Dissociation agent and kit for progesterone determination
By using hydrocortisone, prednisolone, and/or MEHP as dissociation agents, the problem of poor performance of existing progesterone dissociation agents has been solved, resulting in a significant improvement in the sensitivity and accuracy of progesterone detection. The linearity and sensitivity of the calibrator are significantly improved after the dissociation agent combination. The dissociation process is carried out simultaneously with the immune reaction, which improves the reaction efficiency.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- BEIJING NORTH INST OF BIOLOGICAL TECH
- Filing Date
- 2026-02-05
- Publication Date
- 2026-05-08
AI Technical Summary
Existing progesterone dissociation agents have poor dissociation effects, resulting in some low-value blood samples having undetectable effective concentrations or excessively low values, making it impossible to accurately detect progesterone.
Hydrocortisone, prednisolone, and/or mono(2-ethylhexyl) phthalate (MEHP) were used as dissociation agents. By optimizing the concentration and combination, the dissociation effect of progesterone from corticosteroid-binding protein, albumin, and sex hormone-binding globulin was improved, the binding of progesterone to capture antibodies was enhanced, and the detection sensitivity and accuracy were improved.
It significantly improves the progesterone dissociation effect, enhances the sensitivity and accuracy of progesterone detection, and significantly improves the linearity and sensitivity of the calibrator after the dissociation agent combination. The sample values have good correlation with the comparison reagents, and the dissociation process and immune reaction occur simultaneously, improving the reaction efficiency.
Smart Images
Figure FT_1 
Figure FT_2 
Figure FT_3
Abstract
Description
Technical Field
[0001] This invention relates to the field of biotechnology, and more particularly to dissociation agents and kits for progesterone assay. Background Technology
[0002] Progesterone (Prog) is a 21-carbon steroid hormone with a molecular weight of 314.5 Daltons, and is an intermediate metabolite in the synthesis of steroid hormones. However, in women, almost all progesterone in the blood is produced by the corpus luteum or placenta; in men, progesterone levels are very low, and it is mainly produced by the adrenal cortex. Progesterone is an important hormone that plays a crucial role not only in regulating the menstrual cycle but also in maintaining pregnancy. In the later stages of the menstrual cycle, progesterone promotes the growth of glands in the uterine lining, causes uterine congestion, and thickens the endometrium, preparing for implantation of the fertilized egg. After implantation, it promotes placental formation, reduces the excitability of the pregnant uterus, inhibits its activity, and ensures safe fetal growth. Progesterone measurement is used to determine ovulation, monitor progesterone therapy, and evaluate early pregnancy status. It is particularly important in assessing the functional status of the corpus luteum and is an indispensable tool for studying ovarian physiology and pathophysiology.
[0003] In plasma, approximately 80%–90% of progesterone binds to corticosteroid-binding globulin (CBD), and 10%–15% binds to albumin and sex hormone-binding globulin (SGH). Progesterone assay reagents require the complete dissociation of progesterone from CBD, albumin, and SGH for accurate detection. Existing progesterone dissociation agents have poor dissociation performance, resulting in undetectable concentrations or excessively low values in some low-value blood samples. Therefore, developing new progesterone dissociation agents with good dissociation performance for accurate detection of progesterone in low-value blood samples is essential. Summary of the Invention
[0004] In view of this, the technical problem to be solved by the present invention is to provide a dissociation agent and a kit for progesterone assay.
[0005] The present invention provides a sample dissociation agent for progesterone detection, comprising: hydrocortisone, prednisolone and / or mono(2-ethylhexyl) phthalate (MEHP).
[0006] Specifically, the dissociation agent described in this invention includes the following types; Scenario 1: The dissociation agent is hydrocortisone; Scenario 2: The dissociation agent is prednisolone; Scenario 3: The dissociation agent is MEHP; Scenario 4: The dissociation agent is MEHP and hydrocortisone; Scenario 5: The dissociation agent is MEHP and prednisolone; Case 6: The dissociation agent is hydrocortisone and prednisolone; Case 7: The dissociation agent is MEHP, prednisolone, or hydrocortisone; This invention compares and screens the effects of prednisolone, hydrocortisone, MEHP, di(2-ethylhexyl) phthalate (DEHP), 2-bromoestradiol, Danazol, and metestosterone on the dissociation of progesterone from samples. It finds that hydrocortisone, prednisolone, and / or MEHP, when used alone, exhibit good dissociation effects and high correlations (above 0.97) with Beckman dissociation results. Simultaneously, employing a combination of dissociation agents significantly improves the linearity and sensitivity of the calibrator, and enhances the correlation between sample measurements and the comparison reagent, resulting in a significant overall improvement in dissociation performance. This method better releases progesterone from corticosteroid-binding proteins, albumin, and sex hormone-binding globulins, facilitating the binding of progesterone to capture antibodies and effectively improving sensitivity and accuracy. It can be directly added to the components of radioimmunoassay reagents to improve the efficiency of the immunoassay reaction.
