Method for detecting thyroid related indexes based on peripheral blood and application

Abstract

The invention belongs to the technical field of medical detection and analysis, particularly relates to a method for detecting thyroid related indexes based on peripheral blood, and further discloses application of the method. According to the method for detecting the thyroid related indexes based on the peripheral blood, the peripheral blood is adopted as a detection sample to replace traditional venous blood sampling, the three thyroid indexes TSH, TT4 and TPOAb can be obtained at the same time through one-time blood sampling and detection, the result can point to the thyroid function and immune state, and the method has the advantages of being small in wound, small in blood sampling amount and easy to operate; the detection requirements in clinical work can be met.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical detection and analysis, and particularly relates to a method for detecting thyroid-related indicators based on peripheral blood, and further discloses its application. Background Art

[0002] Thyroid diseases are one of the common endocrine and metabolic diseases, and often can lead to thyroid function abnormalities such as clinical and subclinical hypothyroidism (referred to as hypothyroidism for short), hyperthyroidism (referred to as hyperthyroidism for short), etc. Research shows that uncontrolled thyroid function abnormalities can lead to abnormalities such as lipid and glucose metabolism disorders, cardiovascular system, digestive system and nervous system. Therefore, patients with thyroid function abnormalities need to regularly review thyroid function indicators to adjust the dosage of thyroid-related drugs.

[0003] The evaluation of the thyroid function of offspring has also received increasing attention. Clinically, the demand for the detection of thyroid function indicators is huge, including physical examination populations, thyroid disease populations, and also some special populations such as newborns and infants.

[0004] However, existing detection methods almost rely on venous blood collection, which not only causes relatively large trauma, requires professional technical personnel for blood collection, and has a large demand for the blood volume of blood specimens, but also has risks such as subcutaneous hematoma, bleeding, congestion, and nerve damage. In addition, it is limited in application and has a low blood collection success rate in populations that are difficult to cooperate such as infants, psychiatric patients, and special populations with poor tolerance to large trauma and shock patients. Clinically, although there is already a method for collecting heel blood and detecting TSH based on the filter paper method, the sample processing of this method requires operations such as punching holes in filter paper, dissolving, and detecting on a machine, and the process is relatively complex; and the actual detection to reporting the value cycle takes nearly 3 weeks, and currently it is only limited to the application of detecting indicators such as TSH in neonatal screening.

[0005] Peripheral blood collection has the advantages of less sampling volume and convenient blood collection, and can effectively reduce the pain of patients. However, at present, there is only one device on the market in China that uses fluorescence immunochromatography to detect TSH in fingertip blood, but it cannot detect TT4 and TPOAb, and the measured TSH result is on the low side and the accuracy is relatively poor. Therefore, it is only recommended for primary screening, and relevant test strips or detection equipment need to be purchased additionally, so it has not been widely used in clinical practice. And simultaneously detecting the three indicators of TSH, TT4, and TPOAb can not only more accurately judge the thyroid function status compared with detecting only one of these indicators separately, but also can evaluate the autoimmune status of the thyroid. Summary of the Invention

[0006] Therefore, the technical problem to be solved by the present invention is to provide a method for detecting thyroid-related indicators based on peripheral blood, and the method can simultaneously detect the three indicators of TSH, TT4, and TPOAb, and has the advantages of small trauma, less blood collection volume, and easy operation;

[0007] The second technical problem to be solved by the present invention is to provide an application of the above method for detecting thyroid-related indicators based on peripheral blood.

[0008] To solve the above technical problems, a method for detecting thyroid-related indicators based on peripheral blood according to the present invention includes the following steps:

[0009] (1) Collect peripheral blood;

[0010] (2) Add the collected peripheral blood into an EP tube pretreated with EDTA anticoagulation, collect the reaction product for centrifugation, and collect the upper-layer plasma;

[0011] (3) Detect thyroid-related indicators based on the collected plasma.

[0012] Specifically, in the method for detecting thyroid-related indicators based on peripheral blood, in step (3), the thyroid-related indicators include TT4, TSH, and TPOAb.

[0013] Specifically, in the method for detecting thyroid-related indicators based on peripheral blood, in step (3), the detection step of the thyroid-related indicators further includes a step of diluting the plasma with a diluent;

[0014] Preferably, the dilution multiple of the dilution step is 5-10 times.

