Method, system and kit for correcting chemiluminescence immunoassay result

Abstract

The invention provides a method, a system and a kit for correcting a chemiluminescence immunoassay result, a group of biotin interference-free samples are subjected to chemiluminescence immunoassay through a first reagent combination and a second reagent combination, and a calibration curve and a preset signal value deviation range are determined according to a detection result; synchronously detecting a to-be-detected sample by using the first reagent combination and the second reagent combination to obtain a detection result signal deviation value; when the detection result signal deviation value is within the preset signal value deviation range, performing sample concentration calculation according to the calibration curve and the first optical signal value; and when the detection result signal deviation value is not within the preset signal value deviation range, calculating the sample concentration according to the calibration curve and the second optical signal value. Through the correction method provided by the invention, the credibility and the accuracy of a chemiluminescence immunoassay result are improved.

Description

Technical Field

[0001] The embodiments of the present application relate to the technical field of chemiluminescence immunoassay, and in particular, to a method, system and kit for correcting chemiluminescence immunoassay results. Background Art

[0002] The biotin-avidin system (BAS) is widely used in chemiluminescence immunoassay systems. Its principle is to amplify the signal of the detection subject using a luminescent substance and directly measure the chemiluminescence immunoassay process by means of the luminescence intensity of the detection subject. However, biotin inside the detection subject often affects the accuracy of chemical detection results.

[0003] In the prior art, methods such as using anti-free biotin antibodies, specific binding modified biotin antibodies, molecular traps, pre-incubation or enantiomers are usually used to eliminate the interference of biotin inside the detection subject.

[0004] Although the methods in the related art can eliminate the interference of biotin inside the detection subject, there are problems such as difficult access to materials and high prices, and they cannot well solve the problem of biotin interference in the chemiluminescence immunoassay process. Summary of the Invention

[0005] In view of the above problems, the embodiments of the present application are proposed to provide a method for correcting chemiluminescence immunoassay results that overcomes or at least partially solves the above problems.

[0006] In a first aspect, the embodiments of the present application disclose a method for correcting chemiluminescence immunoassay results, the method comprising:

[0007] Performing chemiluminescence immunoassay on a group of samples without biotin interference using a first reagent combination and a second reagent combination respectively, and determining a calibration curve and a preset signal value deviation range according to the detection results;

[0008] Synchronously detecting a sample to be tested using the first reagent combination and the second reagent combination to obtain a detection result signal deviation value;

[0009] When the detection result signal deviation value is within the preset signal value deviation range, calculating the sample concentration according to the calibration curve and a first optical signal value; the first optical signal value is obtained by performing chemiluminescence immunoassay using the first reagent combination;

[0010] When the detection result signal deviation value is not within the preset signal value deviation range, calculating the sample concentration according to the calibration curve and a second optical signal value; the second optical signal value is obtained by performing chemiluminescence immunoassay using the second reagent combination.

[0011] Optionally, the detection result signal deviation value is the difference between the second optical signal value and the first optical signal value.

[0012] Optionally, when the detection result signal deviation value is not within the preset signal value deviation range, calculating the sample concentration according to the calibration curve and the second optical signal value, includes:

[0013] In the case where the chemiluminescence immunoassay method is the sandwich method or the indirect method, obtaining the predicted sample concentration according to the calibration curve and the second optical signal value;

[0014] Converting the predicted sample concentration through a first preset formula to obtain the actual sample concentration of the sample to be tested.

[0015] Optionally, when the detection result signal deviation value is not within the preset signal value deviation range, calculating the sample concentration according to the calibration curve and the second optical signal value, further includes:

[0016] In the case where the chemiluminescence immunoassay method is the competitive method, converting the second optical signal value through a second preset formula to obtain the actual optical signal value of the sample;

[0017] Obtaining the actual sample concentration of the sample to be tested according to the calibration curve and the actual optical signal value of the sample.

[0018] In a second aspect, an embodiment of the present application discloses a correction system for chemiluminescence immunoassay results, the system includes:

[0019] A storage module, storing calibration curves and a preset signal value deviation range obtained according to detection results by performing chemiluminescence immunoassay on a group of samples without biotin interference using a first reagent combination and a second reagent combination respectively;

[0020] A light excitation module, configured to perform light excitation when synchronously detecting a sample to be tested using the first reagent combination and the second reagent combination, to obtain a first optical signal value and a second optical signal value;

[0021] A data processing module, configured to obtain a detection result signal deviation value, and determine whether the detection result signal deviation value is within the preset signal value deviation range; if the determination result is yes, calculate the sample concentration according to the calibration curve and the first optical signal value; if the determination result is no, calculate the sample concentration according to the calibration curve and the second optical signal value; the second optical signal value is obtained by performing chemiluminescence immunoassay using the second reagent combination.

[0022] In a third aspect, an embodiment of the present application further discloses a method for determining biotin interference, the method includes:

[0023] Perform chemiluminescent immunoassay on a group of samples without biotin interference using the first reagent combination and the second reagent combination respectively, and determine the calibration curve and the preset signal value deviation range according to the detection results;

[0024] Synchronously detect the sample to be tested using the first reagent combination and the second reagent combination to obtain the signal deviation value of the detection result;

[0025] When the signal deviation value of the detection result is within the preset signal value deviation range, it is determined that there is no biotin interference in the chemiluminescent immunoassay of the sample to be tested;

[0026] When the signal deviation value of the detection result is outside the preset signal value deviation range, it is determined that there is biotin interference in the chemiluminescent immunoassay of the sample to be tested.

[0027] Fourthly, an embodiment of the present application also discloses a kit, including:

[0028] The first reagent, including luminescent particles coated with the first antibody;

[0029] The second reagent, including a biotin-labeled second antibody;

[0030] The third reagent, including a biotin-labeled second antibody and free biotin;

[0031] The photosensitive reagent, including photosensitive particles.

[0032] Optionally, the molar concentration of biotin in the second reagent and the third reagent is the same, and the concentration of the biotin-labeled second antibody in the third reagent is 1 / 2 of the concentration of the biotin-labeled second antibody in the second reagent.

[0033] Optionally, the kit includes the above-mentioned first reagent combination and second reagent combination, the first reagent combination includes the first reagent and the second reagent, the first reagent combination includes the first reagent and the second reagent, and the second reagent combination includes the first reagent and the third reagent.

[0034] Fifthly, an embodiment of the present application also discloses a method for using the kit as described in the fourth aspect, and the method for using includes:

[0035] Mix equal volumes of the sample to be tested with the first reagent combination or the second reagent combination respectively to form two groups of mixtures, and incubate the two groups of mixtures at a preset temperature and a first preset time;

[0036] Add equal volumes of the photosensitive reagent to the two groups of incubated mixtures respectively, and after incubating for a second preset time, obtain a first light signal value and a second light signal value.

