CN112924678A - Kit for identifying benign and malignant thyroid nodules - Google Patents
Kit for identifying benign and malignant thyroid nodules Download PDFInfo
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- CN112924678A CN112924678A CN202110101826.7A CN202110101826A CN112924678A CN 112924678 A CN112924678 A CN 112924678A CN 202110101826 A CN202110101826 A CN 202110101826A CN 112924678 A CN112924678 A CN 112924678A
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- plg
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/574—Immunoassay; Biospecific binding assay; Materials therefor for cancer
- G01N33/57407—Specifically defined cancers
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G01N33/6893—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2800/00—Detection or diagnosis of diseases
- G01N2800/04—Endocrine or metabolic disorders
- G01N2800/046—Thyroid disorders
Abstract
The invention discloses a kit for identifying benign and malignant thyroid nodules, and belongs to the field of tumor detection. The concentration of PLG in the body of a patient with thyroid malignant nodules is abnormally reduced, the reagent disclosed by the invention can be used for assisting in identifying the malignant thyroid nodules and the benign thyroid nodules by detecting the concentration of PLG in blood, and the reagent is convenient, time-saving, high in accuracy and very good in application prospect.
Description
Technical Field
The invention belongs to the field of tumor detection.
Background
Thyroid nodules are masses that appear after abnormal proliferation of thyroid cells. According to the severity, it can be divided into benign and malignant. Benign thyroid nodules include nodular goiter and thyroid adenomas, most of which are relatively safe and can be observed through regular outpatient visits, and adenomas can be treated through surgery. Malignant thyroid nodules are mostly thyroid papillary carcinoma, and require surgical treatment, TSH inhibition treatment and iodine 131 treatment, and advanced lesions are more in need of comprehensive treatment.
In the clinic, thyroid nodules are often preliminarily assessed for malignancy and wellness by thyroid color ultrasonography. For suspected malignant thyroid nodules, fine needle biopsies are performed. However, the thyroid color Doppler ultrasound examination requires training of professional technicians, and the accuracy cannot reach 100%. Color ultrasound guided needle biopsy has trauma. The detection method usually takes a long time and is high in cost.
There is a lack of serum markers for rapid and efficient identification of benign and malignant thyroid nodules.
PLG, known as plasminogen, UniprotKB No. P00747, is an inactive proenzyme that, upon activation by an activator, is converted to a protease that functions to degrade fibrin in the blood clot. PLG is not currently available for differentiation of thyroid nodule benign and malignant.
Disclosure of Invention
The problems to be solved by the invention are as follows: provides a novel reagent for detecting benign and malignant thyroid nodules.
The technical scheme of the invention is as follows:
use of a reagent for detecting PLG in the preparation of a kit for identifying malignant thyroid nodules and benign thyroid nodules; the reagent for detecting the PLG takes blood, plasma or serum of a thyroid nodule patient as a detection sample.
Further, the malignant thyroid nodule is papillary thyroid carcinoma.
Further, the kit has a differentiation limit of 225.2 μ g/ml of peripheral blood PLG concentration, and the risk of thyroid malignant nodules is high in the patients below the differentiation limit.
Further, the reagent for detecting the PLG is an enzyme-linked immunosorbent assay reagent, a radioimmunoassay reagent or an immunoradiometric assay reagent.
Further, the reagent for detecting the PLG is an electrochemiluminescence reagent or a protein chip detection reagent.
A kit for identifying malignant thyroid nodules from benign thyroid nodules, the reagents comprising reagents for detecting PLG;
the reagent for detecting the PLG takes blood, plasma or serum of a thyroid nodule patient as a detection sample.
Further, the malignant thyroid nodule is papillary thyroid carcinoma.
Further, the kit has a differentiation limit of 225.2 μ g/ml of peripheral blood PLG concentration, and the risk of thyroid malignant nodules is high in the patients below the differentiation limit.
Further, the reagent for detecting the PLG is an enzyme-linked immunosorbent assay reagent, a radioimmunoassay reagent or an immunoradiometric assay reagent.
Further, the reagent for detecting the PLG is an electrochemiluminescence reagent or a protein chip detection reagent.
Has the advantages that:
the reagent for detecting PLG can accurately distinguish the benign and malignant thyroid nodules. Taking papillary thyroid carcinomas, which are the majority of malignant nodules, as an example, the risk of malignant nodules is high when the PLG concentration is 225.2 mug/ml, and the malignant nodules are judged to be lower than 225.2 mug/ml, the sensitivity can reach 87.50%, and the specificity is 75.00%. The accuracy of the detection reagent can reach the level of the existing reagent for distinguishing benign and malignant thyroid nodules. Patent application CN106526028A combined with two markers 1-oleoyl-sn-glycerol-3-phosphatidylcholine, 1-stearoyl-sn-glycerol-3-phosphatidylcholine distinguished benign and malignant thyroid nodules with sensitivity and specificity of 77.7% and 88.0%, respectively. Patent application CN109457032A discloses the expression levels of CK19, Survivin, TG, LGALS3 in circulating tumor cells with sensitivity and specificity of 74% and 74.47%, respectively. Overall, the accuracy of the present invention using a single marker can be as high as the prior art with multiple markers, effectively reducing material and time costs.
