Sample detection system

Abstract

The invention discloses a sample detection system. The system comprises a detection card, a data acquisition module and a data processing module, the detection card at least comprises a first detection channel and a second detection channel, and a sample adding area, a reagent area and a detection area are respectively arranged in the first detection channel and the second detection channel; a first reagent is placed in the reagent area in the first detection channel, and a second reagent is placed in the reagent area in the second detection channel; wherein the first reagent has high sensitivity and HOOK effect, and the second reagent has high detection limit; the data acquisition module is used for acquiring a first detection value corresponding to a first reagent and a second detection value corresponding to a second reagent; and the data processing module is used for determining a detection result according to the first detection value and the second detection value. According to the scheme, the sensitivity of sample detection can be improved, and the detection range can be widened.

Description

Technical Field

[0001] The present invention relates to the technical field of sample detection, and in particular to a sample detection system. Background Art

[0002] In Vitro Diagnosis (IVD) is a very important part of the medical field and plays an irreplaceable role. The IVD market mainly includes immunodiagnosis, molecular diagnosis, point-of-care testing (POCT), case diagnosis and other fields. Among them, immunodiagnosis is the largest market segment of IVD. It is based on immunology and uses the specific reaction of antigen and antibody to perform qualitative or quantitative diagnosis. In immunodiagnosis, according to different principles, it is divided into flow fluorescence technology, chemiluminescence, enzyme-linked immunosorbent, colloidal gold, and other technical methods, each with its own advantages and disadvantages. Flow fluorescence technology has enabled the clinical immunology field to shift towards automated multi-testing and high-throughput detection.

[0003] In the prior art, for some items with a large detection range, it is difficult to take into account both the sensitivity at low values ​​and the detection range at high values. Usually, products on the market will choose to focus on one part of the detection range and abandon the other part. Take βHCG as an example: βHCG is also called human chorionic gonadotropin, which is usually used as an indicator for early pregnancy test, so there are high requirements for its low-value sensitivity. During the product development process, it was found that some tumor patients have extremely high abnormal βHCG in their bodies. Therefore, in order to detect these patients, the product is required to detect ultra-high concentrations of βHCG. For this reason, there are usually two types of products on the market according to the usage scenarios. One type has high sensitivity, but due to the HOOK effect (hook effect: within a certain concentration range, the concentration of the analyte is proportional to the detection signal value; however, when it exceeds a certain concentration limit, the signal value decreases with the increase of concentration) and cannot detect high values; the other type can detect high values ​​(that is, it has a high detection limit), but requires dilution operation to avoid the HOOK effect. At present, most antibody pairs on the market can only detect values ​​in the range of 5-5000IU / L without dilution. When the sample concentration exceeds 5000IU / L, a HOOK will occur. In order to expand the detection range, a series of operations such as screening high-quality antibody pairs, optimizing platforms, optimizing labeling methods, and diluting samples are usually selected to improve product performance. However, these operations will cause problems such as high production costs for producers and difficulty in user operation. Summary of the invention

[0004] The present invention provides a sample detection system to improve the sensitivity of sample detection and increase the detection range.

[0005] To this end, the present invention provides the following technical solutions:

[0006] A sample detection system, the system comprising: a detection card, a data acquisition module, and a data processing module; the detection card comprises at least a first detection channel and a second detection channel, the first detection channel and the second detection channel are respectively provided with a sample addition area, a reagent area, and a detection area; a first reagent is placed in the reagent area in the first detection channel, and a second reagent is placed in the reagent area in the second detection channel; wherein the first reagent has high sensitivity and HOOK effect, and the second reagent has a high detection limit;

[0007] The data acquisition module is used to acquire a first detection value corresponding to the first reagent and a second detection value corresponding to the second reagent;

[0008] The data processing module is used to determine a detection result according to the first detection value and the second detection value.

[0009] Optionally, the first reagent includes a first labeled antibody and a first capture antibody, and the second reagent includes a second labeled antibody and a second capture antibody.

[0010] Optionally, the first labeled antibody and the second labeled antibody are antibodies based on the same raw material and carry different labels.

[0011] Optionally, the fluorescent substance labeled with the first labeled antibody is a fluorescent microsphere, and the fluorescent substance labeled with the second labeled antibody is a fluorescent dye.