[0037] In the embodiments of the present application, a chemiluminescence immunoassay is performed on a group of samples without biotin interference using a first reagent combination and a second reagent combination respectively. A calibration curve and a preset signal value deviation range are determined according to the detection results. The first reagent combination and the second reagent combination are used to synchronously detect a sample to be tested, and a detection result signal deviation value is obtained. When the detection result signal deviation value is within the preset signal value deviation range, the sample concentration is calculated according to the calibration curve and the first optical signal value. When the detection result signal deviation value is not within the preset signal value deviation range, the sample concentration is calculated according to the calibration curve and the second optical signal value. According to the present application, when the detection result signal deviation value is not within the preset signal value deviation range, it is determined that there is biotin interference in the chemiluminescence immunoassay of the sample to be tested, which improves the efficiency and accuracy of detecting biotin interference. And when biotin interference exists, the chemiluminescence immunoassay result is corrected, which improves the credibility, accuracy and applicability of the chemiluminescence immunoassay result, saves the time and cost of chemiluminescence immunoassay, eliminates the influence brought by biotin interference, and more accurately evaluates the actual sample concentration of the sample to be tested. Description of the Drawings

[0038] In the drawings:

[0039] Figure 1 is a flowchart of the steps of a method for correcting chemiluminescence immunoassay results provided by an embodiment of the present application;

[0040] Figure 2 is a flowchart of the steps of a method for determining biotin interference provided by an embodiment of the present application;

[0041] Figure 3 is a flowchart of the steps of a method for using a kit provided by an embodiment of the present application;

[0042] Figure 4 is a structural diagram of a system for correcting chemiluminescence immunoassay results provided by an embodiment of the present application;

[0043] Figure 5 is a block diagram of an electronic device provided by an embodiment of the present application;

[0044] Figure 6 is a block diagram of another electronic device provided by an embodiment of the present application. Detailed Embodiments

[0045] Next, the technical solutions in the embodiments of the present application will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments in the present application without creative efforts shall fall within the protection scope of the present application.

[0046] The terms "first", "second", etc. in the specification and claims of the present application are used to distinguish similar objects, rather than to describe a specific order or sequence. It should be understood that such data can be interchanged under appropriate circumstances so that the embodiments of the present application can be implemented in an order other than those illustrated or described herein, and the objects distinguished by "first", "second", etc. are usually of the same category, and the number of objects is not limited. For example, the first object can be one or multiple. In addition, "and / or" in the specification and claims means at least one of the connected objects, and the character " / " generally means an "or" relationship between the associated objects before and after.

[0047] Referring to Figure 1 , the flowchart of the steps of a method for correcting the results of chemiluminescence immunoassay provided by an embodiment of the present application, the method includes the following steps:

[0048] Step 101, perform chemiluminescence immunoassay on a group of samples without biotin interference through the first reagent combination and the second reagent combination respectively, and determine the calibration curve and the preset signal value deviation range according to the detection results.

[0049] In the embodiments of the present application, chemiluminescence immunoassay (CLIA) is a non-radioactive immunoassay technology that has developed rapidly in recent years. Its principle is to use chemiluminescent substances for signal amplification and directly measure the immune binding process by means of its luminescence intensity. The methods of chemiluminescence immunoassay include competitive method, sandwich method and indirect method. Among them, the competitive method (Competitive Assay) is a method based on the competitive reaction between antigen and antibody. In this method, the target substance in the sample competes with the antigen labeled with a label for binding to the antibody. By measuring the degree of binding of the label to the antibody or the amount of the remaining unbound label, the concentration of the target substance in the sample can be inferred.

[0050] The Sandwich Assay is a method for detecting a target by simultaneously binding antibodies on both sides of the target. In this method, the target in the sample first binds to the first antibody, and then the second antibody is added to bind to other regions of the target, forming a "sandwich" structure. The sandwich structure can be used for amplifying optical signals. By measuring the amount of the second antibody label, the presence and concentration of the target can be quantitatively analyzed.

[0051] The Indirect Assay is a method for detecting a target by using a second antibody. In this method, the target in the sample first binds to a specific first antibody, and then a second antibody labeled with a fluorophore or an enzyme is added to bind to the first antibody, forming an antigen-antibody-label complex. By measuring the amount of the label, the presence and concentration of the target can be determined.

[0052] In the embodiments of the present application, chemiluminescent immunoassay can be performed on a group of samples without biotin interference by the sandwich assay using a first reagent combination and a second reagent combination, so as to determine the calibration curve and the signal value deviation range of chemiluminescent immunoassay without biotin interference according to the detection results. Before performing chemiluminescent immunoassay, it is also necessary to prepare the first reagent combination, the second reagent combination, and confirm the samples without biotin interference.

[0053] In the embodiments of the present application, the present application provides a kit, including a photosensitive reagent, a first reagent combination, and a second reagent combination. Among them, the first reagent combination does not include free biotin, and the second reagent combination includes free biotin. The first reagent combination includes a first reagent and a second reagent. The first reagent includes luminescent particles coated with a first antibody, and the second reagent includes a second antibody labeled with biotin. The second reagent combination includes the first reagent and a third reagent. The third reagent includes a second antibody labeled with biotin and free biotin, and the sum of the molar concentrations of the second antibody labeled with biotin and free biotin in the third reagent is equal to the molar concentration of the second antibody labeled with biotin in the second reagent.

[0054] Among them, the first antibody and the second antibody refer to antibodies that can specifically bind to a certain antigen. For the same antigen, the corresponding first antibody and second antibody can be different or the same, and can bind to the same antigen simultaneously.

[0055] To confirm the samples without biotin interference, it is necessary to first screen out the samples without biotin interference. Therefore, by selecting reference samples and detecting the selected reference samples using at least two kits, when the deviation of the detection results of the kits for detecting the selected reference samples is within the preset deviation range, the reference sample is considered to be a sample without biotin interference.

[0056] A reference sample refers to a mixture that contains or is suspected of containing the target analyte to be measured. Reference samples include, but are not limited to, blood, plasma, serum, urine, semen, saliva, cell cultures, tissue extracts, solvents, seawater, industrial water samples, etc.

[0057] For example, the reference samples are thyroid hormone (TSH, Thyroid-Stimulating Hormone) samples with different sample concentrations. The detection kits include TSH detection kits and Abbott TSH detection kits. The preset deviation range is less than 10%. Therefore, TSH detection kits and Abbott TSH detection kits can perform chemiluminescent immunoassay on TSH samples with the same sample concentration. If the deviation of the chemiluminescent immunoassay results of the two detection kits for the TSH samples, i.e., the sample concentration, is within the preset deviation range, it is determined that the TSH sample is a sample without biotin interference.

