A prion disease test kit is provided that allows for quick sample collection by an untrained individual and accurate testing of the sample in a lab, which is remote from the sample collection location. The prion disease test kit allows a lay person to easily collect tissue samples from the field and submit the collected tissue samples for prion disease testing, such as testing for chronic wasting disease, at a different location.

The present invention relates to diagnostic devices as well as methods of using these devices for detecting proteins of interest associated with diseases or disorders in mammals. In particular, the proteins of interest may be misfolded proteins associated with certain misfolded-protein disorders in mammals including those mammals suspected of or at risk of having such disorders.

The present invention relates to diagnostic devices as well as methods of using these devices for detecting proteins of interest associated with diseases or disorders in mammals. In particular, the proteins of interest may be misfolded proteins associated with certain misfolded-protein disorders in mammals including those mammals suspected of or at risk of having such disorders.

The invention discloses a device, a kit and a method for determining whether a biological sample contains misfolded protein or misfolded protein aggregates. The detection device comprises a testing component and a sample applicator, the testing component comprises one or more microporous membranes, and the sample applicator comprises one or more capillary tubes. The kit comprises a dye that is capable of binding to misfolded proteins and microporous membranes. During the detection, the sample to be tested is mixed with the dye to form a mixture. The mixture is taken up by a capillary tube. The liquid outlet of the capillary tube is then place in close contact with the surface of a microporous membrane, allowing the mixture to be drawn from the capillary tube into the microporous membrane. The presence or absence of misfolded proteins in the test sample is determined based on the diffusion of the dye in the membrane, as observed by naked eyes or using an instrument.

The invention provides anti-Tau antibodies and methods of using the same.

Methods of measuring the amount of singly- or multiply-phosphorylated p217+ tau protein in a sample are provided. Methods of detecting or diagnosing tauopathies, methods of determining the effectiveness of a treatment of a tauopathy, and methods of determining whether a subject is suitable for anti-p217+ tau antibody therapy are also provided. Also described are antibodies for use in the methods and kits comprising the antibodies.

The invention provides an analytical process for analysing the presence of at least one aggregated conformation prion protein in a sample of body fluid or a sample of tissue and uses the dependency of the amplification of the aggregated conformation on the shear-force intensity applied to the native conformation prion protein, which is also dependent on the specific seed present in the admixture with native conformation prion protein, for specifically analysing for the presence of an aggregated conformation prion protein in the sample. The process of the invention contains the step of determining the content of aggregated conformation prion protein generated in admixture with the sample to be analysed using one shear-force intensity, preferably using least at two different shear-force intensities and the step of comparing data on these contents of generated prion protein having an aggregated conformation with data on the content of aggregated prion protein that is pre-determined, each at the same shear-force intensity for a mixture of the same native conformation prion protein with a reference sample as a seed.

Methods of measuring the amount of singly- or multiply-phosphorylated p217+ tau protein in a sample are provided. Methods of detecting or diagnosing tauopathies, methods of determining the effectiveness of a treatment of a tauopathy, and methods of determining whether a subject is suitable for anti-p217+ tau antibody therapy are also provided. Also described are antibodies for use in the methods and kits comprising the antibodies.

The disclosure provides methods of detecting and monitoring brain injury in a test subject comprising analyzing a blood sample from the test subject for increased levels of PrP.sup.C. The disclosure also provides kits for measuring the amount of PrP.sup.C in a blood sample.

Provided herein is a method for quantifying protein aggregates of a protein misfolding disease in a sample, comprising: placing a capture molecule A on a substrate; selecting a complex sample comprising an aggregate of the protein misfolding disease; removing insoluble components from the sample; contacting the sample with capture molecule A on a part of the substrate; contacting a calibration standard with the capture molecule A on another part of the substrate, contacting at least one capture molecule B with both the aggregate of the sample and the calibration standard, wherein the capture molecule B can emit a detectable signal; comparing the signals of the at least one capture molecule B arranged on the sample assembly and on the calibration standard, wherein the steps do not have to be carried out successively. A related device, kit, and method for detecting protein aggregates are also provided.