[0015] Specifically, in the method for detecting thyroid-related indicators based on peripheral blood, the thyroid-related indicators include TT4;

[0016] Preferably, the diluent includes a diluent containing human plasma;

[0017] Preferably, the dilution multiple of the plasma is 8-10 times;

[0018] Preferably, the detection step includes chemiluminescence method.

[0019] Specifically, in the method for detecting thyroid-related indicators based on peripheral blood, the thyroid-related indicators include TSH;

[0020] Preferably, the diluent includes a diluent containing animal serum;

[0021] Preferably, the dilution multiple of the plasma is 4-6 times;

[0022] Preferably, the detection step includes chemiluminescence method.

[0023] Specifically, in the method for detecting thyroid-related indicators based on peripheral blood, the thyroid-related indicators include TPOAb;

[0024] Preferably, the diluent includes a protein-containing diluent;

[0025] Preferably, the plasma is diluted 4 to 6 times;

[0026] Preferably, the detection step includes electrochemiluminescence immunoassay.

[0027] Specifically, in the method for detecting thyroid-related indicators based on peripheral blood, in step (1), the step of collecting peripheral blood includes: the operator surrounds the puncture blood collection finger of the person being blood collected with the index finger and middle finger, and gradually applies pressure from the proximal end of the finger towards the fingertip, adjusts the liquid collection port of the capillary blood collection tube to form an angle of 30° - 45° with the puncture point to collect blood, and collects peripheral blood. By adopting the above collection technique, the present invention can collect more fingertip blood than the conventional technique, thereby meeting the required sample volume for detection; at the same time, it can also avoid the problem that excessive squeezing in the traditional blood collection technique will cause too much tissue fluid, resulting in a reduction in the effective components of the blood and directly affecting the detection result.

[0028] Specifically, in the method for detecting thyroid-related indicators based on peripheral blood, in step (1), the blood collection volume of the peripheral blood is 100 - 300 μl, preferably 200 μl, and the blood collection volume is lower.

[0029] Specifically, in the method for detecting thyroid-related indicators based on peripheral blood, in step (2), the rotation speed of the centrifugation step is 3000 - 4000 r / min, and the centrifugation time is 5 - 15 minutes.

[0030] The present invention also discloses the application of the method for detecting thyroid-related indicators based on peripheral blood in the fields of thyroid diagnosis, detection, and treatment.

[0031] The method for detecting thyroid-related indicators based on peripheral blood according to the present invention uses peripheral blood as a detection specimen to replace traditional venous blood collection, and has the advantages of small trauma, less blood collection volume, and easy operation. The method of the present invention can simultaneously obtain three thyroid indicators, TSH, TT4, and TPOAb, with one blood collection and detection. The results can indicate thyroid function and immune status, effectively solving the defect that the previous peripheral blood detection technology only detected TSH to indicate subclinical thyroid dysfunction, and can more effectively distinguish clinical and subclinical thyroid dysfunction states, and can meet the detection requirements in clinical work.

[0032] The method for detecting thyroid-related indicators based on peripheral blood according to the present invention takes peripheral blood as the detection target, performs EDTA anticoagulation and then centrifuges to take the upper-layer plasma for detection, which can meet the requirements of the instrument detection for the sample type, and verifies the feasibility and accuracy of this method, effectively solving the problem that the existing fingertip blood detection method (i.e., pediatric blood routine) cannot meet the requirements of thyroid function detection.

[0033] The peripheral blood detection method described in this application has a high degree of consistency with the existing gold standard based on venous blood detection. Compared with the existing gold standard, the peripheral blood detection method described in this application has good diagnostic efficacy for thyroid function and immune abnormalities, can be used for the detection of clinically relevant thyroid indicators, provides sufficient diagnostic efficacy for thyroid function and immune abnormalities, can meet the detection needs in clinical work, and the method described in this invention is a reliable minimally invasive detection method, which has reference significance for the screening, diagnosis and treatment of thyroid diseases.

[0034] The method for detecting thyroid-related indicators based on peripheral blood described in this invention can use the instrument equipment widely used in current clinical work. Using peripheral blood as the detection specimen to detect thyroid-related indicators, the process is simple, convenient, easy to operate, and time-consuming. Moreover, peripheral blood has less trauma, less blood collection volume, and is easy to operate.