[0058] Among them, The TSH detection kit is a kit for detecting the TSH concentration in human blood. The TSH detection kit uses the principle of chemiluminescent immunoassay for detection. The kit includes an anti-TSH antibody and a second antibody labeled with a luminescent substance. When the sample contains TSH, it binds to the anti-TSH antibody to form an antigen-antibody complex. Then, the second antibody is added to bind to the complex, forming a "sandwich" structure. Finally, by measuring the intensity of the luminescence signal, the TSH concentration in the sample can be quantitatively analyzed. The TSH detection kit has high sensitivity, high specificity, and a wide dynamic range, and can be used for rapid and accurate quantitative detection of TSH levels in clinical laboratories, and has important application values in aspects such as thyroid function assessment, diagnosis and treatment monitoring of thyroid diseases.

[0059] The Abbott TSH detection kit is a diagnostic tool for detecting the TSH concentration in blood. The kit uses chemiluminescent immunoassay technology and can quickly and accurately measure the TSH concentration in blood.

[0060] In the embodiments of the present application, when the first reagent combination and the second reagent combination perform chemiluminescent immunoassay on a group of samples without biotin interference, a photosensitive reagent also needs to be added for chemiluminescent immunoassay. The photosensitive reagent is, for example, photosensitive microparticles labeled with a label. Therefore, after incubating the mixed reagent of the first reagent combination and the samples without biotin interference for a first preset time and adding the photosensitive reagent, a first optical signal value representing the number of samples without biotin interference of each sample concentration can be obtained through a sensor. Among them, the sensor is, for example, a photometer, a spectrometer, or a photon counter.

[0061] In the embodiments of the present application, the marker-labeled photosensitive particles are, for example, streptavidin-coated photosensitive microparticles. After adding a preset volume of streptavidin-coated photosensitive microparticles to the mixed reagent of the first reagent combination and the biotin-free interference sample, and incubating for a second preset time, the luminescent microparticles coated with the first antibody bind to the antigen in the biotin-free interference sample to form a ternary complex of "antigen - first antibody - luminescent microparticle". The biotin-labeled second antibody binds to other regions of the antigen in the biotin-free interference sample, and finally a sandwich complex of "second antibody - antigen - first antibody - luminescent microparticle" is formed. Because biotin specifically binds to streptavidin, the sandwich complex binds to the streptavidin-coated photosensitive microparticles to form a luminescent composition. The sensor is used to obtain the light intensity value of the biotin-free interference sample that emits light, so as to obtain the first light signal value RLU1 characterizing the sample quantity.

[0062] For example, add 175 μL of streptavidin-coated photosensitive microparticles to the mixed reagent of the first reagent combination and the biotin-free interference sample. After incubating for 15 min, obtain the first light signal value RLU1 characterizing the sample quantity.

[0063] In the embodiments of the present application, after adding a preset volume of streptavidin-coated photosensitive microparticles to the mixed reagent of the second reagent combination and the biotin-free interference sample, and incubating for a second preset time, the second light signal value RLU2 characterizing the sample quantity is obtained. Among them, because the second reagent combination contains free biotin, and the free biotin also binds to the marker-labeled photosensitive microparticles, resulting in a reduction in the marker-labeled photosensitive microparticles bound to the biotin-labeled second antibody. Furthermore, the luminescent composition formed by the binding of the marker-labeled photosensitive microparticles and the sandwich complex decreases, and the intensity of the chemiluminescence signal decreases. Therefore, for the biotin-free interference samples with the same concentration and the same volume, after adding the same preset volume of the marker-labeled photosensitive microparticles, the second light signal value RLU2 characterizing the sample quantity obtained by the second reagent for chemiluminescence immunoassay is less than the first light signal value RLU1 characterizing the sample quantity obtained by the first reagent combination for chemiluminescence immunoassay.

[0064] For example, add 175 μL of streptavidin-coated photosensitive microparticles to the mixed reagent of the second reagent combination and the biotin-free interference sample. After incubating for 15 min, obtain the second light signal value RLU2 characterizing the sample quantity.

[0065] In the embodiments of the present application, according to the first light signal value and the second light signal value, a calibration curve and a preset signal value deviation range are determined. Table 1 is a list of the first light signal value, the second light signal value, and the signal deviation value obtained by detecting the biotin-free interference sample with the first reagent combination and the second reagent combination.

[0066] Table 1

[0067]

[0068] As can be seen from Table 1, the sample concentrations of the biotin-free interference samples with different sample numbers are different. Among them, as the sample number gradually increases, the concentrations of the biotin-free interference samples with different sample numbers can increase exponentially. For example, the sample concentration of sample number 2 is 3 times that of sample number 1, and the sample concentration of sample number 3 is 3 times that of sample number 2, and so on, the sample concentrations of all sample numbers can be obtained. Therefore, according to the first optical signal value and the second optical signal value, the signal deviation value is determined, and the calibration curve is determined according to all the first optical signal values. That is, the ratio of the difference between the second optical signal value RLU2 and the first optical signal value RLU1 to the first optical signal value RLU1 is used as the signal deviation value S1, that is, S1 = [(RLU2 - RLU1) / RLU1] * 100%.

[0069] For example, for the first optical signal value RLU1 corresponding to sample number 1 is 11850, and the corresponding fourth signal value RLU2 is 9298, so the corresponding signal deviation value is [(9298 - 11850) / 11850] * 100% = -22%.

[0070] As can be seen from Table 1, since there is a first optical signal value RLU1 corresponding to the biotin-free interference sample with the sample concentration corresponding to each sample number. Therefore, all the first optical signal values RLU1 can be curve-fitted to obtain a calibration curve located in the two-dimensional rectangular coordinate system. Among them, the abscissa of the calibration curve is the first optical signal value RLU1, the ordinate is the sample concentration or the ordinate is the first optical signal value RLU1, and the abscissa is the sample concentration. The calibration curve characterizes the relationship between the first optical signal value and the sample concentration. Taking the calibration curve as the standard corresponding to the optical signal value and the sample concentration can be used to determine the corresponding sample concentration according to the optical signal value.

[0071] In the embodiment of the present application, according to the preset average deviation value range and each signal deviation value, the preset signal value deviation range can be determined. As can be seen from Table 1, the preset average deviation value range is, for example, -5% - 5%. That is, the average deviation value range is used as the basis for identifying whether there is biotin interference in the sample. Therefore, the preset signal value deviation range can be determined according to the preset average deviation value range and each of the signal deviation values. According to each of the signal deviation values, the average signal deviation value is obtained. As can be seen from Table 1, the average signal deviation value is about -25%. The preset average deviation value range is -5% to 5%. Therefore, the signal value deviation range for determining that the sample to be tested has no biotin interference is -30% to -20%.

[0072] Therefore, by performing chemiluminescence immunoassay on the biotin-free interference sample using the first reagent combination and the second reagent combination, the calibration curve of the chemiluminescence immunoassay for the biotin-free interference sample and the preset signal value deviation range can be determined. The calibration curve and the preset signal value deviation range are stored in the storage module of the computer.

