Lateral flow assay devices, systems, and methods described herein measure concentration of a plurality of analytes of interest in a sample, and can determine the precise concentration of the plurality of analytes of interest, where one or more analytes of interest are present in the sample at high concentration and where one or more analytes of interest are present at low concentration. Precise concentration of each of the plurality of analytes can be determined when a single sample is applied to a single lateral flow assay in a single application, including when a first analyte of interest is present in the single sample at one-millionth the concentration of a second analyte of interest in the single sample.

The present invention provides antibodies and fragments thereof that specifically detect the complex of a specific cognate antigen-binding moiety, in particular antibodies, and its antigen. The antibodies of the present disclosure do not bind either said cognate antigen binding moiety or said antigen alone and this can be used e.g. to directly detect antigen-bound antigen-binding moieties. Further disclosed are methods for production and use of said antibodies and antibody fragments.

The present invention provides antibodies and fragments thereof that specifically detect the complex of a specific cognate antigen-binding moiety, in particular antibodies, and its antigen. The antibodies of the present disclosure do not bind either said cognate antigen binding moiety or said antigen alone and this can be used e.g. to directly detect antigen-bound antigen-binding moieties. Further disclosed are methods for production and use of said antibodies and antibody fragments.

Provided herein are methods, devices, kits, and articles of manufacture for detecting pregnancy-associated plasma protein-A (PAPP-A) in a biological sample, for instance a whole blood or serum sample obtained from a pregnant subject, and estimating gestational age (GA) based on the detection of PAPP-A, such that clinical or personal decisions informed by GA can be made without ultrasound.

Disclosed herein are methods and compositions for prognosing or diagnosing an obstructive renal dysfunction or ureteropelvic junction obstruction (UPJO) in a subject, involving detecting in a urine sample from a subject one or more proteins selected from the group consisting of Immunoglobulin superfamily containing leucine-rich repeat protein (ISLR); Nicotinate-nucleotide pyrophosphorylase [carboxylating] (QPRT); Prostaglandin reductase 1 (PTGR1); Vascular cell adhesion protein 1 (VCAM1); and Ficolin-2 (FCN2), or detectable portions thereof to identify the subject as at risk of or having an obstructive renal dysfunction or UPJO.

Detector systems are described, based on a primary binding compound and a secondary binding compound used in combination with a support to detect a target in a sample. The detection systems include a liquid medium hosting a first binding compound specific to a target, the first binding compound comprising a label; and a solid medium hosting a second binding compound specific to the target, the second binding compound being different from and non-competitive with respect to the first binding compound.

The present invention provides antibodies and fragments thereof that specifically detect the complex of a specific cognate antigen-binding moiety, in particular antibodies, and its antigen. The antibodies of the present disclosure do not bind either said cognate antigen binding moiety or said antigen alone and this can be used e.g. to directly detect antigen-bound antigen-binding moieties. Further disclosed are methods for production and use of said antibodies and antibody fragments.

Point-of-care assays for quantitatively measuring the amount of small analytes, such as opioids, tetrahydrocannibinol (THC), or hormones, in a biological sample are disclosed. The assays are capable of non-competitive detection of a small analyte using binding agents that selectively bind the analyte and capture agents that selectively bind a complex of the binding agent and analyte but do not bind either free binding agent or free analyte. The assay is capable of simultaneous diction of multiple analytes for multiplex analysis and quantitative control. Quantitative measurements are obtained by plotting results against a response surface calculated from a plurality of analyte standards and adjusted using internal controls.

A method of measuring a concentration of an analyte in a bodily fluid sample is provided. The method includes introducing the bodily fluid sample containing the analyte into a test strip for a lateral flow assay (LFA) by a first volume to react the analyte with a metal nano probe for surface-enhanced Raman scattering (SERS), introducing a washing liquid into the test strip by a second volume after a first predetermined time interval has elapsed from the introduction of the bodily fluid sample, and performing a surface-enhanced Raman scattering (SERS)-based spectroscopic analysis on at least one of a test area and a control area of the test strip using a spectroscopic device.

The present invention provides methods, devices, and compositions to rapidly detect analytes, including small analytes, using a lateral flow device. Described herein is such a lateral flow device that can detect and quantify vitamin D in a whole blood, serum, or plasma sample by employing a sandwich-based immunoassay.