[0035] The method for detecting thyroid-related indicators based on peripheral blood described in this invention is based on the collection of peripheral blood and the detection of thyroid-related indicators, which is more suitable for specific populations to detect thyroid indicators, and provides a convenient way for patients with difficult blood collection and infants with poor tolerance to blood collection trauma to detect thyroid indicators.

[0036] The method for detecting thyroid-related indicators based on peripheral blood described in this invention can directly use the instrument equipment widely used in current clinical work for detection, without the need to purchase additional test strips or detection equipment.

[0037] The method for detecting thyroid-related indicators based on peripheral blood described in this invention uses capillary blood collection tubes and EP tubes as blood collection tools, which are easy to obtain in clinical work, inexpensive, and reduce the cost of blood collection tools and consumables; especially, the technical requirements for blood collection operation are low, and the processing and storage processes are simple and convenient; moreover, the advantage of less blood collection volume for detection also provides an advantage for application in epidemiological investigations.

[0038] In the process of sample detection, the method for detecting thyroid-related indicators based on peripheral blood described in this invention explores the diluent and dilution multiple, discusses the different dilution multiples of different detection items respectively, and obtains the best accuracy of the existing dilution multiple, effectively ensuring the accuracy of detection.

[0039] The method for detecting thyroid-related indicators based on peripheral blood described in this invention uses large-scale detection instruments widely used in clinical practice to detect TSH, TT4 and TPOAb based on minimally invasive and trace blood samples. The accuracy and diagnostic efficacy are both good compared with traditional thyroid function and immune detection technologies, and can meet the detection needs in clinical work. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] To make the content of the present invention easier to be clearly understood, the following further detailed description of the present invention is provided according to specific embodiments of the present invention in conjunction with the accompanying drawings, wherein,

[0041] Figure 1 It is the Bland-Altman analysis result of different thyroid-related index detection values. Specific embodiments

[0042] In order to solve the problems existing in the detection of thyroid-related indicators in the prior art, such as large trauma in specimen collection, high blood collection volume requirements, limited detection items and accuracy of peripheral blood, the present invention provides a method for detecting multiple thyroid-related indicators in peripheral blood based on a clinical large-scale detection instrument, which can be widely used in clinical practice. The method of the present invention can detect 3 conventional thyroid-related indicators in peripheral blood, and uses a large-scale detection instrument widely used in clinical practice to detect TSH, TT4 and TPOAb based on minimally invasive and trace blood samples.

[0043] In the following embodiments of the present invention, for the detection of TSH, TT4 and TPOAb indicators, the plasma of the collected peripheral blood is used for detection, and different diluents are used for dilution according to the detection indicators.

[0044] In some specific embodiments, for the detection of TT4 indicator, a diluent containing plasma in the art can be selected for dilution. As an exemplary embodiment, the following embodiment of the present invention selects Atellica IM T4 diluent, and its main components include human plasma and sodium azide (0.1%).

[0045] In some specific embodiments, for the detection of TSH indicator, a diluent containing serum in the art can be selected for dilution. As an exemplary embodiment, the following embodiment of the present invention selects Atellica IM multiplex diluent, and its main components include horse serum, as well as sodium azide (0.1%) and preservatives.

[0046] In some specific embodiments, for the detection of TPOAb indicator, a diluent containing protein in the art can be selected for dilution. As an exemplary embodiment, the following embodiment of the present invention selects Roche TPOAb sample diluent, and its main components include protein matrix and preservatives (<0.1%).

[0047] Example 1

[0048] The following method is adopted in this example for the collection of peripheral blood.

[0049] Preparation before blood collection: Select the ulnar side of the pulp of the middle finger or ring finger as the blood collection site. Before blood collection, ask the patient to repeatedly abduct and adduct the fingers and upper limbs of both hands to promote blood circulation at the fingertips. Disinfect the puncture site twice from the inside out with 75% alcohol, and wait for it to dry.

