CN116298265A - hs-cTnT chemiluminescent assay kit applying multistage signal amplification technology - Google Patents
hs-cTnT chemiluminescent assay kit applying multistage signal amplification technology Download PDFInfo
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
- G01N33/54313—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals the carrier being characterised by its particulate form
- G01N33/54326—Magnetic particles
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Abstract
The invention discloses an hs-cTnT chemiluminescence detection kit applying a multistage signal amplification technology, which comprises a magnetic bead suspension coated with a cardiac troponin T monoclonal antibody 1, a biotin-labeled cardiac troponin T monoclonal antibody 2 solution, a luminescent-labeled streptavidin solution, a biotin-labeled streptavidin antibody solution, a calibrator and a quality control product. The hs-cTnT chemiluminescence detection kit applies a multi-stage signal amplification technology of streptavidin-biotin, and utilizes magnetic particle chemiluminescence method to analyze the level of cardiac troponin T in human serum or plasma so as to improve the sensitivity and accuracy of detection and facilitate more rapid and efficient auxiliary diagnosis of acute myocardial infarction.
Description
Technical Field
The invention belongs to the technical field of biology, and particularly relates to an hs-cTnT chemiluminescent assay kit applying a multistage signal amplification technology.
Background
Cardiac troponin (cTn) is a mediator protein that controls myocardial muscle contraction, consisting of three different subunits: cardiac troponin T (cTnT), cardiac troponin I (cTnI) and troponin C (TnC).
cTn is mainly present in cardiomyocytes and is normally present in very low concentrations in peripheral blood. After myocardial cells are damaged, cTn is released into the blood. The increase in cTn values in peripheral blood suggests myocardial damage, which is common in acute myocardial infarction, unstable angina, pulmonary infarction, heart failure and other diseases causing myocardial damage such as pancreatitis, connective tissue diseases, etc., and the higher the cTn values, the wider the damage range. Since cTn has high sensitivity and specificity, many international organizations such as ESC/ACCF/AHA/WHF in 2012 recommended cTn as a first biochemical index for diagnosis of Acute Myocardial Infarction (AMI).
The trend of change in cTn values caused by myocardial damage from different causes is also different. When the cTn value is transiently increased, transient myocardial injury possibly caused by severe exercise, tachycardia, acute pulmonary embolism and the like can be recovered to be normal within 1-2 days; when the value of cTn is in a slow rising trend, it may be myocardial damage caused by heart failure; when the value of cTn increases significantly within hours and peaks within 6-12 hours and can continue to rise for days or even weeks, it is highly likely that myocardial damage is caused by Acute Myocardial Infarction (AMI). Therefore, the early diagnosis and treatment of the myocardial infarction type I can be facilitated by observing the change rule of the cTn value and combining with ischemia evidence.
The cardiac troponin T (cTnT) mainly exists in a compound form in cardiac muscle cells, when the cardiac muscle cells are damaged, the cTnT is released into blood, the normal value reference range of the cTnT in peripheral blood is 0.02-0.13 mug/L, 0.2 mug/L is a critical value, and the condition that the cTnT exceeds 0.5 mug/L can be used for diagnosing acute myocardial infarction, judging micro-myocardial damage, predicting the occurrence probability of cardiovascular events of hemodialysis patients and can assist in evaluating thrombolysis effects. Clinical application researches show that the clinical application values of the cTnI and the cTnT are basically the same, the micro myocardial damage can be identified, the cTnI is slightly outweighed in specificity, the cTnT is more outstanding in other aspects such as stability and standardization, and the accuracy of long-term prognosis prediction is generally considered to be superior to that of the cTnI.
The hs-cTnT assay has higher sensitivity and accuracy, and can detect cTn values of 99% quantile or lower with a total inaccuracy (CV) of less than 10%. Therefore, cTnT can be detected when the myocardial is slightly damaged, thereby assisting in the clear diagnosis of diseases such as acute myocardial infarction and the like in an earlier time. Meanwhile, due to improvement of precision and improvement of reliability of data and changes thereof lower than the traditional cut-off value, myocardial infarction can be diagnosed or eliminated in advance by observing and analyzing the change value and the change rate of the data. The first consideration compared to early subtle changes in cTn levels is a greater improvement in detection inaccuracy. However, the hs-cTnT project has a particularly high sensitivity requirement that is difficult to achieve by conventional chemiluminescent labeling methods.