[0007] In the sample dissociation agent of the present invention, the concentration of hydrocortisone is 1~10 μg / mL, preferably 6 μg / mL~10 μg / mL, and more preferably 2 μg / mL.
[0008] The concentration of prednisolone is 10~100μg / mL, preferably 60μg / mL~100μg / mL, and more preferably 20μg / mL.
[0009] The concentration of MEHP is 1~10 μg / mL, preferably 8 μg / mL~10 μg / mL, and more preferably 4 μg / mL.
[0010] The sample dissociation agent described in this invention also includes a buffer component.
[0011] The buffering component includes: phosphate.
[0012] The dissociation agent described in this invention also includes stabilizers, preservatives, and other components used to maintain the stability of the dissociation agent; however, this invention does not limit these components.
[0013] Through screening, this invention has obtained other excipients that can bind with the specific dissociation reagent of this invention, so that the sample dissociation agent of this invention has both good dissociation effect and high stability.
[0014] This invention provides a progesterone detection kit, which includes the sample dissociation agent described in this invention and other auxiliary detection reagents.
[0015] Other auxiliary testing reagents include: progesterone standards, antibodies, immunosorbent assay agents, radiolabeled ligands, and / or quality control serum.
[0016] The antibodies include: rabbit anti-P antibody.
[0017] The radiolabeled ligand includes: 125 IP.
[0018] This invention provides a method for detecting progesterone for non-diagnostic purposes, which involves detecting a sample using the sample dissociation agent or the kit described in this invention. The sample is a blood sample.
[0019] This invention, through optimized screening, yields a sample dissociation agent for progesterone detection. The sample dissociation agent comprises hydrocortisone, prednisolone, and mono(2-ethylhexyl) phthalate (MEHP). These dissociation agents, acting alone or in combination, exhibit high sensitivity, good linearity, and good correlation with the comparison reagent, resulting in a significant overall improvement in dissociation efficiency. They effectively release progesterone from corticosteroid-binding protein, albumin, and sex hormone-binding globulin, facilitating the binding of progesterone to capture antibodies and significantly enhancing sensitivity and accuracy. Furthermore, this invention allows for direct addition to reagent components, enabling the dissociation process to occur simultaneously with the immune reaction, simplifying and improving the efficiency of the immune response. Attached Figure Description
[0020] Figure 1 The effect of different final concentrations of the dissociating agent hydrocortisone on the standard curve is shown. Figure 2 The dissociation effect of different final concentrations of hydrocortisone on 10 blood samples was shown. Figure 3 The effect of different final concentrations of the dissociating agent MEHP on the standard curve is shown. Figure 4 The effect of different final concentrations of the dissociation agent MEHP on the dissociation of blood samples is shown. Figure 5 The effect of different final concentrations of the dissociating agent DEHP on the standard curve is shown. Figure 6 The effect of different final concentrations of the dissociating agent DEHP on the dissociation of blood samples is shown. Figure 7 The effect of different final concentrations of the dissociative agent prednisolone on the standard curve is shown. Figure 8 The dissociation effect of different final concentrations of the dissociating agent prednisolone on blood samples is shown; Figure 9 The effect of different final concentrations of the dissociating agent metestosterone on the standard curve is shown. Figure 10The effect of different final concentrations of the dissociation agent metestosterone on the dissociation of blood samples is shown. Figure 11 The effect of different final concentrations of the dissociating agent danazol on the standard curve is shown. Figure 12 The effects of different final concentrations of the dissociating agent danazolidinone on the dissociation of blood samples were shown. Figure 13 The effect of different final concentrations of the dissociation agent 2-bromoestradiol on the standard curve is shown. Figure 14 The effect of different final concentrations of the dissociation agent 2-bromoestradiol on the dissociation of blood samples is shown. Figure 15 This demonstrates the effect of different combinations of dissociating agents on the standard curve; Figure 16 The effects of different combinations of dissociating agents on the dissociation of blood samples are shown. Figure 17 Comparison of dissociation agent combination 1 with Beckman's measurements; Figure 18 Comparison of dissociation agent combination 2 with Beckman's measurement. Detailed Implementation
[0021] This invention provides a dissociation agent and kit for progesterone assay. Those skilled in the art can refer to this document and appropriately modify the process parameters to achieve the desired result. It should be particularly noted that all similar substitutions and modifications are obvious to those skilled in the art and are considered to be included in this invention. The methods and applications of this invention have been described through preferred embodiments. Those skilled in the art will clearly be able to modify or appropriately change and combine the methods and applications described herein without departing from the content, spirit, and scope of this invention to implement and apply the technology of this invention.
