Abstract: Methods for preparing a sample for detection of an analyte of interest that is bound in vivo to a protein are provided. The method comprises providing a processing reagent comprising metaperiodate and contacting a sample suspected of comprising an analyte of interest associated with a protein with the processing reagent to form a mixture. The analyte of interest, if present in the sample (or mixture), is separated from its associated protein for detection of the analyte of interest. In one embodiment, the method is applied to samples for the detection of levels of vitamin D circulating in the blood. Samples are processed using the reagent disclosed herein to separate the analyte of interest, vitamin D or a metabolite thereof, from the vitamin D binding protein and/or albumin, for detection of the analyte separated from its binding protein(s).

Abstract: A system comprised of an apparatus and a test device is described. The test device and the apparatus are designed to interact to determine the presence or absence of an analyte of interest in a sample placed on the test device.

Abstract: A combination of components in a capillary flow channel use capillary forces to passively control the movement of liquid samples within a microfluidic device. To detect a target, a liquid sample introduced to a proximal portion of a capillary channel of a microfluidic device moves by capillary action along the specific components of capillary channel.

Abstract: A method for species-independent measurement of complement (C) activation in animals. The method comprises taking samples in the range of 3-100 microliter of anticoagulated blood, plasma or serum of an animal (specimen), mixing the specimen with a specificity converting protein matrix (SCM), mixing to the specimen/SCM mixture an activator of the C system (Act), incubating the specimen/SCM/Act mixture at a temperature between 36° C. to 38° C. for a time of 5-120 min and determining the production of one or more human proteins by ELISA or other analytical methods.

Abstract: Methods, compositions and kits for detecting Group A streptococcus in a biological sample are described. More particularly, the present disclosure provides an immunoassay in which the specificity of detection of Group A streptococcus is enhanced by addition of N-acetyl-D-glucosamine. These methods, compositions and kits are useful in convenient, reliable and early diagnosis of streptococcal infection in a human subject.

Abstract: A combination of capillary forces and gas pressure is used to control the movement of liquid samples within a microfluidic device. A liquid sample introduced to a proximal portion of a capillary channel of a microfluidic device moves by capillary action partway along the capillary channel. As the liquid sample moves, a pressure of a gas acting upon a distal gas-liquid interface of the liquid sample increases by an amount sufficient to stop further movement of the liquid sample. To initiate further movement of the liquid sample, a pump connected to a distal portion of the capillary channel decreases the pressure of the gas acting upon the distal gas-liquid interface of the liquid sample by an amount sufficient to permit the liquid sample to move by capillary action further along the capillary channel of the microfluidic device.

Abstract: More particularly, the present invention relates to a method for the detection of a target, e.g. pathogen in a human body fluid wherein a body fluid sample is collected with a swab member.

Abstract: Disclosed herein is a method for improving the precision of a test result from an instrument with an optical system that detects a signal. The method comprises including in the instrument a normalization target disposed directly or indirectly in the optical path of the optical system. Also disclosed are instruments comprising a normalization target, and systems comprising such an instrument and a test device that receives a sample suspected of containing an analyte.

Abstract: 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.

Abstract: A device for extraction or isolation of an analyte, such as a nucleic acid, a protein, or a cell, from a sample, and in particular from a biological sample is described. Methods of using the device are also described.

Abstract: A laminated, integrated, analyte assay device and methods of using the device are described. The assay device is useful as an inexpensive, disposable assay device for detecting the presence and/or amount of a particular analyte in a body fluid or other sample.

Abstract: A system comprised of an apparatus and a test device is described. The test device and the apparatus are designed to interact to determine the presence or absence of an analyte of interest in a sample placed on the test device.

Abstract: 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.

Abstract: The invention provides compositions and methods for detecting thyroid hormone blocking immunoglobulin (TBI). The invention's methods are sensitive and specific for TBI, and may be used for the dual detection of both TBI and TSI. The invention's compositions and methods are useful for the diagnosis of diseases that are associated with the presence of TBI and/or TSI, for monitoring the progress of disease and/or treatment regimens, therapeutics, vaccines, etc., and for assisting clinicians in making treatment decisions.

Abstract: Methods, compositions and kits for detecting the complement Factor B cleavage product Ba in a biological sample are described. These methods, compositions and kits are useful in convenient, reliable and early diagnosis of or ruling out pre-eclampsia in a pregnant human subject.

Abstract: The present disclosure is directed to PCR-based assays and compositions for use in molecular detection of viral, bacterial and parasitic infectious agents in body fluid or tissue samples, and in particular to multiplex assays, as well as to solid reagent compositions for use in such assays.

Abstract: A packaging system with a dual chamber configuration is described. The packaging system is comprised of a primary chamber and a secondary chamber, where the primary chamber and the secondary chamber are in or capable of being in fluidic communication by a channel. The secondary chamber has an upper layer and a lower layer, wherein the lower layer is of a material that opens in response to an applied force that the upper layer is able to withstand, whereupon a fluid, preferably a liquid, in the primary chamber can be dispensed from the packaging system. In one embodiment, the packaging system is integrated with a planar cartridge having one or more chambers for processing a sample for detection of an analyte.

Abstract: Methods, compositions and kits for detecting the complement Factor B cleavage product Ba in a biological sample are described. These methods, compositions and kits are useful in convenient, reliable and early diagnosis of or ruling out pre-eclampsia in a pregnant human subject.

Abstract: 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.

Abstract: The present invention provides methods and compositions useful in the diagnosis and management of autoimmune diseases. In particular, the present invention provides improved methods and compositions for the diagnosis and management of Graves' disease. The methods of the present invention not only avoids the need for radioactivity and are much simpler, economical, and rapid than methods traditionally used for the diagnosis of Graves' disease, but also improve upon the sensitivity and detection abilities of previous luciferase-based autoantibody detection assays. Such improvements are based upon the superior performance of assays comprising a chimeric TSH receptor in the presence of a glucocorticoid including, but not limited to, dexamethasone.