A method for image analysis of medical test results, comprising receiving, at a server, information from a mobile device regarding test results from a test performed using a testing device, wherein the testing device includes an alignment target disposed on the testing device and a plurality of immunoassay test strips, receiving at the server an image of the testing device from the mobile device, determining by the server RGB values for a plurality of pixels of the image, normalizing by the server the RGB values into a single value, comparing by the server the single value to a control value stored on the server, and providing by the server a risk indicator, wherein the risk indicator indicates a likelihood of a presence of a medical condition.

An immunochromatographic strip for use in detecting a test substance in a sample by immunochromatography, including: a labeled body-containing section containing a blocked labeled antibody in which a labeling substance and an antibody capable of binding to a test substance are immobilized on a water-soluble carrier made of a water-soluble polymer.

A chemiluminescence immunochromatographic detection assay, comprising a solid membrane, a capture agent, a chemiluminescent conjugate, a testing buffer, a chemiluminescent reaction solution and a chemiluminescent reader. The capture agent is coated on the solid membrane, the chemiluminescent flows through the solid membrane and absorbed in a water absorbent structure, and the target analyte is captured and immobilized by capture agent on the solid membrane, and the uncapped chemiluminescent conjugate is cleaned up by testing buffer through the solid membrane, The complex of chemiluminescent conjugate and target analyte be immobilized on the solid membrane and placed for the quantitative detection of the light by the chemiluminescent reaction solution and the chemiluminescent reader, and complete the quantitative detection. This technology is suitable for chemiluminescent immunochromatographic detection of various analyte immune analysis, and is characterized as high efficiency, convenience, accuracy and high speed in important clinical application.

The invention relates to a respiratory secretion sample collection device that includes a collection reservoir for directly receiving a sample of a respiratory secretion, a displacement member for insertion into the collection reservoir and displacing the sample within the collection reservoir, a container of a diluent for fluid communication with the sample for mixing the diluent with the sample, and an outlet for discharging the mixture of the diluent and the sample to an assay device. In embodiments, the precise volumes of the sample and the diluent are effectively mixed to enable the conduct of assays for which the relative concentration of diluent and sample is critical.

A device for determining the presence and/or quantity of one or more analytes in a sample of human body fluid has a container for receiving a sample of body fluid, with an interior that is delimited by a base and by a circumferential surface. It further comprises at least one test strip and a holding element for receiving and holding the one or more test strips. The holding element is designed such that it has a shape corresponding and adapted to the peripheral circumferential surface of the container. The device further comprises an elongate sampling element having an absorbent sampler that takes up the sample of body fluid and by means of which the sample of body fluid is transferred into the container. The sampling element can include an indicator strip for determining whether the amount of liquid sample sufficient for carrying out an assay.

The present disclosure provides a device and method for measuring an amount of an analyte in a sample, comprising a lateral flow matrix which defines a flow path and which comprises, in series: a sample receiving zone; a labeling zone comprising an unlabeled receptor and a labeled receptor, the unlabeled receptor located downstream of the labeled receptor and separated by a distance; and two serially oriented capture zones capable of providing quantitation of the amount of the analyte in the sample.

The present disclosure relates to devices and methods for identifying conditions in a human or animal body, such as pregnancy or ovulation. For example, the present disclosure relates to devices and methods for identifying pregnancy or ovulation, which devices and methods are adapted to mitigate the “hook effect”, thereby improving accuracy of the devices and methods.

Methods of determining whether a non-diagnostic analyte is present in a non-diagnostic sample are provided. Aspects of the methods include applying a non-diagnostic sample to a sample receiving region of a lateral flow assay device and reading a detection region to determine whether a non-diagnostic analyte is present in the non-diagnostic sample. Also provided are kits that find use in practicing methods of the invention.

Methods, apparatus, systems and articles of manufacture to make and/or process diagnostic tests are disclosed. An example test device, such as a lateral flow immunoassay device, includes a conjugate pad including conjugates for a target analyte; and a test grid including a plurality of zones in a two-dimensional grid, the test grid including: a first test zone in the plurality of zones including at least one of first immobilized antibodies or first immobilized antigens to attach to the target analyte labeled with a first conjugate of the conjugates; and a second test zone in the plurality of zones including at least one of second immobilized antibodies or second immobilized antigens to attach to the target analyte labeled with a second conjugate of the conjugates.

A device for performing an assay comprises a tube, a cap, an insert, and a reaction container. The tube includes a lateral flow strip disposed therein. The cap is coupled to the tube and includes a hollow interior defined at least partially therethrough. The insert is configured to be at least partially received within the hollow interior of the cap. The reaction container includes a cavity configured to store one or more fluids therein, and is rotatably coupled to the cap such that rotation of the cap relative to the reaction container causes (i) mixing of the one or more fluids and (ii) at least a portion of the mixed fluids to be delivered from the reaction container to the lateral flow strip via the insert.