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 are methods for detecting a target nucleic acid in a sample. The methods include contacting the sample, in the presence of a polymerase and an endonuclease, with a first oligonucleotide that includes, in the 5? to 3? direction, a signal DNA generation sequence, an endonuclease recognition site, and a complementary sequence that has at least one abasic moiety and wherein the complementary sequence has a first complementary sequence that is complementary to at least a portion of the signal DNA generation sequence and a second complementary sequence that is complementary to the 3? end of the target nucleic acid. Also disclosed are methods that include a second oligonucleotide including, in the 5? to 3? direction, a second signal DNA generation sequence, an endonuclease recognition site, and a sequence that is homologous to the first signal DNA generation sequence of the first oligonucleotide and that optionally has at least one abasic site.

Abstract: The methods for sample preparation disclosed herein utilize an air phase to reduce aqueous phase associated with magnetic particles bound to nucleic acids to decrease carryover of one or more contaminants, such as, cell debris, chaotropic agents, non-specifically attached molecules, and the like. This air-transfer step is improved by using a combination of a first population of magnetic particles and a second population of magnetic particles, where the first population of magnetic particles is capable of associating with nucleic acids, and the magnetic particles in the second population are at least two-times larger in size than the size of the magnetic particles in the first population. As discussed herein, the use of this second population of magnetic particles improves the transfer of the first population of magnetic particles by reducing loss of the first magnetic particles during the transfer. The sample preparation methods may be semi-automated or completely automated.

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 are methods for detecting a target nucleic acid in a sample. The methods include contacting the sample, in the presence of a polymerase and an endonuclease, with a first oligonucleotide comprising, in the 5? to 3? direction, a first signal DNA generation sequence, an endonuclease recognition site, and a sequence complementary to the 3? end of a target nucleic acid; a second oligonucleotide comprising, in the 5? to 3? direction, a second signal DNA generation sequence, an endonuclease recognition site, and a sequence that is homologous to the first signal DNA generation sequence of the first oligonucleotide; a third oligonucleotide comprising, in the 5? to 3? direction, a third signal DNA generation sequence, an endonuclease recognition site, and a sequence that is homologous to the second signal DNA generation sequence of the second oligonucleotide.

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: 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: Disclosed are methods for detecting a target nucleic acid in a sample. The methods include contacting the sample, in the presence of a polymerase and an endonuclease, with a first oligonucleotide comprising, in the 5? to 3? direction, a first signal DNA generation sequence, an endonuclease recognition site, and a sequence complementary to the 3? end of a target nucleic acid; a second oligonucleotide comprising, in the 5? to 3? direction, a second signal DNA generation sequence, an endonuclease recognition site, and a sequence that is homologous to the first signal DNA generation sequence of the first oligonucleotide; a third oligonucleotide comprising, in the 5? to 3? direction, a third signal DNA generation sequence, an endonuclease recognition site, and a sequence that is homologous to the second signal DNA generation sequence of the second oligonucleotide.

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: Disclosed are methods for detecting a target nucleic acid in a sample. The methods include contacting the sample, in the presence of a polymerase and an endonuclease, with a first oligonucleotide comprising, in the 5? to 3? direction, a first signal DNA generation sequence, an endonuclease recognition site, and a sequence complementary to the 3? end of a target nucleic acid; a second oligonucleotide comprising, in the 5? to 3? direction, a second signal DNA generation sequence, an endonuclease recognition site, and a sequence that is homologous to the first signal DNA generation sequence of the first oligonucleotide; a third oligonucleotide comprising, in the 5? to 3? direction, a third signal DNA generation sequence, an endonuclease recognition site, and a sequence that is homologous to the second signal DNA generation sequence of the second oligonucleotide.

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: Disclosed are methods for detecting a target nucleic acid in a sample. The methods include contacting said sample, in the presence of a polymerase and an endonuclease, with a sequence conversion oligonucleotide. Also disclosed are methods for detecting a target nucleic acid in a sample in which said sample is contacted, in the presence of a polymerase and an endonuclease, with a sequence conversion oligonucleotide and a signal amplifier oligonucleotide. The disclosure also provides compositions and kits comprising such sequence conversion and signal amplifier oligonucleotides.

Abstract: This present invention relates generally to devices, systems, and methods for performing bioimaging at the microscopic scale and, more particularly, to devices and systems including a disposable testing device configured to perform bioimaging at the microscopic scale, and methods of performing the bioimaging using the disposable testing device. In some aspects, a method is provided for imaging assay beads. The method includes moving a blood sample into a sample testing conduit having a first wall formed from at least a portion of an imager chip, a second wall formed from a transparent material layer, and a plurality of wells. The method further including driving a light emitter to project light through the wells, recording an output signal of at least one of absorbance and fluorescence, and converting the output signal to a value indicative of a reaction of a biological sample within each of the plurality of wells.

Abstract: This present invention relates generally to devices, systems, and methods for performing bioimaging at the microscopic scale and, more particularly, to devices and systems including a disposable testing device configured to perform bioimaging at the microscopic scale, and methods of performing the bioimaging using the disposable testing device. In some aspects, a testing device is provided for imaging assay beads. The testing device having a sample entry port for receiving the blood sample; a sample testing conduit fluidically connected to the sample entry port, the sample testing conduit including: (i) a planar member, (ii) a transparent planar member, and (iii) a plurality of wells having a predetermined average well height and disposed between the first planar member and the second planar member; and an imager chip forming at least a portion of the planar member.

Abstract: Disclosed are methods for detecting a target nucleic acid in a sample. The methods include contacting said sample, in the presence of a polymerase and an endonuclease, with a sequence conversion oligonucleotide having locked nucleic acids at select positions sufficient to decrease non-specific background signal amplification. Also disclosed are methods for detecting a target nucleic acid in a sample in which said sample is contacted, in the presence of a polymerase and an endonuclease, with a sequence conversion oligonucleotide and a signal amplifier oligonucleotide, both having locked nucleic acids at select positions sufficient to decrease non-specific background signal amplification. The disclosure also provides compositions and kits comprising such sequence conversion and signal amplifier oligonucleotides.

Abstract: Disclosed are methods for detecting a target nucleic acid in sample, which include contacting the sample with an oligonucleotide having a hairpin structure, where the oligonucleotide includes, in the 5? to 3? direction, an arbitrary sequence, an endonuclease recognition site for a nicking reaction, a sequence complementary to the arbitrary sequence, and a sequence complementary to the target nucleic acid; a polymerase; and an endonuclease capable of nicking the endonuclease recognition site. The disclosure also provides compositions and kits comprising an oligonucleotide having a hairpin structure, where the oligonucleotide includes, in the 5? to 3? direction an arbitrary sequence, an endonuclease recognition site for a nicking reaction, a sequence complementary to the arbitrary sequence, and a sequence complementary to a target nucleic acid.

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: Disclosed are methods for detecting a target nucleic acid in sample, which include contacting the sample with an oligonucleotide having a hairpin structure, where the oligonucleotide includes, in the 5? to 3? direction, an arbitrary sequence, an endonuclease recognition site for a nicking reaction, a sequence complementary to the arbitrary sequence, and a sequence complementary to the target nucleic acid; a polymerase; and an endonuclease capable of nicking the endonuclease recognition site. The disclosure also provides compositions and kits comprising an oligonucleotide having a hairpin structure, where the oligonucleotide includes, in the 5? to 3? direction an arbitrary sequence, an endonuclease recognition site for a nicking reaction, a sequence complementary to the arbitrary sequence, and a sequence complementary to a target nucleic acid.

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.