The presence of analytes can be detected in the bodily fluid using Electrochemical Impedance Spectroscopy (EIS) or Electrochemical Capacitance Spectroscopy (ECS) in devices, such as handheld point-of-care devices. The devices, as well as systems and methods, utilize using Electrochemical Impedance Spectroscopy (EIS) or Electrochemical Capacitance Spectroscopy (EIS) in combination with an antibody or other target-capturing molecule on a working electrode. Imaginary impedance or phase shift, as well as background subtraction, also may be utilized.

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.

Provided herein are methods for determining the serotype of a virus particle and/or or determining the heterogeneity of a virus particle (e.g., an AAV particle). In other embodiments, the invention provides methods to determine the heterogeneity of AAV particles. In some aspects, the invention provides viral particles (e.g., rAAV particles) with improved stability and/or improved transduction efficiency by increasing the acetylation and/or deamidation of capsid proteins.

The present invention relates to a method for virus assay. More closely the invention relates a method for total quantification of adenovirus in a sample as well as total and functional (active) adenovirus in a sample. The method for determining adenovirus concentration in a sample comprises subjecting said sample to SPR (surface plasmon resonance) assay with immobilized FX (Factor X) and/or immobilized CAR (coxsackievirus and adenovirus receptor) on a sensor surface, wherein the adenovirus concentration is determined from sample binding to immobilized FX and/or immobilized CAR. CAR can be replaced by an ligand binding to adenovirus fiber, such as an anti-adenovirus fiber antibody. FX can be replaced by a ligand binding to adenovirus hexon, such as an anti-adenovirus hexon antibody. The method can be used for quality control in an adenovirus purification process, for example for gene therapy.

The present invention relates to a composition comprising a probe for detecting six representative causative viruses of acute enteritis (norovirus genogroup I and genogroup II, rotavirus, hepatitis A virus, coxsackievirus, astrovirus, and adenovirus), and a DNA microarray, a kit, and a detection method comprising the composition. The present invention is effective due to high specificity and sensitivity to viruses. In addition, since the causative viruses can simply be detected at low cost compared to conventional detection methods, without expensive diagnosis devices or specialists, the present invention may be effectively used as a method for diagnosing viruses causing acute enteritis.

Methods of detecting presence of a virus in a sample are provided, the method including contacting the sample with a solid state nanopore comprising a plurality of virus-specific aptamers and measuring a current-voltage curve in the solid state nanopore, wherein a decrease in the current indicates presence of the virus in the sample. Solid state nanopores comprising a plurality of virus-specific aptamers covalently linked to the interior of the solid state nanopore are also provided. Membranes including a plurality of solid state nanopores including a plurality of covalently attached virus-specific aptamers and kits and systems with a membrane including a plurality of solid state nanopores including a plurality of covalently attached virus-specific aptamers are also provided.

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 a polypeptide having the sequence of the 21st to 944th amino acids in the amino acid sequence of SEQ ID NO: 1; and an immunoassay and an immunoassay device, for both of which the monoclonal antibody or an antigen-binding fragment thereof is used.

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.

The present disclosure provides methods and kits for detecting adeno-associated viruses. In some embodiments, the adeno-associated virus is Anc80. Detection methods include HPLC- and ELISA-based methods.

Disclosed are a novel immunoassay format design for determining a total antibody, and a kit accordingly provided for detecting antibodies of a pathogen or pathogens of infectious diseases within a human blood sample, wherein the kit comprises: a first reagent containing at least one antigen coated on a solid phase support and an anti-human IgM antibody coated on a solid phase support; and a second reagent containing at least one labelled antigen and a labelled anti-human IgG antibody, wherein at least one antigen of the at least one antigen coated on a solid phase support and at least one antigen of the at least one labelled antigen can bind to the same IgG antibody or the same IgM antibody in the sample. The kit can overcome the disadvantages caused by detection principles while retaining the advantages of each detection principle. In addition, also provided is a new method for detecting an antibody produced after the infection of a pathogen or pathogens in a sample.