Disclosure of Invention
The present invention addresses the above problems by introducing a technique capable of amplifying signal values into an hs-cTnT chemiluminescent assay kit to accommodate minor numerical changes in hs-cTnT.
The 'streptavidin-biotin' system is a novel biological reaction amplifying system developed at the end of the 70 s. The high affinity and multistage amplification effect between biotin and avidin make BAS immune labeling and relevant tracing analysis more sensitive, and become a new technology widely used for qualitative and quantitative detection and positioning observation research of trace antigens and antibodies. The invention applies the streptavidin-biotin multistage biological reaction amplification system to hs-cTnT chemiluminescence detection to improve the detection precision and sensitivity, thereby diagnosing and eliminating various clinical diseases such as myocardial infarction and the like earlier.
In order to achieve the above purpose, the invention adopts the following technical scheme:
an hs-cTnT chemiluminescent assay kit applying a multistage signal amplification technology comprises an R1 reagent, an R2 reagent, an R3 reagent, an R4 reagent, a calibrator and a quality control product;
the R1 reagent is a magnetic bead suspension coated with a cardiac troponin T monoclonal antibody 1;
the R2 reagent is a biotin-labeled cardiac troponin T monoclonal antibody 2 solution;
the R3 reagent is a streptavidin solution marked by a luminous marker;
the R4 reagent is biotin-labeled streptavidin antibody solution.
According to the invention, the magnetic beads used for coating the cardiac troponin T monoclonal antibody 1 in the R1 reagent are carboxyl magnetic beads.
According to the invention, the molar ratio of biotin to monoclonal antibody 2 in the R2 reagent is 10:1-30:1.
According to the invention, the R2 reagent is obtained by fully and uniformly mixing the cardiac troponin T monoclonal antibody 2 and N-hydroxysuccinimide ester, removing the redundant N-hydroxysuccinimide ester and then compounding with a buffer solution.
According to the invention, the molar ratio of the luminescent marker to streptavidin in the R3 reagent is 10:1-50:1.
According to the invention, the R3 reagent is prepared by thoroughly mixing the luminescent marker with streptavidin and then dialyzing overnight with a buffer solution.
Specifically, the luminescent marker for labeling streptavidin in the R3 reagent is one of acridinium ester, acridine sulfonamide, isoluminol or fluorescein and the like.
According to the invention, the molar ratio of biotin to streptavidin antibody in the R4 reagent is 10:1-30:1.
According to the invention, the R4 reagent is obtained by fully and uniformly mixing a streptavidin antibody and N-hydroxysuccinimide ester, removing redundant N-hydroxysuccinimide ester and then compounding with a buffer solution.
According to the invention, the calibrator and the quality control are both formulated from a cardiac troponin T antigen and a buffer.
The invention has the beneficial effects that:
1. the streptavidin-biotin multistage reaction amplification system is applied to a chemiluminescent detection kit of hs-cTnT, so that multistage luminescent marking is carried out on a limited antigen-antibody sandwich complex, and detection signals are amplified several times. When cTnT is detected, the detection limit is 0.5ng/L, and the sensitivity is very high.
2. The invention applies a signal amplification technology to the hs-cTnT chemiluminescence detection kit, and the precision of a low-value part is greatly improved, so that the data and the change thereof under the condition of being lower than the traditional cut-off value are reliable, and the myocardial infarction can be diagnosed or eliminated in advance by observing and analyzing the change value and the change rate thereof.
Detailed Description
The invention is further illustrated by the following examples. The examples are only for explaining the present invention and do not limit the scope of the present invention. The experimental methods, which are not specified in the following examples, are generally carried out under conventional conditions, and materials, reagents, etc. used in the examples are commercially available unless otherwise specified.
Examples
The embodiment provides an hs-cTnT chemiluminescent assay kit applying a multistage signal amplification technology, which mainly comprises an R1 reagent, an R2 reagent, an R3 reagent, an R4 reagent, a calibrator and a quality control product.
1. The specific components and the preparation modes of the reagents in the kit are as follows:
(1) R1 reagent: a magnetic bead suspension coated with cardiac troponin T monoclonal antibody 1.