[0012] Optionally, the first labeled antibody and the second labeled antibody are antibodies based on different raw materials and carry the same label.

[0013] Optionally, the first detection channel and the second detection channel are non-parallel structures.

[0014] Optionally, the detection channel of the reagent zone is a serpentine channel.

[0015] Optionally, the detection area is located in the middle position of the detection card to be detected.

[0016] Optionally, the sample addition area is provided with a buffer zone for adjusting the flow rate, and is installed with a filter membrane for filtering interfering substances in the sample.

[0017] Optionally, the detection card further includes a first waste liquid bin connected to the reaction zone of the first detection channel, and a second waste liquid bin connected to the reaction zone of the second detection channel.

[0018] Optionally, the data processing module is specifically used to output the first detection value as the detection result when the second detection value is less than a set threshold; and output the second detection value as the detection result when the second detection value is greater than or equal to the set threshold.

[0019] Optionally, the set threshold is between the second reagent detection lower limit value and the first reagent detection upper limit value.

[0020] The sample detection system provided by the present invention utilizes a detection card including at least two detection channels, wherein the two detection channels are respectively provided with a sample addition area, a reagent area and a detection area which are connected in sequence, and a first reagent is placed in the reagent area of ​​the first detection channel, and a second reagent is placed in the reagent area of ​​the second detection channel, and the two reagents have different characteristics, wherein the first reagent has high sensitivity and HOOK effect, and the second reagent has a high detection limit. After the sample to be tested is injected into the detection card, the sample flows through the first detection channel and the second detection channel at the same time, and forms a complex with the reagent in the reagent area in the reaction area. By scanning the detection area, a first detection value corresponding to the first reagent and a second detection value corresponding to the second reagent are obtained, so that the final output detection result can be made more accurate and reliable according to the first detection value and the second detection value, and the reagent characteristics corresponding to the two detection values ​​are comprehensively considered.

[0021] Furthermore, each reagent includes a labeled antibody and a capture antibody. The labeled antibodies in different reagents can be antibodies based on the same raw material with different labels, or antibodies based on different raw materials with the same label, thereby meeting a variety of different application requirements.

[0022] Furthermore, flow fluorescence technology can be used to label antibodies with fluorescent microspheres and fluorescent dyes, respectively, to generate two different labeled antibodies, and then by capturing the composite structure formed by the labeled antibody and the antibody in the sample, the scanning results of the composite structure formed in the two detection channels are obtained, i.e., the detection results. Then, the high sensitivity characteristics of the fluorescent microspheres and the high detection limit characteristics of the fluorescent dye are combined to determine the optimal detection curve, thereby obtaining more accurate detection results and ensuring a wider detection range. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments are briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention, and for ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0024] Figure 1 It is a structural schematic diagram of a sample detection system provided by the present invention;

[0025] Figure 2 It is a structural schematic diagram of a detection card in the sample detection system provided by the present invention. DETAILED DESCRIPTION

[0026] The specific implementation of the present invention is described in detail below in conjunction with the accompanying drawings. It should be understood that the specific implementation described here is only used to illustrate and explain the present invention, and is not used to limit the present invention.

[0027] In order to enable those skilled in the art to better understand the scheme of the present invention, the technical scheme in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work should fall within the scope of protection of the present invention.

[0028] In view of the large detection range of some projects, the existing technology needs to produce different products according to different usage scenarios to meet the corresponding needs, and it is impossible to achieve a product that takes into account both detection sensitivity and detection range. The present invention provides a sample detection system, which uses a detection card with at least two detection channels. The two detection channels are respectively provided with a sample addition area, a reagent area, and a detection area that are connected in sequence. Reagents with different characteristics are respectively placed in the reagent areas in the two detection channels, so that after the sample is injected into the detection card, it flows through the first detection channel and the second detection channel at the same time, and the detection values ​​corresponding to the two different reagents are obtained. The characteristics of each reagent and the size of the corresponding detection value are comprehensively considered to determine the best detection curve, thereby obtaining more accurate detection results and ensuring a wider detection range.

[0029] like Figure 1 The figure is a schematic diagram of the structure of the sample detection system provided by the present invention.

[0030] The sample detection system includes: a detection card 100 , a data acquisition module 200 , and a data processing module 300 .

