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.

Provided herein are nucleic acid-cleaving catalytic nucleic acid probes, biosensors and lateral flow biosensor devices and methods and kits of using the probes, biosensors and lateral flow biosensor devices for detecting an analyte present on or generated from a microorganism in a test sample, including Helicobacter pylori and methods for determining whether a subject has a Helicobacter pylori infection.

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 methods and systems for assaying a sample. A microfluidic device to perform an assay of a sample (e.g., biological sample) is described having a sample application site, a porous component and a flow channel. The porous component provides for uniform dissolution of a reagent and mixing of the sample and reagent without filtering the sample.

The present disclosure provides methods and systems for assaying a sample. A microfluidic device to perform an assay of a sample (e.g., biological sample) is described having a sample application site, a porous component and a flow channel. The porous component provides for uniform dissolution of a reagent and mixing of the sample and reagent without filtering the sample.

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.

The present invention provides ST6GAL1, GALNT7, FUT8 and GCNT1 as novel biological fluid (e.g. blood or urine) biomarkers for prostate cancer. Methods for diagnosing prostate cancer or the risk of developing prostate cancer, or for monitoring prostate cancer progression (including prostate cancer relapse) and methods for treatment of prostate cancer are also provided. The invention also provides methods for determining the therapeutic effect of appropriate treatment regimens for prostate cancer or determining a subject's compliance or adherence with a prescribed treatment regimen for prostate cancer. Corresponding kits, assay devices and uses are also provided.

It is an object of the present invention to provide improved lateral flow test devices that can provide sensitive and accurate quantitative test results, and methods for the manufacture thereof.