[0073] Step 102: Synchronously detect the sample to be tested using the first reagent combination and the second reagent combination, and obtain the detection result signal deviation value.

[0074] In the embodiment of the present application, by synchronously detecting the sample to be tested using the first reagent combination and the second reagent combination for chemiluminescence immunoassay, the detection result signal deviation value can be obtained.

[0075] Among them, before performing chemiluminescence immunoassay on the sample to be tested, the sample to be tested can be prepared using Randox quality control to determine the samples to be tested with the first preset concentration, the second preset concentration, and the third preset concentration. Among them, the first preset concentration, the second preset concentration, and the third preset concentration increase in sequence.

[0076] Among them, the sample to be tested refers to a mixture containing or suspected of containing the target to be tested. The sample to be tested includes, but is not limited to, blood, plasma, serum, urine, semen, saliva, cell culture, tissue extract, solvent, seawater, industrial water sample, etc.

[0077] Further, after adding biotin solutions with different biotin concentrations and a photosensitive reagent to the mixed reagents of the first reagent combination and the second reagent combination and the sample to be tested with the same sample concentration, the first light signal value RLU1 and the second light signal value RLU2 representing the number of samples are obtained.

[0078] In the embodiment of the present application, Table 2 is a list of the first light signal value RLU1, the second light signal value RLU2, and the detection result signal deviation value S2 obtained by performing chemiluminescence immunoassay using the first reagent combination and the second reagent.

[0079] Table 2

[0080]

[0081] As can be seen from Table 2, the sample to be tested is, for example, a TSH sample. Therefore, the samples to be tested with the first preset concentration, the second preset concentration, and the third preset concentration are the TSH samples with the first preset concentration, the TSH samples with the second preset concentration, and the TSH samples with the third preset concentration. For TSH samples with the same preset concentration, the first optical signal value RLU1 decreases as the biotin concentration in the TSH sample increases. When the biotin concentration in the TSH sample is lower than 400 ng / mL, the decrease rate of the second optical signal value obtained by chemiluminescence immunoassay of the sample to be tested is higher than that of the second optical signal value obtained by chemiluminescence immunoassay without biotin interference, and most of the signal deviation values of the detection results are higher than the preset signal value deviation range. When the biotin concentration in the TSH sample is higher than 400 ng / mL, the decrease rate of the second optical signal value obtained by chemiluminescence immunoassay of the sample to be tested is lower than that of the second optical signal value obtained by chemiluminescence immunoassay without biotin interference, and the signal deviation value of the detection result is lower than the preset signal value deviation range. Therefore, in the chemiluminescence immunoassay of the sample to be tested, biotin interference is very serious. If you want to obtain the actual sample concentration, you need to correct the chemiluminescence immunoassay results.

[0082] Wherein, the ratio of the difference between the second optical signal value RLU2 obtained by chemiluminescence immunoassay of the sample to be tested and the first optical signal value RLU1 to the first optical signal value RLU1 is used as the signal deviation value S2 of the detection result, that is, S2 = [(RLU2 - RLU1) / RLU1]*100%.

[0083] Step 103, when the signal deviation value of the detection result is within the preset signal value deviation range, calculate the sample concentration according to the calibration curve and the first optical signal value; the first optical signal value is obtained by chemiluminescence immunoassay with the first reagent combination.

[0084] In the embodiment of the present application, when the signal deviation value of the detection result is within the preset signal value deviation range, it is determined that there is no biotin interference in the chemiluminescence immunoassay of the sample to be tested corresponding to the signal deviation value of the detection result. Then, according to the calibration curve and the first optical signal value corresponding to the signal deviation value of the detection result, the first chemiluminescence immunoassay result is determined. Among them, the first optical signal value is obtained by chemiluminescence immunoassay of the sample to be tested with the first reagent combination. Because the calibration curve reflects the relationship between the optical signal value and the sample concentration, after determining the first optical signal value corresponding to the signal deviation value of the detection result, the sample concentration corresponding to the first optical signal value can be obtained on the calibration curve, and the sample concentration corresponding to the first optical signal value is the first chemiluminescence immunoassay result.

[0085] For example, when the sample to be tested is a TSH sample, the signal deviation value S3 of the test result is -26%, and the preset signal value deviation range is -30% to -20%. At this time, it can be determined that the signal deviation value S2 of the test result is within the preset signal value deviation range, so it is determined that there is no biotin interference in the chemiluminescent immunoassay of the TSH sample. Substituting the first optical signal value RLU1 corresponding to the signal deviation value of the test result into the calibration curve can determine the actual sample concentration of the sample to be tested.

[0086] Step 104, when the signal deviation value of the test result is not within the preset signal value deviation range, calculate the sample concentration according to the calibration curve and the second optical signal value; the second optical signal value is obtained by performing chemiluminescent immunoassay with the second reagent combination.

[0087] In the embodiment of the present application, when the signal deviation value of the test result is not within the preset signal value deviation range, it is determined that there is biotin interference in the chemiluminescent immunoassay of the sample to be tested, and then according to the calibration curve and the second optical signal value corresponding to the signal deviation value of the test result, the second chemiluminescent immunoassay result is determined.

[0088] Among them, the second optical signal value is obtained by performing chemiluminescent immunoassay with the second reagent combination. Since there is biotin interference in the chemiluminescent immunoassay of the sample to be tested corresponding to the signal deviation value of the test result, it is necessary to correct it through the second optical signal value corresponding to the signal deviation value of the test result to determine the actual concentration of the sample to be tested.

[0089] For example, when the sample to be tested is a TSH sample, the signal deviation value S2 of the test result is -34%, and the preset signal value deviation range is -30% to -20%. At this time, it can be determined that the signal deviation value S2 of the test result is not within the preset signal value deviation range. Therefore, the second optical signal value RLU2 corresponding to the signal deviation value S2 of -34% can be obtained as 251816, and according to the second optical signal value RLU2 and the calibration curve, the actual sample concentration of the sample to be tested can be obtained.

[0090] Optionally, step 104 may include the following sub-steps:

[0091] Sub-step 1041, when the chemiluminescent immunoassay method is the sandwich method or the indirect method, obtain the predicted sample concentration according to the calibration curve and the second optical signal value.

[0092] In an embodiment of the present application, when the chemiluminescent immunoassay method is the sandwich method or the indirect method, the change trend of the first light signal value RLU1 or the second light signal value RLU2 is basically consistent with the change trend of the sample concentration. If there is biotin interference in the chemiluminescent immunoassay of the sample to be tested, then in the case where the chemiluminescent immunoassay method is the sandwich method or the indirect method, the second light signal value RLU2 corresponding to the detection result signal deviation value is used as the first light signal value RLU1 and substituted into the calibration curve to obtain the corresponding predicted sample concentration.

