TROP2 immunohistochemical detection quality control product as well as preparation method and application thereof

Abstract

The invention relates to a TROP2 immunohistochemical detection quality control product as well as a preparation method and application thereof, the quality control product is a cell line paraffin section, and the quality control product comprises a negative quality control product which is an MDA-MB-231 cell line paraffin section and is derived from human breast cancer cells, and a positive quality control product which is an MDA-MB-231 cell line paraffin section and is derived from human breast cancer cells; the weak positive quality control product is an MDA-MB-453 cell line paraffin section and is derived from human breast cancer cells; the middle positive quality control product is an MCF-7 cell line paraffin section and is derived from human breast cancer cells; the strongly positive quality control product is a T-47D cell line paraffin section and is derived from human breast duct cancer cells. The invention overcomes the defects of quality control of negative / positive tissues, provides a cell paraffin sample for quality control of 0, 1 +, 2 + and 3 + staining intensity of TROP2, particularly relates to application of H-Score interpretation of a TROP2 staining result in tumor tissues, and provides a reliable experimental basis clinically.

Description

Technical Field

[0001] The invention belongs to the field of immunohistochemical detection, and specifically relates to a TROP2 immunohistochemical detection quality control product or reference product, and a preparation method and application thereof. Background Art

[0002] Immunohistochemistry (IHC) is a technique that uses the specific binding between antigens and antibodies to locate and detect target proteins at the cell and tissue levels. It is generally observed and interpreted by professional pathologists under an optical microscope. It has become an important auxiliary technology for clinical diagnosis of pathology, and immunohistochemical staining is increasingly used to provide predictive and prognostic information.

[0003] Initially, immunohistochemistry was used as a qualitative analysis tool. Quality control required the simultaneous staining of negative and positive quality control tissues to avoid false positives or false negatives. With the widespread and in-depth application of this technology in clinical diagnosis, the initial qualitative analysis has gradually evolved into quantitative / semi-quantitative analysis needs. The identification of positive staining is also subdivided into weak positive (1+), moderate positive (2+) and strong positive (3+). However, relying on the human eye to subjectively count cells of different staining intensities will lead to large deviations, resulting in unreliable pathological interpretation results. Therefore, the quality control settings should also be further optimized.

[0004] Trophoblast cell-surface antigen-2 (TROP2) was initially reported as a surface marker of trophoblast cells, but TROP2 expression was subsequently found to be elevated in many solid tumors, while it was expressed at a lower level in some normal tissues. It regulates tumor growth, invasion, and spread through multiple signaling pathways. Studies have shown that TROP2 is positive in more than 100 types of tumors, especially squamous cell carcinomas of various origins, urothelial carcinomas, breast cancers, prostate cancers, pancreatic cancers, and ovarian cancers. Its high expression is closely related to shortened survival and poor prognosis of tumor patients.

[0005] In experiments, tonsils are often used as positive and negative controls for TROP2. The tonsil crypt epithelium shows strong positive cell membrane staining (positive control); while other areas except the crypt epithelium are negative (negative control). Normal skin tissue can also be selected as a positive quality control, and epidermal cells should show strong positive cell membrane staining. However, the current TROP2 pathological interpretation mostly uses the H-Score interpretation standard. H-Score is an immunohistochemical staining result indicator that comprehensively considers the positive cell rate and positive staining intensity. The percentage of cells with staining intensities of 0, 1+, 2+, and 3+ in the stained samples is determined, and finally the comprehensive positive score is obtained by calculation.

[0006] The current quality control of normal tonsil / skin tissue can only roughly control the positive and negative, but cannot control the specific staining intensity. The selection of tumor tissues with different expression intensities as control samples is limited by sample sources and sustainable supply. In addition, due to tumor heterogeneity, the stability of the same tissue wax block may be poor. Summary of the invention

[0007] The purpose of the present invention is to overcome the shortcomings of the above-mentioned normal / tumor tissue quality control and provide a cell paraffin sample for quality control of the 0, 1+, 2+, and 3+ staining intensity of TROP2, especially involving the application of H-Score interpretation of TROP2 staining results in tumor tissue, providing a reliable experimental basis in clinical practice.

[0008] Technical solution:

[0009] On the one hand, the present invention provides a TROP2 immunohistochemistry detection quality control product, the quality control product is a cell line paraffin section, and the quality control product includes: the negative quality control product is an MDA-MB-231 cell line paraffin section, which is derived from human breast cancer cells; the weak positive quality control product is an MDA-MB-453 cell line paraffin section, which is derived from human breast cancer cells; the medium positive quality control product is an MCF-7 cell line paraffin section, which is derived from human breast cancer cells; the strong positive quality control product is a T-47D cell line paraffin section, which is derived from human ductal breast cancer cells.

