WO2019136947A1 - 一种快速免疫检测系统在手术中的新用途 - Google Patents

一种快速免疫检测系统在手术中的新用途 Download PDF

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WO2019136947A1
WO2019136947A1 PCT/CN2018/095063 CN2018095063W WO2019136947A1 WO 2019136947 A1 WO2019136947 A1 WO 2019136947A1 CN 2018095063 W CN2018095063 W CN 2018095063W WO 2019136947 A1 WO2019136947 A1 WO 2019136947A1
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surgery
rapid
blood
test paper
test
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French (fr)
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杨洪
黄文喜
杨胤瑾
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广州市康润生物科技有限公司
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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
    • 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
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/50—Determining the risk of developing a disease

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  • the present invention relates to the field of medical device technology, and in particular to a new use of a rapid immunodetection system in surgery.
  • Thyroglobulin Tg is a macromolecular glycoprotein secreted by the thyroid follicular epithelium. It is often found in normal thyroid tissue, well-differentiated thyroid carcinoma tissue and metastatic lymph nodes, and the concentration in tissue fluid is much higher than that in serum, so differentiation In the follow-up of thyroid cancer, if a high concentration of Tg is detected in the extrathyroid tissue, the possibility of thyroid cancer metastasis should be highly alert.
  • FNA-Tg FNA fine needle aspiration Tg value detection technology was first reported by Pacini et al in 1992. Its operation is simple and accurate, and it can avoid the subjectivity of pathological diagnosis to a certain extent. It has been widely used in clinical practice. Accurate assessment of lymph nodes is the basis for clinical decision making.
  • ATA American Thyroid Association
  • FNA-Tg FNA fine needle aspiration Tg value examination based on the molecular characteristics of thyroid cancer, in the diagnosis of differentiated thyroid cancer metastasis, as a subsidiary product and auxiliary examination of needle biopsy, does not increase patient trauma, but FNA-Tg It is a semi-quantitative indicator and there is currently no diagnostic reference value. Therefore, it is necessary to comprehensively apply auxiliary diagnostic techniques to foster strengths and avoid weaknesses.
  • FNA-Tg-assisted FNAC can improve the diagnosis of lymph node metastasis of papillary thyroid carcinoma by about 13%, and the combined use can help reduce the false negative rate.
  • the data of many units also show that the combination of ultrasound, FNAC and FNA-Tg can evade the weakness of single technique and improve the sensitivity and accuracy of diagnosis in the evaluation of cervical lymph nodes. It can be integrated in cervical lymph node dissection decision. application.
  • the operation of the FNA-Tg detection process itself is relatively complicated. It is necessary to select fine needle puncture (the needle is 21-25G needle, connect 5ml syringe), then remove the puncture smear, absolute ethanol fixation, HE staining, all puncture lesions. The position and the corresponding specimens are clearly marked, and after one-to-one correspondence, the pathology department is sent to perform cytological examination. Then, a water washing solution was prepared, and Tg level detection was performed, and Tg detection was performed by electrochemiluminescence.
  • FNA-Tg 100 ng/ml as FNA-Tg to diagnose whether the cervical lymph node is a cutoff of metastatic lymph nodes, FNA-Tg>100 ng/ml is metastatic, and FNA-Tg ⁇ 100 ng/ml is benign.
  • FNA-Tg measurement A 0.3 ml 0.9% physiological saline solution was taken using a 1 ml syringe to prepare an eluate of about 1 ml for examination. The eluate was centrifuged at 1 000 g for 5 min in a Beckman-Coulter Mi-crofuge 18 centrifuge, and the supernatant was taken for detection of Tg content by immunoelectrochemiluminescence.
  • the measurement object In practice, in the case where an immediate determination is required, especially in the case of an immediate judgment during surgery, if the test method is used in the prior art, the measurement object needs to be repeatedly centrifuged and tested. The actual operation is often to transfer the sample from the operating room to the detection room, and then perform repeated centrifugation operations in the detection room, and then feed back the detection structure to the operator. This type of processing not only takes a lot of time, but also has complicated operations and cannot meet the needs of instant convenience.