[0093] Sub-step 1042, convert the predicted sample concentration through a first preset formula to obtain the actual sample concentration of the sample to be tested.

[0094] In an embodiment of the present application, the first preset formula is:

[0095] Actual sample concentration = (predicted sample concentration corresponding to the second light signal value / (k * labeled antibody competition amount)) * (free biotin competition amount + k * labeled antibody competition amount),

[0096] Wherein, the labeled antibody competition amount is the molar mass of the biotin-labeled second antibody in the third reagent, and the free biotin competition amount is the molar mass of the free biotin in the third reagent. k is a constant term, and k is equal to the molar mass of the biotin of the biotin-labeled second antibody and the free biotin in the third reagent and the molar mass of the added free biotin. Therefore, the first preset formula can be used to convert the predicted sample concentration to obtain the actual sample concentration of the sample to be tested. The first preset formula can also be used to convert the predicted sample concentration corresponding to the first light signal value.

[0097] For example, when preparing the third reagent, the molar mass of biotin in the biotin-labeled second antibody can be detected, so as to calculate the biotin concentration in the biotin-labeled second antibody. The Thermo Scientific Pierce Biotin Quantitation Kit can be used to detect the molar mass of biotin in the biotin-labeled second antibody to obtain the molar mass ratio of the second antibody to biotin, and then the labeled biotin concentration in the 1 g / mL biotin-labeled second antibody reagent can be calculated to be about 60 ng / mL according to the molar mass ratio. Therefore, if 25 μL of 60 ng / mL free biotin is added to the third reagent, then the molar mass of the free biotin is 0.51 * 10 -10 mol. As shown in Table 1, the average signal deviation value of the biotin-free sample is about 25%, so it can be obtained that the molar mass of the biotin of the biotin-labeled second antibody and the free biotin in the third reagent is 1.53 * 10 -10mol, which is 3 times the amount of free biotin. Therefore, in the embodiments of the present application, k = 3.

[0098] Sub-step 1043, when the chemiluminescence immunoassay method is a competitive method, convert the second optical signal value through a second preset formula to obtain the actual optical signal value of the sample.

[0099] In the embodiments of the present application, because when the chemiluminescence immunoassay method is a competitive method, the change trend of the first optical signal value RLU1 or the second optical signal value RLU2 is quite different from the change trend of the sample concentration, it is determined that there is biotin interference in the chemiluminescence immunoassay of the analyte sample, and the second optical signal value corresponding to the signal deviation value of the detection result is converted through the second preset formula to obtain the actual optical signal value of the sample.

[0100] Among them, the second preset formula is:

[0101] Actual optical signal value of the sample = (Second optical signal value / (k * labeled antibody competition amount)) * (Free biotin competition amount + k * labeled antibody competition amount),

[0102] Among them, the labeled antibody competition amount is the molar mass of the biotin-labeled second antibody in the third reagent, the free biotin competition amount is the molar mass of the free biotin in the third reagent, and k is equal to the molar mass of the biotin-labeled second antibody and the free biotin in the third reagent and the molar mass of the added free biotin. The second optical signal value corresponding to the signal deviation value of the detection result is processed through the second preset formula to obtain the actual optical signal value of the sample.

[0103] Sub-step 1044, obtain the actual sample concentration of the sample to be tested according to the calibration curve and the actual optical signal value of the sample.

[0104] In the embodiments of the present application, according to the calibration curve and the actual signal value of the sample, the actual signal value of the sample is used as the first optical signal value RLU1 and substituted into the calibration curve to obtain the actual sample concentration of the sample to be tested.

[0105] In the embodiments of the present application, Table 3 is a conversion detection value table obtained by applying the first preset formula to the predicted sample concentration corresponding to the first optical signal value and the predicted sample concentration corresponding to the second optical signal value obtained from the TSH sample with the first preset concentration.

[0106] Table 3

[0107]

[0108] In the embodiments of the present application, Table 4 is a conversion detection value table obtained by applying a first preset formula to the predicted sample concentration corresponding to the first optical signal value and the predicted sample concentration corresponding to the second optical signal value obtained from the TSH sample at the second preset concentration.

[0109] Table 4

[0110]

[0111] In the embodiments of the present application, Table 5 is a conversion detection value table obtained by applying a first preset formula to the predicted sample concentration corresponding to the first optical signal value and the predicted sample concentration corresponding to the second optical signal value obtained from the TSH sample at the third preset concentration.

[0112] Table 5

[0113]

[0114] As can be seen from Table 3, Table 4, and Table 5, when there is biotin interference, the predicted sample concentrations corresponding to the first optical signal value and the second optical signal value are converted by the first preset formula to obtain the conversion detection value. It can be known that when the biotin concentration is lower than 700 ng / mL, the deviation of the conversion detection value from the predicted sample concentration of the first optical signal value when the biotin concentration is 0 remains less than 25%. When the biotin concentration is lower than 1000 ng / mL, the deviation of the conversion detection value from the predicted sample concentration of the first optical signal value when the biotin concentration is 0 remains less than 30%. In this way, the existing deviation after conversion can improve the detection deviation of the chemiluminescence immunoassay results when affected by biotin.

[0115] In summary, in the embodiments of the present application, chemiluminescence immunoassays are respectively performed on a group of samples without biotin interference using the first reagent combination and the second reagent combination. The calibration curve and the preset signal value deviation range are determined according to the detection results. The first reagent combination and the second reagent combination are used to synchronously detect the sample to be tested, and the detection result signal deviation value is obtained. When the detection result signal deviation value is within the preset signal value deviation range, the sample concentration is calculated according to the calibration curve and the first optical signal value. When the detection result signal deviation value is not within the preset signal value deviation range, the sample concentration is calculated according to the calibration curve and the second optical signal value. In the present application, when the detection result signal deviation value is not within the preset signal value deviation range, it is determined that there is biotin interference in the chemiluminescence immunoassay of the sample to be tested, which improves the efficiency and accuracy of detecting biotin interference. Moreover, when there is biotin interference, the chemiluminescence immunoassay results are corrected, which improves the credibility, accuracy, and applicability of the chemiluminescence immunoassay results, saves the time and cost of chemiluminescence immunoassay, eliminates the influence brought by biotin interference, and more accurately evaluates the actual sample concentration of the sample to be tested.

[0116] Reference Figure 2 , Figure 2 is a flowchart of steps of a method for determining biotin interference provided by an embodiment of the present application. The method includes:

[0117] Step 201: Perform chemiluminescence immunoassay on a group of biotin interference-free samples through a first reagent combination and a second reagent combination respectively, and determine a calibration curve and a preset signal value deviation range according to the detection results.

[0118] Specifically, the implementation manner of this step can refer to the foregoing step 101.

