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High-throughput mass spectrometry detection kit and quality inspection method thereof

A technology of mass spectrometry detection and kit, which is applied in the field of mass spectrometry detection of biological samples, can solve the problems of unstable data, low accuracy rate, and large batch-to-batch difference, and achieve the effect of improving accuracy rate, high repeatability, and stable production process

Active Publication Date: 2020-06-05
HANGZHOU WELL HEALTHCARE TECH CO LTD
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  • Abstract
  • Description
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  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In the MALDI MS test, the existing sample mass spectrometry detection reagents require complex sample pretreatment process, resulting in large batch-to-batch differences and unstable data, which greatly interferes with the discovery of biomarkers
In addition, the market also lacks effective quality control methods for mass spectrometry reagents in order to monitor the production process and product quality of mass spectrometry reagents, which cannot meet the stability requirements of industrialization and clinical testing; cosine, etc. With a single measurement, the recognition rate of various spectral variations is very low, the accuracy rate is less than 70%, and the quality of mass spectrometry peaks cannot be accurately evaluated; the market needs a reagent with simple detection steps, high throughput, specificity, and high sensitivity box and quality inspection method, the present invention solves such problems

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  • High-throughput mass spectrometry detection kit and quality inspection method thereof
  • High-throughput mass spectrometry detection kit and quality inspection method thereof
  • High-throughput mass spectrometry detection kit and quality inspection method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] Embodiment 1, formula and method one:

[0055] High-throughput mass spectrometry detection kit includes: well plate, biological sample pretreatment material, mass spectrometry test reagent, quality control sample; biological sample pretreatment material is 0.05mg porous silicon particles; mass spectrometry test reagent includes: incubation solution, cleaning solution, matrix Dissolving solution, matrix; the specific reagents are acetonitrile, trifluoroacetic acid, ultrapure water, α-cyano-4-hydroxycinnamic acid, the matrix dissolving solution formula is 50% acetonitrile aqueous solution, and the incubation solution formula is 0% acetonitrile aqueous solution, The cleaning solution was 0% acetonitrile in water. Quality control samples were serum standard samples.

Embodiment 2

[0056] Embodiment 2, formula and method two:

[0057] High-throughput mass spectrometry detection kit includes: well plate, biological sample pretreatment material, mass spectrometry test reagent, quality control sample; biological sample pretreatment material is 0.04mg porous silicon particles; mass spectrometry test reagent includes: incubation solution, cleaning solution, matrix Dissolving solution, matrix; the specific reagents are acetonitrile, trifluoroacetic acid, ultrapure water, α-cyano-4-hydroxycinnamic acid, the matrix dissolving solution formula is 45% acetonitrile aqueous solution, and the incubation solution formula is 10% acetonitrile aqueous solution, The cleaning solution is 15% acetonitrile in water. Quality control samples were serum standard samples.

Embodiment 3

[0058] Embodiment 3, formula and method three:

[0059] High-throughput mass spectrometry detection kit includes: well plate, biological sample pretreatment material, mass spectrometry test reagent, quality control sample; biological sample pretreatment material is 0.03mg porous silicon particles; mass spectrometry test reagent includes: incubation solution, cleaning solution, matrix Dissolving solution, matrix; specific reagents are acetonitrile, trifluoroacetic acid, ultrapure water, α-cyano-4-hydroxycinnamic acid, matrix dissolving solution formula is 40% acetonitrile aqueous solution, incubation solution formula is 20% acetonitrile aqueous solution, The cleaning solution is 30% acetonitrile in water. Quality control samples were serum standard samples.

[0060] It should be noted that the above is only an example, and only lists the detection methods of serum peptide spectrum, and is not exhaustive; the quality inspection database and the judgment standard establishment m...

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Abstract

The invention discloses a high-throughput mass spectrometry detection kit and a quality inspection method thereof. The high-throughput mass spectrometry detection kit comprises a pore plate, a biological sample pretreatment material, a mass spectrometry test reagent and a quality control sample; the biological sample pretreatment material is 0.03-0.05 mg of porous silicon particles; the mass spectrum test reagent comprises an incubation solution, a cleaning solution, a matrix dissolving solution and a matrix; according to the quality inspection method, the average distance DL value between thedetection sample and the quality inspection standard database is calculated, and the two-dimensional measurement is carried out on the mass spectrum by combining the cityblock distance and the minkowski distance, so that the identification accuracy can be improved; the identification Youden index of various variants is higher than 98%; according to the quality inspection method, the quality inspection qualification rate is judged by evaluating the similarity of the mass spectra, the whole production process of the kit can be effectively controlled, and the production process stability and theproduct stability are evaluated; therefore, the high repeatability of the mass spectrum reagent in the biological sample detection process is achieved, and the variable coefficient is controlled within 15%.

Description

technical field [0001] The invention relates to the field of mass spectrometry detection of biological samples, in particular to a high-throughput mass spectrometry detection kit and a quality inspection method thereof. Background technique [0002] Matrix-assisted laser desorption ionization mass spectrometry (MALDI MS) is one of the main methods used to analyze complex biological samples at this stage, and can simultaneously detect dozens or even hundreds of biomarkers in a single analysis. Compared with traditional diagnostic techniques, MALDI MS has the advantages of high sensitivity, high throughput and low cost, and is a potential clinical testing platform. Due to the lack of LC separation process, MALDI MS has high requirements for the pretreatment of complex samples. The complex sample pretreatment process will lead to the loss and missed detection of low-abundance components, and the existing technical solutions have low throughput and high cost. For example, whil...

Claims

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Application Information

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IPC IPC(8): G01N27/62
CPCG01N27/62G01N33/6848
Inventor 余捷凯陈锡胜李科钟巧玲栾春燕邬建敏
Owner HANGZHOU WELL HEALTHCARE TECH CO LTD