[0010] The present invention also provides a method for preparing a TROP2 immunohistochemical detection quality control product, the steps of which are: S1: pretreatment of HistoGel, melting the HistoGel and placing it in a water bath at 65° C. to keep it in a liquid state;

[0011] S2: Cell collection: collect cells by centrifugation to obtain a cell suspension;

[0012] S3: Cell washing: take the cell suspension in step S2, centrifuge to remove the supernatant, add PBS buffer and mix, and centrifuge again to collect the cell pellet;

[0013] S4: Cell fixation, adding neutral formalin to the cell pellet;

[0014] S5: Making a cell gel column, centrifuging the fixed cells to remove the supernatant, then adding PBS buffer to wash, collecting the cell clusters, adding melted HistoGel to obtain a cell suspension, adding the cell suspension to the mold, waiting for HistoGel to solidify, and making a cell gel column;

[0015] S6: Dehydrate the cells, place the cell gel column in a long hole embedding box, rinse slowly with running water, and then soak the cell gel column in 50%, 75%, 85%, 95% ethanol, and 100% ethanol in sequence;

[0016] S7: cells are transparent, and the cell gel column after cell dehydration is put into xylene;

[0017] S8: Cell wax dipping, the dehydrated and transparent cell gel column is immersed in melted liquid paraffin; S9: Cell embedding, the cell gel column is transferred and fixed in the bottom mold of the stainless steel embedding box, the plastic embedding box is covered, the paraffin is poured in, and the wax block is placed on a cold table to solidify the wax block, and the cell wax block is completed;

[0018] S10: Slice preparation, placing the cell wax block on a slicer for slicing, and then scooping and baking the obtained cell white slices;

[0019] S11: immunohistochemical staining;

[0020] S12: Dehydration of sections;

[0021] S13: slices are transparent;

[0022] S14: Seal the slides.

[0023] Preferably, the number of cells in the cell suspension in the S3 cell washing step is at least 10 8 Order of magnitude.

[0024] Preferably, in the S4 cell fixation step, formalin and PBS are removed by centrifugation.

[0025] Preferably, in the step of preparing the cell gel column in S5, the ratio of cells to HistoGel is 1×10 8 Add 0.3-0.6 mL of melted HistoGel per cell.

[0026] Preferably, in the S7 cell transparency step, it is necessary to observe whether xylene turbidity occurs. If xylene turbidity occurs, it is necessary to return to the cell dehydration step and use 100% ethanol for re-dehydration.

[0027] Preferably, in the slice preparation step S10, the thickness of the slice is 3-5 μm.

[0028] The present invention also provides a TROP2 immunohistochemistry kit, comprising the quality control product.

[0029] The kit further comprises one or more of xylene, ethanol, antigen repair solution, hydrogen peroxide, immunochromogenic reagent, DAB chromogenic reagent, hematoxylin, and neutral gum.

[0030] Beneficial effects:

[0031] 1. The present invention proposes for the first time a cell quality control product (cell quality control film) with 0, 1+, 2+, and 3+ staining intensities made from paraffin sections of a cell line, which provides a standard reference point for the interpretation of TROP2 immunohistochemistry results, so that the differences between staining rounds can be accurately monitored, reducing the occurrence of false positive and false positive results.

[0032] 2. Tissue quality control films cannot provide accurate staining quality control references to some extent due to biological differences between individuals and even heterogeneity before and after the same paraffin sample. However, cell quality control films generally have a high degree of uniformity and heterogeneity and do not have this problem.

[0033] 3. Cell quality control slices can be mass-produced and easy to store and use, reducing the complexity of preparation and processing.

