TH17657U - Solutions for preserving the quality of conjugates and conjugate packaging plates, including the molecules used in signal provision or amplification, and the processes for using solutions to prepare conjugates and packaging plates. - Google Patents

Abstract

------February 21, 2020------(OCR) Page 1 of 1. Abstract of the Invention: A solution for preserving the quality of conjugated substances and conjugated membranes, including molecules used for signal amplification, and a process for using the solution to prepare conjugated substances and conjugated membranes. The preservation solution consists of a buffer solution, a non-specific anti-aggregation agent, and dimer or chain carbohydrates, and may include additional antimicrobial agents. The process for using the solution to prepare conjugated substances for use with the test kit includes the steps of dissolving the conjugated substance in the solution and packing the conjugated particle mixture into the conjugated membranes of the test kit. The process for using the solution to prepare conjugated membranes or molecules used for signal amplification for use with the test kit includes the steps of conditioning the conjugated membranes with the solution by soaking and/or spraying, drying the membranes, and storing the membranes. This invention was developed to preserve the quality of conjugates and their encapsulated membranes, maintaining their ability to bind to target molecules and provide or amplify signals. This improves the efficiency of assay kits containing conjugates related to chromatography and targeting ligands, ensuring their effectiveness and stability. The assay kits utilize horizontal, lateral, immersion, or vertical flow chromatography for target molecule detection. This method can be applied to detect various target molecules such as pathogens, chemicals, drug molecules, biomarkers, and specific targeted substances. ------------ Page 1 of 1 Summary of Invention: A reagent for preserving the quality of conjugates, including conjugate membranes and/or molecules used for signal amplification, and a method for preparing the reagent and membrane, have been developed to maintain their quality and ability to bind to target molecules and provide or amplify signals, thereby improving the effectiveness of assay kits. The efficiency of assay kits containing conjugate components, related to chromatography techniques and targeting ligands, can be improved to ensure effective and stable performance. This can also enhance the overall efficiency of the assay kit, which relies on horizontal, lateral, dip, or vertical flow chromatography for target molecular detection. This method can be applied to detect various target molecules such as pathogens, chemicals, drug molecules, biomarkers, and specific targeted substances.

Claims (8)

