CN103163303A - Reagent kit for auxiliary diagnosis of lung adenocarcinoma paitent - Google Patents

Abstract

x1代表IDH1的浓度；x2代表CA125的浓度；x3代表CYFRA21-1的浓度。采用本发明提供的试剂盒并按照相应的诊断标准辅助诊断肺腺癌患者，具有灵敏性高、特异性强的特点，诊断结果可信度远远高于采用各个单独的蛋白质标记物进行诊断，对于肺腺癌的诊断和治疗具有重大价值和应用前景。The invention discloses a kit for auxiliary diagnosis of lung adenocarcinoma patients. The kit provided by the present invention includes a product for detecting the protein marker IDH1, a product for detecting the protein marker CA125, a product for detecting the protein marker CYFRA21-1, and a carrier recorded with the following functional formula:

x1 represents the concentration of IDH1; x2 represents the concentration of CA125; x3 represents the concentration of CYFRA21-1. Using the kit provided by the invention and assisting in the diagnosis of patients with lung adenocarcinoma according to the corresponding diagnostic criteria has the characteristics of high sensitivity and strong specificity, and the reliability of the diagnosis result is much higher than that of using individual protein markers for diagnosis. It has great value and application prospect for the diagnosis and treatment of lung adenocarcinoma.

Description

Kit for auxiliary diagnosis of patients with lung adenocarcinoma

technical field

The invention relates to a kit for auxiliary diagnosis of lung adenocarcinoma patients. the

Background technique

Lung cancer is a major disease that seriously threatens human life and health. In 2011, the World Health Organization (WHO) International Cancer Research Agency IARC released the results of 2008 global statistical data, showing that lung cancer is the malignant tumor with the highest incidence and mortality. Every year, there are 1.608 million new cases and 1.377 million deaths worldwide, accounting for 12.7% and 18.2% of all malignant tumors. According to statistics released by the American Cancer Society, it is estimated that in 2012, the number of new lung cancer cases in the United States will reach 226,000, and the number of deaths due to lung cancer will reach 160,000. In my country, the results of the third national retrospective sampling survey of causes of death hosted by the Ministry of Health show that lung cancer is the first cause of death from malignant tumors in the sample area, with a crude death rate of 30.83/100,000, of which 41.34/100,000 are males and 19.84/10 are females It is the first cause of cancer death in both men and women. With the acceleration of global aging and the intensification of environmental pollution and other factors, the incidence of lung cancer will continue to rise. Therefore, the demand for research on the diagnosis and treatment of lung cancer must become stronger and stronger. the

Pathologically, lung cancer can be divided into non-small cell lung cancer (NSCLC, accounting for about 85%) and small cell lung cancer (SCLC, accounting for about 15%). Among them, NSCLC is mainly composed of squamous cell carcinoma (also known as squamous cell carcinoma or squamous cell carcinoma of the lung), adenocarcinoma (also known as lung adenocarcinoma) and large cell carcinoma. Squamous cell carcinoma and adenocarcinoma each account for 40% of NSCLC. the

The onset of lung cancer is relatively hidden, and more than 70% of patients have developed to the middle and late stages when they see a doctor, and they have lost the opportunity for surgery. This is also one of the main reasons for the poor curative effect and high mortality rate of lung cancer. Therefore, early screening and diagnosis have become the top priority in the prevention and treatment of lung cancer. At present, the clinically used lung cancer screening and diagnosis methods are mainly imaging techniques such as chest X-ray examination and CT scan. Although these imaging data play an important role in diagnosis, there are also many limitations, such as a high false positive rate, and the inability to detect occult lesions, subclinical lesions, and micrometastases. In addition, the diagnostic methods for lung cancer also include invasive operations such as bronchoscopy and puncture biopsy. Such methods are time-consuming and increase the suffering of patients. Therefore, it is an urgent need for early diagnosis of cancer to find non-invasive, non-radiation, low-cost, fast-diagnosing, sensitive, and high-specificity screening and diagnostic methods. the

Tumor markers refer to biologically active substances produced by tumor cells or tissues due to the abnormal expression of oncogenes or other tumor-related genes and their products, or they are shed from cancer tissues, and have a certain degree of expression or production in normal tissues or benign diseases. little. It reflects the occurrence and development of cancer and can be detected in tissues, body fluids, and excrements of tumor patients. It is widely used in tumor diagnosis, monitoring recurrence, metastasis, prognosis, and predicting curative effect. Several major markers that are widely recognized clinically are: Tumor antigen 125 (CA125) for ovarian cancer, antigen-like 19-9 (CA19-9) for pancreatic cancer, and CA19-9 for colorectal cancer Carcinoembryonic Antigen (CEA) and Prostate Specific Antigen (PSA) for Prostate Cancer. Other cancers, such as breast and lung, still lack reliable tumor markers for screening. the