  • the gold standard for judging the metastasis of cervical lymph nodes in thyroid cancer is intraoperative rapid pathological section. It requires technicians of relevant pathology, experienced pathologists and their expensive fine equipment. The routine examination takes about 40 minutes.
  • a rapid immunodetection system is provided as a new use in surgery to achieve a rapid, simple, and accurate determination of the Tg content of the lateral subject to determine whether there is cervical lymph node metastasis of thyroid cancer to overcome the existing Technical deficiencies are necessary.
  • the object of the present invention is to provide a new use of a rapid immunodetection system in surgery, which avoids the deficiencies of the prior art, can be directly operated during surgery, and has the characteristics of convenient operation, time saving and high efficiency.
  • the above-mentioned rapid immunodetection system has a new use in surgery, and specific operational steps include
  • the elution is carried out to the TG test paper, and the detection line and the quality control line on the TG test paper are scanned by the detector of the immunodetection system, and the parameter calculation is performed by the processing unit set inside the detector. Treatment, the content of thyroglobulin TG in the tissue is obtained.
  • the above-mentioned rapid immunoassay system has a new use in surgery, and the processing unit automatically determines the TG content of the lymph nodes in the puncture area.
  • the above-mentioned rapid immunodetection system has a new use in surgery, and step d specifically compares the TG value in the eluate with the basal value of the TG in the same blood.
  • step d specifically compares the TG value in the eluate with the basal value of the TG in the same blood.
  • the ratio is greater than 1, the thyroid cancer region is determined to exist. Lymph node metastasis.
  • the above-mentioned rapid immunoassay system has a new use in surgery, and the basic value in the blood is obtained by dropping a blood or blood treatment sample onto the test TG test paper, and then scanning the TG test paper by the detector of the immunodetection system.
  • the detection line and the quality control line are obtained, and the TG content in the blood or blood treatment sample is obtained by a processing unit provided inside the detector.
  • the TG detection basis value in the blood is obtained by detecting the blood collected in the field or by detecting the blood collected in advance at the start of the surgery.
  • the above-mentioned rapid immunoassay system has a new use in surgery, eluting droplets to TG test strips, and the TG test strips exhibit different color strips, and the detector scans the color depth readings according to the strips presented on the TG test strips, and colors Dark and light strip assignments.
  • the above TG test paper is used for testing and displaying thyroglobulin Tg content
  • the TG test paper is an immunocolloidal gold test paper
  • the display scale on the test paper is indicated as a content.
  • the above-mentioned rapid immunoassay system has a new use in surgery, and step a specifically adopts fine needle puncture.
  • the puncture needle tip enters the inside of the target part, the syringe is pumped back to generate a negative pressure, and the repeated multi-point suction is not less than 3 times, and then Take a needle sampling;
  • step b the puncture needle and the syringe were rinsed with 1 ml of 0.9% sodium chloride injection to prepare 1 ml of the eluate.
  • the rapid immunoassay system of the present invention identifies the presence or absence of cervical lymph node metastasis in thyroid cancer by detecting the content of thyroglobulin.
  • the operation room can be directly operated in the operating room, and the prior art needs to send the puncture tissue to the laboratory and then undergo the centrifugal detection process, which is convenient and fast.
  • Figure 1 is a schematic diagram of the three-dimensional structure of thyroglobulin Tg.
  • FIG. 2 is a schematic view of a quantitative analysis and detection system based on a Tg test paper of the present invention.
  • a rapid immunoassay system is used as a new application in surgery to detect the presence of cervical lymph node metastasis in thyroid cancer by detecting the content of thyroglobulin.
  • Thyroglobulin is an iodinated glycoprotein in thyroid tissue and is a homodimer with a molecular mass of about 660 kDa.
  • the subunit of human thyroglobulin consists of 2767 amino acid residues.
  • the biological half-life of Tg was 65.2 hours.
  • the rapid immunoassay system used in this embodiment is composed of a Tg test paper and a detector, as shown in FIG.