1.5 μm carboxyl magnetic beads were purchased from JSR and the myocardial troponin T monoclonal antibody 1 was coated on the magnetic beads according to the procedure described in the specification at a working concentration of 0.2mg/mL.
The magnetic bead buffer solution comprises the following components: 20mM PB, 150mM sodium chloride, 1% bovine serum albumin, 0.1% Triton X-100, 10% glycerol, 5% sucrose, 0.2% Proclin300.
(2) R2 reagent: biotin-labeled cardiac troponin T monoclonal antibody 2 solution.
The cardiac troponin T monoclonal antibody 2 and N-hydroxysuccinimide ester (BNCS) were mixed at room temperature for 30min, the molar ratio of BNCS to cardiac troponin T monoclonal antibody 2 was 20:1. excess biotin ester was then dialyzed out using PBS phosphate buffer.
The R2 reagent consists of a labeled antibody and a buffer solution, wherein the buffer solution comprises the following components: 20mM PB, 150mM sodium chloride, 1% bovine serum albumin, 5% trehalose, 0.2% proclin300.
(3) R3 reagent: acridinium ester-labeled streptavidin solution.
Firstly, uniformly mixing acridinium ester (NSP-DMAE-NHS) and Streptavidin (SA) at room temperature for reaction for 1h, wherein the molar ratio of the acridinium ester to the streptavidin is 20:1. the solution was dialyzed overnight against PBS phosphate buffer.
The R3 reagent consists of marked streptavidin and buffer solution, wherein the buffer solution comprises the following components: 20mM PB, 1% bovine serum albumin, 0.2% proclin300.
(4) R4 reagent: biotin-labeled streptavidin antibody solution.
Uniformly mixing and reacting the streptavidin antibody and BNCH at room temperature for 30min, wherein the molar ratio of the BNCH to the streptavidin antibody is 20:1. excess biotin ester was then dialyzed away using PBS.
The R4 reagent consists of a labeled streptavidin antibody and a buffer solution, wherein the buffer solution comprises the following components: 20mM PB, 1% bovine serum albumin, 0.2% proclin300.
(5) Calibrator and quality control product:
is prepared from cardiac troponin T antigen and buffer solution. The buffer solution comprises the following components: 20mM PB, 150mM sodium chloride, 1% bovine serum albumin, 0.05% Tween 20, 0.2% Proclin300. The components of the calibrator and the quality control product in the embodiment of the invention are consistent, but the usage is different.
2. The use mode of the kit is as follows:
(1) mu.L of the sample was pipetted into the reaction cup, followed by the sequential addition of 50. Mu. L R1 and 50. Mu. L R2, and reacted at 37℃for 10min.
(2) Then, 15. Mu. L R3 and 15. Mu. L R4 were added thereto, and the mixture was reacted at 37℃for 10 minutes.
(3) Finally, an excitation solution is added to the reaction complex, and then the relative light intensity (RLU) is measured.
The concentration of cTnT in the analyte is proportional to the relative light intensity (RLU) measured by the optical system of the full-automatic chemiluminescence immunoassay. The instrument calculates cTnT concentration by automatic fitting of a calibration curve of concentration versus luminescence (RLU).
3. The reaction mode of the kit is as follows:
(1) The cTnT antigen in the test object reacts with the cTnT monoclonal antibody 1 (Ab 1) coated on the magnetic sphere in the R1 reagent and the biotin-marked cardiac troponin T monoclonal antibody 2 (Ab 2-Bio) in the R2 reagent to form immune complexes. Unbound material was removed by washing with magnetic separation after incubation.
(2) Acridinium ester-labeled streptavidin (SA-AE) in the R3 reagent binds biotin on the immune complex.
(3) The biotin-labeled streptavidin antibody (Anti-SA-Bio) in the R4 reagent recognizes streptavidin in the R3 reagent that binds to the complex.
(4) SA-AE in the R3 reagent binds to biotin in Anti-SA-Bio on the complex formed in (3).
(5) The Anti-SA-Bio in the R4 reagent in turn binds to the avidin in SA-AE on the complex formed in (4).
