An object of the present invention is to provide a novel method that enables determination or evaluation of the undifferentiated state of human pluripotent stem cells simply, efficiently and non-invasively. The present invention provides a method for determining or evaluating the undifferentiated state of human pluripotent stem cells, comprising a step of detecting or measuring fibronectin in a culture supernatant of human pluripotent stem cells.

A method for performing an enzyme-linked immunosorbent assay (ELISA), the method comprising immobilizing a capture antibody to a substrate, wherein the capture antibody is configured to bind to a laminin beta-1 chain; adding a micronized tissue sample to the substrate containing the capture antibody; adding a detection antibody to the substrate containing the capture antibody and the micronized tissue sample, wherein the detection antibody is configured to bind to a laminin gamma-1 chain; detecting whether a complex of the capture antibody, a target antigen in the micronized tissue sample, and the detection antibody has been formed, wherein presence of the complex indicates presence of the target antigen with intact tertiary structure in the micronized tissue sample, and absence of the complex indicates absence of the target antigen with intact tertiary structure in the micronized tissue sample.

Provided herein are systems, devices and methods for the rapid and accurate measurement of analytes by assay of binding events, by direct, digital measurement of individually resolved analyte/reporter binding events. The digital molecular assay systems, devices and methods disclosed herein are capable of particle-by-particle readout using optical reporter molecules that detect and report the binding of a single analyte molecule, and report each such binding in binary format. Such digital molecular assay systems, devices and methods are useful in a variety of applications, such as on mobile electronic devices for use in the field.

Disclosed herein are methods of detecting a coronavirus, e.g., SARS-CoV-2, using a sandwich assay.

An object of the present invention is to provide: a monoclonal antibody that makes it possible that adenovirus contained in a test specimen is detected and measured rapidly, simply, and with high-sensitivity; and an immunoassay for adenovirus and an immunoassay device therefor, for both of which the monoclonal antibody is used. The present invention provides: a monoclonal antibody or an antigen-binding fragment thereof, which undergoes antigen-antibody reaction with each subtype of adenovirus: type 1, type 2, type 3, type 4, type 5, type 6, type 7 type 8, type 11, type 19, type 31, type 37, type 53, type 54, type 56, type 64, type 79, type 81, and type 85; and an immunoassay and an immunoassay device, for both of which the monoclonal antibody or an antigen-binding fragment thereof is used.

Disclosed herein are recombinant antibodies or the fragment thereof for detecting severe acute respiratory syndrome coronavirus (SARS-CoV). According to some embodiments, the SARS-CoV is SARS-CoV-1. According to some alternative embodiments, the SARS-CoV is SARS-CoV-2. Also disclosed herein are a kit comprising the recombinant antibodies, and a method for diagnosing the infection of SARS-CoV by using the recombinant antibody or the kit.

A diagnostic assay strip includes a first layer that includes an iron mobile labelled specific binding partner that will bind to and iron biomarker from a sample and produce an iron complex and a vitamin A mobile labelled specific binding partner that will bind to a vitamin A biomarker from the sample and produce a vitamin A complex. A second layer includes iron and vitamin A test regions, and a control region. The iron test region has immobilized specific binding partners that will bind to the iron complex. The vitamin A test region has immobilized vitamin A biomarker that will bind to vitamin A mobile labelled specific binding partner, which is not bound to the vitamin A biomarker, passing from the first layer to the second layer. The control region has a moiety which will non-specifically bind to and immobilize the iron and vitamin A labelled specific binding partners. Methods of using the diagnostic assay strip are also discussed.

Disclosed is an isolated binding protein including a cardiac troponin I (cTnI) antigen binding domain, and preparation and a use and the like of the binding protein. The antigen binding domain includes at least one complementarity determining region selected from an amino acid sequence defined in this article, or has at least 80% sequence identity with the complementarity determining region of the amino acid sequence and has KD≤9.96×10.sup.−8 mon affinity with cTnI. The binding protein may be used in the detection field of the cTnI protein.

Disclosed is an isolated binding protein including a cardiac troponin I (cTnI) antigen binding domain, and preparation and a use and the like of the binding protein. The antigen binding domain includes at least one complementarity determining region selected from an amino acid sequence defined in this article, or has at least 80% sequence identity with the complementarity determining region of the amino acid sequence and has KD≤7.51×10.sup.−8 mol/L affinity with cTnI. The binding protein may be used in the detection field of the cTnI.

A test kit for detecting viral or biochemical infections is disclosed comprising a housing, at least one test well in the housing comprising a test material for detecting and indicating the presence of a virus, biochemical agent or antibodies in a test sample, and a control material adjacent the housing comprising a damage indicating material, a taggant material or a track and trace element. A method of detecting viral or biochemical infections using the test kit is also disclosed. The method includes contacting a test material with a test sample, and observing any change in appearance of the test material to determine the presence or absence of the virus, biochemical agent or antibodies.