  • Tg test paper tested and showed the content of tissue thyroglobulin Tg, and a positive detection line appeared when FNA-Tg was detected to be greater than the rated value;
  • the detector scans the detection line and the quality control line on the Tg test paper, and performs parameter calculation processing through the processing unit provided inside the detector to obtain the content of thyroglobulin Tg in the tissue.
  • the rapid immune detection system is further provided with a display screen, and the display screen is connected with the processing unit of the detector to display the parameters calculated by the processing unit.
  • the detection of the content of thyroglobulin Tg in the regional lymph node tissue it can be used as a basis for determining whether there is lymph node metastasis of thyroid cancer in the regional lymph nodes, and provide guidance for clinical cervical lymph node dissection.
  • the utility model has the advantages of convenient operation, simple and intuitive result, and can be used for detection in any occasion, and has wide application range.
  • the rapid immunoassay system is used as a new use in surgery, and specific steps include
  • step a specifically adopts fine needle puncture, the puncture needle tip enters the inside of the target part, and then the syringe is pumped to generate negative pressure, and the repeated multi-point suction times are not less than 3 times, and then the needle is sampled; and then the step b is performed, and the puncture needle and the puncture needle are The syringe was rinsed with 1 ml of 0.9% sodium chloride injection to make an eluate.
  • Step c specifically, the elution is dropped onto the TG test paper, and then the detection line and the quality control line on the TG test paper are scanned by the detector of the immunodetection system, and the parameter calculation processing is performed through the processing unit provided inside the detector to obtain an organization.
  • the content of thyroglobulin TG are applied to the TG test paper, and the TG test paper presents different color strips.
  • the detector scans the color depth readings according to the strips presented on the TG test paper, and assigns values to the strips of the dark color.
  • the operation by Tg test paper is very simple, and the test result is directly displayed on the Tg test paper, which is intuitive and convenient.
  • the Tg test paper is set as an immunocolloidal gold test paper for displaying the content of tissue thyroglobulin Tg in the FNA-Tg test.
  • the thyroglobulin (Tg) detection reagent adopts the solid phase immunochromatographic analysis technique, and adopts the principle of double antibody sandwich method, and the antibody against the gold standard monoclonal antibody or the microsphere is combined with the Tg protein to be detected in the sample to form an immune complex. And as the sample is chromatographed to the test area, it is further combined with the pre-coated capture antibody to form a detection line. Within a certain range, the color of the detection line is proportional to the thyroglobulin (Tg) in the sample. After the reaction is completed, the detection line and the quality control line are scanned and analyzed by the detector, and calculated according to the parameters preset in the instrument, thereby quantitatively detecting the content of thyroglobulin (Tg) in the blood.
  • Tg thyroglobulin
  • the Tg test paper directly detects the tissue and directly displays the TGI content of the thyroglobulin in the tissue, and the operation is convenient and simple. It can be used for inspection in any occasion and has a wide range of applications.
  • the cumbersome process of continuously measuring the thyroglobulin Tg content in the tissue in the prior art is overcome, and the operation is convenient and simple.
  • the rapid immunoassay system is a new use in surgery to detect the presence of cervical lymph node metastasis in thyroid cancer by detecting the content of thyroglobulin.
  • the utility model can directly operate in the operation, and avoids the trouble that the puncture tissue needs to be sent to the laboratory centrifugal detection processing in the prior art, and has the characteristics of convenient operation and quickness.
  • step d specifically compares the TG value in the eluate with the basal value of the TG in the same blood.
  • the ratio is greater than 1, it is determined that there is regional lymph node metastasis of thyroid cancer.
  • blood refers to the blood of the same subject at the same time.
  • the basic value of the blood is obtained by dropping the blood or blood treatment sample into the detection TG test paper, and then scanning the detection line and the quality control line on the TG test paper through the detector of the immunological detection system, and processing through the internal setting of the detector.
  • the unit obtains the TG content in the treated sample of blood or blood.
  • the basal value of the TG test in the blood may be obtained by detecting blood collected in the field or by detecting blood collected in advance at the start of the surgery.
