Abstract: A compact optical imaging system including a single filter and a light source that provides lateral illumination for bead detection in digital assays. The light source is configured to emit light toward the detection vessel. The single filter is positioned to receive light reflected from a sample in the detection vessel, that originated from the light source, and receive an output from a sample in the detection vessel. A detector is configured to receive a portion of the reflected light and a portion of the output that passes through the single filter.

Abstract: Disclosed herein are biomarkers for hepatocellular carcinoma and pancreatic cancer. The biomarkers may be laminin gamma 2 monomer, PIVKA-II, AFP, CEA, CA19-9, or combinations thereof. Also disclosed herein are methods of diagnosing, prognosing, classifying risk, and monitoring progression of hepatocellular carcinoma or pancreatic cancer by the detecting the level of laminin gamma 2 monomer, PIVKA-II, AFP, CEA, CA19-9, or combinations thereof.

Abstract: A compact optical imaging system including a single filter and a light source that provides lateral illumination for bead detection in digital assays. The light source is configured to emit light toward the detection vessel. The single filter is positioned to receive light reflected from a sample in the detection vessel, that originated from the light source, and receive an output from a sample in the detection vessel. A detector is configured to receive a portion of the reflected light and a portion of the output that passes through the single filter.

Abstract: Methods of reducing background noise in signal-generating digital assays, such as fluorescent digital immunoassays, using a colorant are disclosed. The methods utilize a binding member that specifically binds to an analyte in a biological sample. The binding member is conjugated to a signal generating compound, e.g., an enzyme, which is dissociated from the binding member. A colorant is added with a signal generating substrate, e.g., a fluorogenic or chromogenic substrate for the enzyme, or after a signal generating substrate to reduce background noise in a fluorescent digital immunoassay. The signal generated between the signal generating compound and the signal generating substrate is detected and correlated to the presence and/or concentration of the analyte.

Abstract: The present disclosure describes methods and kits for reducing interferences in immunoassays performed on solid phase and on samples containing serum or plasma, by adding an effective amount of a polycationic derivative of dextran to the assay.

Abstract: A compact optical imaging system including a single filter and a light source that provides lateral illumination for bead detection in digital assays. The light source is configured to emit light toward the detection vessel. The single filter is positioned to receive light reflected from a sample in the detection vessel, that originated from the light source, and receive an output from a sample in the detection vessel. A detector is configured to receive a portion of the reflected light and a portion of the output that passes through the single filter.

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: To provide a more convenient and more accurate method of assaying ProGRP by improving the stability of ProGRP which is known to be unstable in a biological sample. By using a blood sample in a condition in which a blood coagulation factor is not activated is used as a sample, the degradation of ProGRP is suppressed, whereby it is possible to store a sample for a long period of time and to improve the accuracy of an assay.

Abstract: To provide a more convenient and more accurate method of assaying ProGRP by improving the stability of ProGRP which is known to be unstable in a biological sample. By using a blood sample in a condition in which a blood coagulation factor is not activated is used as a sample, the degradation of ProGRP is suppressed, whereby it is possible to store a sample for a long period of time and to improve the accuracy of an assay.

Abstract: The present disclosure relates to antibodies and immunoassay methods for use in the diagnosis, treatment and prevention of hepatocellular carcinoma (HCC), liver cancer and related conditions.

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

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.