(6) Thus, the detection signal can be amplified several times by linking a plurality of acridine esters through multistage linking of the repeating units of (SA-AE) - (Anti-SA-Bio). Unbound material was removed by washing with magnetic separation after incubation.
By adopting the technical scheme, the multistage acridinium ester mark on the limited antigen-antibody sandwich complex is realized by using a streptavidin-biotin system, and the detection signal is amplified several times through multistage connection of repeated units of (SA-AE) - (Anti-SA-Bio). When cTnT is detected, the detection limit is 0.5ng/L, and the sensitivity is very high.
In the above examples, the molar ratio of biotin to antibody in the R2 and R4 reagents may also be 10:1 to 30:1; NSP-DAME-NHS in the R3 reagent can be replaced by NSP-SA-NHS; the molar ratio of acridinium ester to streptavidin in the R3 reagent can also be 10:1-50:1.
Comparative example 1
The comparative example provides an hs-cTnT chemiluminescent assay kit which mainly comprises an R1 reagent, an R2 reagent and an R3 reagent.
1. The reagent components in the kit and the preparation method thereof are as follows:
(1) R1 reagent: a magnetic bead suspension coated with cardiac troponin T monoclonal antibody 1.
1.5 μm carboxyl magnetic beads, purchased from JSR, were coated with cardiac troponin T monoclonal antibody 1 according to their instructions at a working concentration of 0.2mg/mL.
The magnetic bead buffer solution comprises the following components: 20mM PB, 150mM sodium chloride, 1% bovine serum albumin, 0.1% Triton X-100, 10% glycerol, 5% sucrose, 0.2% Proclin300.
(2) R2 reagent: sample dilutions.
The components of the sample diluent are: 20mM PB, 1% bovine serum albumin, 0.2% proclin300.
(3) R3 reagent: acridinium ester-labeled cardiac troponin T monoclonal antibody 2 solution.
The molar ratio of acridinium ester to cardiac troponin T monoclonal antibody 2 was 20:1, mixing and reacting for 1h at room temperature, and dialyzing with PBS overnight.
The R3 reagent consists of a labeled antibody and a buffer solution, wherein the buffer solution comprises the following components: 20mM PB, 150mM sodium chloride, 1% bovine serum albumin, 5% trehalose, 0.2% Proclin300.
(4) Calibrator and quality control product
Is prepared from cardiac troponin T antigen and buffer solution, wherein the buffer solution comprises the following components: 20mM PB, 150mM sodium chloride, 1% bovine serum albumin, 5% trehalose, 0.2% proclin300.
2. The using method and the reaction mode of the kit are as follows:
(1) The sample was pipetted into a reaction cup at 30. Mu.L, followed by sequentially adding 50. Mu. L R1, 30. Mu. L R2, 50. Mu. L R3, and reacting at 37℃for 10min.
(2) Unbound material was removed by washing with magnetic separation after incubation.
(3) Finally, an excitation solution is added to the reaction complex, and then the relative light intensity (RLU) is measured.
The concentration of cTnT in the analyte is proportional to the relative light intensity (RLU) measured by the optical system of the full-automatic chemiluminescence immunoassay. The instrument calculates cTnT concentration by automatic fitting of a calibration curve of concentration versus luminescence (RLU).
Comparative example 2
The comparative example provides an hs-cTnT chemiluminescent assay kit which mainly comprises an R1 reagent, an R2 reagent and an R3 reagent.
1. The reagent components in the kit and the preparation method thereof are as follows:
(1) R1 reagent: a magnetic bead suspension coated with cardiac troponin T monoclonal antibody 1.
1.5 μm carboxyl magnetic beads, purchased from JSR, were coated with cardiac troponin T monoclonal antibody 1 according to their instructions at a working concentration of 0.2mg/mL.
The magnetic bead buffer solution comprises the following components: 20mM PB, 150mM sodium chloride, 1% bovine serum albumin, 0.1% Triton X-100, 10% glycerol, 5% sucrose, 0.2% Proclin300.
(2) R2 reagent: biotin-labeled cardiac troponin T monoclonal antibody 2 solution.
The myocardial troponin T monoclonal antibody 2 and the biotinylation reagent BNCS prepared from N-hydroxysuccinimide ester are uniformly mixed at room temperature for 30min, and the molar ratio of BNCS to the myocardial troponin T monoclonal antibody 2 is 20:1. Excess biotin ester was dialyzed against PBS.
