The inventors produced substances that neutralize the activity of a bispecific antibody having an activity of functionally substituting for FVIII, and undertook the construction of methods for measuring the reactivity of FVIII that can ensure accuracy even in the presence of this bispecific antibody. As a result, the inventors discovered that in APTT-based one-stage clotting assay, FVIII activity in the plasma of a hemophilia A patient can be evaluated accurately, and also that in APTT-based Bethesda assay, FVIII inhibitor titer in the plasma of a hemophilia A patient carrying a FVIII inhibitor can be evaluated accurately.

The invention provides methods for identifying a patient as likely to have an onset of massive hemorrhage. In one embodiment, the invention provides a method for identifying a patient as likely to have an onset of massive hemorrhage, the method comprising measuring at least one of first coagulation characteristic parameter reflective of a clotting time in a sample of blood of the patient, a second coagulation characteristic parameter reflective of clot formation in a sample of blood of the patient using the viscoelastic assay to obtain a second result; a third coagulation characteristic parameter reflective of clot strength in a sample of blood of the patient using the viscoelastic assay to obtain a third result; and a fourth coagulation characteristic parameter reflective of clot lysis in a sample of blood of the patient using the viscoelastic assay to obtain a fourth result; wherein, a positive for at least one of the first result, second result, third result and fourth result identifies the patient as likely to have an onset of massive hemorrhage.

The invention provides methods for identifying a patient as likely to have an onset of massive hemorrhage. In one embodiment, the invention provides a method for identifying a patient as likely to have an onset of massive hemorrhage, the method comprising measuring at least one of first coagulation characteristic parameter reflective of a clotting time in a sample of blood of the patient, a second coagulation characteristic parameter reflective of clot formation in a sample of blood of the patient using the viscoelastic assay to obtain a second result; a third coagulation characteristic parameter reflective of clot strength in a sample of blood of the patient using the viscoelastic assay to obtain a third result; and a fourth coagulation characteristic parameter reflective of clot lysis in a sample of blood of the patient using the viscoelastic assay to obtain a fourth result; wherein, a positive for at least one of the first result, second result, third result and fourth result identifies the patient as likely to have an onset of massive hemorrhage.

Increased levels of soluble urokinase-type plasminogen activator receptor (suPAR), particularly a plasma level of over 4.75 ng/ml or 6 ng/nl, have been found to be a predictor of whether a subject with COVID-19 symptoms and/or SARS-CoV-2 infection will require oxygen supplementation.

The present invention relates to clinical decision support systems. In detail, the present invention relates to a method for determining the initial fibrinogen concentration in a biological sample, to the use of fibrinogen added to a biological sample in at least one predetermined concentration, to a device for determining the initial fibrinogen concentration in a biological sample, to a computer program comprising program code means for causing a computer to carry out at least several steps of the method according to the invention, to a computer readable non-transitory storage medium containing instructions for carrying out at least some steps of the method according to the invention, and to a kit for determining the initial fibrinogen concentration in a biological sample.

The present invention relates to clinical decision support systems. In detail, the present invention relates to a method for determining the initial fibrinogen concentration in a biological sample, to the use of fibrinogen added to a biological sample in at least one predetermined concentration, to a device for determining the initial fibrinogen concentration in a biological sample, to a computer program comprising program code means for causing a computer to carry out at least several steps of the method according to the invention, to a computer readable non-transitory storage medium containing instructions for carrying out at least some steps of the method according to the invention, and to a kit for determining the initial fibrinogen concentration in a biological sample.

A problem to be solved by the invention is to improve the sensitivity of measurement of an analyte in a sample by a sandwich immunoassay. The sensitivity can be improved significantly in a sandwich immunoassay using a first antibody and a second antibody when one or both of the first antibody and the second antibody are a mixture of a monoclonal antibody recognizing a linear epitope and a monoclonal antibody recognizing a conformational epitope.

The present disclosure provides, among other aspects, codon-altered polynucleotides encoding Factor VIII variants for expression in mammalian cells. In some embodiments, the disclosure also provides mammalian gene therapy vectors and methods for treating hemophilia A. In some embodiments, the present disclosure provides methods for dosing a hemophilia A patient with a polynucleotide, e.g., a codon-altered polynucleotide, encoding a Factor VIII polypeptide.

The present disclosure provides, among other aspects, codon-altered polynucleotides encoding Factor VIII variants for expression in mammalian cells. In some embodiments, the disclosure also provides mammalian gene therapy vectors and methods for treating hemophilia A. In some embodiments, the present disclosure provides methods for dosing a hemophilia A patient with a polynucleotide, e.g., a codon-altered polynucleotide, encoding a Factor VIII polypeptide.

This invention provides a method that enables determining the fibrinogen concentration in plasma of a sample. The method comprises: computing the fibrinogen concentration in whole blood of the sample using magnetic particles; computing the waveform-based hematocrit value based on the peak value of the movement signal of the magnetic particles; subjecting the fibrinogen concentration in whole blood to hematocrit correction using the waveform-based hematocrit value; and computing the fibrinogen concentration in plasma of the sample.