  • the TG value in the tissue to be tested is compared with the basic value in the simultaneous blood, and another judgment mode is provided, which has the characteristics of convenient detection and accurate result.

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Abstract

一种快速免疫检测系统在手术中的新用途，通过检测甲状腺球蛋白的含量来鉴别甲状腺癌是否存在颈部淋巴结转移。具体步骤为：a，对甲状腺区域淋巴结组织进行穿刺；b，制备穿刺组织的洗脱液；c，通过快速免疫检测系统直接对制备的洗脱液进行TG定量检测；d，根据TG检测结果鉴别区域淋巴结是否存在甲状腺癌转移。

Description

一种快速免疫检测系统在手术中的新用途 技术领域
本发明涉及医疗设备技术领域，特别是涉及一种快速免疫检测系统在手术中的新用途。
背景技术
甲状腺球蛋白Tg是甲状腺滤泡上皮分泌的大分子糖蛋白，常存在于正常甲状腺组织、分化好的甲状腺癌组织及转移的淋巴结内，且组织液中的浓度远高于血清中的浓度，故分化型甲状腺癌术后随访中，若在甲状腺外组织内检测出高浓度Tg，应高度警惕甲状腺癌转移的可能性。
FNA-Tg(FNA细针穿刺Tg值)检测技术于1992年由Pacini等首先报道，其操作简便、准确，且可一定程度上避免病理诊断的主观性，已广泛应用于临床。淋巴结的精确评估是临床决策的基础，美国甲状腺协会(ATA)指南将FNA-Tg作为甲状腺癌术前术后淋巴结评估的新技术加以推荐，为颈淋巴结清扫策略的制定提供新的依据。
FNA-Tg(FNA细针穿刺Tg值)检查基于甲状腺癌的分子特征，在分化型甲状腺癌转移的诊断中异军突起，作为穿刺活检的附属产物和辅助检查，并不增加病人创伤，但FNA-Tg是一种半定量指标，目前尚无通行的诊断参考值。因此，须综合应用辅助诊断技术以扬长避短。Al-Hilli等研究中FNA-Tg辅助FNAC能将甲状腺乳头状癌淋巴结转移诊断提升约13％，联合使用有助于减少假阴性率。目前很多单位的研究数据也显示在颈侧区淋巴结的评估中超声、FNAC、FNA-Tg联合应用可以规避单个技术 的弱点，提高诊断的敏感度和准确率，可在颈部淋巴结清扫决策时综合应用。
但是，FNA-Tg检测过程本身操作还是相对复杂，需要选择细针穿刺(穿刺针为21—25G针，连接5ml注射器)，然后取出穿刺物涂片、无水乙醇固定、HE染色，所有穿刺病灶位置与对应标本均明确标记，一一对应后，送病理科做细胞学检查。然后制成水洗液，送Tg水平检测，Tg检测采用电化学发光法。以100ng/ml作为FNA—Tg诊断颈部淋巴结是否为转移淋巴结的截断值，FNA—Tg>100ng/ml为转移性，FNA—Tg<100ng/ml为良性。
FNA—Tg测定用1ml针筒吸取0.3ml0.9％生理盐水，制成约1ml的洗脱液送检。洗脱液采用Beckman—Coulter Mi—crofuge 18离心机1 000g离心5min，取上清液，采用免疫电化学发光法检测Tg含量。
在实际中，对于需要即时判定特别是在手术中需要即时判定的情况，如果像现有技术中的测试方法则需要将测定对象反复离心、测试。实际操作往往是从手术室将样本转到检测室，检测室再进行反复离心处理等操作，再将检测结构反馈至手术方。这种处理方式不仅大大花费时间，而且操作复杂，不能满足即时方便的需求。