The R2 reagent consists of a labeled antibody and a buffer solution, wherein the buffer solution comprises the following components: 20mM PB, 150mM sodium chloride, 1% bovine serum albumin, 5% trehalose, 0.2% proclin300.
(3) R3 reagent: acridinium ester-labeled streptavidin solution.
The molar ratio of acridinium ester to streptavidin is 20:1, uniformly mixing and reacting for 1h at room temperature. And dialyzed overnight against PBS.
The R3 reagent consists of labeled streptavidin and a buffer solution, wherein the buffer solution comprises the following components: 20mM PB, 1% bovine serum albumin, 0.2% proclin300.
(4) Calibrator and quality control product
Is prepared from cardiac troponin T antigen and buffer solution. The buffer solution comprises the following components: 20mM PB, 150mM sodium chloride, 1% bovine serum albumin, 0.05% Tween 20, 0.2% Proclin300.
2. The using method and the reaction mode of the kit are as follows:
(1) mu.L of the sample was pipetted into the reaction cup, followed by the sequential addition of 50. Mu. L R1 and 50. Mu. L R2, and reacted at 37℃for 10min.
(2) Then, 15 mu L R of the mixture was added thereto, and the mixture was reacted at 37℃for 10 minutes.
(3) Finally, an excitation solution is added to the reaction complex, and then the relative light intensity (RLU) is measured.
The concentration of cTnT in the analyte is proportional to the relative light intensity (RLU) measured by the optical system of the full-automatic chemiluminescence immunoassay. The instrument calculates cTnT concentration by automatic fitting of a calibration curve of concentration versus luminescence (RLU).
Experimental results
1. Luminescence intensity test
Experimental instrument: full-automatic chemiluminescence immunoassay instrument kunlroni 2000 manufactured by Shanghai peak medical science and technology limited.
The experimental steps are as follows: according to the using method of the kit, luminescence intensity values of cTnT samples with different concentrations are measured by adopting a chemiluminescent immunoassay analyzer, and test results are recorded in table 1.
Table 1 table of luminescence values for examples and comparative examples 1, 2 for cTnT gradient samples
Fitting a linear regression curve of the concentration value measured by the Rogowski reagent and the luminescence value measured by the chemiluminescent immunoassay analyzer to obtain R respectively 2 。
As can be seen from Table 1, examples and comparative examples 1 and 2 test the cTnT gradient samplesR of light value and concentration value measured by Rogowski reagent 2 All are above 0.99, and the correlation is good; the overall luminescence value of the examples is higher, about 6 times that of comparative examples 1 and 2; and the ratio of S1/S0 is also higher, about 5 times that of comparative examples 1 and 2.
2. Detection limit verification
Experimental instrument: full-automatic chemiluminescence immunoassay instrument kunlroni 2000 manufactured by Shanghai peak medical science and technology limited.
The experimental steps are as follows: low value samples with approximate detection limits (LoD, 0.5 ng/L) for 5 concentrations were tested. 5 times of detection are carried out on each sample, the detection results are ordered according to the size, and the number of the detection results with the values lower than the blank limit (LoB, 0.3 ng/L) is less than or equal to 3; the detection result above the lower limit of the reference interval (14.0 ng/L) should be 0. The results of verification of the detection limits of examples and comparative examples are shown in table 2.
Table 2 verification of detection limits for examples and comparative examples 1, 2
As can be seen from table 2, the number of detection results lower than the blank limit value in the detection results of the examples is 0, not more than 3, and no detection results higher than the lower limit (14.0 ng/L) of the reference interval, and the detection limit verification is successful; the number of detection results lower than the blank limit value in the detection results of comparative examples 1 and 2 is 25, more than 3, and no detection result higher than the lower limit (14.0 ng/L) of the reference interval is detected, and the detection limit fails to verify.
3. Repeatability verification
Experimental instrument: full-automatic chemiluminescence immunoassay instrument kunlroni 2000 manufactured by Shanghai peak medical science and technology limited.