[0031] The detection card 100 includes at least two detection channels, and reagents with different characteristics are respectively placed in the two detection channels.

[0032] Figure 2 A schematic structural diagram of a detection card in an embodiment of the present invention is shown.

[0033] Also refer to Figure 2 , Figure 2The detection card shown includes a transparent upper cover 20, a channel layer 10 and a bottom shell 30 stacked in sequence. The channel layer 10 has two detection channels, namely a first detection channel 11 and a second detection channel 12. Among them:

[0034] The first detection channel 11 is provided with a first sample adding area and a first reagent area 111 that are connected to each other, and a first detection area 41; the first reagent area 111 is placed with a first reagent;

[0035] The second detection channel 12 is provided with a second sample adding area and a second reagent area 112 that are connected to each other, and a second detection area 42 ; the second reagent area 112 is filled with a second reagent, and the first reagent and the second reagent have different characteristics.

[0036] The detection card in the embodiment of the present invention forms a first detection channel 11 and a second detection channel 12 of a cavity structure through the upper cover 20, the lower cover 30, and the channel layer 10. The two detection channels are divided by a partition 141 to ensure that the two detection channels are independent of each other.

[0037] When testing a sample, the sample injected into the sample adding area will flow into the first detection channel 11 and the second detection channel 12, and then form a complex with the reagents in the detection channels. By scanning the detection areas of the two detection channels, a first detection value corresponding to the first reagent and a second detection value corresponding to the second reagent are obtained. Figure 2 As shown, the first detection area 41 of the first detection channel 11 and the second detection area 42 of the second detection channel 12 are both located in the middle of the detection card.

[0038] It should be noted that Figure 2 The positions of the first detection area 41 and the second detection area 42 are only exemplary, and they can be within the detectable area of ​​the detection card. For example, they can be set within the identifiable area of ​​the existing signal acquisition device, so that the first detection value and the second detection value can be obtained by using the existing signal acquisition device without adding another set of signal acquisition devices, which effectively avoids the increase in the volume of the signal acquisition device or the increase in manufacturing costs.

[0039] In addition, in order to adapt to the existing signal acquisition equipment, the first detection channel 11 and the second detection channel 12 can be designed as a non-parallel structure, for example, the detection channel of the reagent area is designed as a serpentine channel. Accordingly, the first detection area 41 and the second detection area 42 can be on a straight line, which is convenient for scanning the two detection areas using the same signal acquisition equipment to obtain the detection values ​​corresponding to each detection channel.

[0040] In a non-limiting embodiment, the first detection channel 11 and the second detection channel 12 can be connected to the same sample addition area 101. Figure 2Correspondingly, a sample loading port 201 corresponding to the position of the sample loading area 101 is provided on the upper cover 20, and a recessed portion 301 for accommodating the sample liquid from the sample loading port 201 is provided on the bottom shell 30. When the sample is injected from the sample loading port 201 of the upper cover 20, the injected sample flows into the sample loading area 101, and then is divided into the first detection channel 11 and the second detection channel 12.

[0041] In another non-limiting embodiment, the first detection channel 11 and the second detection channel 12 can be connected to their respective sample addition areas, that is, two sample addition areas need to be set. When injecting samples, the corresponding samples are injected into the channels connected to the detection channels. This structure can increase the versatility of the detection card and can also be applied when different samples need to be injected into different detection channels.

[0042] Of course, in the embodiment of the present invention, the same sample needs to be injected into the first detection channel 11 and the second detection channel 12, so any of the above structures can be applied. In addition, the detection card can also be provided with a waste liquid tank connected to the detection channel, such as Figure 2 As shown, in a non-limiting embodiment, it includes a first waste liquid tank 131 connected to the first detection channel 11 and a second waste liquid tank 132 connected to the second detection channel 12 .

[0043] In an embodiment of the present invention, a first reagent is placed in the first reagent area 111 in the first detection channel 11, and a second reagent is placed in the second reagent area 112 in the second detection channel 12; wherein the first reagent has high sensitivity and HOOK effect, and the second reagent has a high detection limit, so that reagents with different characteristics can be used to detect the same sample at the same time.