Obviously, many modifications, substitutions, and variations are possible in light of the above teachings of the invention, without departing from the basic technical spirit of the invention, as defined by the following claims. It is particularly emphasized that the key point of the present invention is to differentiate benign and malignant thyroid nodules by detecting PLG, without limiting the specific technique of detection, but any means for differentiating benign and malignant thyroid nodules by detecting PLG is within the scope of the present invention.
The present invention will be described in further detail with reference to the following examples. This should not be understood as limiting the scope of the above-described subject matter of the present invention to the following examples. All the technologies realized based on the above contents of the present invention belong to the scope of the present invention.
Detailed Description
Example 1 enzyme-linked immunosorbent assay (ELISA) detection kit
1. Compositions of the kits of the invention
As shown in table 1.
TABLE 1 kit composition
2. Kit using method
(1) Adding 50 mu L of standard substance or sample (anticoagulated peripheral blood, plasma or serum) into each hole of a 96-well plate, sealing the membrane, and then incubating for 2 hours at room temperature by shaking; samples were from persons with thyroid nodules.
(2) Washing the plate for 3 times by using 100 mu L of plate washing liquid;
(3) adding 50 mu L biotin-labeled secondary antibody into each hole, sealing the membrane, and then incubating for 30min at room temperature by shaking;
(4) washing the plate for 3 times by using 100 mu L of plate washing liquid;
(5) adding 50 μ L of chromogenic substrate into each hole, shaking and mixing for 2min at room temperature;
(6) reading by a microplate reader.
The PLG concentration of 225.2. mu.g/ml was used as a differentiation boundary, and those below 225.2. mu.g/ml were considered to be at greater risk of developing malignant thyroid nodules.
The advantageous effects of the present invention are further illustrated in the form of experimental examples.
Experimental example 1 PLG assay for peripheral blood of thyroid nodule patients
1. Method of producing a composite material
Anticoagulated peripheral venous blood was collected from 24 patients with thyroid papillary carcinoma (the main type of malignant nodules) and 24 patients with thyroid benign nodules, diagnosed pathologically at western hospital, university of Sichuan, group of thyroid papillary carcinomas: 4 cases of males and 20 cases of females; mean age 40.3 ± 11 years old; benign tubercle group of thyroid: wherein, the male is 2 cases, and the female is 22 cases; mean age 54.4 ± 13.6 years; PLG was detected with the kit described in example 1. After the detection values are obtained, the detection threshold, accuracy and sensitivity are analyzed by the following methods:
t-tests of the two groups of samples were used to compare the differences in PLG expression levels between the papillary thyroid carcinoma group and the benign thyroid nodule group. And setting a threshold value according to the ROC curve. The sensitivity is the number of true positive samples/(number of true positive samples + number of false negative samples); specificity is the number of true negative specimens/(true negative specimens + false positive specimens).
TABLE 2 comparison of peripheral blood PLG concentration (. mu.g/mL)
| Benign tubercular patients | Papillary carcinoma of thyroid |
| 242.3893666 | 191.1253389 |
| 258.1417436 | 186.7376779 |
| 304.2952601 | 205.0218622 |
| 269.3963892 | 198.0536211 |
| 251.5585234 | 160.1647721 |
| 231.9796101 | 220.3596199 |
| 219.7169528 | 232.6280164 |
| 178.0131266 | 187.9895892 |
| 214.5867539 | 206.2930357 |
| 290.7904573 | 230.6836889 |
| 243.6958198 | 176.7723859 |
| 225.5119705 | 176.1525498 |
| 196.7909336 | 193.0108532 |
| 238.4769427 | 198.6854605 |
| 244.3494775 | 166.2843474 |
| 219.0745937 | 187.3634622 |
| 235.2245995 | 224.8668614 |
| 266.0780442 | 171.8237483 |
| 219.0745937 | 194.8993913 |
| 284.7463974 | 293.4833553 |
| 248.9330808 | 188.6160582 |
| 346.0843187 | 168.7426289 |
| 283.4061083 | 160.7750316 |
| 233.9257174 | 206.2930357 |
2. Results
As shown in table 2, PLG protein levels in papillary thyroid carcinoma patients are overall lower than in benign tubercular patients. It was calculated that when 225.2. mu.g/mL was used as the detection threshold (below which malignant nodules were detected), the sensitivity of the detection was 87.50% and the specificity was 75.00%.
In conclusion, the reagent can quickly and accurately detect the benign and malignant thyroid nodules, avoids the pain caused by nodule puncture sampling, and is beneficial to popularization.