[0050] Blood collection: Use a disposable capillary blood collector or a disposable blood collection needle to puncture and collect blood at the puncture site. The operator surrounds the punctured finger of the blood donor with the index finger and middle finger, and gradually applies pressure from the proximal end to the distal end of the finger. This method can avoid squeezing the surrounding tissues of the puncture site, reduce the dilution of fingertip blood by tissue fluid, and increase the blood collection volume of a single puncture.

[0051] Use a 100 μl capillary blood collection tube as the tool for collecting fingertip blood. Collect blood at an angle of 30° - 45° between the liquid collection port of the capillary blood collection tube and the puncture site. Due to the siphon effect, the peripheral blood slides along the inner wall of the tube and gradually rises in the blood collection tube. During this period, the operator needs to keep the index finger and middle finger surrounding and applying pressure to the punctured finger of the blood donor. When the blood sample gradually rises to the scale line, a sufficient amount of blood specimen is collected. If the amount of the blood specimen is insufficient, the operator releases the fingers and repeats surrounding the punctured finger of the blood donor with the index finger and middle finger, and gradually applying pressure from the proximal end to the distal end of the finger. Take another capillary blood collection tube and repeat the above operation. A total of two capillary blood collection tubes are collected, accumulating 200 μl of peripheral blood.

[0052] Example 2

[0053] This example is based on the anticoagulation treatment of the peripheral blood collected in Example 1.

[0054] Currently, most of the specimens used in clinical detection of thyroid-related indicators such as TSH, TT4, and TPOAb are serum obtained by directly centrifuging non-anticoagulated venous blood. For peripheral blood specimens, due to the small amount of peripheral blood, if plasma obtained by centrifuging after anticoagulation treatment is used for detection, the blood collection volume required for detection can be minimized.

[0055] The anticoagulation treatment method in this example uses anticoagulant EP tubes, that is, 1.5 ml finished EDTA anticoagulant EP tubes pretreated with EDTA anticoagulation in advance.

[0056] Anticoagulation of peripheral blood specimens: Lean the capillary blood collection tube containing peripheral blood in Example 1 against the inner wall of the EP tube. The fingertip blood can flow out along the inner wall of the EP tube. Use a rubber cap to blow out the remaining peripheral blood in the capillary blood collection tube. After screwing on the cap, rotate the fingertip blood in the EP tube along the inner wall for 2 - 3 weeks to fully mix the peripheral blood with EDTA. Then, place the EP tube on the blood collection rack for further processing.

[0057] Centrifugation: Centrifuge the EP tube containing 200 μl of peripheral blood at room temperature at a speed of 3500 r / min for 10 minutes. After centrifugation, subsequent dilution and detection can be carried out.

[0058] Storage: In this embodiment, if immediate detection is not possible, the sample can be stored in a 4°C refrigerator without centrifugation. The storage time in the 4°C refrigerator should not exceed 48 hours until the detection time. The specimen processing and storage procedures are simple and easy to obtain.

[0059] Example 3

[0060] In this embodiment, the plasma collected in Example 2 is used to detect thyroid-related indicators. For different detection indicators, the plasma is first diluted by an appropriate multiple with different diluents, and then the target indicators are detected by conventional means and equipment in the art. Finally, corresponding calculations are performed using the detection results.

[0061] In this embodiment, different diluents and dilution ratios are selected according to the different thyroid indicators detected for pretreatment and then tested on the machine. This not only meets the required sample loading volume for machine testing but also ensures the accuracy of the detection indicators. For example, TT4 is tested after diluting the plasma with Atellica IM T4 diluent; TSH is tested after diluting the plasma with Atellica IM multiple diluent; TPOAb is tested after diluting the plasma with Roche TPOAb sample diluent.

[0062] In this embodiment, for the detection platforms of TT4, TSH, and TPOAb indicators, commonly used and recognized detection instruments for detecting thyroid-related indicators in venous blood in clinical practice can be selected, without the need to purchase additional test strips or detection equipment.

[0063] 1. Detection of TSH

[0064] In this embodiment, 30 subjects were included. The plasma of fingertip blood collected was diluted 5-fold, 8-fold, and 10-fold with Atellica IM multiple diluent respectively. The consistency correlation coefficients (CCC) between the detected TSH and the serum-detected TSH were 0.9999, 0.9998, and 0.9997 (P < 0.0001) respectively. It can be seen that the consistency correlation coefficients among the 5-fold dilution, 8-fold dilution, and 10-fold dilution are very close. The higher the dilution factor, the less fingertip blood is required. Therefore, 10-fold dilution was used to detect TSH in fingertip blood in this embodiment.