[0022] The test materials used in this invention are all common commercially available products. The invention is further illustrated below with reference to embodiments: Example 1: Preparation of the dissociating agent for the progesterone assay reagent I. Main Reagents and Instruments Progesterone (P, hereinafter referred to as P) standard, rabbit anti-P antibody (blue) 125 IP (red), donkey anti-rabbit immunosorbent, P control serum (all of which are self-made by our company), gamma radioimmunoassay counter (Anhui Zhongke Zhongjia Scientific Instruments Co., Ltd.), MEHP (Sigma-Aldrich), hydrocortisone (Shanghai Yuanye Biotechnology Co., Ltd.), prednisolone (Shanghai Aladdin Biochemical Technology Co., Ltd.), AccessPROGESTERONE reagent kit manufactured by Beckman Coulter, Inc., and ACCESS2 fully automated chemiluminescence immunoassay analyzer (Beckman Coulter Trading (China) Co., Ltd.).
[0023] II. Methods
[0024] 1. Preparation of dissociation agent
[0025] Prednisolone, hydrocortisone, MEHP, di(2-ethylhexyl) phthalate (hereinafter referred to as DEHP), 2-bromoestradiol, Danazol, and metestosterone were first dissolved in DMSO, and then prepared into different concentrations using phosphate buffer at pH 7.4.
[0026] The final test concentration used for each of hydrocortisone, MEHP, and DEHP is 1~10 μg / mL; The final test concentration used for each of prednisolone, metestosterone, danazol, and 2-bromoestradiol is 10-100 μg / mL; Hydrocortisone, MEHP, and DEHP were added to the labeling buffer (the labeling buffer is a phosphate buffer at pH 7.4 with 125 I-P added, which appears red) at final concentrations of 2 μg / mL, 4 μg / mL, 6 μg / mL, 8 μg / mL, and 10 μg / mL, respectively. Prednisolone, metestosterone, danazol, and 2-bromoestradiol were added to the labeling buffer at final concentrations of 20 μg / mL, 40 μg / mL, 60 μg / mL, 80 μg / mL, and 100 μg / mL, respectively. Combined dissociation agents (combination one) were added to the labeling buffer at final concentrations of 2 μg / mL hydrocortisone, 20 μg / mL prednisolone, and 4 μg / mL MEHP, respectively. Combined dissociation agents (combination two) were added to the labeling buffer at final concentrations of 4 μg / mL hydrocortisone, 40 μg / mL prednisolone, and 6 μg / mL MEHP, respectively.
[0027] 2. Detection Method
[0028] Applying the principle of competition, P in the standard or sample and the added... 125 IP, together with a certain amount of specific antibodies, generates a competitive immune response. 125 The amount of IP binding to the antibody is functionally related to the P content in the standard or sample. After separating the bound fraction (B) from the free fraction (F) using immunosorbent assay (PR), the radioactivity intensity of the bound fraction, total count (total T) per tube, and nonspecific binding (NSB) is measured, and the corresponding binding ratio B / B0 is calculated. A standard inhibition curve is obtained by plotting the known standard P content against the corresponding binding ratio. The P content in the test sample corresponding to the corresponding binding ratio can be determined from the standard curve.
[0029] 3. Data Processing
[0030] One option is online processing: the computer automatically processes the data and produces the results. It is recommended that users use log-logit or four-parameter data processing mode. Second, manual plotting: Plot a standard curve on ordinary graph paper with the standard concentration as the x-axis and the corresponding logit value as the y-axis, or plot the standard concentration as the x-axis and the corresponding B / B0 as the y-axis on log-logit graph paper (ideally a straight line). The concentration value of the sample can be found on the graph paper based on the B / B0 of the sample to be tested. The formula for calculating the logit value is logit=ln[(B / B0) / (1-B / B0)].