[0044] The channel layer 10 can be made, for example, by a molding process, or by a double-sided adhesive layer designed with the above-mentioned detection channel and having a certain thickness (for example, a thickness of 0.05 mm to 0.25 mm) and biosafety, the double-sided adhesive layer sticks the upper cover 20 and the lower cover 30 together, and forms a detection channel structure. Of course, other processes can also be used according to different materials, and this embodiment of the present invention is not limited to this.

[0045] The upper cover 20 and the lower cover 30 may be made of the same or different materials. For example, in a non-limiting embodiment, the lower cover 30 may be made of a transparent material or a non-transparent material. For example, a plastic material with a certain hydrophilicity may be preferred to facilitate the flow of the sample in the detection channel.

[0046] by Figure 2 Taking the detection card structure shown as an example, when performing detection, the sample to be detected is injected from the sample loading port 201 of the upper cover 20 into the sample loading area 101 on the channel layer 10 , and then divided into the first detection channel 11 and the second detection channel 12 .

[0047] The sample flows through the first detection channel 11 and the second detection channel 12 simultaneously, and forms a complex with the reagents in the detection channels.

[0048] In another non-limiting embodiment, the sample adding area 101 may also be provided with a buffer zone for adjusting the flow rate, and a filter membrane for filtering interfering substances in the sample may be installed to better ensure the quality of the sample flowing into the detection channel.

[0049] It should be noted that the test card in the sample detection system of the present invention is not limited to Figure 2 The structure shown can be used in the sample detection system of the present invention as long as it includes at least two detection channels, and the two detection channels are respectively provided with a sample addition area and a reagent area, and can achieve the same purpose and the same effect.

[0050] Continue to refer to Figure 1 and Figure 2 In the sample detection system of the present invention, the data acquisition module 20 is used to scan the complex formed in the first detection channel 11 and the second detection channel 12 to obtain a first detection value corresponding to the first reagent and a second detection value corresponding to the second reagent. Accordingly, the data processing module 300 is used to determine the detection result according to the first detection value and the second detection value. Since the first detection value and the second detection value are detection values ​​based on reagents with different characteristics, by comprehensively considering the reagent characteristics corresponding to the two detection values, the detection result finally outputted can be made more accurate and reliable.

[0051] In a non-limiting embodiment, the first reagent placed in the first detection channel 11 may include a first labeled antibody and a first capture antibody, and the second reagent placed in the second detection channel 12 may include a second labeled antibody and a second capture antibody.

[0052] Accordingly, when testing the sample, the sample is made to flow through the first detection channel 11 and the second detection channel 12 respectively, and form a complex with the reagents in the detection channels in the reaction area; the detection areas of the first detection channel 11 and the second detection channel 12 are scanned respectively by the data acquisition module 200 to obtain the first detection value and the second detection value.

[0053] Using different reagents in the above two detection channels to detect the sample simultaneously is equivalent to performing two different detection methods on the sample at the same time to obtain the corresponding first detection value and second detection value. Since the first reagent has high sensitivity and HOOK effect, and the second reagent can detect high values, the data processing module 300 can determine the final detection result according to the characteristics of each reagent and the size of the corresponding detection value, so that the final detection result is more accurate and reliable. Specifically, if the second detection value is less than the set threshold, the first detection value is used as the detection result; otherwise, the second detection value is used as the detection result. Among them, the set threshold is between the lower limit value of the second reagent detection and the upper limit value of the first reagent detection.

[0054] By utilizing the sample detection system provided by the present invention, the characteristics of each reagent and the corresponding detection value can be comprehensively considered to achieve accurate detection of samples and obtain accurate and reliable detection results, especially for projects that are prone to HOOK effect. There is no need to dilute the samples, etc., and the system has high detection sensitivity and a wide detection range.

[0055] The sample detection system provided by the present invention can be applied to a variety of detection items, such as βHCG detection, alpha-fetoprotein (AFP) detection in the serum of patients with primitive liver cancer, etc.

[0056] It should be noted that, in a specific implementation, the labeled antibodies in different reagents can be not only antibodies based on the same raw material and with different labels, but also antibodies based on different raw materials and with the same label, so as to meet a variety of different application requirements. In addition, the capture antibodies in different reagents can be the same or different, which is not limited in this embodiment of the present invention.

