The present disclosure an ELISA-based assay that uses a glycosylated polypeptide fragment derived from the SARS-CoV-2 spike protein (Covid-19) receptor binding domain (S1RBD) that has affinity for the extracellular domain of Angiotensin Converting Enzyme 2 (ACE2). The S1RBD polypeptide is generated by expression of an encoding nucleic acid by a human cell expression system resulting in glycosylation of the expressed spike receptor binding domain (S1RBD) protein at least at the N343 N-glycosylation site thereof, and which surprisingly and significantly increases the affinity of the S1RBD for ACE2, provides a significant increase in the sensitivity of the assay compared to other known assays.

Provided herein are antibodies that bind to SARS-CoV-2 spike protein or a fragment thereof (e.g., receptor binding domain (RBD)), host cells for producing such antibodies, and kits comprising such antibodies. Also provided herein are compositions comprising antibodies that bind to SARS-CoV-2 spike protein or a fragment thereof (e.g., receptor binding domain) and methods of using such antibodies to diagnose, prevent or treat a SARS-CoV-2 infection, or COVID-19.

The present disclosure discloses a biological nanoparticle detection method with high-sensitivity in which the biological nanoparticle is reacted with a corresponding aptamer-modified copper compound nanoparticle for a period of time; then a surfactant is added to prevent the reactant particles from agglomeration; next, the reaction solution is passed through a filter membrane to enrich the biological nanoparticle-copper compound conjugate, during which small-sized molecules including proteins and uric acid pass directly through the filter membrane; then the filter membrane is washed with PBS, and silver nitrate is added for reaction; and finally a mixed solution of triethylamine hydrochloride, 3,3′,5,5′-tetramethylbenzidine and hydrogen peroxide are added for development, and the color change of the filter membrane is visually observed by naked eyes or by means of a camera.

A method of detecting a pathogen uses a 3D nanochannel device having top and bottom chambers, and a plurality of nanochannels. The method also includes functionalizing a nanochannel by coupling an oligonucleotide probe to an inner surface thereof. The method further includes adding a lysis buffer and patient sample to the top chamber. Moreover, the method includes extracting an oligonucleotide from the patient sample. In addition, the method includes placing top and bottom electrodes in the top and bottom chambers respectively and applying an electrophoretic bias therethrough. The method also includes applying a selection bias across first and second gating nanoelectrodes to direct flow of the oligonucleotide through the nanochannel. Moreover, the method includes applying a sensing bias through a sensing nanoelectrode. In addition, the method includes detecting an output current from the sensing nanoelectrode, and analyzing the output current from the sensing nanoelectrode to detect the oligonucleotide.

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.

The present disclosure relates to methods of detecting a protein from the SARS-CoV-2 virus, or a fragment thereof, in a sample obtained from a subject using a first antibody or antigen-binding fragment thereof that binds to a protein from the SARS-CoV-2 virus, or a fragment thereof, and a second antibody or antigen-binding fragment thereof which binds to a protein from the SARS-CoV-2 virus, or a fragment thereof.

The invention relates to the diagnosis of a SARS-associated coronavirus, such as a SARS CoV-2 infection and SARS-CoV infection, using the SARS-CoV and SARS-CoV-2 nucleocapsid proteins and antibodies binding to these proteins. The invention encompasses reagents, methods and kits for the detection of a SARS-associated coronavirus.

An article of manufacture comprises an optical shade configured for removable attachment to eyewear, e.g., eyeglasses that are retrofitted to include a micro-fluidic tear collector in a nose pad. The optical shade comprises a lens having a lateral flow assay comprising an antibody having an associated fluorescent tag. The fluorescent tag is configured to fluoresce and change a color of the lens upon detection by the flow assay of an antigen that matches the antibody. The antigen comprises viral constituents, such as SARS-CoV-2. The color change of the lens is visible and indicates presence of Covid-19 infection.

Disclosed herein, are compositions, methods, systems, and apparatus for collecting biological material from the nasal cavity of a subject or the olfactory region of a subject's nasal cavity. In some embodiments, the biological material is collected from a targeted sub-region of the nasal cavity, such as a targeted sub-region of the olfactory region, wherein such biological material is specific to the targeted sub-region. In some embodiments, the biological material collected from a targeted sub-region is preserved according to its localization. In some embodiments, the biological material comprises cerebrospinal fluid, one or more microbes of the patient's microbiome, one or more components of the patient's metabolome, one or more pathogens, and/or one or more biomarkers of interest. In some embodiments, a specific formulation is delivered to the region in the nasal cavity for facilitating biological material collection located therein.

The present invention relates to the development of novel immunoassays for the detection of neutralizing antibodies and/or high avidity neutralizing antibodies to SARS-CoV-2 spike protein variants or fragments thereof and, optionally, one or more cytokine in patient samples. Novel multiplex and singleplex immunoassays for the detection of neutralizing antibodies and/or high avidity neutralizing antibodies to SARS-CoV-2 spike protein variants or fragments thereof and, optionally, one or more cytokine in patient samples are also provided.