[0031] III. Results
[0032] (I) Optimization of individual component concentrations
[0033] 1. Selection of concentration level for hydrocortisone use
[0034] Hydrocortisone competes with progesterone for binding to corticosteroid-binding protein, albumin, and sex hormone-binding globulin, causing progesterone to be released from clinical blood samples. However, excessively high levels of hydrocortisone can reduce the maximum antigen-antibody binding rate (B0 / T) and decrease the overall gamma count. Therefore, it is necessary to select an appropriate concentration level of hydrocortisone. (See Tables 1, 2, and 3.) Figure 1 , Figure 2 As shown, the addition of 2 μg / mL to 4 μg / mL hydrocortisone has little effect on the standard curve, with the maximum binding rate decreasing by less than 10%. The addition of 6 μg / mL to 10 μg / mL hydrocortisone can completely dissociate clinical blood samples, while the correlation with Beckman reagent reaches above 0.97.
[0035] Table 1. Effects of hydrocortisone at different concentration levels on the standard curve and maximum binding rate
[0036] Table 2. Effects of non-hydrocortisone at different concentration levels on clinical blood sample measurements.
[0037] Table 3. Correlation between sample measurements and Beckman reagent at different hydrocortisone concentration levels
[0038] 2. Selection of MEHP concentration level
[0039] MEHP competes with progesterone for binding to corticosteroid-binding protein, albumin, and sex hormone-binding globulin, causing progesterone to be released from clinical blood samples. However, excessively high MEHP levels can reduce the maximum antigen-antibody binding ratio (B0 / T) and decrease the overall gamma count; therefore, it is necessary to select an appropriate MEHP concentration level. See Tables 4, 5, and 6. Figure 3 , Figure 4 As shown, adding 2 μg / mL to 4 μg / mL MEHP has little effect on the standard curve, with the maximum binding rate decreasing by less than 10%. Adding 8 μg / mL to 10 μg / mL MEHP can completely dissociate clinical blood samples, while the correlation with Beckman reagent reaches above 0.97.
[0040] Table 4. Effects of MEHP at different concentration levels on the standard curve and maximum binding rate
[0041] Table 5. Effects of MEHP at different concentration levels on clinical blood sample measurements
[0042] Table 6. Correlation between sample measurements and Beckman reagent at different MEHP concentration levels
[0043] 3. Selection of DEHP concentration level
[0044] DEHP competes with progesterone for binding to corticosteroid-binding protein, albumin, and sex hormone-binding globulin, causing progesterone to be released from clinical blood samples. However, excessively high DEHP levels can reduce the maximum antigen-antibody binding ratio (B0 / T) and decrease the overall gamma count; therefore, it is necessary to select an appropriate DEHP concentration level. (See Tables 7, 8, and 9.) Figure 5 , Figure 6 As shown, adding 2 μg / mL DEHP had little effect on the standard curve, with the maximum binding rate decreasing by less than 10%. Even when added to 10 μg / mL DEHP in clinical blood samples, complete dissociation was not achieved, and the correlation with Beckman reagent was less than 0.97.
[0045] Table 7. Effects of DEHP at different concentration levels on the standard curve and maximum binding rate
[0046] Table 8. Effects of DEHP at different concentration levels on clinical blood sample measurements
[0047] Table 9. Correlation between sample measurements and Beckman reagent at different DEHP concentration levels
[0048] 4. Selection of Prednisolone Concentration Levels
[0049] Prednisolone competes with progesterone for binding to corticosteroid-binding protein, albumin, and sex hormone-binding globulin, leading to the release of progesterone from clinical blood samples. However, excessively high levels of prednisolone can reduce the maximum antigen-antibody binding ratio (B0 / T) and decrease the overall gamma count; therefore, it is necessary to select an appropriate concentration level of prednisolone. See Tables 10, 11, and 12. Figure 7 , Figure 8 As shown, the addition of 20 μg / mL to 40 μg / mL prednisolone had little effect on the standard curve, with the maximum binding rate decreasing by less than 10%. The addition of 60 μg / mL to 100 μg / mL prednisolone could completely dissociate clinical blood samples, and the correlation with Beckman reagent reached above 0.97 (correlation coefficient R value).