Claims (10)
1. Use of a reagent for detecting PLG in the preparation of a kit for identifying malignant thyroid nodules and benign thyroid nodules; the reagent for detecting the PLG takes blood, plasma or serum of a thyroid nodule patient as a detection sample.
2. Use according to claim 1, characterized in that: the malignant thyroid nodule is papillary thyroid carcinoma.
3. Use according to claim 1 or 2, characterized in that: the kit takes the concentration of the peripheral blood PLG of 225.2 mug/ml as a distinguishing limit, and the risk of suffering from thyroid malignant nodules is high when the distinguishing limit is lower.
4. Use according to claim 1 or 2, characterized in that: the reagent for detecting the PLG is an enzyme-linked immunosorbent assay reagent, a radioimmunoassay reagent or an immunoradiometric assay reagent.
5. Use according to claim 1 or 2, characterized in that: the reagent for detecting the PLG is an electrochemiluminescence reagent and a protein chip detection reagent.
6. A kit for identifying malignant thyroid nodules and benign thyroid nodules, which is characterized in that: the reagents include a reagent for detecting PLG;
the reagent for detecting the PLG takes blood, plasma or serum of a thyroid nodule patient as a detection sample.
7. The kit of claim 6, wherein: the malignant thyroid nodule is papillary thyroid carcinoma.
8. The kit of claim 6 or 7, wherein: the kit takes the concentration of the peripheral blood PLG of 225.2 mug/ml as a distinguishing limit, and the risk of suffering from thyroid malignant nodules is high when the distinguishing limit is lower.
9. The kit of claim 6 or 7, wherein: the reagent for detecting the PLG is an enzyme-linked immunosorbent assay reagent, a radioimmunoassay reagent or an immunoradiometric assay reagent.
10. The kit of claim 6 or 7, wherein: the reagent for detecting the PLG is an electrochemiluminescence reagent and a protein chip detection reagent.
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| Application Number | Priority Date | Filing Date | Title |
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| CN202110101826.7A CN112924678B (en) | 2021-01-25 | 2021-01-25 | Kit for identifying benign and malignant thyroid nodules |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110101826.7A CN112924678B (en) | 2021-01-25 | 2021-01-25 | Kit for identifying benign and malignant thyroid nodules |
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| CN112924678A true CN112924678A (en) | 2021-06-08 |
| CN112924678B CN112924678B (en) | 2022-04-19 |
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Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104321439A (en) * | 2012-03-15 | 2015-01-28 | 凯杰科技有限公司 | Thyroid cancer biomarker |
| CN106405101A (en) * | 2016-08-30 | 2017-02-15 | 山东博科生物产业有限公司 | Plasminogen detection kit |
| CN106526028A (en) * | 2016-11-14 | 2017-03-22 | 中国药科大学 | Applications of metabolic markers in diagnosing and identifying benign or malignant lesions of thyroid gland |
| CN107110867A (en) * | 2014-12-12 | 2017-08-29 | 首尔大学校产学协力团 | Biomarker for diagnosing cancer of liver and application thereof |
| CN107748263A (en) * | 2017-08-31 | 2018-03-02 | 北京臻惠康生物科技有限公司 | The new application and kit of a kind of plasminogen |
| CN108841954A (en) * | 2018-06-27 | 2018-11-20 | 上海思路迪生物医学科技有限公司 | Application of the biomarker in oophoroma assessment |
-
2021
- 2021-01-25 CN CN202110101826.7A patent/CN112924678B/en active Active
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104321439A (en) * | 2012-03-15 | 2015-01-28 | 凯杰科技有限公司 | Thyroid cancer biomarker |
| CN107110867A (en) * | 2014-12-12 | 2017-08-29 | 首尔大学校产学协力团 | Biomarker for diagnosing cancer of liver and application thereof |
| CN106405101A (en) * | 2016-08-30 | 2017-02-15 | 山东博科生物产业有限公司 | Plasminogen detection kit |
| CN106526028A (en) * | 2016-11-14 | 2017-03-22 | 中国药科大学 | Applications of metabolic markers in diagnosing and identifying benign or malignant lesions of thyroid gland |
| CN107748263A (en) * | 2017-08-31 | 2018-03-02 | 北京臻惠康生物科技有限公司 | The new application and kit of a kind of plasminogen |
| CN108841954A (en) * | 2018-06-27 | 2018-11-20 | 上海思路迪生物医学科技有限公司 | Application of the biomarker in oophoroma assessment |
Non-Patent Citations (3)
| Title |
|---|
| RUGGERI, ROSARIA M 等: "What is New on Thyroid Cancer Biomarkers", 《BIOMARKER INSIGHTS》 * |
| 周溪等: "超声及血清学指标诊断甲状腺结节的研究进展", 《现代医药卫生》 * |
| 张攀 等: "甲状腺原发鳞状细胞癌诊治进展", 《中国普外基础与临床杂志》 * |
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