SBYR® Gold cyanine dye. Once fluorescently tagged, the phage-substrate combination can be illuminated with a light source, at a wavelength that corresponds to an excitation wavelength for the fluorescent tag to establish a baseline intensity for the device. The device can then be exposed to the sample and illuminated to establish a test intensity. The bacteria to be detected can be deemed as being present if the test intensity is less than the baseline intensity.

Abstract: An object of the present invention is to provide a method of detecting a specific tissue or cell in a sample tissue section and accurately specifying both the position(s) and amount of a biological substance of interest that is expressed on the specific tissue or cell.

Abstract: The present invention intends to provide an immunochromatographic test piece that makes it possible to achieve both highly sensitive detection of a substance to be detected and a simple test piece structure, which are usually difficult to be made compatible with each other.

Abstract: The present invention relates to an enlarged sample of interest for microscopy and methods for enlarging a sample of interest and the optical imaging of a sample of interest with resolution better than the classical microscopy diffraction limit, by synthesizing a swellable polymer network within a sample, it can be physically expanded, resulting in physical magnification.

Abstract: The present invention provides a test kit capable of rapid and highly sensitive detection. The test kit is provided with a first member, which contains a region in which is held a labeling substance with a label immobilized on a substance that specifically binds with a substance to be detected, and a second member, which has a detection zone where the labeling substance is captured through the substance to be detected, which is connected downstream of the first member in the developing direction, and which allows the labeling substance contained in a liquid sample that flows in from the first member, to develop into the detection zone.

Abstract: Disclosed is an at-home blood pregnancy test kit that can identify the presence of hCG in a blood sample to detect pregnancy in female mammals. The present kit includes a housing having a sample strip that is in fluid communication with a sample pad for holding a blood sample, a test pad, and a conjugate pad. The housing further includes a test window and a push button for releasing a reagent that can react with hCG. The reagent and the test pad include antibodies that can bind with hCG antigens to detect presence of the same. The test window is adapted to display a symbol that indicates a negative pregnancy test result in the absence of hCG, or display a symbol that indicates a positive pregnancy test result in the presence of hCG.

Abstract: This invention is in the field of medical devices. Specifically, the present invention provides portable medical devices that allow detection of analytes from a biological fluid. The methods and devices are particularly useful for providing point-of-care testing for a variety of medical applications.

Abstract: Methods and apparatus are provided to resolve analytes within a fluid path using isoelectric focusing, gel electrophoresis, or other separation means. Materials within the fluid path that are compatible with these separation means are used to attach resolved analytes to the wall of the fluid path. Attachment results from a triggerable event such as photoactivation, thermal activation, or chemical activation. In accordance with a further aspect of the present invention, the material in the capillary may also be disrupted, by either the triggerable event or a subsequent event such as melting or photocleavage. Thus, an open lumen or porous structure may be created within the fluid path, allowing unbound analyte materials to be washed from the fluid path, and detection agents to be washed into the fluid path. The separation-compatible materials may be polymerizable monomers, gels, entangled polymers or other materials.

Abstract: The invention is drawn to a method of using nanoparticle aggregates to form sensors and optical filters. Properly sized (60 and 200 nm) nanoparticle aggregates with cores having a sulfur-oxygen molecular species and a shell with a surface in contact with the core are obtained. Those nanoparticle aggregates have a first resonance profile to wavelengths between 350 nm and 1075 nm. A modified resonance profile for those nanoparticle aggregates is determined. The nanoparticle aggregates are then selectively sized by irradiating them with electromagnetic energy at sufficient intensity and spectral content to modify the first resonance profile towards the modified resonance profile. The resulting nanoparticle aggregates can be used as sensors or optical filters at a selected wavelength.

Abstract: An automated microscope slide staining system and staining apparatus and method that features a plurality of individually operable miniaturized pressurizable reaction compartments or a pressurizable common chamber for individually and independently processing a plurality of microscope slides. The apparatus preferably features independently movable slide support elements each having an individually operable heating element.

Abstract: Described here is an automated robotic device that isolates circulating tumor cells (CTCs) or other biological structures with extremely high purity. The device uses powerful magnetic rods covered in removable plastic sleeves. These rods sweep through blood samples, capturing, e.g., cancer cells labeled with antibodies linked to magnetically responsive particles such as superparamagnetic beads. Upon completion of the capturing protocol, the magnetic rods undergo several rounds of washing, thereby removing all contaminating blood cells. The captured target cells are released into a final capture solution by removing the magnetic rods from the sleeves. Additionally, cells captured by this device show no reduced viability when cultured after capture. Cells are captured in a state suitable for genetic analysis. Also disclosed are methods for single cell analysis. Being robotic allows the device to be operated with high throughput.

Abstract: The invention relates to diagnostic methods for assessing the need of a subject for treatment with an anti-oxidant, or alternatively, for determining the utilization efficiency and ultimate effectiveness of anti-oxidant therapy in subjects having been treated with antioxidants. More specifically, the methods of the present invention are particularly useful in prophylactic assessment of individuals at risk for developing diseases or conditions in which oxidative stress plays a role, such that an appropriate therapeutic regimen can be prescribed for that individual, thus leading to alternative therapies and/or life style changes. The invention further relates to methods for assessing the need for, the utilization efficiency and the effectiveness of therapy in subjects having received therapy with specific antioxidant and immune enhancing formulations. Kits are also provided for measuring the levels of markers of oxidative stress and immune cell numbers.

Abstract: This invention provides novel liposome-based articles of manufacture and microarrays and methods of making and using them (1) to detect the presence of one or more agents in a sample, (2) to determine the amount of one or more agents in a sample, and (3) to determine whether a subject is afflicted with a disorder. This invention also provides kits which comprise the instant microarrays.