US 12,416,633 B2
Method and system for exposing hidden or masked antigenic sites of viral specimens present in biosamples using a home-based COVID-19 rapid lateral flow immunoassay test
Norberto A. Guzman, East Brunswick, NJ (US)
Assigned to Princeton Biochemicals, Princeton, NJ (US)
Filed by PRINCETON BIOCHEMICALS, INC., Princeton, NJ (US)
Filed on Dec. 27, 2022, as Appl. No. 18/088,996.
Prior Publication US 2024/0210398 A1, Jun. 27, 2024
Int. Cl. G01N 33/569 (2006.01); G01N 33/543 (2006.01)
CPC G01N 33/56983 (2013.01) [G01N 33/54388 (2021.08); G01N 33/54393 (2013.01); G01N 2333/165 (2013.01); G01N 2469/10 (2013.01)] 8 Claims
OG exemplary drawing
 
1. A disease detection system, comprising:
a platform or cartridge configured to perform a rapid lateral flow chromatographic immunoassay (LFIA) test;
a container or tube configured for receiving a sample;
a detergent contained in the container or tube, the detergent comprising one or more non-ionic detergents;
a digestive enzyme, the digestive enzyme is in solution with the detergent contained in the container or tube or the digestive enzyme is immobilized on a solid support, the solid support being a surface of a particle within the container or tube or the solid support being an inner surface of the container or tube, the digestive enzyme is one or more of subtilisin, trypsin, pepsin, chymotrypsin, pronase, papain, proteinase K, thermophilic enzyme, hyaluronidase, and amylase;
a sample application zone disposed on or in the platform or cartridge configured for receiving the sample, the sample having been disrupted by the digestive enzyme and the detergent contained in the container or tube to release content and digest proteins and glycoproteins of the sample to form a lysed-digested-extracted sample; and
a migration zone disposed on the platform or cartridge receiving flow of the lysed-digested-extracted sample from the sample application zone by capillary action, the migration zone including a binding molecule to bind with an analyte of interest to generate an analyte of interest complex,
wherein qualitative detection of the analyte of interest complex in the migration zone indicates presence of the analyte of interest in the lysed-digested-extracted sample and wherein the analyte of interest is a nucleocapsid protein antigen from SARS-CoV-2 and wherein when the digestive enzyme is one or more digestive enzymes in a solution with the detergent, the one or more digestive enzymes being in an amount ranging from about 0.1% to about 10% of total volume of the sample and the one or more detergents being in an amount ranging from about 0.1% to about 2% of total volume of the sample.