[0065] Detection of TSH: Take 30 μl of plasma and dilute it by a volume ratio of 1:10 (i.e., 30 μl of plasma + 270 μl of diluent). After adding the diluent, use an oscillator to shake for 10 s.

[0066] In this embodiment, chemiluminescence method is used to determine TSH. For the detection of TSH in this embodiment, Atellicasolution chemiluminescence analyzer of German Siemens company is used for determination.

[0067] In this embodiment, the obtained test result is multiplied by the corresponding dilution factor to obtain the actual thyroid-related index result of peripheral blood. That is, the TSH index result is the measured value × 10.

[0068] 2. Detection of TT4

[0069] In this embodiment, 30 subjects were included. After the plasma of fingertip blood was diluted 5-fold, 8-fold, and 10-fold with Atellica IM T4 diluent respectively, the consistency correlation coefficients (CCC) between the detected TT4 and the TT4 detected in serum were 0.9511, 0.9593, and 0.9288 respectively (P < 0.0001 for all). It can be seen that the consistency correlation coefficients between 5-fold dilution and 8-fold dilution are very close. Since the increase in dilution factor will lead to an increase in error, 5-fold dilution was used to detect TT4 in fingertip blood in this embodiment.

[0070] Detection of TT4: Take 20 μl of plasma and dilute it 1:5 by volume (i.e., 20 μl of plasma + 80 μl of diluent);

[0071] After adding the diluent, shake it with an oscillator for 10 s.

[0072] In this embodiment, chemiluminescence method was used to determine TT4. For the detection of TT4 in this embodiment, Atellicasolution chemiluminescence analyzer of German Siemens Company was used for determination.

[0073] In this embodiment, the obtained test result is multiplied by the corresponding dilution factor to obtain the actual thyroid-related index result of peripheral blood. That is, the TT4 index result is the measured value × 5.

[0074] 3. Detection of TPOAb

[0075] In this embodiment, 30 subjects were included. After the plasma of fingertip blood was diluted 5-fold, 8-fold, and 10-fold with Roche TPOAb sample diluent respectively, the consistency correlation coefficients (CCC) between the detected TPOAb and the TPOAb detected in serum were 0.78, 0.69, and 0.67 respectively (P < 0.0001 for all). It can be seen that the consistency correlation coefficient of 5-fold dilution is significantly higher than that of 8-fold dilution and 10-fold dilution. Therefore, 5-fold dilution was used to detect TPOAb in fingertip blood.

[0076] Detection of TPOAb: Take 20 μl of plasma and dilute it 1:5 by volume (i.e., 20 μl of plasma + 80 μl of diluent). After adding the diluent, shake it with an oscillator for 10 s.

[0077] In this embodiment, the electrochemiluminescence immunoassay was used to measure TPOAb. For the detection of TPOAb in this embodiment, a Cobas Elecsys 601 (Roche Diagnostics, Switzerland) electrochemiluminescence immunoassay analyzer of Roche was used for determination.

[0078] In this embodiment, the obtained test results are multiplied by the corresponding dilution factor to obtain the actual results of thyroid-related indicators in peripheral blood. That is, the TPOAb indicator result is the measured value × 5.

[0079] For the detection of the above thyroid indicators in this embodiment, the test results can be obtained approximately 1 hour after the specimen is received, which has the advantages of high efficiency and speed.

[0080] Example 4

[0081] In this embodiment, 130 subjects including healthy and thyroid disease patients were recruited, including 77 subjects with normal thyroid function and 53 subjects with abnormal thyroid function. Among them, there were 69 females (accounting for 53.08%), and the average age was 52.56 ± 14.97 years. The general information of the specific subjects is shown in Table 1 below, and there are no special requirements for the type or degree of thyroid diseases. Among them, *venous serum detection was used as the standard, and the reference ranges of Peking University First Hospital were: TSH 0.55 - 4.78 uIU / mL, TT4 58.1 - 140.6 nmol / L, and TPOAb 0 - 34 IU / mL.

