Superparamagnetic nanoparticle-based analytical method comprising providing a sample having analytes in a sample matrix, providing a point of care chip having analytical regions, each of which is a stationary phase having at least one or more sections, labeling each of the analytes with a superparamagnetic nanoparticle and immobilizing the labeled analytes in the stationary phase, providing an analytical device having a means for exciting the superparamagnetic nanoparticles in vitro and a means for sensing, receiving, and transmitting response of the excited superparamagnetic nanoparticles, placing the chip in the analytical device and exciting the superparamagnetic nanoparticles in vitro, sensing, receiving, and transmitting the response of the superparamagnetic nanoparticles, and analyzing the response and determining characteristic of the analytes, wherein the response of the superparamagnetic nanoparticles comprises harmonics. The present invention also provides the hybrid point of care chip and analyzer to be used in the analytical method.

A nanoparticle measurement device includes a timing signal generation unit, a low-frequency component extraction unit, a low-frequency component calculation unit, a threshold correction unit, and a measurement unit. The timing signal generation unit generates timing signals. The low-frequency component extraction unit extracts low-frequency components according to the timing signals. The low-frequency component calculation unit calculates an interpolated low-frequency component in accordance with the low-frequency components. The threshold correction unit sets a corrected threshold in accordance with the interpolated low-frequency component. The measurement unit extracts and counts nanoparticle pulse signals from a light reception signal according to the timing signals and the corrected threshold.

A configurable washing arrangement (176) washes away at least unreacted components (230, 630) of patient samples (224, 624) from a reaction cell (220, 320) with a multiple number of wash actions (206, 210, 606). The configurable washing arrangement is suitable for use with an immunoassay diagnostic system (100) and washes the reaction cell within a predetermined timed sequence (Tww). The number of the wash actions correspond with an assay type of a plurality of assay types (200, 600). The various number of wash actions may be selected without compromising overall process speed. The immunoassay diagnostic system is configured to perform the plurality of the assay types and thereby detect analytes (244, 644) in patient samples (224, 624) by at least combining each of the patient samples with at least one reagent (216, 232, 616) in the reaction cell.

A microfluidic device for detection of an analyte in a fluid is described. The microfluidic device comprises a substrate having a first surface defining entrances to one or more chambers defined in the substrate, surfaces of the chambers defining a second surface of the substrate, the first surface being modified for selective targeting and capture of at least one analyte to operably effect a blocking of the entrance to at least one of the chambers, and wherein a response characteristic of the microfluidic device is operably varied by the blocking of the entrance to the at least one of the chambers, thereby providing an indication of the presence of the analyte within the fluid.

The present invention provides assays and assay systems for use in spatially encoded biological assays. The invention provides an assay system comprising an assay capable of high levels of multiplexing where reagents are provided to a biological sample in defined spatial patterns; instrumentation capable of controlled delivery of reagents according to the spatial patterns; and a decoding scheme providing a readout that is digital in nature.

Coccidioidomycosis is most often diagnosed serologically and the quantitative complement-fixing antibody test (CF) is considered prognostically useful. Because CF is complex, labor-intensive, and poorly standardized, an enzyme-linked immunoassay (ELISA) alternative would be attractive. The present invention features an antibody-binding domain that is restricted to a 200 amino acid recombinant peptide of the known antigen responsible for CF activity. Overlapping truncations of this peptide do not bind CF antibodies, suggesting that the responsible epitope(s) are conformational. Further, anchoring the antigenic peptide to the ELISA plate by means of a C-terminal tag instead of allowing the peptide to randomly adhere to the plastic plate improves sensitivity of antibody detection by one to two logs in different sera. The newly developed ELISA shows a significant quantitative correlation with CF. This ELISA shows potential as the basis for a new quantitative assay for coccidioidal antibodies.

A system for detecting analytes in a test sample, and a method for processing the same, is provided. The system includes a cartridge reader unit that has a control unit and a pneumatic system, and a cartridge assembly that prepares the samples with mixing material(s) through communication channels. The assembly has a memory chip with parameters for preparing the sample and at least one sensor. The assembly, pneumatic system, and control unit operate together to prepare the sample and provide the prepared sample to the sensor for detecting analytes, and also process measurements from the sensor to generate test results.

This disclosure generally relates to embodiments for detecting presence of one or more allergens in mammalian milk. An exemplary embodiment relates to a method to detect presence of one or more allergen molecules in a composition of mammalian milk, the method includes the steps of: providing a substrate having a plurality of detection sites thereon, each of the plurality of detection sites configured to detect presence of one or more allergen molecules; exposing the plurality of detection sites to a quantity of mammalian milk; detecting presence of a first allergen molecule at a first of the plurality of detection sites by detecting a fragment of DNA, RNA, or amino acids corresponding to the first allergen molecule; wherein the detected fragment excludes naturally occurring molecules present in the composition of mammalian milk.

Enzyme-based diagnostic testing systems for detecting and quantifying at least one of the activity level or the concentration of an enzyme or a biochemical analyte in a biological sample. Such enzyme-based diagnostic testing systems can provide rapid, accurate, affordable laboratory-quality testing at the point of care. An enzyme-based diagnostic testing system may include a lateral-flow chromatographic assay cassette that is configured for assaying an amount or activity of an enzyme in a sample or for enzymatically determining the concentration of an enzyme substrate in a sample. Additionally, the enzyme-based diagnostic testing systems may include testing devices (e.g., a smartphone or a similar remote computing device) having data collection and data analysis capabilities. Such testing devices may also include automated data reporting and decision support.

A sample test cassette includes an inlet configured to introduce a sample liquid into the sample test cassette; an elongate channel configured to receive an elongate lateral flow test strip and configured with a first end that is configured to be in liquid communication with the inlet; and a mechanical transport system that is an integral part of the sample test cassette and is configured to generate a flow of the sample liquid from outside of the inlet and towards the first end of the elongate channel.