[0034] 4. From an ethical perspective, cell quality control products reduce dependence on human tissue, thereby reducing the ethical issues that may be involved in obtaining tissue samples. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 It is a combination diagram of the quality control products of the present invention;

[0036] Figure 2 The results of IHC test on T-47D (strong positive reference) using the Baidao FAIP-48T fully automatic immunohistochemical stainer;

[0037] Figure 3 The results of IHC test on MCF-7 (medium positive reference) were performed by Baidao FAIP-48T fully automatic immunohistochemical staining instrument;

[0038] Figure 4 The results of IHC test of MDA-MB-453 (weak positive reference) were performed by Baidao FAIP-48T fully automatic immunohistochemical staining instrument;

[0039] Figure 5 The results of IHC test of MDA-MB-231 (negative reference) were performed by Baidao FAIP-48T fully automatic immunohistochemical staining instrument;

[0040] Figure 6 The results of IHC test of MDA-MB-468 (negative reference) were performed by Baidao FAIP-48T fully automatic immunohistochemical staining instrument;

[0041] Figure 7 The results of IHC test on MDA-MB-175VII negative reference) were performed by Baidao FAIP-48T fully automatic immunohistochemical staining instrument;

[0042] Figure 8 The results of IHC test on PA-1 (negative reference) were performed by Baidao FAIP-48T fully automatic immunohistochemical staining instrument;

[0043] Fig. 9 The results of IHC detection of SK-Br-3 (strong positive reference) using the Baidao FAIP-48T fully automatic immunohistochemical staining instrument. DETAILED DESCRIPTION

[0044] The present invention will be further described in detail below in conjunction with specific examples. The following examples are not intended to limit the present invention, but are only intended to illustrate the present invention. The experimental methods used in the following examples are generally conventional, unless otherwise specified, and the materials, reagents, etc. used in the following examples are commercially available, unless otherwise specified.

[0045] Pathological immunohistochemistry quality control products are the control materials set by the pathology department during the immunohistochemistry test relative to the samples to be tested. They are used to verify the immunohistochemistry test system established by the pathology department. They are used to monitor the stability of the test process and the effectiveness of the test reagents to ensure the accuracy of the test results and achieve the purpose of immunohistochemistry quality control. They are referred to as "quality control products" for short.

[0046] The initial judgment standard of TROP2 was based on the interpretation of positive and negative, and the quality control tissues were mostly selected from breast cancers with negative / positive expression. After the emergence of the H-Score interpretation standard, the positive interpretation of TROP2 was refined into weakly positive, moderately positive, and strongly positive standards. Therefore, the original negative / positive tissue quality control was not sufficient to support the quality control of the H-Score interpretation standard. It was necessary to add weakly positive, moderately positive, and strongly positive quality control samples on the original basis.

[0047] The present invention provides a TROP2 immunohistochemistry detection quality control product, comprising:

[0048] Negative control (0): paraffin sections of MDA-MB-231 cell line, derived from human breast cancer cells;

[0049] Weak positive quality control (1+): paraffin sections of MDA-MB-453 cell line, derived from human breast cancer cells;

[0050] Medium positive quality control (2+): paraffin sections of MCF-7 cell line, derived from human breast cancer cells;

[0051] Strong positive control (3+): paraffin sections of T-47D cell line, derived from human ductal breast carcinoma cells.

[0052] The specific information of the samples used is as follows:

[0053]

[0054] A method for preparing a quality control product for TROP2 immunohistochemistry detection is also proposed, and the steps are as follows:

[0055] S1: HistoGel pretreatment

[0056] Set the water bath temperature to 65°C. Melt HistoGel in a microwave oven at low temperature for 5-15 seconds or in a boiling water bath for 3-10 minutes, then place in a water bath at 65°C to keep it in liquid form.

[0057] S2: Cell collection

[0058] Before collecting cells, ensure that the cells are in good condition;

[0059] Adherent cells: Digest the expanded cells with trypsin, blow them off, add serum to terminate the digestion, and collect the cells by centrifugation.

[0060] Suspension cells: Collect the cells directly by centrifugation.

[0061] S3: Cell washing

[0062] Take fresh cell suspension, centrifuge at 1500rpm for 5 minutes to remove supernatant, add PBS buffer and mix well, and centrifuge again to collect cells.

[0063] At this step, the number of cells in the cell suspension should be at least 10 8 Too few cells are not conducive to the preparation of wax blocks. After dehydration and transparency, the cell gel blocks will shrink, affecting embedding and prone to over-dehydration.

[0064] If you want to preserve the fixed cell suspension for a long time, you need to change it to 100% ethanol and store it in a -80℃ refrigerator. Do not use low concentration ethanol and formalin as they will freeze.

[0065] S4: Cell Fixation

[0066] Add 35 ml of 10% neutral formalin to the cell mass collected by centrifugation for fixation, resuspend after adding formalin, and fix at room temperature in a fume hood for 1-24 hours. After the cell fixation is completed, formalin and PBS need to be removed as thoroughly as possible by centrifugation, otherwise it will affect the quality of the wax block.