At present, the only markers that have been used in the clinical auxiliary diagnosis of lung cancer are protein markers, which are the following:

(1) CEA: Gold and Freeman first discovered CEA in colorectal cancer in 1965. It is a glycoprotein with a molecular weight of 180KD and a half-life of 3-4 days. It is an antigen produced during embryonic development, and it decreases significantly after birth; Its specificity is not strong, but it can be used for the monitoring of tumor development, curative effect judgment and prognosis estimation, and it is not sensitive for early diagnosis; although it is elevated in lung cancer patients, there are high false negatives and false positives, so it is not suitable for lung cancer screening. Used alone in diagnosis;

(2) CA125: Bast first discovered CA125, a macromolecular glycoprotein in 1981, with a half-life of about 4.8 days. It is mainly used in ovarian cancer, and it is also increased in lung cancer;

(3) CYFRA21-1 (CYFRA211): CYFRA211 is a water-soluble fragment of cytokeratin 19, with a half-life of about 4 days;

Although the above protein markers have been used in the auxiliary diagnosis of lung cancer, their diagnostic efficiency is low and cannot meet the clinical needs. Therefore, the development of new diagnostic markers and diagnostic methods cannot wait. the

IDH1 is a NADP ⁺ -dependent isocitrate dehydrogenase located in the cytoplasm and peroxisomes that catalyzes the oxidative decarboxylation of isocitrate to α-ketoglutarate. The inventors of the present invention have found in previous studies that the IDH1 levels of patients with lung squamous cell carcinoma and lung adenocarcinoma are significantly higher than those of normal population and patients with benign lung tumors, and can be used as a new diagnostic marker for lung cancer.

Contents of the invention

The purpose of the present invention is to provide a kit for auxiliary diagnosis of lung adenocarcinoma patients. the

The kit for auxiliary diagnosis of lung adenocarcinoma patients provided by the present invention includes products for detecting protein marker IDH1, products for detecting protein marker CA125, products for detecting protein marker CYFRA21-1 and records There are the following functional vectors:

$\mathrm{<span\; class="notranslate">\; p</span>}<span\; class="notranslate">\; =</span>\frac{\mathrm{<span\; class="notranslate">\; 1</span>}}{\mathrm{<span\; class="notranslate">\; 1</span>}<span\; class="notranslate">\; +</span>{<span\; class="notranslate">\; (</span>\mathrm{<span\; class="notranslate">\; 18.283</span>}<span\; class="notranslate">\; *</span>{\mathrm{<span\; class="notranslate">\; 0.373</span>}}^{{\mathrm{<span\; class="notranslate">\; x</span>}}_{\mathrm{<span\; class="notranslate">\; 1</span>}}}<span\; class="notranslate">\; *</span>{\mathrm{<span\; class="notranslate">\; 0.933</span>}}^{{\mathrm{<span\; class="notranslate">\; x</span>}}_{\mathrm{<span\; class="notranslate">\; 2</span>}}}<span\; class="notranslate">\; *</span>{\mathrm{<span\; class="notranslate">\; 0.858</span>}}^{{\mathrm{<span\; class="notranslate">\; x</span>}}_{\mathrm{<span\; class="notranslate">\; 3</span>}}}<span\; class="notranslate">\; )</span>}^{<span\; class="notranslate">\; -</span>\mathrm{<span\; class="notranslate">\; 1</span>}}}<span\; class="notranslate">\; ;</span>$

X1 represents the concentration of the protein marker IDH1, x2 represents the concentration of the protein marker CA125, and x3 represents the concentration of the protein marker CYFRA21-1. the

The protein marker IDH1 can specifically be the protein shown in GENBANK ACCESSION NO.CAG46496.1 (sequence 1 in the sequence listing; GENBANK ACCESSION NO.CAG46496.1; GI:49456351; linear PRI16-OCT-2008). The protein marker CA125 may specifically be the protein shown in GENBANK ACCESSION NO.AAL65133.2 (GENBANK ACCESSION NO.AAL65133.2; GI: 24419041; linear PRI29-OCT-2002). The protein marker CYFRA21-1 can specifically be the protein shown in GENBANK ACCESSIONNO.NP 002267.2 (sequence 2 in the sequence listing; GI: 24234699; linear PRI06-MAY-2012). the

