Abstract: Methods for diagnosis of HPV infection in a subject are provided. HPV infection in a subject can be determined by generating mass profile data for a biological sample from the subject and correlating the mass profile data with reference mass profiles to detect the presence or absence, and/or quantity of at least one biomarker associated with HPV infection. Methods for detecting at least one biomarker associated with HPV infection in a biological sample are also provided.

Abstract: Methods for diagnosis of HPV infection in a subject are provided. HPV infection in a subject can be determined by generating mass profile data for a biological sample from the subject and correlating the mass profile data with reference mass profiles to detect the presence or absence, and/or quantity of at least one biomarker associated with HPV infection. Methods for detecting at least one biomarker associated with HPV infection in a biological sample are also provided.

Abstract: Devices, kits, and methods are provided for analyzing a sample for the presence or amount of a bacterium in a sample, and for determining whether or not conditions present while practicing the invention allow for accurate test results. Specifically, the invention provides devices, kits, and methods for analyzing a sample for the presence or amount of a bacterial carbohydrate, while using an analog of the bacterial carbohydrate as a control reagent. In certain embodiments, the invention may provide for analyzing a sample for the presence or amount of a Group A Streptococcus (GAS) bacterium, by determining the presence or amount of ?-N-Acetyl-D-Glucosamine attached to a poly-rhamnose backbone, a bacterial carbohydrate found in GAS, in the sample, and by using Albumin, Bovine, p-Aminophenyl N-Acetyl B-D Glucosaminide, an analog to ?-N-Acetyl-D-Glucosamine as a control reagent.

Abstract: The present invention relates to a device for determining an analyte in a fluid sample in an assay. The device comprises a lid having a plurality of elements and a membrane. The elements have openings which allow passage of fluid to the membrane. The membrane is supported by the lid and covers the openings of the elements. The undersurface of the membrane is in contact with a porous wick which contains a first zone which includes binder attached to a particulate label and a second zone containing salt. The wick extends downward from the membrane and is in contact with the fluid sample.

Abstract: A patient's health may be diagnosed by centrifuging blood samples in a transparent tube, which tube contains one or more bodies or groups of bodies such as floats, inserts, liposomes, or plastic beads of different densities. Each density-defined body carries analyte-capture binding materials such as antigens or antibodies, which are specific to an epitope, or other specific high affinity binding site on a target analyte which target analyte may be in the blood or other sample being tested; and the level of which analyte is indicative of the patient's health. At least one labeled binding material which is also specific to an epitope, or other specific high affinity binding site on the target analyte is added to the sample so as to form labeled binding material/analyte/body complexes in the sample.

Abstract: The present invention relates to a method and assay device for detecting small analytes. The results of the assay can be directly read from the device, which is a lateral flow device.

Abstract: A patient's health may be diagnosed by centrifuging blood samples in a transparent tube, which tube contains one or more bodies or groups of bodies such as floats, inserts, liposomes, or plastic beads of different densities. Each density-defined body carries analyte-capture binding materials such as antigens or antibodies, which are specific to an epitope, or other specific high affinity binding site on a target analyte which target analyte may be in the blood or other sample being tested; and the level of which analyte is indicative of the patient's health. At least one labeled binding material which is also specific to an epitope, or other specific high affinity binding site on the target analyte is added to the sample so as to form labeled binding material/analyte/body complexes in the sample.

Abstract: An indirect assay for analyte employs a particle derivatized with a plurality of molecules of one or more compounds to increase assay sensitivity. In an indirect sandwich assay format, at least one of the compounds is a binder for the analyte, and the tracer is comprised of a binder for at least one of the compounds on the particle. In this manner, a plurality of tracer molecules may be indirectly bound to a single analyte molecule which is bound in a complex formed in the assay.