G01N33/56983

Diagnostic test for vaccine validation and authentication and methods of use thereof

The present invention encompasses a diagnostic test and method to authenticate the veracity of a vaccine. The diagnostic test and method are especially useful in a specific and sensitive immunochromatographic assay, performable within about 15 minutes for the authentication, validation, and veracity of a vaccine, such as a COVID-19 vaccine, in a vial prior to administration to a human.

AIRBORNE AGENT COLLECTORS, METHODS, SYSTEMS AND DEVICES FOR MONITORING AIRBORNE AGENTS

Air flow systems, devices and methods for monitoring airborne agents include airborne agent collectors. Airborne agent collectors for collecting and detecting the presence and/or identification of an airborne agent(s) include a soluble and hydrophilic polycaprolactone (PCL) that has been treated with a base (e.g., a base having a pH greater than 8 (e.g., NaOH, NaHCO.sub.3, KOH, Na.sub.2CO.sub.3, and CA(OH).sub.2) and in some embodiments, also treated with a neutralizing agent for increasing hydrophilicity. Detection and identification of airborne agents captured by an airborne agent collector can be performed using any suitable analytical protocols. Such protocols are well known in the art, and include nucleic acid assays, protein assays (e.g., mass spectrometry), and bioassays (e.g., in vitro and in vivo assays). The airborne agent collectors can be used for the detection and identification of nucleic acid from cells or organisms of any type (e.g., viruses, bacteria, fungi) in fixed structures (e.g., homes, sports arenas, theaters, buildings such as offices, laboratories, hospitals, schools, airports, train stations, bus stations, etc.) and in mobile, portable devices or machines (e.g., aircraft, automobiles, air-freshener, air-purifier, air re-circulator, vacuum cleaner, etc.).

NS1-BINDING PROTEIN
20210395347 · 2021-12-23 ·

Provided is an isolated binding protein including an antigen binding domain binding to an NS1 protein, and including specific heavy chain CDR and light chain CDR. The binding protein can specifically identify and bind to NS1, and has relatively high sensitivity and specificity, so as to detect dengue vims. Moreover, the binding protein does not need to be produced by injecting hybridoma cells into mouse peritoneal cavity, while simplifying production, thus stabilizing antibody functionality.

LOW-COST DETECTION OF NOROVIRUS USING PAPER-BASED CELL-FREE SYSTEMS AND SYNBODY-BASED VIRAL ENRICHMENT
20210396745 · 2021-12-23 ·

Provided herein are methods and systems for low-cost, low-equipment detection of pathogens in biological sample. In particular, provided herein is a low-cost method for detecting norovirus that provides reliable, visible test with femtomolar, attomolar, and zeptomolar detection limits and that uses materials suitable for deployment of the methods in the field.

CRISPR EFFECTOR SYSTEM BASED DIAGNOSTICS FOR HEMORRHAGIC FEVER DETECTION

The embodiments disclosed herein utilize RNA targeting effectors to provide a robust CRISPR-based diagnostic for hemorrhagic fever virus applications. Embodiments disclosed herein can differentiate between hemorrhagic fever viruses that present with similar symptoms, as well as between strains of a hemorrhagic fever virus.

BACTERIOPHAGE-BASED SERS-ACTIVE GOLD NANOHALO STRUCTURE AND MANUFACTURING METHOD THEREFOR

The present invention relates to a bacteriophage-based gold nanohalo structure and a fabrication method therefor, and more particularly to a SERS-active gold nanohalo structure in which gold nanoparticles are regularly arranged on bacteriophage MS2, and a fabrication method therefor. The gold nanohalo structure according to the present invention may generate a consistent SERS signal due to regular arrangement of hot spots between the gold nanoparticles, and may be effectively used in the development of a SERS-based detection system.

SYSTEM AND METHOD FOR DIGITAL REMOTE PRIMARY, SECONDARY, AND TERTIARY COLOR CALIBRATION VIA SMART DEVICE IN ANALYSIS OF MEDICAL TEST RESULTS

A method for providing immunoassay test results includes collecting at least one biologic with a testing device, conjugating the biologic with particles on a conjugate pad of a test strip to create an immune complex, binding antigens or antibodies of the immune complex to antigens or antibodies of a test line, providing a software application to be stored on a mobile device having a camera; capturing an image of the testing device, including a color mosaic having at least one color value corresponding to a positive test result, comparing the color values of the test line image to the color values of the image of the color mosaic, determining if the color values of the image of the test line are within a predetermined range of the at least one color value of the image of the color mosaic corresponding to a positive test result; and presenting test results on the viewing screen.

RAPID MULTIPLEXED SEROLOGICAL TEST

Disclosed herein are methods of performing multiplexed serological immunoassays to detect multiple antigens in parallel to determine if a patient has an infection or an immune disorder. Use of multiple antigens in parallel increases specificity and/or sensitivity towards assaying the infection or immune disorder. The infection may be a viral infection such as a SARS-CoV-2 viral infection, a variant of a SARS-CoV-2 viral infection, or a non-SARS-CoV-2 coronavirus infection. Also disclosed herein are methods of performing the multiplexed serological immunoassays on an optical ring resonator substrate. Also disclosed herein are methods of detecting antibodies specific for an antigen that belong to more than one immunoglobulin type.

DIAGNOSTIC TESTING DEVICE
20210396749 · 2021-12-23 ·

A diagnostic testing device along with a method of manufacturing the diagnostic testing device is provided. The diagnostic testing device includes a sheet of foam; a top web including a recess shaped and sized for a lateral flow matrix; a bottom web attachable to the top web; and a sealing layer allocated on the top web configured to prevent contamination of the lateral flow matrix; wherein the lateral flow matrix includes a sample port. The method of manufacturing includes a series of die cutting mechanisms applied to various webs of material unified via a lamination process.

Device and associated methods for performing luminescence and fluorescence measurements of a sample

Apparatuses and methods of optically analyzing fluid within a pipette are described herein. In an embodiment, an optical reader subassembly includes a pipette configured to aspirate and hold a fluid sample within its tip, a housing configured to receive at least the tip of the pipette through a reentrant seal so that the tip of the pipette is located in a light tight manner within an internal area, a light source positioned to be in proximity to the tip of the pipette when the tip of the pipette is received by the housing, the light source configured to project light through the tip of the pipette and onto the fluid sample held within the tip, and an optical sensor configured to take a reading of the fluid sample held within the tip of the pipette without any of the fluid sample being injected from the pipette.