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Kit and method for detecting antituberculous drugs and metabolites thereof in sample

A kit and anti-tuberculosis technology, which can be used in measurement devices, instruments, scientific instruments, etc., can solve the problem of inability to monitor metabolic status, and achieve the effect of eliminating the need for step-by-step operations, expanding types, and improving reliability.

Pending Publication Date: 2022-04-15
THE THIRD PEOPLES HOSPITAL OF SHENZHEN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The first purpose of the embodiment of the present invention is to provide a kit to solve the problem that the existing anti-tuberculosis drug detection can only monitor the concentration of anti-tuberculosis drugs but not the corresponding metabolic status

Method used

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  • Kit and method for detecting antituberculous drugs and metabolites thereof in sample
  • Kit and method for detecting antituberculous drugs and metabolites thereof in sample
  • Kit and method for detecting antituberculous drugs and metabolites thereof in sample

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] A method for detecting anti-tuberculosis drugs and anti-tuberculosis drugs in a plasma sample, comprising the following steps:

[0059] S10, kit situation

[0060] Kit components: calibrator, 1 tube, 200μL / tube; quality control product, 1 tube, 200μL / tube; instrument quality control product, 1 tube, 200μL / tube; isotope internal standard, 1 tube, dry powder / tube; Mobile phase additive, 1 piece, 2mL / bottle; calibrator diluent, 1 piece, 1mL / bottle; 96-well microplate, 2 pieces; pre-treatment plate sealing film, 1 piece; upper plate sealing film, 1 piece; Operating manual, 1 copy;

[0061] Among them, the calibrator is blank plasma without anti-tuberculosis drugs, and the calibrator contains 51.2mg / L rifampicin, 19.2mg / L isoniazid, 51.2mg / L rifapentine, 128mg / L Pyrazinamide, 25.6mg / L ethambutol, 6.4mg / L clofazimine, 64mg / L cycloserine, 16.6mg / L moxifloxacin, 41.7mg / L levofloxacin, 50mg / L Linezolid, 19.2 mg / L acetyl isoniazid, 8.3 mg / L bedaquiline and 20.4 mg / L deacetyl r...

Embodiment 2

[0081] The method for detecting anti-tuberculosis drugs and anti-tuberculosis drugs in serum samples of tuberculosis patients comprises the following steps:

[0082] S20. Kit situation

[0083] Kit components: calibrator, 1 tube, 200μL / tube; quality control product, 1 tube, 200μL / tube; instrument quality control product, 1 tube, 200μL / tube; isotope internal standard, 1 tube, dry powder / tube; Mobile phase additive, 1 piece, 2mL / bottle; calibrator diluent, 1 piece, 1mL / bottle; 96-well microplate, 2 pieces; pre-treatment plate sealing film, 1 piece; upper plate sealing film, 1 piece; Operating manual, 1 copy;

[0084] Among them, the calibrator is blank serum without anti-tuberculosis drugs, and the calibrator contains 51.2mg / L rifampin, 19.2mg / L isoniazid, 51.2mg / L rifapentine, 128mg / L Pyrazinamide, 25.6mg / L ethambutol, 6.4mg / L clofazimine, 64mg / L cycloserine, 16.6mg / L moxifloxacin, 41.7mg / L levofloxacin, 50mg / L Linezolid, 19.2 mg / L acetyl isoniazid, 8.3 mg / L bedaquiline and ...

Embodiment 3

[0100] The method for detecting anti-tuberculosis drugs and anti-tuberculosis drugs in cerebrospinal fluid samples of tuberculosis patients comprises the following steps:

[0101] S30, kit situation

[0102] Kit components: calibrator, 1 tube, 200μL / tube; quality control product, 1 tube, 200μL / tube; instrument quality control product, 1 tube, 200μL / tube; isotope internal standard, 1 tube, dry powder / tube; Mobile phase additive, 1 piece, 2mL / bottle; calibrator diluent, 1 piece, 1mL / bottle; 96-well microplate, 2 pieces; pre-treatment plate sealing film, 1 piece; upper plate sealing film, 1 piece; Operating manual, 1 copy;

[0103] Among them, the calibrator is blank cerebrospinal fluid without anti-tuberculosis drugs, and the calibrator contains 51.2mg / L rifampicin, 19.2mg / L isoniazid, 51.2mg / L rifapentine, 128mg / L Pyrazinamide, 25.6mg / L ethambutol, 6.4mg / L clofazimine, 64mg / L cycloserine, 16.6mg / L moxifloxacin, 41.7mg / L levofloxacin, 50mg / L Linezolid, 19.2 mg / L acetyl isonia...

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Abstract

The invention particularly provides a kit and a method for detecting antituberculous drugs and metabolites thereof in a sample. The kit is used for detecting antituberculous drugs and metabolites thereof in a sample, and comprises a calibration product, a quality control product, an instrument quality control product and an isotope internal standard product, both the calibration material and the quality control material contain rifampicin, isoniazide, rifapentine, pyrazinamide, ethambutol, clofazimine, cycloserine, moxifloxacin, levofloxacin, linezolid, acetyl isoniazide, bedaquiline and deacetylrifampicin; the instrument quality control product comprises a methanol solution containing rifampicin, isoniazid, rifapentine, pyrazinamide, ethambutol, clofazimine, cycloserine, moxifloxacin, levofloxacin, linezolid, acetyl isoniazid, bedaquiline and deacetylrifampicin; the isotope internal standard substance contains an internal standard substance corresponding to a substance contained in the calibrator. The kit disclosed by the invention can be used for detecting the concentrations of the antituberculous drugs and metabolites thereof in various sample types.

Description

technical field [0001] The invention belongs to the technical field of detection of anti-tuberculosis drugs, in particular to a detection method for anti-tuberculosis drugs and their metabolites in a kit and a sample. Background technique [0002] Tuberculosis has the characteristics of multidrug resistance (MDR-TB) and extreme drug resistance (XDR-TB), so how to suppress the drug resistance of tuberculosis is very important. Early personalized treatment and optimized treatment provide reference. Existing anti-tuberculosis drug concentration monitoring methods generally use kits for detection, but the current kits can only analyze a single drug or evaluate first-line anti-tuberculosis drugs at the same time, and can only detect the concentration of anti-tuberculosis drugs in plasma or serum, which can detect There are few samples, and according to the test results of the current kit, the drug metabolism status of the patient cannot be obtained, nor can it be effectively ana...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/72
CPCG01N30/02G01N30/06G01N30/72G01N2030/045
Inventor 曲久鑫林梁邹瑾饶维桥廖云莉张健聪
Owner THE THIRD PEOPLES HOSPITAL OF SHENZHEN
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