[0067] S5: Making cell gel column

[0068] The fixed cells were centrifuged at 1500 rpm at room temperature for 5 minutes and the supernatant was removed;

[0069] Then add 15 mL of PBS buffer and wash three times, centrifuge at 1500 rpm for 5 minutes each time, remove PBS and collect cell pellets.

[0070] Proportional to every 1×10 8 Add 0.5 mL of HistoGel preheated to melt at 65°C to each cell, shake and mix the cells in a water bath, and gently blow and suck to avoid bubbles to fully mix the cells and HistoGel. Finally, add the cell suspension to the mold (remove the bottom tip of the 1 mL pipette, and then seal the incision with a sealing film), place it at 4°C for 30 minutes, and wait for the HistoGel to solidify.

[0071] In this step, the ratio of cells to HistoGel should be reasonably controlled, and the ratio of cells to HistoGel should be 1×10 8 Add 0.3-0.6 mL of melted HistoGel per 1×10 cells. 8 Add 0.5mL of melted HistoGel to each cell. Otherwise, the prepared cell gel column is fragile. If the cell gel block breaks at the touch, it may be due to too few cells or too much HistoGel. The ratio of cells to HistoGel needs to be adjusted. If it is still fragile, it may be due to insufficient dehydration or too large a cell block.

[0072] S6: Cell dehydration

[0073] Place the cell gel column in a long hole embedding box in a 250mL beaker and rinse slowly with running water for 1 hour. Then, immerse the cell gel column in 50%, 75%, 85%, and 95% ethanol in sequence for 1 hour each, and 100% ethanol twice, each for 1 hour.

[0074] Note: When dehydrating with 50% or 75% ethanol, it can be done overnight. When dehydrating, drain the liquid in the embedding box and then put it into the next gradient of ethanol.

[0075] S7: Cell Transparency

[0076] The cell gel column was taken out from the anhydrous ethanol and immersed in xylene twice, each time for 1 hour.

[0077] It is necessary to observe whether xylene turbidity appears. If xylene turbidity appears, it means that the dehydration is not complete, and it is necessary to return to the cell dehydration step and use 100% ethanol to dehydrate again until there is no xylene turbidity.

[0078] S8: Cell wax immersion

[0079] Set the temperature of the paraffin bath to melt it in advance. Place the dehydrated and transparent cell gel column in the melted liquid paraffin and soak it twice, 1 hour each time, or overnight.

[0080] S9: Cell Embedding

[0081] Use preheated tweezers to transfer the cell gel column to the bottom mold of the stainless steel embedding box, so that the cell gel column is located in the center of the mold, cover with a plastic embedding box (mark the embedding box in advance to distinguish the wax blocks), fill with paraffin, and place on a cold table to solidify the wax blocks.

[0082] After the paraffin in the embedding mold is completely solidified, remove the excess paraffin around the embedding box and take out the cell wax block, and the cell wax block is ready.

[0083] S10: Slice preparation

[0084] Place the embedded cell wax block in the slot of the slicer, fix it securely, and slice it. First, adjust the slice thickness to about 10μm and trim it until all the cells are exposed. Then adjust the slice thickness, cut out 3-5μm white slices, and transfer them to a 45℃ spreading pool to ensure that the cell white slices are completely spread out.

[0085] After the cell white sheet is fully spread in the slide pool, it is scooped out with a clean and uncontaminated adhesive slide so that the cell white sheet adheres to the center of the slide.

[0086] The glass slide with the cell white film attached is shaken dry slightly and placed in a fume hood to dry slightly before baking. Generally, the baking time is more than 0.5 hours in a 60°C constant temperature box.

[0087] After baking, the slices were placed in the FAIP 48T fully automatic immunohistochemical staining instrument for staining.

[0088] S11: Immunohistochemical staining

[0089] The reagent sequence and staining time of the FAIP 48T fully automatic immunohistochemical staining instrument are as follows:

[0090]

[0091]

[0092]

[0093]

[0094] *RT, room temperature, means the experimental condition is room temperature;

[0095] The incubation time is / , which means that this step is a washing step and the reagent does not stay on the slice sample.

[0096] In the above process, the specific information of some detection reagents is as follows:

[0097] Reagent Type Reagent name Part Number factory Primary Antibody Reagents TACSTD2 Antibody Reagents (Immunohistochemistry) PA159 Momochi Secondary Antibody Kit Immunochromogenic reagents PS001 Momochi Antigen retrieval solution Immunohistochemistry Antigen Retrieval Buffer PS900 Momochi Dewaxing solution Paraffin cleaning fluid PS000 Momochi

[0098] The manufacturer of the reagents in the above table is Suzhou Baidao Medical Technology Co., Ltd., referred to as Baidao in this application.

