Mass spectrum kit for accurately determining concentration of bile acid in serum

A technology for accurate determination of bile acid, which is applied in the field of medical testing, can solve problems such as the difficulty of traceability of detection methods, and achieve the effect of small sample size, short time, and guaranteed accuracy

Inactive Publication Date: 2020-07-31
NINGBO MEDICAL SYSTEM BIOTECHNOLOGY CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Mass spectrometry clinical testing methods are all methods established by the laboratory (laboratory developed tests, LDT), and most of the reagents used are non-kit products. , Time comparability needs to be further verified clinically

Method used

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  • Mass spectrum kit for accurately determining concentration of bile acid in serum
  • Mass spectrum kit for accurately determining concentration of bile acid in serum
  • Mass spectrum kit for accurately determining concentration of bile acid in serum

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0114] A kit for the determination of the concentrations of 15 bile acids in human serum, including

[0115] Contains calibrators with six concentration gradients, and the calibrators of each concentration gradient are freeze-dried powders of methanol solutions of 15 bile acids;

[0116] Among them, the six concentration points of cholic acid, deoxycholic acid, chenodeoxycholic acid, ursodeoxycholic acid, lithocholic acid, glycocholic acid, glycodeoxycholic acid, and glycochenodeoxycholic acid are the same, in order: 10nmol / L, 100nmol / L, 500nmol / L, 1000nmol / L, 2500nmol / L, 5000nmol / L; glycursodeoxycholic acid, glycinolithocholic acid, taurocholic acid, taurodeoxycholic acid, taurine goosecholic acid The six concentration points of deoxycholic acid, tauroursodeoxycholic acid, and taurolithocholic acid are the same, in order: 10nmol / L, 50nmol / L, 100nmol / L, 250nmol / L, 500nmol / L, 1000nmol / L; ;

[0117] Internal standard: The internal standard solution contains deoxycholic acid-d...

Embodiment 2

[0146] A kit for the determination of the concentrations of 15 bile acids in human serum, including

[0147] Contains calibrators with six concentration gradients, and the calibrators of each concentration gradient are serum freeze-dried powders of 15 bile acids;

[0148] Among them, the six concentration points of cholic acid, deoxycholic acid, chenodeoxycholic acid, ursodeoxycholic acid, lithocholic acid, glycocholic acid, glycodeoxycholic acid, and glycochenodeoxycholic acid are the same, in order: 10nmol / L, 100nmol / L, 500nmol / L, 1000nmol / L, 2500nmol / L, 5000nmol / L; glycursodeoxycholic acid, glycinolithocholic acid, taurocholic acid, taurodeoxycholic acid, taurine goosecholic acid The six concentration points of deoxycholic acid, tauroursodeoxycholic acid, and taurolithocholic acid are the same, in order: 10nmol / L, 50nmol / L, 100nmol / L, 250nmol / L, 500nmol / L, 1000nmol / L; ;

[0149] Internal standard: The internal standard solution contains deoxycholic acid-d 4 , glycodeoxy...

Embodiment 3

[0158] A kit for the determination of the concentrations of 15 bile acids in human serum, including

[0159] Contains calibrators with six concentration gradients, and the calibrators of each concentration gradient are freeze-dried powders of methanol solutions of 15 bile acids;

[0160] Among them, the six concentration points of cholic acid, deoxycholic acid, chenodeoxycholic acid, ursodeoxycholic acid, lithocholic acid, glycocholic acid, glycodeoxycholic acid, and glycochenodeoxycholic acid are the same, in order: 10nmol / L, 100nmol / L, 500nmol / L, 1000nmol / L, 2500nmol / L, 5000nmol / L; glycursodeoxycholic acid, glycinolithocholic acid, taurocholic acid, taurodeoxycholic acid, taurine goosecholic acid The six concentration points of deoxycholic acid, tauroursodeoxycholic acid, and taurolithocholic acid are the same, in order: 10nmol / L, 50nmol / L, 100nmol / L, 250nmol / L, 500nmol / L, 1000nmol / L; ;

[0161] Internal standard: The internal standard solution contains deoxycholic acid-d...

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Abstract

The invention discloses a mass spectrum kit for accurately determining the concentration of bile acid in serum. The mass spectrum kit is characterized by comprising a calibrator containing 15 kinds ofbile acid, an internal standard of deoxycholic acid-d4, glycodeoxycholic acid-d4 and taurodeoxycholic acid-d4, a quality control material of the 15 kinds of bile acid, an extracting solution, a mobile phase and a reconstitution fluid. The method has the advantages that complex purification steps are not needed, the required sample size is small, and the method can be matched with a liquid chromatograph tandem mass spectrometer for use and is applied to inspection of clinical samples. Meanwhile, the product can detect 15 bile acids with different structures at the same time, achieves a single-sample multi-index synchronous detection function, and has the characteristics of high accuracy, short detection time, low reagent consumption, convenience in operation and the like. In addition, themeasurement result can be directly traced back to the reference system, thereby guaranteeing the accuracy of the measurement result.

Description

technical field [0001] The invention relates to the technical field of medical testing, in particular to a mass spectrometry kit for accurately measuring the concentration of bile acids in serum. Background technique [0002] Bile acid (bilo acid, BA) is the main component of bile, synthesized by the liver, and is the main metabolic outlet of endogenous cholesterol; it is also an essential substance for the digestion and absorption of lipids. According to the structure, bile acids are divided into: free bile acids, including cholic acid (CA), deoxycholic acid (DCA), chenodeoxycholic acid (CDCA), ursodeoxycholic acid (ursodeoxycholic acid) , UDCA) and lithocholic acid (1ithocholic acid, LCA), etc.; conjugated bile acids are mainly the products of free bile acids combined with glycine or taurine. According to the source, it is divided into primary bile acids (synthesized in the liver cells) and secondary bile acids (synthesized in the intestine). Abnormal bile acid metabolis...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88G01N30/06
CPCG01N30/88G01N30/06G01N2030/045G01N2030/8822
Inventor 邹继华沈敏杨晓东屠敏敏邹炳德
Owner NINGBO MEDICAL SYSTEM BIOTECHNOLOGY CO LTD
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