The present invention relates generally to an assay for detecting and differentiating multiple analytes, if present, in a single fluid sample, including devices and methods therefore.

A diagnostic test system includes a housing, a reader, and a data analyzer. The housing includes a port constructed and arranged to receive a test strip that includes a flow path for a fluid sample, a sample receiving zone couple to the flow path, a label that specifically binds a target analyte, a detection zone coupled to the flow path and comprising a test region exposed for optical inspection and having an immobilized test reagent that specifically binds the target analyte, and at least one reference feature. The reader is operable to obtain light intensity measurements from exposed regions of the test strip when the test strip is loaded in the port. The data analyzer is operable to perform operations including at least one of (a) identifying ones of the light intensity measurements obtained from the test region based on at least one measurement obtained from the at least one reference feature, and (b) generating a control signal modifying at least one operational parameter of the reader based on at least one measurement obtained from the at least one reference feature.

Devices and methods for performing a point of care diagnostic test for detecting and quantifying at least one analyte in a biological sample. The device may include an immunoassay apparatus and a holder with a variable angle stage for positioning the immunoassay apparatus relative to a light source and a detector device. In one embodiment, the device is based upon elastic light scattering, so the variation in the angle of incidence and angle of reflection are optimized to maximize signal generation due to elastic light scattering. The detector device may include a wired or wireless connection to a computer network for communicating with an electronic medical records system, uploading the amount or concentration of at least one analyte present in the sample to the electronic medical records system, or querying a decision support algorithm stored in a computer readable format. The detector device may further include an onboard interpretive algorithm.

Devices and methods for performing a point of care diagnostic test for detecting and quantifying at least one analyte in a biological sample. The device may include an immunoassay apparatus and a holder with a variable angle stage for positioning the immunoassay apparatus relative to a light source and a detector device. In one embodiment, the device is based upon elastic light scattering, so the variation in the angle of incidence and angle of reflection are optimized to maximize signal generation due to elastic light scattering. The detector device may include a wired or wireless connection to a computer network for communicating with an electronic medical records system, uploading the amount or concentration of at least one analyte present in the sample to the electronic medical records system, or querying a decision support algorithm stored in a computer readable format. The detector device may further include an onboard interpretive algorithm.

The present invention relates to a diagnostic method for the detection of small quantities of amniotic fluid in the vagina. More specifically, the invention relates to the detection of PAMG-1 in the vagina using anti-PAMG-1 antibodies.

The present invention relates generally to an assay for detecting and differentiating multiple analytes, if present, in a single fluid sample, including devices and methods therefore.

A diagnostic test system includes a housing, a reader, and a data analyzer. The housing includes a port constructed and arranged to receive a test strip that includes a flow path for a fluid sample, a sample receiving zone couple to the flow path, a label that specifically binds a target analyte, a detection zone coupled to the flow path and comprising a test region exposed for optical inspection and having an immobilized test reagent that specifically binds the target analyte, and at least one reference feature. The reader is operable to obtain light intensity measurements from exposed regions of the test strip when the test strip is loaded in the port. The data analyzer is operable to perform operations including at least one of (a) identifying ones of the light intensity measurements obtained from the test region based on at least one measurement obtained from the at least one reference feature, and (b) generating a control signal modifying at least one operational parameter of the reader based on at least one measurement obtained from the at least one reference feature.

An assay test strip includes a flow path, a sample receiving zone, a label, a detection zone that includes a region of interest, and at least one position marker. The at least one position marker is aligned with respect to the region of interest such that location of the at least one position marker indicates a position of the region of interest. A diagnostic test system includes a reader that obtains light intensity measurement from exposed regions of the test strip, and a data analyzer that performs at least one of (a) identifying ones of the light intensity measurements obtained from the test region based on at least one measurement obtained from the at least one reference feature, and (b) generating a control signal modifying at least one operational parameter of the reader based on at least one measurement obtained from the at least one reference feature.

The present invention relates to an assay device and a method for using such for the quantitative determination of an analyte, based on a test strip, which contains a porous test membrane allowing for capillary flow of the analyte and complexes of the analyte, a porous upstream membrane in fluid connection with the test membrane and a porous downstream membrane in fluid connection with the test membrane, wherein the test membrane contains a test site having immobilized thereon a ligand capable of reacting with the analyte and binding such to the test site, and two standard band sites having immobilized thereon known high and low concentrations of a calibrator agent capable of reacting with a label conjugate and binding such to the standard sites, wherein the upstream membrane has a site for the application of a sample to be analyzed, and has a site downstream from the sample application site for depositing label conjugates capable of reacting with the analyte and label conjugates capable of reacting with the immobilized calibrator agents in the standard bands to provide a known label response in the standards bands, and the downstream membrane is capable of absorbing said sample and providing the capillary flow for the sample through the upstream and test membrane.

Devices and methods for performing a point of care diagnostic test for detecting and quantifying at least one analyte in a biological sample. The device may include an immunoassay apparatus and a holder with a variable angle stage for positioning the immunoassay apparatus relative to a light source and a detector device. In one embodiment, the device is based upon elastic light scattering, so the variation in the angle of incidence and angle of reflection are optimized to maximize signal generation due to elastic light scattering. The detector device may include a wired or wireless connection to a computer network for communicating with an electronic medical records system, uploading the amount or concentration of at least one analyte present in the sample to the electronic medical records system, or querying a decision support algorithm stored in a computer readable format. The detector device may further include an onboard interpretive algorithm.