[0099] After staining, remove the sections.

[0100] S12: Dehydration of sections

[0101] The sections were immersed in gradient alcohol in sequence: 75%, 95%, 100%, and 100%, for 3 minutes each time.

[0102] S13: Slice transparent

[0103] The sections were dehydrated and cleared in fresh xylene for 10 min.

[0104] S14: Seal the slides.

[0105] The samples were mounted using neutral gum.

[0106] The following samples are selected as comparative examples, and the specific information is as follows:

[0107]

[0108]

[0109] The cells numbered 1 to 8 were used and the above preparation method was used to prepare the sealing slides. The results were observed under a microscope after sealing. The staining results are shown in Figure 1-8 .

[0110] The results show that Figure 2-5 Among them, T-47D cell line, MCF-7 cell line, MDA-MB-453 cell line and MDA-MB-231 cell line showed specific staining, clear color development and easy identification.

[0111] IHC interpretation criteria:

[0112] Negative (0): No coloration.

[0113] Weakly positive (1+): ≤10% of the cell membrane is clearly visible under a 40x microscope and is brown-yellow in color.

[0114] Moderately positive (2+): ≥10% of the cell membranes are clearly visible under a 10-20x microscope, showing complete but uneven brown staining.

[0115] Strong positive (3+): >30% of the cell membranes are clearly visible under a 2-5x objective lens and are completely tan in color.

[0116] According to the above IHC interpretation criteria, it can be determined that the T-47D cell line shows strong positive membrane staining in TROP2 immunohistochemical staining, the MCF-7 cell line shows moderate positive membrane staining, the MDA-MB-453 cell line shows weak positive membrane staining, and the MDA-MB-231 cell line shows negative. The MDA-MB-231 cell line, the MDA-MB-453 cell line, the MCF-7 cell line, and the T-47D cell line show obvious staining intensities of 0, 1+, 2+, and 3+. This allows the differences between staining rounds to be accurately monitored, reducing the occurrence of false positive and false positive results.

[0117] Figure 6-9 In the results, MDA-MB-468 cell line, MDA-MB-175VII cell line, and PA-1 cell line were negative, and SK-Br-3 cell line was strongly positive. Although MDA-MB-468, MDA-MB-175VII, and PA-1 were negative, there was a certain degree of nonspecific staining (weak). Both MDA-MB-231 and PA-1 could be used as negative quality controls. Since TROP2 is widely used in breast cancer tumors, MDA-MB-231 is preferred here. The initial evaluation of SK-Br-3 staining intensity was strongly positive, which was strictly between moderately positive and strongly positive, and there was a certain degree of nonspecific staining (weak), so it was not selected as a strongly positive quality control.

[0118] Moreover, the quality control sheet prepared by the present invention using cell line paraffin sections has a high degree of uniformity and heterogeneity compared to the tissue quality control sheet, and does not have the biological variability and heterogeneity problems of the tissue quality control sheet; moreover, the cell quality control sheet can be mass-produced and easy to store and use, reducing the complexity of preparation and processing. And from an ethical perspective, cell quality control products reduce dependence on human tissue, thereby reducing the ethical issues that may be involved in obtaining tissue samples.

[0119] In summary, if Figure 1As shown, paraffin sections of MDA-MB-231 cell line can be used as negative quality control (0); paraffin sections of MDA-MB-453 cell line can be used as weak positive quality control (1+); paraffin sections of MCF-7 cell line can be used as moderate positive quality control (2+); paraffin sections of T-47D cell line can be used as strong positive quality control (3+).

[0120] The present invention also provides a TROP2 immunohistochemistry kit, including a quality control product:

[0121] Negative quality control: paraffin sections of MDA-MB-231 cell line, derived from human breast cancer cells;

[0122] Weak positive quality control: paraffin sections of MDA-MB-453 cell line, derived from human breast cancer cells;

[0123] Positive quality control: paraffin sections of MCF-7 cell line, derived from human breast cancer cells;

[0124] Strong positive quality control: paraffin sections of T-47D cell line, derived from human ductal breast carcinoma cells.

[0125] It also includes one or more of xylene, ethanol, antigen repair solution, hydrogen peroxide, immunochromogenic reagent, DAB chromogenic reagent, hematoxylin, and neutral gum.