[0050] Table 10. Effects of prednisolone at different concentration levels on the standard curve and maximum binding rate
[0051] Table 11. Effects of prednisolone at different concentration levels on clinical blood sample measurements
[0052] Table 12. Correlation between sample measurements and Beckman reagent at different prednisolone concentration levels
[0053] 5. Selection of metronidazole concentration levels
[0054] Metestosterone competes with progesterone for binding to corticosteroid-binding protein, albumin, and sex hormone-binding globulin, leading to the release of progesterone from clinical blood samples. However, excessively high levels of metestosterone can reduce the maximum antigen-antibody binding rate (B0 / T) and decrease the overall gamma count. Therefore, it is necessary to select an appropriate concentration level of metestosterone. (See Tables 13, 14, and 15.) Figure 9 , Figure 10 As shown, the addition of metestosterone has a significant impact on the standard curve, with the maximum binding rate decreasing by more than 10%. The addition of 60 μg / mL to 100 μg / mL metestosterone can completely dissociate clinical blood samples, while the correlation with Beckman reagent is less than 0.97.
[0055] Table 13. Effects of metestosterone at different concentration levels on the standard curve and maximum binding rate
[0056] Table 14. Effects of different concentration levels of metestosterone on clinical blood sample measurements
[0057] Table 15. Correlation between sample measurements and Beckman reagent at different metestosterone concentration levels
[0058] 6. Selection of concentration levels for Danatuo
[0059] Danazolidin competes with progesterone for binding to corticosteroid-binding protein, albumin, and sex hormone-binding globulin, leading to the release of progesterone from clinical blood samples. However, excessively high danazolidin levels can reduce the maximum antigen-antibody binding ratio (B0 / T) and decrease the overall gamma count; therefore, it is necessary to select an appropriate danazolidin concentration. See Tables 16, 17, and 18. Figure 11 , Figure 12 As shown, the addition of 20 μg / mL danazolidinone had little effect on the standard curve, with the maximum binding rate decreasing by less than 10%. The addition of danazolidinone could not completely dissociate clinical blood samples, and its correlation with Beckman Coulter reagent was less than 0.97.
[0060] Table 16. Effects of Danazolidone at different concentration levels on the standard curve and maximum binding rate
[0061] Table 17. Effects of Danazol at different concentration levels on clinical blood sample measurements
[0062] Table 18. Correlation between sample measurements and Beckman reagent at different Danazot concentration levels
[0063] 7. Selection of 2-bromoestradiol concentration levels
[0064] 2-Bromide estradiol competes with progesterone for binding to corticosteroid-binding protein, albumin, and sex hormone-binding globulin, causing progesterone to be released from clinical blood samples. However, excessively high levels of 2-bromoestradiol can reduce the maximum antigen-antibody binding ratio (B0 / T) and decrease the overall gamma count. Therefore, it is necessary to select an appropriate concentration level of 2-bromoestradiol. See Tables 19, 20, and 21. Figure 13 , Figure 14 As shown, the addition of 2-bromoestradiol has a significant impact on the standard curve, with the maximum binding rate decreasing by more than 10%. The addition of 60 μg / mL to 100 μg / mL of 2-bromoestradiol can completely dissociate clinical blood samples, but the correlation with Beckman reagent is less than 0.97.
[0065] Table 19. Effects of 2-bromoestradiol at different concentration levels on the standard curve and maximum binding rate.
[0066] Table 20. Effects of 2-bromoestradiol at different concentration levels on clinical blood sample measurements.
[0067] Table 21. Correlation between sample measurements and Beckman reagent at different 2-bromoestradiol concentration levels
[0068] (II) Optimization of Combined Use
[0069] 1. Concentration level selection when using hydrocortisone and prednisolone in combination
[0070] Both hydrocortisone and prednisolone competitively bind progesterone to corticosteroid-binding protein, albumin, and sex hormone-binding globulin, causing progesterone to be released from clinical blood samples. However, excessively high levels of these additives reduce the maximum antigen-antibody binding ratio (B0 / T) and decrease the overall gamma count. Therefore, it is necessary to use an appropriate concentration of hydrocortisone and prednisolone in combination to reduce the required concentration level. As shown in Tables 22, 23, 24, and 25, both combinations can completely dissociate progesterone from clinical blood samples, with a correlation higher than 0.97 with Beckman Coulter's reagent.