[0057] Flow fluorescence is an optical flow, an emerging technology that combines fluorescent coded microspheres and optical flow, but the object of its detection and analysis is no longer cells or particles. Its core technology is fluorescent coded microspheres, especially magnetic coded microspheres, which are the preferred solution for flow fluorescence automation. In clinical testing applications, it uses microspheres as carriers and detects free proteins, antigens, and antibodies in body fluids, similar to chemiluminescence. By combining multiple coded microspheres, flow fluorescence has shown unique advantages in detection flux. Different antibodies or antigens can be coated or adsorbed on different coded microspheres in the same reaction, free antigens or antibodies in liquid samples can be captured, and dozens or even hundreds of detection indicators can be analyzed in one test. The principle of flow fluorescence is almost the same as that of traditional chemiluminescence. Both are liquid phase reactions. Its sensitivity, accuracy, linear range, and repeatability can reach the level of chemiluminescence, while the flux is much higher than that of chemiluminescence. The more items are tested together, the more obvious its advantages are. A single flow fluorescence machine can achieve the flux of multiple chemiluminescence machines, and can also save a lot of laboratory space in clinical testing departments and reduce laboratory space costs.

[0058] Therefore, in the sample detection system of the embodiment of the present invention, the flow fluorescence technology can be used to detect the sample. For example, the first labeled antibody and the second labeled antibody can be obtained based on the same raw material and labeled with different fluorescent substances.

[0059] For example, the modified antigen (i.e. the antigen of the test item) is injected into the body of an animal such as a mouse / rabbit / goat to produce antibodies, and two antibodies with strong affinity are obtained through monoclonal antibody preparation. For the convenience of description, they are called the first antibody and the second antibody. The first antibody and the second antibody can bind to different sites of the test antigen to form a sandwich structure.

[0060] It should be noted that the first antibody and the second antibody are two different antibodies with different characteristics, which are mainly reflected in: (1) there are certain differences in the binding sites with the detection antigen; (2) the first antibody and the second antibody can be produced from the same species or different species, and the cultured cell lines can be the same or different.

[0061] Then, the first antibody is labeled with different fluorescent substances to obtain a first labeled antibody and a second labeled antibody, and the second antibody is used to generate a first capture antibody and a second capture antibody.

[0062] In a specific implementation, the fluorescent substance may include any one of the following: fluorescent microspheres, fluorescent dyes. For example, in a non-limiting embodiment, the fluorescent substance labeled with the first labeled antibody may be fluorescent microspheres, and the fluorescent substance labeled with the second labeled antibody may be fluorescent dyes.

[0063] In addition, the first capture antibody and the second capture antibody can be generated in the same or different ways, for example, the second antibody is coated onto latex microspheres to obtain the first capture antibody and the second capture antibody.

[0064] The first labeled antibody and the first capture antibody are placed in the first detection channel 11, and the second labeled antibody and the second capture antibody are placed in the second detection channel 12, for example, the antibodies are spotted and fixed in the corresponding channels.

[0065] It should be noted that the fixed positions of the labeled antibody and the capture antibody in the detection channel are not limited in the embodiment of the present invention, but it is necessary to ensure that after the sample is injected into the detection channel, it can flow through the labeled antibody first and then through the capture antibody.

[0066] Unless otherwise specified, the labeled antibodies mentioned above and subsequently refer to the first labeled antibody and the second labeled antibody.

[0067] When the sample flows through the detection channel, the antigen in the sample first combines with the labeled antibody to form a composite structure, and then combines with the capture antibody. The remaining liquid enters the waste liquid tank, and finally the liquid reaches a stable state and no longer flows.

[0068] It should be noted that when using the sample detection system of the present invention to perform sample detection, antigens (or antibodies) from different manufacturers can also be labeled with the same fluorescent substance, such as using microspheres. If one of the raw materials has high sensitivity but cannot measure high values, and the other has low sensitivity but good high values, these two raw materials can be set in two detection channels respectively to obtain the first detection result and the second detection result based on different raw materials.

[0069] After the liquid in the detection channel reaches a stable state, the first detection channel 11 and the second detection channel 12 are scanned respectively by the data acquisition module 200 to obtain the first detection value and the second detection value.

[0070] It should be noted that the data acquisition module 200 may be an optical instrument.