[0082] Table 1 General information of the subjects

[0083]

[0084]

[0085] Blood specimens of all subjects were collected within 48 hours, and TSH and TT4 in serum, plasma, and peripheral blood were detected (by chemiluminescence analyzer) and TPOAb was detected (using an electrochemiluminescence immunoassay analyzer). Among them, the detection of indicators in peripheral blood was carried out according to the methods in the aforementioned Examples 1 - 3.

[0086] In the above subject group, in this embodiment, after screening, 118, 118, and 35 subjects were included respectively to analyze the consistency and correlation between fingertip blood and venous plasma for TSH, TT4, and TPOAb; and 125, 124, and 38 subjects were included respectively to analyze the consistency and correlation between fingertip blood and venous serum for TSH, TT4, and TPOAb.

[0087] In this embodiment, the detection results of the above three blood samples were respectively tested for consistency using Bland-Altman plots, Passing-Bablok regression, and weighted kappa tests, and the diagnostic efficacy of the three collection and detection methods was evaluated by the AUC, sensitivity, and specificity of the ROC curve.

[0088] In this embodiment, SPSS 26.0 and MedCalc 22.0 were used for statistical analysis.

[0089] For the Bland-Altman plot test, the best result is that the difference in sample results of more than 95% falls within the 95% LoA range, and the more that fall within the 95% LoA range, the better.

[0090] For the Passing-Bablok regression results, 0.36 < correlation coefficient (r) < 0.67 indicates moderate correlation, r > 0.68 indicates strong correlation, and P < 0.05 is considered statistically significant.

[0091] For the weighted kappa test, the meaning of the weighted kappa coefficient is as follows: kappa coefficient < 0.20 indicates poor consistency, kappa coefficient of 0.21 - 0.4 indicates general consistency, kappa coefficient of 0.41 - 0.60 indicates moderate consistency, kappa coefficient of 0.61 - 0.80 indicates strong consistency, kappa coefficient of 0.81 - 1.00 indicates very strong consistency, and P < 0.05 is considered statistically significant.

[0092] For the ROC curve, calculate the AUC value of the ROC curve, and the closer it is to 1, the better the accuracy.

[0093] In this embodiment, the Bland-Altman plots in the above two ways are as shown in the appendix Figure 1 shown. The results show that the differences in TSH, TT4, and TPOAb between fingertip blood (FB) and venous blood (including serum and plasma) in more than 90% of the subjects are within the 95% consistency limit range (as shown in Table 2 below).

[0094] Table 2 Results of the Bland-Altman method for thyroid-related indicators in different ranges

[0095]

[0096] In addition, the Passing-Bablok regression analysis of the two shows as shown in Table 3 below. The Passing-Bablok regression analysis shows that there is a strong correlation between the TSH, TT4, and TPOAb levels in fingertip blood (FB) and serum, fingertip blood (FB) and plasma, and serum and plasma.

[0097] Passing-Bablok Regression between Detection Results of Different Specimens

[0098]

[0099] *r is the correlation coefficient of Passing-Bablok regression

[0100] Furthermore, the results of the weighted kappa test are shown in Table 4 below. It can be seen that there is a very strong consistency in the consistency of TSH and TPOAb among the three samples. For TT4, there is a moderate consistency between fingertip blood (FB) and serum, and between FB and plasma; there is a strong consistency between serum and plasma.

[0101] Table 4 Weighted kappa test between detection results of different specimens

[0102]

[0103]

[0104] *k is the weighted kappa coefficient

[0105] Therefore, the above results all indicate that there is a good consistency in the detection of TSH, TT4 and TPOAb levels between venous plasma and serum. In order to reduce the blood collection volume, the present invention selects the plasma specimen anticoagulated from fingertip blood for blood specimen detection.

[0106] Example 5

[0107] Currently, the gold standard for thyroid-related detection in this field is serum or plasma obtained after venous blood collection.

[0108] In this example, when using venous blood serum (n = 116) as the gold standard, the diagnostic sensitivities and specificities of FB for thyroid function abnormalities, hyperthyroidism, hypothyroidism, subclinical hyperthyroidism, and subclinical hypothyroidism are: 89.58%, 92.65%; 70%, 100%; 57.14%, 99.08%; 88.89%, 93.46%; 77.27%, 95.74%. When using venous blood plasma (n = 112) as the diagnostic standard, the sensitivities and specificities of FB for thyroid function abnormalities, hyperthyroidism, hypothyroidism, subclinical hyperthyroidism, and subclinical hypothyroidism are: 95.24%, 92.86%; 77.77%, 100%; 55.55%, 100%; 100%, 94.23%; 87.5%, 94.79%.