[0071] Table 22. Effects of different combinations of prednisolone and hydrocortisone on the standard curve and maximum binding rate.
[0072] Table 23. Effects of different combinations of prednisolone and hydrocortisone on clinical blood sample measurements.
[0073] Table 24. Correlation between different combinations of prednisolone and hydrocortisone on sample measurements and Beckman reagent.
[0074] Table 25. Linear equations and correlation coefficients of different combinations of prednisolone and hydrocortisone on the correlation between sample measurements and Beckman reagent.
[0075] 2. Concentration level selection when using hydrocortisone, prednisolone, and MEHP in combination.
[0076] Hydrocortisone, prednisolone, and MEHP all competitively bind progesterone to corticosteroid-binding protein, albumin, and sex hormone-binding globulin, causing progesterone to be released from clinical blood samples. However, excessively high levels of these additives can reduce the maximum antigen-antibody binding rate (B0 / T) and decrease the overall gamma count. Therefore, it is necessary to use appropriate concentrations of hydrocortisone, prednisolone, and MEHP in combination to reduce the required concentration level. See Tables 26, 27, 28, and 29. Figure 15 , Figure 16 , Figure 17 , Figure 18 As shown, adding one combination pair had little effect on the standard curve, with the maximum binding rate decreasing by less than 10%. Both combinations could completely dissociate clinical blood samples, but their correlation with Beckman Coulter's reagent was higher than 0.97.
[0077] Table 26. Effects of different combinations of hydrocortisone, prednisolone, and MEHP on the standard curve and maximum binding rate.
[0078] Table 27. Effects of different combinations of hydrocortisone, prednisolone, and MEHP on clinical blood sample measurements.
[0079] Table 28. Correlation between different combinations of hydrocortisone, prednisolone, and MEHP on sample measurements and Beckman reagent.
[0080] Table 29. Linear equations and correlation coefficients of different combinations of hydrocortisone, prednisolone, and MEHP on the correlation between sample measurements and Beckman reagent.
[0081] 3. Discussion
[0082] Progesterone in the blood exists primarily in a protein-bound form. To accurately measure progesterone levels, it is necessary to release progesterone from corticosteroid-binding protein, albumin, and sex hormone-binding globulin. This study first screened for superior dissociation agents by examining their effects on the antigen-antibody maximum binding ratio (B0 / T) and comparing sample measurements with Beckman Coulter measurements, then combined them. Results showed that using hydrocortisone, prednisolone, and MEHP in combination one effectively released the portion of progesterone bound to corticosteroid-binding protein, albumin, and sex hormone-binding globulin, resulting in higher dissociation efficiency and better correlation with Beckman Coulter serum sample measurements compared to using any single dissociation agent alone, while having minimal impact on the antigen-antibody maximum binding ratio (B0 / T). The correlation coefficient between combination one and Beckman Coulter serum sample measurements was 0.9924, with an average relative deviation of 1.75%, indicating high consistency with clinical test values.
[0083] The above are merely preferred embodiments of the present invention. It should be noted that those skilled in the art can make various improvements and modifications without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.
Claims
1. A sample dissociation agent for progesterone detection, characterized in that, include: Hydrocortisone, prednisolone and / or mono(2-ethylhexyl) phthalate.
2. The sample dissociation agent according to claim 1, characterized in that, The concentration of hydrocortisone is 1~10 μg / mL.
3. The sample dissociation agent according to claim 1, characterized in that, The concentration of prednisolone is 10~100 μg / mL.
4. The sample dissociation agent according to claim 1, characterized in that, The concentration of MEHP is 1~10 μg / mL.
5. The sample dissociation agent according to any one of claims 1 to 4, characterized in that, The sample dissociation agent also includes a buffer component.
6. The sample dissociation agent according to claim 5, characterized in that, The buffering component includes: phosphate.
7. A progesterone test kit, characterized in that, Includes the sample dissociation agent and other auxiliary detection reagents as described in claims 1 to 6.
8. The progesterone detection kit according to claim 7, characterized in that, Other auxiliary testing reagents include: progesterone standards, antibodies, immunosorbent assay agents, radiolabeled ligands, and / or quality control serum.
9. The progesterone detection kit according to claim 8, characterized in that, The antibodies include: rabbit anti-P antibody.
10. The progesterone detection kit according to claim 8, characterized in that, The radiolabeled ligand includes: 125 IP.