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Bile acid marker composition, application and serum detection kit

A bile acid and marker technology, applied in the fields of laboratory medicine, clinical chemistry, and clinical medicine, can solve the problems of poor patient compliance, poor accuracy of serum tumor markers, and low popularity of gastroscopic examination, and achieve simple combination and diagnostic sensitivity. Effectiveness with highly specific, noninvasive patient compliance

Pending Publication Date: 2022-07-29
云谱康(大连)生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The present invention addresses many challenges in clinically carrying out gastric cancer / early gastric cancer screening in high-risk groups, such as poor patient compliance due to the invasiveness of endoscopy, poor accuracy of existing serum tumor markers, and precise examination of gastroscopy limited by clinical conditions. To solve the problems of limited resources and low popularity, a new marker combination based on the quantitative detection of two serum bile acids and a serum detection kit are provided, which can be applied to gastric cancer / early gastric cancer screening and / or precise stratification of high-risk groups

Method used

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  • Bile acid marker composition, application and serum detection kit
  • Bile acid marker composition, application and serum detection kit
  • Bile acid marker composition, application and serum detection kit

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] [Example 1] Auxiliary screening for gastric cancer based on the combination of two bile acid markers

[0020] 1. Clinical trial design: The research project has been approved by the Medical Ethics Association, and the subjects signed an informed consent form before being included in the clinical trial. The training set used to construct the gastric cancer screening and diagnosis model included 145 subjects in the healthy control group (age 60.31±12.15 years, 108 males and 37 females) and 113 subjects in the gastric cancer group (age 63.33±10.59 years old, There were 79 males and 34 females), of which 68 were advanced gastric cancer (cancer tissue infiltrated beyond the submucosa of the gastric wall and invaded the muscular layer of the gastric wall under the pathological section), and 45 were early gastric cancer (the cancer tissue had not invaded the gastric wall under the pathological section). Muscular layer, limited to gastric mucosa and submucosa). According to th...

Embodiment 2

[0037] [Example 2] Auxiliary screening for gastric cancer based on the combination of three bile acid markers

[0038] 1. Clinical trial design: same as Example 1 (ie, using the same subjects as Example 1).

[0039] 2. Subject serum collection: the same process and conditions as in Example 1.

[0040] 3. Pretreatment of the subject's serum to be tested: On the basis of Example 1, the extract added an internal standard substance deuterated Beta-murocholic acid-d5, and the concentration was 50ng / mL, and the rest were the same as in Example 1. This corresponding process and condition.

[0041] 4. Liquid chromatography tandem mass spectrometry detection: the same process and conditions as in Example 1.

[0042] 4.1 Liquid chromatography method: the same process and conditions as in Example 1.

[0043] 4.2 Mass spectrometry method: On the basis of Example 1, the detection of n-cholic acid was added, and the rest were the same as those of Example 1. The scanning ion pair of posi...

Embodiment 3

[0053] [Example 3] Auxiliary screening for gastric cancer based on the combination of four bile acid markers

[0054] 1. Clinical trial design: same as Example 1 (ie, using the same subjects as Example 1).

[0055] 2. Subject serum collection: the same process and conditions as in Example 1.

[0056] 3. Pretreatment of the subject's serum to be tested: On the basis of Example 1, the internal standard substances deuterated Beta-mouse cholic acid-d5 and deuterated cholic acid-d4 were added to the extract, and the concentration was 50ng / mL, and the rest were the same as Example 1 This corresponding process and conditions.

[0057] 4. Liquid chromatography tandem mass spectrometry detection: the same process and conditions as in Example 1.

[0058] 4.1 Liquid chromatography method: the same process and conditions as in Example 1.

[0059] 4.2 Mass spectrometry method: On the basis of Example 1, the detection of orthocholic acid and porcine cholic acid was added, and the rest we...

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Abstract

The invention relates to novel application of bile acid small molecule metabolites taurine conjugated lithocholic acid and 3-glucuronic acid conjugated deoxycholic acid as markers in preparation of a serum detection kit for auxiliary screening of gastric cancer / early gastric cancer. The invention further relates to a serum detection kit for auxiliary screening of gastric cancer / early gastric cancer, serum concentrations of the two bile acid metabolites of a subject are detected through liquid chromatography-tandem mass spectrometry, and the serum concentrations are substituted into a binary logistic regression model to calculate the gastric cancer / early gastric cancer positive predicted value of the marker combination. And comparing with the optimal cutoff value of the diagnosis model so as to judge whether the subject is a gastric cancer / early gastric cancer positive case or not, so that accurate layering of whether high-risk groups need to be subjected to gastroscope precise examination or not can be realized. The combined application of the two bile acid marker combinations has a good auxiliary effect on screening of gastric cancer and early gastric cancer of high-risk groups. The detection kit provided by the invention has the characteristics of high diagnostic specificity and sensitivity, simple combination, determination by a single method, low detection cost, good subject compliance, noninvasive property and the like, and is beneficial to improving the screening popularity and accuracy of gastric cancer / early gastric cancer.

Description

【Technical field】 [0001] The invention relates to a bile acid marker combination and a serum detection kit for assisting the screening of high-risk groups for gastric cancer / early gastric cancer, belonging to the fields of laboratory medicine, clinical chemistry and clinical medicine. 【Background technique】 [0002] Gastric cancer is a highly aggressive and lethal malignant digestive tract tumor. According to the authoritative report of the 2015 "Clinical Oncology Journal" (CA: A Cancer Journal for Clinicians), the incidence of gastric cancer worldwide ranks fourth among male tumors. The mortality rate is the third highest [Torre, L.A. et al. Global cancer statistics, 2012. CA. Cancer J. Clin. 65, 87–108 (2015).]. At present, surgery and chemotherapy are the main clinical methods for the treatment of gastric cancer. The timing of diagnosis and treatment and pathological grading of gastric cancer determine the prognosis of patients. Early detection and early treatment result ...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/72G01N30/88G16H50/30G16H50/50
CPCG01N30/02G01N30/06G01N30/72G01N30/88G16H50/30G16H50/50G01N2030/8822
Inventor 吴泽明尹沛源
Owner 云谱康(大连)生物科技有限公司
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