The unit of the concentration of the protein marker IDH1 is specifically U/L, the unit of the concentration of the protein marker CA125 is specifically U/mL, and the unit of the concentration of the protein marker CYFRA21-1 is specifically ng/mL . the

The following diagnostic criteria may also be recorded on the carrier: when p≥0.5762, the patient to be tested is a candidate lung adenocarcinoma patient; when p<0.5762, the patient to be tested is a candidate non-lung adenocarcinoma patient. the

The present invention also protects the products used to detect the protein marker IDH1, the product used to detect the protein marker CA125, the product used to detect the protein marker CYFRA21-1, and the carrier with the functional formula and diagnostic criteria recorded in the preparation of auxiliary diagnostic lung cancer. Application of the kit in patients with adenocarcinoma:

The function formula is as follows:

$\mathrm{<span\; class="notranslate">\; p</span>}<span\; class="notranslate">\; =</span>\frac{\mathrm{<span\; class="notranslate">\; 1</span>}}{\mathrm{<span\; class="notranslate">\; 1</span>}<span\; class="notranslate">\; +</span>{<span\; class="notranslate">\; (</span>\mathrm{<span\; class="notranslate">\; 18.283</span>}<span\; class="notranslate">\; *</span>{\mathrm{<span\; class="notranslate">\; 0.373</span>}}^{{\mathrm{<span\; class="notranslate">\; x</span>}}_{\mathrm{<span\; class="notranslate">\; 1</span>}}}<span\; class="notranslate">\; *</span>{\mathrm{<span\; class="notranslate">\; 0.933</span>}}^{{\mathrm{<span\; class="notranslate">\; x</span>}}_{\mathrm{<span\; class="notranslate">\; 2</span>}}}<span\; class="notranslate">\; *</span>{\mathrm{<span\; class="notranslate">\; 0.858</span>}}^{{\mathrm{<span\; class="notranslate">\; x</span>}}_{\mathrm{<span\; class="notranslate">\; 3</span>}}}<span\; class="notranslate">\; )</span>}^{<span\; class="notranslate">\; -</span>\mathrm{<span\; class="notranslate">\; 1</span>}}}<span\; class="notranslate">\; ;</span>$

X1 represents the concentration of the protein marker IDH1 in U/L, x2 represents the concentration of the protein marker CA125 in U/mL, x3 represents the concentration of the protein marker CYFRA21-1 in ng/mL;

The diagnostic criteria are as follows:

When p≥0.5762, the patient to be tested is a candidate lung adenocarcinoma patient, and when p<0.5762, the patient to be tested is a candidate non-lung adenocarcinoma patient. the

The protein marker IDH1 can specifically be the protein shown in GENBANK ACCESS ION NO.CAG46496.1 (sequence 1 in the sequence listing; GENBANK ACCESSION NO.CAG46496.1; GI:49456351; linear PRI16-OCT-2008). The protein marker CA125 may specifically be the protein shown in GENBANK ACCESSION NO.AAL65133.2 (GENBANK ACCESSION NO.AAL65133.2; GI: 24419041; linear PRI29-OCT-2002). The protein marker CYFRA21-1 can specifically be the protein shown in GENBANK ACCESSION NO.NP_002267.2 (sequence 2 in the sequence listing; GI: 24234699; linear PRI06-MAY-2012). the

Any of the above-mentioned products for detecting the protein marker IDH1 can specifically be the IDH1 enzyme-linked immunosorbent assay kit (ELISA Kit; including IDH1 standard) purchased from Wuhan Uersen Technology Co., Ltd. the

Any of the above-mentioned products for detecting the protein marker CYFRA21-1 can specifically be the CYFRA21-1 quantitative assay kit purchased from Roche Diagnostics Products (Shanghai) Co., Ltd. the

Any of the above-mentioned products for detecting the protein marker CA125 can specifically be the CA125 quantitative assay kit of Roche Diagnostic Products (Shanghai) Co., Ltd. the

Lung cancer ranks first in the cause of cancer death in the world, and it is also the number one cancer killer that endangers the health of our people. Therefore, finding tumor markers that can be used for early diagnosis, individual treatment, prognosis and recurrence monitoring of lung cancer has become a research hotspot in recent years. Using the kit provided by the invention and assisting in the diagnosis of patients with lung adenocarcinoma according to the corresponding diagnostic criteria has the characteristics of high sensitivity and strong specificity, and the reliability of the diagnosis result is much higher than that of using individual protein markers for diagnosis. It has great value and application prospect for the diagnosis and treatment of lung adenocarcinoma. the