目前判断甲状腺癌颈部淋巴结是否转移的黄金标准为术中快速病理切片，需要相关病理专业的技术人员、经验丰富病理医师及其昂贵的精细设备，常规检查耗时40分钟左右。
因此，针对现有技术不足，提供一种快速免疫检测系统作为手术中的新用途，以实现快速、简单、准确得到被侧对象Tg含 量情况从而判断是否存在甲状腺癌颈部淋巴结转移以克服现有技术不足甚为必要。
发明内容
本发明的目的在于避免现有技术的不足之处而提供一种快速免疫检测系统在手术中的新用途，能够在术中直接操作，具有操作方便，省时高效的特点。
本发明的上述目的通过如下技术手段实现。
提供一种快速免疫检测系统在手术中的新用途，通过检测甲状腺区域淋巴结的TG水平，判断区域淋巴结是否存在甲状腺癌转移。
优选的，上述的快速免疫检测系统在手术中的新用途，具体操作步骤包括，
a，对甲状腺区域淋巴结组织进行穿刺；
b，制备穿刺组织的洗脱液；
c，通过快速免疫检测系统直接对制备的洗脱液进行甲状腺球蛋白TG定量检测处理；
d，根据快速免疫检测系统得到的TG检测结果鉴别区域淋巴结是否存在甲状腺癌转移。
优选的，上述步骤c具体是，将洗脱液滴到TG试纸，再通过免疫检测系统的检测仪扫描TG试纸上的检测线和质控线，并通过检测仪内部设置的处理单元进行参数计算处理，得到组织中的甲状腺球蛋白TG的含量。
优选的，上述快速免疫检测系统在手术中的新用途，处理单元自动判断穿刺区域淋巴结的TG含量情况。
优选的，上述快速免疫检测系统在手术中的新用途，步骤d 具体是将洗脱液中的TG值与同时血液中的TG检测基础值相比，当比值大于1，则判定存在甲状腺癌区域淋巴结转移。
优选的，上述快速免疫检测系统在手术中的新用途，血液中基础值的获得具体是，将血液或者血液的处理样品滴到检测TG试纸，再通过免疫检测系统的检测仪扫描TG试纸上的检测线和质控线，并通过检测仪内部设置的处理单元得到血液或者血液的处理样品中的TG含量。
优选的，血液中的TG检测基础值是对现场采集的血液进行检测得到或者是对对手术开始当时预先采集的血液进行检测得到。
优选的，上述快速免疫检测系统在手术中的新用途，洗脱液滴到TG试纸，TG试纸呈现不同的颜色条带，检测仪扫描根据TG试纸上呈现的条带颜色深浅读数，并对颜色深浅的条带赋值。
优选的，上述TG试纸用于测试并显示甲状腺球蛋白Tg含量，所述TG试纸为免疫胶体金试纸；试纸上的显示刻度标示为含量。
优选的，上述快速免疫检测系统在手术中的新用途，步骤a具体采用细针穿刺，穿刺针尖进入目标部位内部后回抽注射器产生负压，反复多点抽吸次数不低于3次，然后退针取样；
再进入步骤b，将穿刺针及注射器用1ml0.9％氯化钠注射液冲洗，制成1ml洗脱液。
本发明的一种快速免疫检测系统作为手术中的新用途，通过检测甲状腺球蛋白的含量来鉴别甲状腺癌是否存在颈部淋巴结转移。能够在术中手术室特别是能够实现在手术室床边直接操作， 避免了现有技术中需要将穿刺组织送到化验室再经过离心检测处理的麻烦，具有操作方便、快捷的特点。
附图说明
利用附图对本发明作进一步的说明，但附图中的内容不构成对本发明的任何限制。
图1是甲状腺球蛋白Tg的三维结构示意图。
图2是本发明基于Tg试纸的定量分析检测系统的示意图。
具体实施方式
结合以下实施例对本发明作进一步描述。
实施例1。
一种快速免疫检测系统作为手术中的新用途，通过检测甲状腺球蛋白的含量来鉴别甲状腺癌是否存在颈部淋巴结转移。
