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Biomarker detection kit for cholestasis indication prognosis

A technology for prognostic markers, cholestasis, applied in the field of medicine

Active Publication Date: 2021-10-15
CHILDRENS HOSPITAL OF FUDAN UNIV +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Moreover, there is currently no relevant research on the bile acid profile of children with ALGS in the world, and the analysis of bile acid profile in children with ALGS has very important clinical significance

Method used

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  • Biomarker detection kit for cholestasis indication prognosis
  • Biomarker detection kit for cholestasis indication prognosis
  • Biomarker detection kit for cholestasis indication prognosis

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Example 1 Research Object Determination, Followup and Packet

[0033] 1.1 research object

[0034] Fudan University of Fudan University and its medical affiliated members of Fudan University Affiliated, Jinshan Hospital, clinical and clinical, and gene diagnosis, and gene diagnosis of JAG1-mutation caused by blood specimens. During the 2015 / 01 / 01-2017 / 12 / 30 period, the specimen is discovered, and the specimen is retained as the verification set during 2018 / 01 / 01-2020 / 10 / 31. The Algs diagnostic criteria are as follows: no family history, via pathologically confirmed the lack of bile ducts in liver, in line with cardiac, eye abnormal eye (corneal embryo), butterfly vertebrae, nephrotomy and special faces in 5 items in 5 Diagnosis; no family history, no liver pathological examination, in line 4 or more people can be diagnosed; there is 1 JAG1 gene mutator in compliance with 1 of the above 5 items.

[0035] 1.2 follow-up and group

[0036] The clinical data of children co...

Embodiment 2

[0041] Example 2 Study object specimen processing and analysis

[0042] 2.1 Specimen Processing (1) Discovering Excavation / Plasma lyophilized specimens:

[0043] Serum / plasma 100 μl, dried in vacuo, and stored in a -80 ° C refrigerator, and the UPLC / MRM-MS technology was quantified after treatment.

[0044] S1 extraction bile acid: take out 100 μL of serum / plasma lyophilized specimens, add LC-MS grade water (H 2 O) 100 μL dissolved, and then put it in the ultrasonic oscillator for 15 minutes, apply a vortex to 15 minutes, so that serum / plasma solute is fully dissolved; 30 μL of the new EP tube is taken, add pre-formulated acetonitrile: methanol volume ratio 1 : 1 mixed solution 90 μL (water: organic solvent to maintain 1: 3 ratio), vortex for 10 seconds, ice water in ice water 120 seconds, repeating the above vortex and ultrasonic oscillating step three times to make the solute fully dissolved, then high-speed low temperature, centrifugation conditions It was 15000 rpm, ...

Embodiment 3

[0087] Example 3 results analysis discussion

[0088] 3.1 Population Characteristics

[0089] A total of 21 JAG1 gene mutations and clinical diagnosis of ALGS were incorporated into the blood specimen discovery (Table 2), including 10 cases of Poor Prognos, male 5 cases; good prognosis 11 cases, male 6 For example, there were no statistical differences in gender (P = 0.771). In the 10 cases of the child, 2 patients died during the age of 10, 4 cases were left and right, and 4 patients were followed up to 2 years old and 1st to 3 years old, still continued to severe jaundice. 11 patients with preliminary children, 5 cases of light jaundice, 6 patients with jaundice fell back. The pre-prognosis is 2.83 (1.83, 4.00) elder than the prognosis of children 1.80 (1.00, 2.44) year (P = 0.003), may be terminated by liver transplant surgery or death due to 6 patients in the prognosis group. Follow-up. The selection specimens of the two groups were 1 year before the jaundice did not completel...

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PUM

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Abstract

The invention relates to a biomarker for cholestasis indication prognosis, a marker detection method and a corresponding kit. The prognosis indication biomarker is selected from one or more of glycyl acylated hyocholic acid (Glyco-hyoCA or GHCA), taurosylated-2 [beta], 3 [alpha], 7 [alpha], 12 [alpha]-tetrahydroxycholic acid (Tauro-2 [beta], 3 [alpha], 7 [alpha], 12 [alpha]-Tetraphydroxy bileacid or Tauro-2 [beta], 3 [alpha], 7 [alpha], 12 [alpha]-THBA),taurosylated hyocholic acid (Tauro-hyoCA or THCA), Tauro-3 [alpha], 6 [beta], 7 [alpha], 12 [alpha]-THBA, Tauro-3 [alpha], 6 [alpha], 7 [alpha], 12 [alpha]-THBA, and total Tauro-THBAs. The detection finds that bile acid spectrums in serum / plasma samples of subjects are concentrated, different bile acids are screened out to serve as candidate indication prognosis markers, meanwhile, corresponding cutoff values are formulated, and the cutoff values are applied to a verification set to verify the indication prognosis efficiency of the verification set. The invention provides the method and the kit for prognosis judgment of cholestasis for the first time, the detection efficiency is high, the result is accurate, the method and the kit are suitable for early prognosis effect judgment of patients with cholestasis, and guidance is provided for individual treatment and medication schemes.

Description

Technical field [0001] The present invention relates to the field of medical technology, and more particularly to the prognostic kit of the bile silcissions and its use in the prognosis of bile sludge. Background technique [0002] Alagille Syndrome (abbreviated as Algs) is the most common cause of chronic bile siltation with phenotypic characteristics. It is a hereditary disease that is involved in multi-system, from about 94% of Algs caused by JAG1 gene mutation. This syndrome was first reported by Alagille in 1969. The organs involved in Alagille syndrome include liver, heart, bones, eyes and face, etc. The incidence is approximately 1 / 30,000-70,000. Its clinical phenotype is very different, and the severe infancy requires liver transplantation, or no obvious liver disease performance is survived to adults. In addition, some children suffer from bile siltation in the past few years ago, and gradually improved. [0003] The type and position of JAG1 mutation and the lack of s...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/72G01N33/50
CPCG01N30/02G01N30/72G01N33/50G01N2030/027G01N2800/08G01N2800/52
Inventor 王建设王梦宣刘腾
Owner CHILDRENS HOSPITAL OF FUDAN UNIV
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