The experimental steps are as follows: the concentration of the duplicate property controls Q1, Q2, Q3 was measured 10 times each at 3ng/L, 14ng/L, 6000ng/L, respectively, the mean M and standard deviation SD of the concentration values were calculated, and the coefficient of variation CV (%) =sd/M x 100%, the Coefficient of Variation (CV) was required to be no more than 10.0%. The results of the test for repeatability of the examples and comparative examples are shown in Table 3.
Table 3 verification of repeatability for examples and comparative examples 1, 2
As can be seen from Table 3, the variation coefficients of the results of the repeatability test of examples for Q1, Q2 and Q3 are all <10%, and the variation coefficients of comparative examples 1 and 2 are 14.38% and 11.01%, more than 10% when the Q1 is measured at a low value, which is not in accordance with the requirement of the repeatability test of less than 10%.
The experimental result shows that when the hs-cTnT chemiluminescence detection kit is used for detecting cTnT, the detection limit is 0.5ng/L, and compared with the conventional method (comparative example 1) and the chemiluminescence detection kit adopting the specific binding of biotin-avidin but not adopting multistage amplification measures (comparative example 2), the numerical value of S1/S0 is improved by 4 times, and the sensitivity is higher; the precision of the low-value part is greatly improved, the low-value quality control Q1 (3 ng/L) which is lower than the lower limit (14.0 ng/L) of the reference interval is measured, and the repeatability variation coefficient can be controlled within 10 percent.
The foregoing is merely exemplary of the invention and it should be noted that modifications and variations could be made by those skilled in the art without departing from the technical principles of the invention, and such modifications and variations should also be regarded as being within the scope of the invention.
Claims (10)
1. An hs-cTnT chemiluminescent assay kit applying a multistage signal amplification technology is characterized by comprising an R1 reagent, an R2 reagent, an R3 reagent, an R4 reagent, a calibrator and a quality control product;
the R1 reagent is a magnetic bead suspension coated with a cardiac troponin T monoclonal antibody 1;
the R2 reagent is a biotin-labeled cardiac troponin T monoclonal antibody 2 solution;
the R3 reagent is a streptavidin solution marked by a luminous marker;
the R4 reagent is biotin-labeled streptavidin antibody solution.
2. The hs-cTnT chemiluminescent assay kit of claim 1 wherein the magnetic beads of the R1 reagent for coating cardiac troponin T monoclonal antibody 1 are carboxyl magnetic beads.
3. The hs-cTnT chemiluminescent assay kit of claim 1 wherein the molar ratio of biotin to cardiac troponin T monoclonal antibody 2 in the R2 reagent is from 10:1 to 30:1.
4. The hs-cTnT chemiluminescent assay kit of claim 1 wherein the R2 reagent is prepared by thoroughly mixing cardiac troponin T monoclonal antibody 2 and N-hydroxysuccinimide ester, removing excess N-hydroxysuccinimide ester, and then compounding with a buffer.
5. The hs-cTnT chemiluminescent assay kit of claim 1 wherein the molar ratio of luminescent label to streptavidin in the R3 reagent is from 10:1 to 50:1.
6. The hs-cTnT chemiluminescent assay kit of claim 1 wherein the R3 reagent is prepared by thoroughly mixing a luminescent label with streptavidin and then compounding with a buffer.
7. The hs-cTnT chemiluminescent assay kit of claim 1 wherein the luminescent label for labeling streptavidin in the R3 reagent is one of acridinium ester, acridine sulfonamide, isoluminol, or fluorescein.
8. The hs-cTnT chemiluminescent assay kit of claim 1 wherein the molar ratio of biotin to streptavidin antibody in the R4 reagent is from 10:1 to 30:1.
9. The hs-cTnT chemiluminescent assay kit of claim 1 wherein the R4 reagent is prepared by thoroughly mixing a streptavidin antibody and N-hydroxysuccinimide ester, removing excess N-hydroxysuccinimide ester, and then compounding with a buffer solution.
10. The hs-cTnT chemiluminescent assay kit of claim 1 wherein the calibrator and quality control are formulated from a cardiac troponin T antigen and a buffer.
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| CN112526140A (en) * | 2020-11-16 | 2021-03-19 | 北京利德曼生化股份有限公司 | Magnetic particle chemiluminescence detection kit for determining content of hypersensitive troponin T |
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