甲状腺球蛋白Tg的三维结构如图1所示，甲状腺球蛋白是甲状腺组织中的一种碘化糖蛋白，为同源二聚体，分子质量约660kDa。人甲状腺球蛋白的亚基由2767个氨基酸残基组成。Tg体内生物半衰期为65.2小时。通过检测区域淋巴结组织中甲状腺球蛋白Tg含量判定是否存在甲状腺癌颈部淋巴结转移，可以为颈部淋巴结清扫决策提供依据。
本实施例中所采用的快速免疫检测系统，由Tg试纸和检测仪构成，如图2所示。
Tg试纸，测试并显示组织甲状腺球蛋白Tg的含量，在检测到FNA—Tg大于额定值时出现阳性检测线；
检测仪，扫描Tg试纸上的检测线和质控线，并通过检测仪内部设置的处理单元进行参数计算处理，得到组织中的甲状腺球蛋白Tg的含量。
该快速免疫检测系统，还设置有显示屏，显示屏与检测仪的 处理单元连接，将处理单元计算的参数进行显示。
根据检测所得到的区域淋巴结组织中的甲状腺球蛋白Tg的含量，可以作为判定区域淋巴结是否存在甲状腺癌颈部淋巴结转移的依据，为临床颈部淋巴结清扫提供指导依据。具有操作方便简单、结果直观，可用于任何场合的检测，适用范围广泛。
该快速免疫检测系统作为手术中的新用途，具体操作步骤包括，
a，对甲状腺区域淋巴结组织进行穿刺；
b，制备穿刺组织的洗脱液；
c，通过快速免疫检测系统直接对制备的洗脱液进行甲状腺球蛋白TG定量检测处理；
d，根据快速免疫检测系统得到的TG检测结果鉴别区域淋巴结是否存在甲状腺癌转移。
其中，步骤a具体采用细针穿刺，穿刺针尖进入目标部位内部后回抽注射器产生负压，反复多点抽吸次数不低于3次，然后退针取样；再进入步骤b，将穿刺针及注射器用1ml0.9％氯化钠注射液冲洗，制成洗脱液。
步骤c具体是，将洗脱液滴到TG试纸，再通过免疫检测系统的检测仪扫描TG试纸上的检测线和质控线，并通过检测仪内部设置的处理单元进行参数计算处理，得到组织中的甲状腺球蛋白TG的含量。其中，洗脱液滴到TG试纸，TG试纸呈现不同的颜色条带，检测仪扫描根据TG试纸上呈现的条带颜色深浅读数，并对颜色深浅的条带赋值。通过Tg试纸操作非常简单，检测结果直接在Tg试纸上显示，具有直观方便的特点。
具体的，Tg试纸设置为免疫胶体金试纸，用于在FNA—Tg 检测中显示组织甲状腺球蛋白Tg的含量。
甲状腺球蛋白(Tg)检测试剂采用固相免疫层析分析技术，采用双抗体夹心法原理，金标单抗或微球包被的抗体与样本中的待检Tg蛋白结合，形成免疫复合物，并随着样品层析至测试区，与已预包被的捕获抗体进一步结合形成检测线，在一定范围内，检测线颜色的深浅与样品中的甲状腺球蛋白(Tg)呈正比例关系。反应完成后，通过检测仪对检测线和质控线进行扫描分析，并按照仪器内部预置的参数进行计算，从而定量检测血液中甲状腺球蛋白(Tg)的含量。
该Tg试纸，对组织进行直接检测，直接显示组织中甲状腺球蛋白Tg含量，操作方便简单。可用于任何场合的检测，适用范围广泛。通过本实施例的Tg试纸，克服了现有技术中检测组织中甲状腺球蛋白Tg含量需要不断离心处理的繁琐过程，具有操作方便简单的特点。
本快速免疫检测系统作为手术中的新用途，通过检测甲状腺球蛋白的含量来鉴别甲状腺癌是否存在颈部淋巴结转移。能够在术中直接操作，避免了现有技术中需要将穿刺组织送到化验室离心检测处理的麻烦，具有操作方便、快捷的特点。
实施例2。
一种快速免疫检测系统作为手术中的新用途，其它特征与实施例1相同，不同之处在于：步骤d具体是将洗脱液中的TG值与同时血液中的TG检测基础值相比，当比值大于1，则判定存在甲状腺癌区域淋巴结转移。同时血液是指同时期、同一对象的血液。