[0126] The kit is suitable for the interpretation standard of H-Score, and can be used for H-Score interpretation of TROP2 staining results in tumor tissues, providing a reliable experimental basis in clinical practice. The tumors include breast cancer, urothelial carcinoma, cervical cancer, non-small cell lung cancer, etc.

[0127] The foregoing description of specific exemplary embodiments of the present invention is for the purpose of illustration and demonstration. These descriptions are not intended to limit the present invention to the precise form disclosed, and it is clear that many changes and variations can be made based on the above teachings. The purpose of selecting and describing the exemplary embodiments is to explain the specific principles of the present invention and its practical application, so that those skilled in the art can realize and utilize various different exemplary embodiments of the present invention and various different selections and changes. The scope of the present invention is intended to be limited by the claims and their equivalents.

Claims

1. A TROP2 immunohistochemistry detection quality control product, characterized in that: The quality control product is a paraffin section of a cell line. The negative quality control product is a paraffin section of the MDA-MB-231 cell line, which is derived from human breast cancer cells; the weak positive quality control product is a paraffin section of the MDA-MB-453 cell line, which is derived from human breast cancer cells; The positive quality control product is a paraffin section of the MCF-7 cell line, which is derived from human breast cancer cells; The strong positive quality control product is a paraffin section of the T-47D cell line, which is derived from human ductal breast carcinoma cells.

2. A method for preparing a TROP2 immunohistochemistry quality control product as claimed in claim 1, characterized in that: The steps are: S1: HistoGel pretreatment: melt the HistoGel and place it in a water bath at 65°C to keep it in liquid state; S2: Cell collection: collect cells by centrifugation to obtain a cell suspension; S3: Cell washing: take the cell suspension in step S2, centrifuge to remove the supernatant, add PBS buffer and mix, and centrifuge again to collect the cell pellet; S4: Cell fixation, adding neutral formalin to the cell pellet; S5: Making a cell gel column, centrifuging the fixed cells to remove the supernatant, then adding PBS buffer to wash, collecting the cell clusters, adding melted HistoGel to obtain a cell suspension, adding the cell suspension to the mold, waiting for HistoGel to solidify, and making a cell gel column; S6: Dehydrate the cells, place the cell gel column in a long hole embedding box, rinse slowly with running water, and then soak the cell gel column in 50%, 75%, 85%, 95% ethanol, and 100% ethanol in sequence; S7: cells are transparent, and the cell gel column after cell dehydration is put into xylene; S8: Cell wax immersion: the dehydrated and transparent cell gel column is immersed in melted liquid paraffin; S9: Cell embedding: transfer and fix the cell gel column into the bottom mold of the stainless steel embedding box, cover the plastic embedding box, fill it with paraffin, place it on a cold table to solidify the wax block, and the cell wax block is completed; S10: Slice preparation, placing the cell wax block on a slicer for slicing, and then scooping and baking the obtained cell white slices; S11: immunohistochemical staining; S12: Dehydration of sections; S13: slices are transparent; S14: Seal the slides.

3. The method for preparing a TROP2 immunohistochemistry quality control product according to claim 2, characterized in that: The number of cells in the cell suspension in the S3 cell washing step is at least 10 8 Order of magnitude.

4. The method for preparing a TROP2 immunohistochemical detection quality control product according to claim 2, characterized in that: During the S4 cell fixation step, formalin and PBS were removed by centrifugation.

5. The method for preparing a TROP2 immunohistochemical detection quality control product according to claim 2, characterized in that: In the step of making the cell gel column in S5, the ratio of cells to HistoGel is 1×10 8 Add 0.3-0.6 mL of melted HistoGel per cell.

6. The method for preparing a quality control product for TROP2 immunohistochemistry detection according to claim 2, characterized in that: In the S7 cell transparency step, it is necessary to observe whether xylene turbidity occurs. If xylene turbidity occurs, it is necessary to return to the cell dehydration step and use 100% ethanol for re-dehydration.

7. The method for preparing a TROP2 immunohistochemical detection quality control product according to claim 2, characterized in that: In the S10 slice preparation step, the thickness of the slice is 3-5 μm.

8. A TROP2 immunohistochemistry kit, characterized in that: Including the quality control product described in claim 1 or 2.

9. The kit according to claim 8, characterized in that It also includes one or more of xylene, ethanol, antigen repair solution, hydrogen peroxide, immunochromogenic reagent, DAB chromogenic reagent, hematoxylin, and neutral gum.

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