[0109] In this example, the AUC values of the ROC curves for the diagnosis of abnormal TSH, TT4, and TPOAb by FB are 0.936 (95% CI 0.891 - 0.980), 0.865 (95% CI 0.801 - 0.92), and 1 respectively.

[0110] The above results fully demonstrate that the peripheral blood detection method described in this application has a high degree of consistency with the existing gold standard based on venous blood detection. Moreover, compared with the existing gold standard, the peripheral blood detection method described in this application has good diagnostic efficacy for thyroid function and immune abnormalities, can be used for the detection of clinical thyroid-related indicators, provides sufficient diagnostic efficacy for thyroid function and immune abnormalities, can meet the detection needs in clinical work, and the method described in this invention is a reliable minimally invasive detection method, which has reference significance for the screening, diagnosis and treatment of thyroid diseases.

[0111] Obviously, the above embodiments are merely examples given for clear illustration and are not limitations on the implementation manners. For those of ordinary skill in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to enumerate all the implementation manners here. And the obvious changes or modifications derived therefrom still fall within the protection scope of this invention.

Claims

1. A method for detecting thyroid-related indicators based on peripheral blood, characterized in that: The steps include: (1) Collecting peripheral blood; (2) Anticoagulating the collected peripheral blood with EDTA, collecting the reaction product for centrifugation, and collecting the upper plasma; (3) Detecting thyroid-related indicators based on the collected plasma.

2. The method for detecting thyroid-related indicators based on peripheral blood according to claim 1, characterized in that: In the step (3), the thyroid-related indicators include TT4, TSH and TPOAb.

3. The method for detecting thyroid-related indicators based on peripheral blood according to claim 2, characterized in that: In the step (3), the step of detecting the thyroid-related indexes further comprises the step of adding a diluent to dilute the plasma; Preferably, the dilution factor in the dilution step is 5-10 times.

4. The method for detecting thyroid-related indicators based on peripheral blood according to claim 3, characterized in that: The thyroid-related indicators include TT4; Preferably, the diluent comprises a diluent containing human plasma; Preferably, the dilution factor of the plasma is 8-10 times; Preferably, the detecting step comprises chemiluminescence.

5. The method for detecting thyroid-related indicators based on peripheral blood according to claim 3, characterized in that: The thyroid-related indicators include TSH; Preferably, the diluent includes a diluent containing animal serum; Preferably, the plasma is diluted 4-6 times; Preferably, the detecting step comprises chemiluminescence.

6. The method for detecting thyroid-related indicators based on peripheral blood according to claim 3, characterized in that: The thyroid-related indicators include TPOAb; Preferably, the diluent comprises a protein-containing diluent; Preferably, the plasma is diluted 4-6 times; Preferably, the detecting step comprises electrochemiluminescence immunoassay.

7. The method for detecting thyroid-related indicators based on peripheral blood according to any one of claims 1 to 6, characterized in that: In step (1), the peripheral blood collection step includes: the operator surrounds the punctured blood collection finger of the person whose blood is being collected with the index finger and the middle finger, and gradually applies pressure from the proximal end of the finger to the fingertip, and adjusts the liquid collection port of the capillary blood collection tube to form an angle of 30°-45° with the puncture point to collect blood and collect peripheral blood.

8. The method for detecting thyroid-related indicators based on peripheral blood according to any one of claims 1 to 7, characterized in that: In the step (1), the amount of peripheral blood collected is 100-300 μl, preferably 200 μl.

9. The method for detecting thyroid-related indicators based on peripheral blood according to any one of claims 1 to 8, characterized in that: In the step (2), the rotation speed of the centrifugation step is 3000-4000 r / min, and the centrifugation time is 5-15 minutes.

10. Application of the method for detecting thyroid-related indicators based on peripheral blood according to any one of claims 1 to 9 in the field of thyroid diagnosis, detection and treatment.

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