Description of drawings

Figure 1 is the ROC curve of the lung adenocarcinoma diagnosis model. the

Detailed ways

The following examples facilitate a better understanding of the present invention, but do not limit the present invention. The experimental methods in the following examples are conventional methods unless otherwise specified. The test materials used in the following examples, unless otherwise specified, were purchased from conventional biochemical reagent stores. Quantitative experiments in the following examples were all set up to repeat the experiments three times, and the results were averaged. Sensitivity: The number of cancer patients diagnosed positive as a percentage of the total number of cancer patients. Specificity: The number of healthy people diagnosed negative as a percentage of the total healthy population. the

Embodiment 1, establishment of the inventive method

1. Model establishment

A total of 473 plasma samples from patients with lung adenocarcinoma and 479 plasma samples from healthy people (normal controls) were collected from lung cancer patients diagnosed by pathology in the Department of Thoracic Surgery, Cancer Hospital, Chinese Academy of Medical Sciences, and normal people who participated in cancer screening. This experiment was approved by the Ethics Committee, and all subjects were informed and signed an informed consent form. Among patients with lung adenocarcinoma, there were 239 males and 234 females, with an age range of 26-87 years, and an average age of 60.50 years; in the normal population, there were 240 males and 239 females, with an age range of 41-70 years, and an average age of 60.50 years. For 57.39 years. Plasma samples were obtained before surgery, and the patients had not received chemotherapy, radiotherapy, or interventional treatment before. the

Data processing uses curve expert 1.4 to process the standard curve; GraphPad Prism 5.01 to process the Column statistical chart; SPSS13.0 for data fitting and establishment of mathematical models; SAS 9.2 for mathematical model testing; MedCalc9.6.2.0 version calculation model ROC curve and cutoff value ;Adobe illustrator CS3 for image processing. the

The ROC curve (receiver operating characteristic curve, receiver operating curve) takes the sensitivity as the vertical axis (Y axis) and the specificity as the horizontal axis (X axis). When different cutoffs are given to the test, it can be generated The corresponding coordinate points are connected into a line to generate a curve that is the ROC curve. The ROC curve can compare the diagnostic efficiency of different tumor markers, and the larger the area under the curve (AUC), the higher the diagnostic efficiency. the

The data were analyzed by Logistic binomial regression of SPSS software, and the model was tested using SAS, and finally a model was determined for the diagnosis of lung adenocarcinoma. The calculation results of the model were plotted on the ROC curve (see Figure 1), and the area under the curve was 0.855 (95% confidence interval: 0.831-0.877, p<0.0001), which was compared with the marker with the highest diagnostic efficiency for lung adenocarcinoma - IDH1 ( AUC was 0.822), there was a significant difference (p<0.001). . the

2. Specific description of the model

In step 1, through the detection of various protein markers on a large number of clinical samples, a large amount of data simulation and model establishment, the function formula used to assist in the diagnosis of lung adenocarcinoma is obtained as follows:

$\mathrm{<span\; class="notranslate">\; p</span>}<span\; class="notranslate">\; =</span>\frac{\mathrm{<span\; class="notranslate">\; 1</span>}}{\mathrm{<span\; class="notranslate">\; 1</span>}<span\; class="notranslate">\; +</span>{<span\; class="notranslate">\; (</span>\mathrm{<span\; class="notranslate">\; 18.283</span>}<span\; class="notranslate">\; *</span>{\mathrm{<span\; class="notranslate">\; 0.373</span>}}^{{\mathrm{<span\; class="notranslate">\; x</span>}}_{\mathrm{<span\; class="notranslate">\; 1</span>}}}<span\; class="notranslate">\; *</span>{\mathrm{<span\; class="notranslate">\; 0.933</span>}}^{{\mathrm{<span\; class="notranslate">\; x</span>}}_{\mathrm{<span\; class="notranslate">\; 2</span>}}}<span\; class="notranslate">\; *</span>{\mathrm{<span\; class="notranslate">\; 0.858</span>}}^{{\mathrm{<span\; class="notranslate">\; x</span>}}_{\mathrm{<span\; class="notranslate">\; 3</span>}}}<span\; class="notranslate">\; )</span>}^{<span\; class="notranslate">\; -</span>\mathrm{<span\; class="notranslate">\; 1</span>}}}<span\; class="notranslate">\; ;</span>$