血液中基础值的获得具体是，将血液或者血液的处理样品滴 到检测TG试纸，再通过免疫检测系统的检测仪扫描TG试纸上的检测线和质控线，并通过检测仪内部设置的处理单元得到血液或者血液的处理样品中的TG含量。
血液中的TG检测基础值可以是对现场采集的血液进行检测得到或者是对手术开始当时预先采集的血液进行检测得到。
本实施例将待测组织中的TG值与同时血液中的基础值进行比对，提供了另外一种判断方式，具有检测方便、结果准确的特点。
最后应当说明的是，以上实施例仅用以说明本发明的技术方案而非对本发明保护范围的限制，尽管参照较佳实施例对本发明作了详细说明，本领域的普通技术人员应当理解，可以对本发明的技术方案进行修改或者等同替换，而不脱离本发明技术方案的实质和范围。

Claims (10)

  1. 一种快速免疫检测系统在手术中的新用途，其特征在于：通过检测甲状腺区域淋巴结的TG水平，判断区域淋巴结是否存在甲状腺癌转移。
  2. 根据权利要求1所述的快速免疫检测系统在手术中的新用途，其特征在于：
    具体操作步骤包括，
    a，对甲状腺区域淋巴结组织进行穿刺；
    b，制备穿刺组织的洗脱液；
    c，通过快速免疫检测系统直接对制备的洗脱液进行甲状腺球蛋白TG定量检测处理；
    d，根据快速免疫检测系统得到的TG检测结果鉴别区域淋巴结是否存在甲状腺癌转移。
  3. 根据权利要求2所述的快速免疫检测系统在手术中的新用途，其特征在于：
    所述步骤c具体是，将洗脱液滴到TG试纸，再通过免疫检测系统的检测仪扫描TG试纸上的检测线和质控线，并通过检测仪内部设置的处理单元进行参数计算处理，得到组织中的甲状腺球蛋白TG的含量。
  4. 根据权利要求3所述的快速免疫检测系统在手术中的新用途，其特征在于：处理单元自动判断穿刺区域淋巴结的TG含量情况。
  5. 根据权利要求4所述的快速免疫检测系统在手术中的新用途，其特征在于：步骤d具体是将洗脱液中的TG值与同时血液中的TG检测基础值相比，当比值大于1，则判定存在甲状腺癌区域淋巴结转移。
  6. 根据权利要求5所述的快速免疫检测系统在手术中的新用途，其特征在于：血液中基础值的获得具体是，将血液或者血液的处理样品滴到检测TG试纸，再通过免疫检测系统的检测仪扫描TG试纸上的检测线和质控线，并通过检测仪内部设置的处理单元得到血液或者血液的处理样品中的TG含量。
  7. 根据权利要求6所述的快速免疫检测系统在手术中的新用途，其特征在于：血液中的TG检测基础值是对现场采集的血液进行检测得到或者是对手术开始当时预先采集的血液进行检测得到。
  8. 根据权利要求7所述的快速免疫检测系统在手术中的新用途，其特征在于：洗脱液滴到TG试纸，TG试纸呈现不同的颜色条带，检测仪扫描根据TG试纸上呈现的条带颜色深浅读数，并对颜色深浅的条带赋值。
  9. 根据权利要求8所述的快速免疫检测系统在手术中的新用途，其特征在于：所述TG试纸用于测试并显示甲状腺球蛋白Tg含量，所述TG试纸为免疫胶体金试纸；试纸上的显示刻度标示为含量。
  10. 根据权利要求9所述的快速免疫检测系统在手术中的新用途，其特征在于：
    步骤a具体采用细针穿刺，穿刺针尖进入目标部位内部后回抽注射器产生负压，反复多点抽吸次数不低于3次，然后退针取样；
    再进入步骤b，将穿刺针及注射器用1ml 0.9％氯化钠注射液冲洗，制成1ml洗脱液。
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