[0119] Step 202: Synchronously detect the sample to be tested with the first reagent combination and the second reagent combination, and obtain a detection result signal deviation value.

[0120] Specifically, the implementation manner of this step can refer to the foregoing step 102.

[0121] Step 203: When the detection result signal deviation value is within the preset signal value deviation range, determine that there is no biotin interference in the chemiluminescence immunoassay of the sample to be tested.

[0122] Specifically, the implementation manner of this step can refer to the foregoing step 103.

[0123] Step 204: When the detection result signal deviation value is outside the preset signal value deviation range, determine that there is biotin interference in the chemiluminescence immunoassay of the sample to be tested.

[0124] Specifically, the implementation manner of this step can refer to the foregoing step 104.

[0125] Reference Figure 3 , Figure 3 is a flowchart of steps of a method for using a kit provided by an embodiment of the present application. The method applies a kit provided by the present application. The method for using includes:

[0126] Step 301: Mix equal volumes of the sample to be tested with the first reagent combination or the second reagent combination respectively to form two groups of mixtures, and incubate the two groups of mixtures at a preset temperature and a first preset time.

[0127] In an embodiment of the present application, the first reagent combination includes a first reagent and a second reagent. Mix a preset volume of the sample to be tested with the first reagent combination to form a third reagent combination, and incubate the third reagent combination at a preset temperature and a first preset time. The first reagent includes luminescent microparticles coated with a first antibody at a first preset concentration, and the second reagent includes a second antibody labeled with biotin at a second preset concentration.

[0128] For example, when the sample to be tested is a TSH sample, at this time, the luminescent particles coated with the first antibody are luminescent particles coated with the first TSH antibody, the first preset concentration of the first reagent is 30 g / mL, the second antibody labeled with biotin is the second TSH antibody labeled with biotin, the second preset concentration of the second reagent is 2 g / mL, and the first preset time is 17 min. Mix 25 μL of the sample to be tested, 25 μL of the first reagent, and 25 μL of the second reagent to form a third reagent combination, and then incubate the third reagent combination at a preset temperature of 37 °C for 17 min.

[0129] In the embodiment of the present application, the second reagent combination includes the first reagent and the third reagent. Mix a preset volume of the sample to be tested and the second reagent combination to form a fourth mixed reagent, and incubate the fourth mixed reagent at the preset temperature and the first preset time.

[0130] For example, when the sample to be tested is a TSH sample, at this time, the luminescent particles coated with the first antibody are luminescent particles coated with the first TSH antibody, the first preset concentration of the first reagent is 30 g / mL, the second antibody labeled with biotin is the second TSH antibody labeled with biotin, the third preset concentration of the second reagent and the fourth preset concentration of the TSH sample are both 1 g / mL, and the first preset time is 17 min. After mixing 25 μL of the sample, 25 μL of the first reagent, and 25 μL of the third reagent, incubate the second reagent combination at a preset temperature of 37 °C for 17 min.

[0131] Step 302: Add equal volumes of the photosensitive reagent to the two groups of incubated mixtures respectively, and obtain a first optical signal value and a second optical signal value after incubating for a second preset time.

[0132] In the present application, add a preset volume of the photosensitive reagent to the incubated third reagent combination, and obtain a first optical signal value after incubating for a second preset time.

[0133] For example, when the photosensitive reagent is photosensitive particles coated with streptavidin, add 175 μL of the photosensitive particles coated with streptavidin to the third reagent combination, and obtain a first optical signal value RLU1 after incubating for 15 min.

[0134] In the present application, add a preset volume of the photosensitive reagent to the incubated fourth reagent combination, and obtain a second optical signal value after incubating for a second preset time.

[0135] For example, when the photosensitive reagent is photosensitive particles coated with streptavidin, add 175 μL of the photosensitive particles coated with streptavidin to the fourth reagent combination, and obtain a second optical signal value RLU2 after incubating for 15 min.

[0136] In summary, in the embodiments of the present application, a chemiluminescence immunoassay is performed on a group of samples without biotin interference using a kit respectively, and a calibration curve and a preset signal value deviation range are determined according to the detection results; the first reagent combination and the second reagent combination are used to synchronously detect the sample to be tested, and a detection result signal deviation value is obtained; when the detection result signal deviation value is within the preset signal value deviation range, it is determined that there is no biotin interference in the chemiluminescence immunoassay of the sample to be tested; when the detection result signal deviation value is not within the preset signal value deviation range, it is determined that there is biotin interference in the chemiluminescence immunoassay of the sample to be tested. According to the present application, when the detection result signal deviation value is not within the preset signal value deviation range, it is determined that there is biotin interference in the chemiluminescence immunoassay of the sample to be tested, which improves the efficiency and accuracy of detecting biotin interference.

[0137] The embodiments of the present application also provide a kit, including:

[0138] A first reagent, including luminescent microparticles coated with a first antibody;

[0139] A second reagent, including a second antibody labeled with biotin;

[0140] A third reagent, including a second antibody labeled with biotin and free biotin;

[0141] A photosensitive reagent, including photosensitive microparticles.

[0142] Optionally, the molar concentration of biotin in the second reagent and the third reagent is the same, and the concentration of the second antibody labeled with biotin in the third reagent is 1 / 2 of the concentration of the second antibody labeled with biotin in the second reagent.

[0143] Optionally, the kit includes the above-mentioned first reagent combination and second reagent combination, the first reagent combination includes the first reagent and the second reagent, the first reagent combination includes the first reagent and the second reagent, and the second reagent combination includes the first reagent and the third reagent.

[0144] Herein, the first antibody and the second antibody refer to antibodies that can specifically bind to a certain antigen. For the same antigen, the corresponding first antibody and second antibody can be different or the same, and can bind to the same antigen simultaneously.

[0145] In the embodiments of the present application, a first reagent combination without free biotin is composed of the first reagent and the second reagent, and a second reagent combination including free biotin is composed of the first reagent and the third reagent. Furthermore, the above-mentioned method for correcting the chemiluminescence immunoassay results and the method for determining biotin interference can be performed based on the above kit.

[0146] ReferenceFigure 4 , Figure 4 It shows a block diagram of a correction system for chemiluminescence immunoassay results provided by an embodiment of the present application. The system 400 includes:

[0147] A storage module 401, storing a calibration curve and a preset signal value deviation range;

[0148] A light excitation module 402, configured to perform light excitation when synchronously detecting a test sample with the first reagent combination and the second reagent combination, and obtain a first light signal value and a second light signal value;

[0149] A data processing module 403, configured to obtain a detection result signal deviation value, and determine whether the detection result signal deviation value is within the preset signal value deviation range; if the determination result is yes, calculate the sample concentration according to the calibration curve and the first light signal value; if the determination result is no, calculate the sample concentration according to the calibration curve and the second light signal value.