X1 represents the concentration of the protein marker IDH1 (in U/L), x2 represents the concentration of the protein marker CA125 (in U/mL), and x3 represents the concentration of the protein marker CYFRA21-1 (in ng/mL) . the

The method for auxiliary diagnosis of lung adenocarcinoma based on the above functional formula is as follows:

(1) Take peripheral venous blood from the patient to be tested on an empty stomach, let it stand at room temperature for 1 hour, then centrifuge at 3000r/min for 15 minutes, take the supernatant, aliquot into 1.5mL EP tubes, and store in a -80°C refrigerator. the

(2) Detect the concentration of protein marker IDH1, protein marker CA125 and protein marker CYFRA211 in the sample obtained in step (1), and then calculate the p value through the above function formula, when p≥0.5762, the patient to be tested is a candidate Lung adenocarcinoma patients, when p<0.5762, the patient to be tested is a candidate non-lung adenocarcinoma patient. the

Embodiment 2, verification of the inventive method

The patients used in this example were 150 patients with clinically confirmed lung adenocarcinoma (peripheral venous blood was obtained before surgery, and the patients had not received chemotherapy, radiotherapy, intervention, etc.) and 50 healthy people (non-lung adenocarcinoma patients), all volunteers who gave informed consent. the

1. Take 5ml of peripheral venous blood from the patient to be tested on an empty stomach, let it stand at room temperature for 1 hour, then centrifuge at 3000r/min for 15 minutes, take the supernatant, divide it into two 1.5mL EP tubes, and store it in a -80°C refrigerator. the

2. Dissolve the sample from step 1 at room temperature for 3 hours, then centrifuge at 3000r/min for 5 minutes. the

3. Detect the concentration of the protein marker IDH1 (in U/L), the concentration of the protein marker CA125 (in U/mL), and the concentration of the protein marker CYFRA211 (in ng/mL) in the sample (supernatant) obtained in step 2. mL) and protein marker CEA concentration (unit: ng/mL). the

The protein marker IDH1 can specifically be the protein shown in GENBANK ACCESS ION NO.CAG46496.1 (sequence 1 in the sequence listing; GENBANK ACCESS ION NO.CAG46496.1; GI: 49456351; linear PRI16-OCT-2008). The protein marker CA125 may specifically be the protein shown in GENBANK ACCESSION NO.AAL65133.2 (GENBANK ACCESSION NO.AAL65133.2; GI: 24419041; linear PRI29-OCT-2002). The protein marker CYFRA21-1 can specifically be the protein shown in GENBANK ACCESSION NO.NP_002267.2 (sequence 2 in the sequence listing; GI: 24234699; linear PRI06-MAY-2012). The protein marker CEA can specifically be the protein shown in GENBANK ACCESSION NO.CAE75559.1 (sequence 3 in the sequence listing; GENBANK ACCESSION NO.CAE75559.1; GI:38522495; linear PAT 25-NOV-2003). the

The IDH1 enzyme-linked immunosorbent assay kit (ELISA Kit; including IDH1 standard; product catalog number E97839Hu 96T) purchased from Wuhan Uersen Technology Co., Ltd. was used to detect the concentration of the protein marker IDH1 according to the instructions of the kit. the

The CYFRA21-1 Quantitative Assay Kit (catalogue number 11820966122) purchased from Roche Diagnostic Products (Shanghai) Co., Ltd. was used to detect the concentration of the protein marker CYFRA21-1 according to the instructions of the kit. the

The CEA quantitative assay kit of Roche Diagnostic Products (Shanghai) Co., Ltd. was used to detect the concentration of protein marker CEA according to the instructions of the kit (catalogue number 11731629322). the

The CA125 Quantitative Assay Kit (catalogue number 11776223822) of Roche Diagnostic Products (Shanghai) Co., Ltd. was used to detect the concentration of the protein marker CA125 according to the instructions of the kit. the

4. Substitute the protein marker IDH1 concentration, protein marker CA125 concentration and protein marker CYFRA21-1 concentration obtained in step 3 into the functional formula of Example 1 to obtain the p value, and judge whether the patient is a lung adenocarcinoma according to the standard of Example 1. cancer patients. the

The results of Step 3 and Step 4 are shown in Table 1 and Table 2 (for gender, 1 represents male and 2 represents female). the