------February 21, 2020------(OCR) Page 1 of 2 pages. Claim 1. The solution for maintaining the quality of conjugates and conjugate packaging plates, including molecules used in signal provision or amplification, consists of: a. At least one selectable buffer solution from tris-hydrochloride buffer, borate buffer, borax buffer, phosphate buffer, or carbonate buffer, with a buffer solution concentration of 0.1-100 millimolar. b. At least one selectable nonspecific anti-binding agent from bromine albumin, egg albumin, human albumin, casein, skim milk, or polyvinylpyrrolidone polymer. where a nonspecific anti-aggregation agent is present in a proportion of 0.1–40% by weight of the total mixture, and c. At least one selectable dimer or chain carbohydrate from maltodextrin, hydroxylpropyl beta-cyclodextrin, beta-cyclodextrin, cyclodextrin, mannitol, trehalose, or raffinose, where the dimer or chain carbohydrate is present in a proportion of 0.1–40% by weight of the total mixture, to which a buffer solution is added to the reagent to adjust the total mixture to 100% by weight.2. The reagent for maintaining the quality of the conjugate and conjugate packaging, including the molecules used for signaling or amplification according to claim 1, shall be supplemented with at least one selectable antimicrobial agent from sodium azide or thymerrosal, where the antimicrobial agent is present in a proportion of 0.01–0.1% by weight of the total mixture.3. Reagents for preserving the quality of conjugates and conjugate membranes, including molecules used for signal delivery or amplification, under Patent 1 or 2, where the reagents are used with at least one selected assay kit from the target molecule detection assay kits or signal display assay kits. 4. Reagents for preserving the quality of conjugates and conjugate membranes, including molecules used for signal delivery or amplification, under Patent 3, where at least one selected target molecule from pathogens, chemicals, drug molecules, biomarkers, hormones, and at least one selected specific target from biomolecules. 5. Reagents for preserving the quality of conjugates and conjugate membranes, including molecules used for signal delivery or amplification, under Patent 3 or 4, where the target molecule detection assay kit relies on lateral flow, dip, and vertical flow chromatography techniques. Either one, page 2 of 2, page 6. The reagents for preserving the quality of the conjugate and conjugate membranes, including the molecules used for signal delivery or amplification, as per claim 3, whereby the signal-displaying assay kit contains: a. At least one target-specific molecule selected from antibody molecules, antibody-synthetic fragments or derivatives, DNA fragments, RNA fragments, nucleic acid strands, aptamers, peptides, PNA, avidin, and biotin; and b. At least one signal delivery/amplification molecule selected from gold nanoparticles, metallic particles, and inorganic substances, colorants, coloring enzymes, fluorescent signaling agents, Raman signaling agents, infrared signaling agents, coloring polymers, and signaling polymers, where the target-specific molecule is labeled with the signal delivery/amplification molecule. 7. The procedure for using the reagents for preserving the quality of the conjugate and conjugate membranes, including the molecules used for signal delivery or amplification, as per claim 1-6. The preparation of conjugates for use with the test kit consists of the following steps: a. Mixing the prepared conjugate with an opacity value of 0.1-30 into the specified reagent to obtain the conjugate mixture; and b. Loading the conjugate particle mixture into the conjugate packing plates of the test kit using a volume of 0.1-10 microliters per test kit. 8. The method for using the reagent for maintaining the quality of the conjugate and conjugate packing plates, including the molecules used for signal generation or amplification, as per any one of Patents 1-6, for the preparation of conjugate packing plates/molecules used for signal generation or amplification for use with the test kit. The process consists of the following steps: a. Conditioning the conjugated/molecular membrane used for signal amplification or expansion with the aforementioned solution for 1-30 minutes by immersion and/or spraying. b. Drying the membrane at a temperature of 4-37°C with a relative humidity of 10-60% for 1-12 hours. c. Storing the dried membrane at a temperature of 4-25°C with a relative humidity of 10-60% and keeping it away from light. ------------ Page 1 of 2 pages. Claims. 1. The solution for maintaining the quality of the conjugate, including the conjugate and/or molecule packaging used for signaling or amplification, consists of: a. At least one selected buffer solution from three-hydrochloride buffer, borate buffer, borax buffer, phosphate buffer, or carbonate buffer, with a buffer solution concentration of 0.1–100 millimolar. b. At least one selected nonspecific anti-binding agent from bovine albumin, egg albumin, human albumin, casein, skim milk, or polyvinylpyrrolidone polymer. Where the nonspecific anti-aggregation agent constitutes 0.1-40% by weight of the total mixture, and C. At least one selectable dimer or chain carbohydrate from maltodextrin, hydroxylpropyl beta-cyclodextrin, beta-cyclodextrin, cyclodextrin, mannitol, trehalose, or raffinose, where the dimer or chain carbohydrate constitutes 0.1-40% by weight of the total mixture, at which point a buffer solution is added to the solution to adjust the total mixture to 100% by weight. 2. The solution, as per claim 1, shall be further composed of at least one selectable antimicrobial agent from sodium azide or thymerosal, with the antimicrobial agent present in a proportion of 0.01-0.1% by weight of the total mixture. 3. Reagents as per claim 1 or 2, whereby at least one selected assay kit from the assay kits for target molecule detection or signal presentation. 4. Reagents pursuant to claim 3, where at least one selectable target molecule from the pathogen, chemical, drug molecule, biomarker, hormone, and at least one selectable specific target from the biomolecule. 5. Reagents as per claim 3 or 4, whereby the assay kit for the detection of the target molecule relies on one of the following techniques: lateral flow, immersion, or vertical flow chromatography. (Page 2 of 2) 6. Reagents, as per claim 3, whereby the signal-displaying assay kit shall consist of: a. a molecule specific to the target molecule, of which at least one may be selected from antibody molecules, antibody fragments or synthetic derivatives, DNA fragments, RNA fragments, nucleic acid strands, aptamers, peptides, PNA, avidin, and biotin; and b. a signal-giving/amplifying molecule, of which at least one may be selected from gold nanoparticles, metallic particles and inorganic substances, colorants, coloring enzymes, fluorescent signaling agents, Raman signaling agents, infrared signaling agents, coloring polymers, and signaling polymers, whereby the molecule specific to the target molecule is labeled with the signal-giving/amplifying molecule. 7. The procedure for using any one of the reagents according to claims 1-6 for the preparation of conjugates for use with the test kit consists of: a. Mixing the prepared conjugate with an opacity value of 0.1-30 into the said reagent to obtain the conjugate mixture; and b. Loading the conjugate particle mixture into the conjugate packing plate of the test kit using a volume of 0.1-10 microliters per test kit. 8. The procedure for using any one of the reagents described in claims 1-6 for the preparation of conjugate/molecule-conjugated membranes used for signal amplification or activation in use with the test kit includes: a. Conditioning the conjugate/molecule-conjugated membranes with the aforementioned reagents for approximately 1-30 minutes by immersion and/or spraying; b. Drying the membranes at a temperature of 4-37°C with a relative humidity of 10-60% for at least 1-12 hours; and c. Storing the dried membranes at a temperature of 4-25°C with a relative humidity of 10-60% and keeping them away from light.