[0150] Optionally, the data processing module 403 is further configured to obtain a predicted sample concentration according to the calibration curve and the second light signal value when the chemiluminescence immunoassay method is a sandwich method or an indirect method.

[0151] Optionally, the data processing module 403 is further configured to convert the predicted sample concentration through a first preset formula to obtain the actual sample concentration of the test sample.

[0152] Optionally, the data processing module 403 is further configured to convert the second light signal value through a second preset formula to obtain the actual light signal value of the sample when the chemiluminescence immunoassay method is a competitive method.

[0153] Optionally, the data processing module 403 is further configured to obtain the actual sample concentration of the test sample according to the calibration curve and the actual light signal value of the sample.

[0154] Optionally, the data processing module 403 is further configured to determine that there is no biotin interference in the chemiluminescence immunoassay of the test sample when the detection result signal deviation value is within the preset signal value deviation range.

[0155] Optionally, the data processing module 403 is further configured to determine that there is biotin interference in the chemiluminescence immunoassay of the test sample when the detection result signal deviation value is not within the preset signal value deviation range.

[0156] In summary, in the embodiments of the present application, by determining the calibration curve for chemiluminescence immunoassay and the signal value deviation range for the biotin-free interference sample, chemiluminescence immunoassay is respectively performed on the first reagent combination and the second reagent combination containing the sample to be tested, the detection result signal deviation value of the sample to be tested is determined, and when the detection result signal deviation value is within the preset signal value deviation range, according to the calibration curve and the first optical signal value corresponding to the detection result signal deviation value, the first chemiluminescence immunoassay result is determined, and when the detection result signal deviation value is not within the preset signal value deviation range, according to the calibration curve and the second optical signal value corresponding to the detection result signal deviation value, the second chemiluminescence immunoassay result is determined. According to the present application, when the detection result signal deviation value is not within the preset signal value deviation range, it is determined that there is biotin interference in the chemiluminescence immunoassay of the sample to be tested, which improves the efficiency and accuracy of detecting biotin interference, and when biotin interference exists, the chemiluminescence immunoassay result is corrected, which improves the credibility, accuracy and applicability of the chemiluminescence immunoassay result, saves the time and cost of chemiluminescence immunoassay, eliminates the influence brought by biotin interference, and more accurately evaluates the actual sample concentration of the sample to be tested.

[0157] Figure 5 The block diagram of an electronic device 600 shown according to an exemplary embodiment. For example, the electronic device 600 may be a mobile phone, a computer, a digital broadcast terminal, a messaging device, a game console, a tablet device, a medical device, a fitness device, a personal digital assistant, etc.

[0158] Refer to Figure 5 , the sub-device 600 may include one or more of the following components: a processing component 602, a memory 604, a power supply component 606, a multimedia component 608, an audio component 610, an input / output (I / O) interface 612, a sensor component 614, and a communication component 616.

[0159] The processing component 602 generally controls the overall operation of the electronic device 600, such as operations associated with display, telephone call, data communication, camera operation, and recording operation. The processing component 602 may include one or more processors 620 to execute instructions to complete all or part of the steps of the above method. In addition, the processing component 602 may include one or more modules to facilitate the interaction between the processing component 602 and other components. For example, the processing component 602 may include a multimedia module to facilitate the interaction between the multimedia component 608 and the processing component 602.

[0160] The memory 604 is used to store various types of data to support the operation of the electronic device 600. Examples of such data include instructions for any application or method operating on the electronic device 600, contact data, phone book data, messages, pictures, multimedia, and the like. The memory 604 can be implemented by any type of volatile or non-volatile storage device or a combination thereof, such as static random access memory (SRAM), electrically erasable programmable read-only memory (EEPROM), erasable programmable read-only memory (EPROM), programmable read-only memory (PROM), read-only memory (ROM), magnetic memory, flash memory, magnetic disk, or optical disk.

[0161] The power supply component 606 provides power for various components of the electronic device 600. The power supply component 606 may include a power management system, one or more power supplies, and other components associated with generating, managing, and distributing power for the electronic device 600.

[0162] The multimedia component 608 includes a screen that provides an output interface between the electronic device 600 and the user. In some embodiments, the screen may include a liquid crystal display (LCD) and a touch panel (TP). If the screen includes a touch panel, the screen can be implemented as a touch screen to receive input signals from the user. The touch panel includes one or more touch sensors to sense touches, swipes, and gestures on the touch panel. The touch sensors can not only sense the boundaries of touch or swipe actions but also detect the duration and pressure associated with the touch or swipe operation. In some embodiments, the multimedia component 608 includes a front camera and / or a rear camera. When the electronic device 600 is in an operating mode, such as a shooting mode or a multimedia mode, the front camera and / or the rear camera can receive external multimedia data. Each of the front camera and the rear camera can be a fixed optical lens system or have focal length and optical zoom capabilities.

[0163] The audio component 610 is used to output and / or input audio signals. For example, the audio component 610 includes a microphone (MIC) that is used to receive external audio signals when the electronic device 600 is in an operating mode, such as a call mode, a recording mode, and a voice recognition mode. The received audio signals can be further stored in the memory 604 or transmitted via the communication component 616. In some embodiments, the audio component 610 further includes a speaker for outputting audio signals.

[0164] The I / O interface 612 provides an interface between the processing component 602 and a peripheral interface module, which can be a keyboard, a click wheel, buttons, etc. These buttons can include, but are not limited to: a home button, a volume button, a power-on button, and a lock button.

[0165] The sensor assembly 614 includes one or more sensors for providing status assessments of various aspects for the electronic device 600. For example, the sensor assembly 614 can detect the on / off state of the electronic device 600, the relative positioning of components, such as the display and keypad of the electronic device 600. The sensor assembly 614 can also detect a change in the position of the electronic device 600 or a component of the electronic device 600, the presence or absence of user contact with the electronic device 600, the orientation or acceleration / deceleration of the electronic device 600, and a change in the temperature of the electronic device 600. The sensor assembly 614 can include a proximity sensor configured to detect the presence of nearby objects without any physical contact. The sensor assembly 614 can also include a light sensor, such as a CMOS or CCD image sensor, for use in imaging applications. In some embodiments, the sensor assembly 614 can also include an acceleration sensor, a gyroscope sensor, a magnetic sensor, a pressure sensor, or a temperature sensor.

[0166] The communication component 616 is used to facilitate communication between the electronic device 600 and other devices in a wired or wireless manner. The electronic device 600 can access a wireless network based on communication standards, such as WiFi, a carrier network (such as 2G, 3G, 4G, or 5G), or a combination thereof. In an exemplary embodiment, the communication component 616 receives a broadcast signal or broadcast-related information from an external broadcast management system via a broadcast channel. In an exemplary embodiment, the communication component 616 further includes a near field communication (NFC) module to facilitate short-range communication. For example, the NFC module can be implemented based on radio frequency identification (RFID) technology, infrared data association (IrDA) technology, ultra-wideband (UWB) technology, Bluetooth (BT) technology, and other technologies.