[0071] Accordingly, the data processing module 300 determines the test result according to the first test value and the second test value. In the sample detection system of the present invention, when determining the test result, the data processing module 300 can comprehensively consider the characteristics of the two detection methods and combine the magnitudes of the first test value and the second test value to output an accurate and reliable test result.

[0072] The following takes the case where different fluorescent substances label the same antigen as an example to describe in detail the process of determining the final detection result by the data processing module 300.

[0073] In a non - restrictive embodiment, the first detection value and the second detection value are values corresponding to the concentration value, that is, they have a certain corresponding relationship with the concentration value. Using this corresponding relationship, the concentration value corresponding to the detection value can be obtained.

[0074] For example, assume that the concentration corresponding to the first detection value is a, which is the first detection value obtained based on the first labeled antibody labeled with fluorescent microspheres and the first capture antibody coated with latex microspheres; the concentration corresponding to the second detection value is b, which is the second detection value obtained based on the second labeled antibody labeled with fluorescent dye and the second capture antibody coated with latex microspheres. Because the first detection method is prone to the HOOK effect at high values, the curve of sample concentration versus signal (i.e., detection value) first increases and then decreases, while the curve of sample concentration versus signal of the second detection method shows a monotonically increasing trend. Therefore, a concentration threshold m can be taken in the second detection method for comparison and used as the set threshold.

[0075] Correspondingly, the final detection result can be determined in the following way, that is:

[0076] When b < m, the first detection value is output as the detection result;

[0077] When b ≥ m, the second detection value is output as the detection result.

[0078] Of course, according to the calibrated test curve, the concentration threshold m can also be converted into a measurement value the same as the detection value, and the second detection value is directly compared with this measurement value (for the sake of easy description, it is called the set threshold) to determine the final detection result. The set threshold can be set between the lower limit of detection of the second reagent and the upper limit of detection of the first reagent.

[0079] Taking the βHCG detection as an example below, the detection results obtained by using the solution of the present invention are further illustrated through experimental data.

[0080] As shown in Table 1 below, it is the detection result using the above - mentioned first method (i.e., the method based on the first labeled antibody labeled with fluorescent microspheres, hereinafter referred to as Method A) under the condition of single - channel undiluted samples.

[0081] Table 1

[0082]

[0083]

[0084] As shown in Table 2 below, it is the detection result using the above - mentioned second method (i.e., the method based on the second labeled antibody labeled with fluorescent dye, hereinafter referred to as Method B) under the condition of single - channel undiluted samples.

[0085] Table 2

[0086]

[0087]

[0088] As shown in Table 3 below, it is the detection result of the above method A under the condition of single channel dilution of sample 20 times.

[0089] Table 3

[0090] Sample concentration (IU / L) Signal value (i.e. detection value) 3.73 62 4.42 130 9.62 253 12.67 326 10663.24 128685 56662.36 227319 111613.23 248165 116503.54 241929 150144.85 233956 167154.18 255532

[0091] From the data in Table 1 and Table 3 above, it can be seen that in the sample detection method based on fluorescent microsphere labeling, when the sample is not diluted, the HOOK effect is entered at a sample concentration of about 5381.36 IU / L; after the sample is diluted 20 times, the HOOK effect is entered at a sample concentration of about 11613.23 IU / L. This shows that the upper limit of detection can only be increased after the sample is diluted, and the HOOK effect will still exist at a higher value, the upper limit of detection is still limited, and the dilution operation is cumbersome, which adds a burden to the operator.

[0092] As shown in Table 4 below, it is the test results of the samples using the solution of the present invention.

[0093] Table 4

[0094]

[0095] According to the data in Table 4, it can be seen that method A has higher sensitivity and method B has a higher detection limit. Combining the two methods can obtain a larger detection range.

[0096] From the above test results, it can be seen that the detection upper limit of method A corresponds to a sample concentration of approximately 7521 IU / L, and the effective detection sensitivity of method B corresponds to a sample concentration of approximately 19.8 IU / L, so the above threshold m can be set to a value greater than 19.8 and less than 7521.51, such as 3000 IU / L.

[0097] When the signal value of method B is back-calculated into a concentration value, if it is less than m, the concentration value calculated by method A is taken as the output value; if it is greater than m, the concentration value calculated by method B is taken as the output value.

