Abstract: Sample analysis systems and methods using assay surfaces, assay processing units (APUs), assay processing systems (APSs), and laboratory systems are disclosed. An assay surface includes a sample processing component comprising a plurality of regions, including at least one wash region and at least one storage region configured to hold a plurality of solid supports moveable through the regions under a magnetic force, and a detection component configured to receive the solid supports. An APU includes an assay surface receiving component, a magnetic element configured to generate a moveable magnetic field, and one or more processors configured to move the magnetic field. An APS includes one or more assay surfaces and an APU. A laboratory system includes one or more APSs and a controller for parallel processing. Sample processing and detection methods are disclosed with a reduced sample volume and/or shortened processing time and/or higher sensitivity.

Abstract: Disclosed herein are methods, kits, and systems relates for detecting the presence or determining the amount of SARS-CoV-2 nucleocapsid protein in one or more samples obtained from a subject.

Abstract: Methods and kits for reducing non-specific binding in an immunoassay for PIVKA-II in a test sample are described, in which the test sample is reacted with an anti-prothrombin antibody in the presence of one or more of the following additives: skim milk, saponin, CaCl2, MgCl2, and a sulfobetaine zwitterionic detergent.

Abstract: Methods for diagnosing rheumatoid arthritis (RA) are disclosed, using measurement of the CCL8 protein level in a test sample from a subject. Testing for CCL8 as an indicator of RA can be combined with testing for other indicators of RA, including clinical assessments, imaging or other RA markers such as Rheumatoid factor (RF). CCL8 testing can be used for discriminating RA from other diseases or conditions, evaluating the severity of RA. Related diagnostic reagents, kits, pharmaceutical compositions, and methods for identifying a candidate substance as a therapeutic agent for treating rheumatoid arthritis are also described.

Abstract: Provided are methods of diagnosing rheumatoid arthritis in a patient by detecting the presence and/or amount of a biomarker of rheumatoid arthritis in a sample from the patient. The methods and biomarkers may be used to develop an accurate prognosis for a patient having rheumatoid arthritis or suspected of having rheumatoid arthritis, or to accurately diagnose a patient having, or suspected of having rheumatoid arthritis. The methods and biomarkers may be used to identify and/or classify a patient as a candidate for a rheumatoid arthritis therapy.

Abstract: Methods and kits for reducing non-specific binding in an immunoassay for PIVKA-II in a test sample are described, in which the test sample is reacted with an anti-prothrombin antibody in the presence of one or more of the following additives: skim milk, saponin, CaCl2, MgCl2, and a sulfobetaine zwitterionic detergent.

Abstract: Methods for diagnosing rheumatoid arthritis (RA) are disclosed, using measurement of the CCL8 protein level in a test sample from a subject. Testing for CCL8 as an indicator of RA can be combined with testing for other indicators of RA, including clinical assessments, imaging or other RA markers such as Rheumatoid factor (RF). CCL8 testing can be used for discriminating RA from other diseases or conditions, evaluating the severity of RA. Related diagnostic reagents, kits, pharmaceutical compositions, and methods for identifying a candidate substance as a therapeutic agent for treating rheumatoid arthritis are also described.

Abstract: An immunoassay device which comprises a Chromatography strip having a substrate adhered to the under surface thereof and a protective laminate adhered to the top surface thereof, wherein a space is arranged on the top and/or under surface of at least a partial region of a coloring region of the chromatography strip.

Abstract: An immunoassay device which comprises a Chromatography strip having a substrate adhered to the under surface thereof and a protective laminate adhered to the top surface thereof, wherein a space is arranged on the top and/or under surface of at least a partial region of a coloring region of the chromatography strip.