[0167] In an exemplary embodiment, the electronic device 600 can be implemented by one or more application-specific integrated circuits (ASICs), digital signal processors (DSPs), digital signal processing devices (DSPDs), programmable logic devices (PLDs), field programmable gate arrays (FPGAs), controllers, microcontrollers, microprocessors, or other electronic components for implementing the chemiluminescence immunoassay result correction method provided in the embodiments of the present application.

[0168] In an exemplary embodiment, a non-transitory computer-readable storage medium including instructions is also provided, such as a memory 604 including instructions, and the above instructions can be executed by the processor 620 of the electronic device 600 to complete the above method. For example, the non-transitory storage medium can be a ROM, a random access memory (RAM), a CD-ROM, a magnetic tape, a floppy disk, and an optical data storage device, etc.

[0169] Figure 6Block diagram of an electronic device 700 shown according to an exemplary embodiment. For example, the electronic device 700 may be provided as a server. Referring to Figure 5 , the electronic device 700 includes a processing component 722, which further includes one or more processors, and memory resources represented by a memory 732 for storing instructions executable by the processing component 722, such as application programs. The application programs stored in the memory 732 may include one or more modules each corresponding to a set of instructions. In addition, the processing component 722 is configured to execute instructions to perform a method for correcting chemiluminescence immunoassay results provided in an embodiment of the present application.

[0170] The electronic device 700 may also include a power supply component 726 configured to perform power management of the electronic device 700, a wired or wireless network interface 750 configured to connect the electronic device 700 to a network, and an input / output (I / O) interface 758. The electronic device 700 may operate based on an operating system stored in the memory 732, such as Windows ServerTM, Mac OS XTM, UnixTM, LinuxTM, FreeBSD TM or the like.

[0171] Those skilled in the art will readily conceive of other embodiments of the present application after considering the specification and practicing the application disclosed herein. The present application is intended to cover any variations, uses, or adaptations of the present application that follow the general principles of the present application and include known common knowledge or conventional technical means in the technical field not disclosed in the present disclosure. The specification and embodiments are to be considered exemplary only, and the true scope and spirit of the present application are pointed out by the following claims.

[0172] It should be understood that the present application is not limited to the exact structures described above and shown in the drawings, and various modifications and changes can be made without departing from its scope. The scope of the present application is only limited by the appended claims.

Claims

1. A method for correcting the results of chemiluminescence immunoassay, characterized in that, the method comprises: Performing chemiluminescence immunoassay on a group of samples without biotin interference by using a first reagent combination and a second reagent combination respectively, and determining a calibration curve and a preset signal value deviation range according to the detection results; Synchronously detecting the sample to be tested by using the first reagent combination and the second reagent combination, and obtaining a detection result signal deviation value; When the detection result signal deviation value is within the preset signal value deviation range, calculating the sample concentration according to the calibration curve and the first optical signal value; the first optical signal value is obtained by performing chemiluminescence immunoassay with the first reagent combination; When the detection result signal deviation value is not within the preset signal value deviation range, calculating the sample concentration according to the calibration curve and the second optical signal value; the second optical signal value is obtained by performing chemiluminescence immunoassay with the second reagent combination.

2. The method according to claim 1, characterized in that, the detection result signal deviation value is the ratio of the difference between the second optical signal value and the first optical signal value to the first optical signal value.

3. The method according to claim 1, characterized in that, when the detection result signal deviation value is not within the preset signal value deviation range, calculating the sample concentration according to the calibration curve and the second optical signal value, includes: In the case where the chemiluminescence immunoassay method is the sandwich method or the indirect method, obtaining the predicted sample concentration according to the calibration curve and the second optical signal value; Converting the predicted sample concentration through a first preset formula to obtain the actual sample concentration of the sample to be tested.

4. The method according to claim 1, characterized in that, when the detection result signal deviation value is not within the preset signal value deviation range, calculating the sample concentration according to the calibration curve and the second optical signal value, further includes: In the case where the chemiluminescence immunoassay method is the competitive method, converting the second optical signal value through a second preset formula to obtain the actual optical signal value of the sample; Obtaining the actual sample concentration of the sample to be tested according to the calibration curve and the actual optical signal value of the sample.

5. A system for correcting the results of chemiluminescence immunoassay, characterized in that, the system comprises: A storage module, storing a calibration curve and a preset signal value deviation range; A light excitation module, configured to perform light excitation when synchronously detecting the sample to be tested by using the first reagent combination and the second reagent combination, and obtain a first optical signal value and a second optical signal value; A data processing module, configured to obtain a detection result signal deviation value and determine whether the detection result signal deviation value is within the preset signal value deviation range; If the judgment result is yes, calculating the sample concentration according to the calibration curve and the first optical signal value; If the judgment result is no, calculating the sample concentration according to the calibration curve and the second optical signal value.

6. A method for determining biotin interference, characterized in that, the method comprises: Perform chemiluminescent immunoassay on a group of samples without biotin interference using the first reagent combination and the second reagent combination respectively, and determine the calibration curve and the preset signal value deviation range according to the detection results; Synchronously detect the sample to be tested using the first reagent combination and the second reagent combination, and obtain the signal deviation value of the detection result; When the signal deviation value of the detection result is within the preset signal value deviation range, it is determined that there is no biotin interference in the chemiluminescent immunoassay of the sample to be tested; When the signal deviation value of the detection result is outside the preset signal value deviation range, it is determined that there is biotin interference in the chemiluminescent immunoassay of the sample to be tested.

7. A kit, characterized in that, the kit includes: The first reagent, including luminescent particles coated with the first antibody; The second reagent, including biotin-labeled second antibody; The third reagent, including biotin-labeled second antibody and free biotin; The photosensitive reagent, including photosensitive particles.

8. The kit according to claim 7, characterized in that, the biotin molar concentrations in the second reagent and the third reagent are the same, and the concentration of the biotin-labeled second antibody in the third reagent is 1 / 2 of the concentration of the biotin-labeled second antibody in the second reagent.

9. The kit according to claim 8, characterized in that, it includes the first reagent combination and the second reagent combination according to claim 1 or claim 6, the first reagent combination includes the first reagent and the second reagent, and the second reagent combination includes the first reagent and the third reagent.

10. A method for using the kit according to claim 9, characterized in that, the method for using includes: Mix equal volumes of the sample to be tested with the first reagent combination or the second reagent combination respectively to form two groups of mixtures, and incubate the two groups of mixtures at a preset temperature and a first preset time; Add equal volumes of the photosensitive reagent to the two groups of incubated mixtures respectively, and after incubating for a second preset time, obtain the first light signal value and the second light signal value.

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