[0098] The sample detection system provided by the present invention not only has high sensitivity and a wide detection range, but also does not require sample dilution, which greatly reduces the costs of the production, filling, and transportation of the diluent, and also avoids the uncertainty brought to customers by the dilution operation, such as whether the sampler can accurately sample, whether the volatilization of the diluent over time will affect the detection accuracy, the different operating habits of different operators, and whether the mixed solution is uniform after dilution.

[0099] In addition, compared with a single detection channel, the dual-channel solution allows the channel to be designed to be narrower, and the amount of detection raw materials can be halved, so there will be no problem of increased raw material costs.

[0100] The two detection channels in the sample detection system provided by the present invention can share the existing optical path detection equipment without the need to develop new equipment.

[0101] Furthermore, the difference in working time caused by changing from single-channel spotting to dual-channel spotting can also be solved by existing multi-probe equipment. Only by adjusting the spotting program, two sets of needles can spot at the same time, and the increase in working time is negligible.

[0102] In the above embodiments, the description of each embodiment has its own emphasis. For parts that are not described in detail in a certain embodiment, reference can be made to the relevant descriptions of other embodiments.

[0103] In several embodiments provided by the present invention, it should be understood that each part of the disclosed system may also be implemented in other ways.

[0104] In the description of the present invention, it should be understood that the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of the present invention, the meaning of "plurality" is two or more, unless otherwise clearly and specifically defined.

[0105] The embodiments of the present invention are described in detail above. The present invention is described in detail using specific implementation methods herein. The description of the above embodiments is only used to help understand the method and system of the present invention. It is only a part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work should belong to the scope of protection of the present invention, and the content of this specification should not be understood as limiting the present invention. Therefore, any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A sample detection system, characterized in that: The system comprises: a detection card, a data acquisition module, and a data processing module; the detection card comprises at least a first detection channel and a second detection channel, wherein the first detection channel and the second detection channel are respectively provided with a sample addition area, a reagent area, and a detection area; a first reagent is placed in the reagent area in the first detection channel, and a second reagent is placed in the reagent area in the second detection channel; wherein the first reagent has high sensitivity and HOOK effect, and the second reagent has a high detection limit; The data acquisition module is used to acquire a first detection value corresponding to the first reagent and a second detection value corresponding to the second reagent; The data processing module is used to determine a detection result according to the first detection value and the second detection value.

2. The sample detection system according to claim 1, characterized in that: The first reagent includes a first labeled antibody and a first capture antibody, and the second reagent includes a second labeled antibody and a second capture antibody.

3. The sample detection system according to claim 2, characterized in that: The first labeled antibody and the second labeled antibody are antibodies based on the same raw material and carrying different labels.

4. The sample detection system according to claim 3, characterized in that: The fluorescent substance labeled with the first labeled antibody is a fluorescent microsphere, and the fluorescent substance labeled with the second labeled antibody is a fluorescent dye.

5. The sample detection system according to claim 2, characterized in that: The first labeled antibody and the second labeled antibody are antibodies based on different raw materials and carry the same label.

6. The sample detection system according to claim 1, characterized in that: The first detection channel and the second detection channel are non-parallel structures.

7. The sample detection system according to claim 6, characterized in that: The detection channel of the reagent zone is a serpentine channel.

8. The sample detection system according to claim 1, characterized in that: The detection area is located in the middle position of the detection card to be detected.

9. The sample detection system according to claim 1, characterized in that: The sample adding area is provided with a buffer zone for adjusting the flow rate, and is installed with a filter membrane for filtering interfering substances in the sample.

10. The sample detection system according to claim 1, characterized in that: The detection card also includes a first waste liquid bin connected to the reaction area of ​​the first detection channel, and a second waste liquid bin connected to the reaction area of ​​the second detection channel.

11. The sample detection system according to any one of claims 1 to 10, characterized in that: The data processing module is specifically used to output the first detection value as a detection result when the second detection value is less than a set threshold; and to output the second detection value as a detection result when the second detection value is greater than or equal to the set threshold.

12. The sample detection system according to claim 11, characterized in that: The set threshold is between the second reagent detection lower limit value and the first reagent detection upper limit value.

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