In Table 1 and Table 2, the diagnostic results based on each individual protein marker are used as a comparison of the diagnostic results using the functional formula in Example 1. When the protein marker IDH1 is used alone, according to the conventional threshold, when the concentration is ≥ 2.0874, the patient to be tested is a candidate lung adenocarcinoma patient, and when the concentration is <2.0874, the patient to be tested is a candidate non-lung adenocarcinoma patient. When the protein marker CA125 is used alone, according to the conventional threshold, when the concentration is ≥35, the patient to be tested is a candidate lung adenocarcinoma patient, and when the concentration is <35, the patient to be tested is a candidate non-lung adenocarcinoma patient. When the protein marker CYFRA21-1 is used alone, according to the conventional threshold, when the concentration is ≥3.3, the patient to be tested is a candidate lung adenocarcinoma patient, and when the concentration is <3.3, the patient to be tested is a candidate non-lung adenocarcinoma patient. When the protein marker CEA is used alone, according to the conventional threshold, when the concentration ≥ 5, the patient to be tested is a candidate lung adenocarcinoma patient, and when the concentration is <5, the patient to be tested is a candidate non-lung adenocarcinoma patient. the

Table 1 Patients diagnosed with lung adenocarcinoma (+ represents positive diagnosis, - represents negative diagnosis)

Table 2 Diagnosed healthy persons (+ represents positive diagnosis, - represents negative diagnosis)

Carry out result judgment according to the functional formula and diagnostic method of embodiment 1, sensitivity is 66.67%, and specificity is 90%. The protein marker IDH1 and its threshold were used alone to judge the results, with a sensitivity of 58% and a specificity of 90%. The protein marker CA125 and its threshold were used alone to judge the results, with a sensitivity of 12.67% and a specificity of 98%. The protein marker CYFRA21-1 and its threshold were used alone to judge the results, with a sensitivity of 29.33% and a specificity of 82%. The protein marker CEA and its threshold were used alone to judge the results, with a sensitivity of 36.67% and a specificity of 7%. Considering sensitivity and specificity comprehensively, using the functional formula and diagnostic method of Example 1 is significantly better than using several individual protein markers for diagnosis. the

Claims (6)

1. Kits for auxiliary diagnosis of lung adenocarcinoma patients, including products for detecting the protein marker IDH1, products for detecting the protein marker CA125, products for detecting the protein marker CYFRA21-1 and are described as follows Functional vectors:

X1 represents the concentration of the protein marker IDH1, x2 represents the concentration of the protein marker CA125, and x3 represents the concentration of the protein marker CYFRA21-1. 2. The kit according to claim 1, characterized in that: the protein marker IDH1 is the protein shown in GENBANK ACCESSION NO.CAG46496.1; the protein marker CA125 is the protein shown in GENBANK ACCESSION NO.AAL65133.2 The protein shown; the protein marker CYFRA21-1 is the protein shown in GENBANK ACCESSION NO.NP_002267.2. 3. The kit according to claim 1 or 2, characterized in that: the unit of the concentration of the protein marker IDH1 is U/L, the unit of the concentration of the protein marker CA125 is U/mL, the The unit of the concentration of the protein marker CYFRA21-1 is ng/mL. 4. The kit according to claim 3, characterized in that: the carrier also records the following diagnostic criteria: when p≥0.5762, the patient to be tested is a candidate lung adenocarcinoma patient; when p<0.5762, The patient to be tested is a candidate non-lung adenocarcinoma patient. 5. Products for the detection of the protein marker IDH1, products for the detection of the protein marker CA125, products for the detection of the protein marker CYFRA21-1, and vectors with functional formulas and diagnostic criteria are used in the preparation of aided diagnosis of lung adenocarcinoma Patient's Kit Application: The functional formula is as follows: X1 represents the concentration of the protein marker IDH1 in U/L, x2 represents the concentration of the protein marker CA125 in U/mL, x3 represents the concentration of the protein marker CYFRA21-1 in ng/mL; The diagnostic criteria are as follows: when p≥0.5762, the patient to be tested is a candidate lung adenocarcinoma patient, and when p<0.5762, the patient to be tested is a candidate non-lung adenocarcinoma patient. 6. The application according to claim 5, characterized in that: said protein marker IDH1 is the protein shown in GENBANK ACCESSION NO.CAG46496.1; said protein marker CA125 is shown in GENBANK ACCESSION NO.AAL65133.2 The protein; the protein marker CYFRA21-1 is the protein shown in GENBANK ACCESSION NO.NP_002267.2. the

Images