System for performing immunoassay
By setting a reflective element on the inner surface of the cuvette holder in the photometer, the problem of insufficient light collection in the photometer is solved, the optical detection efficiency is improved, the amount of samples and reagents used is reduced, and the cost is lowered.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- SIEMENS HEALTHCARE DIAGNOSTICS INC
- Filing Date
- 2024-09-18
- Publication Date
- 2026-04-17
AI Technical Summary
When performing immunoassays, existing photometers cannot effectively collect a sufficient amount of light using the photodetector, resulting in high consumption and cost of test samples and reagents.
A reflective element is placed on the inner surface of the cuvette holder of the photometer to guide light toward the optical detector and increase light collection efficiency.
This increases the amount of light received by the optical detector, reduces the amount of test samples and reagents used, and lowers the cost of immunoassay.
Smart Images
Figure CN121889657A_ABST
Abstract
Description
Technical Field
[0001] This embodiment relates to medical devices. More specifically, this embodiment relates to medical devices for performing immunoassays. Background Technology
[0002] Many medical conditions can be diagnosed through complex tests such as immunoassays. Immunoassays are biochemical tests that measure the presence or concentration of an analyte in bodily fluids using antibodies or antigens. One method of performing a biochemical test is by using an immunoassay analyzer. Typically, an immunoassay analyzer is a photometer that measures very low levels of light generated by a chemical reaction between a test sample and reagents and / or other reagents capable of displaying chemiluminescence (CL). Reagents include molecules that emit light upon binding to an analyte, such as acridine ester molecules. Each reagent binds to a specific analyte present in the test sample, such as a blood sample taken from a patient. The test sample and reagents are bound to a solid-phase medium in a reaction vessel, such as a cuvette or test tube. The solid-phase medium provides sites for the binding of the test sample and reagents. The light emitted by the chemical reaction between the test sample and reagents in the cuvette is received and measured by a photodetector such as a photomultiplier tube (PMT) to identify the amount of analyte present in the test sample.
[0003] To accurately determine the analytes present in a test sample, a sufficient amount of light must be collected. However, a photometer with a photometer (PMT) can only collect and measure a portion of the light directed towards itself from the cuvette. Therefore, the PMT does not receive enough light for accurate determination of the chemical components present in the test sample. To address the aforementioned challenge, conventional photometers utilize large quantities of test samples and reagents to generate a sufficient amount of light. In this way, the consumption and cost associated with each test sample and reagent remain high.
[0004] Therefore, there is a need for a system for performing immunoassays that addresses the shortcomings of conventional photometers mentioned above. Summary of the Invention
[0005] The scope of this invention is defined only by the appended claims and is not affected to any extent by the statements within this summary.
[0006] This embodiment can eliminate one or more of the defects or limitations in the prior art. For example, it provides a system for performing immunoassays.
[0007] As another example, this increases the optical efficiency of the photometer.
[0008] As yet another example, the optical efficiency of a photometer was increased with minimal changes to its existing shape or design.
[0009] As another example, reduce the volume of test samples and reagents required for immunoassays.
[0010] As another example, it reduces the cost of performing immunoassays.
[0011] Other aspects and advantages of the invention will become apparent from the following description taken in conjunction with the accompanying drawings, which illustrate the principles of the invention by way of example.
[0012] In one embodiment, a system for performing an immunoassay is described. The system includes a photometer ring having a plurality of cuvette holders. Each of the plurality of cuvette holders contains a cuvette containing a test sample and a light-generating reagent. The light-generating reagent reacts with the test sample and causes light emission through the cuvette. The system also includes an optical detector positioned in front of an opening in the photometer ring. The optical detector is configured to receive light emitted through the cuvette for determining one or more parameters of the test sample. The inner surface of each cuvette holder has a reflective element for guiding light toward the optical detector.
[0013] In one aspect, the reflective element is positioned on the bottom and side surfaces of each cuvette holder.
[0014] In one aspect, the reflective element is positioned on the bottom, back, left, and right surfaces of each cuvette holder.
[0015] In one aspect, the reflective element is a reflective strip, a mirror, a reflective coating, a shiny metallic surface, or a treated surface.
[0016] In one aspect, the optical detector may be a photomultiplier tube (PMT), a silicon photomultiplier tube (SiPM), an avalanche photodiode (APD), or a single-photon avalanche photodiode (SPAD).
[0017] In one respect, cuvettes can be made of transparent materials.
[0018] In one aspect, the transparent material can be glass or Teflon®. Attached Figure Description
[0019] The accompanying drawings form part of the description and are used to provide a further understanding of the invention. These drawings illustrate embodiments of the invention, which serve to describe the principles of the invention. Embodiments are shown in the drawings by way of example and not limitation, and similar reference numerals indicate similar elements. It should be noted that references to "a" or "one" embodiment do not necessarily refer to the same embodiment, and at least one embodiment is provided. In the drawings:
[0020] Figure 1A top view of a photometer for detecting light emitted from a test sample, according to an embodiment, is shown.
[0021] Figure 2 A front view of a photometer according to an embodiment is shown;
[0022] Figure 3(a) shows a comparative analysis of the amount of light received at the PMT when using different concentrations of the third-generation thyroid-stimulating hormone hypersensitivity assay kit with and without a reflective element, according to an embodiment.
[0023] Figure 3(b) shows a comparative analysis of the amount of light received at the PMT when using different concentrations of the troponin I hypersensitivity assay kit with and without a reflective element, according to an embodiment.
[0024] Figure 4(a) shows a graph of the light received at the PMT when using different volumes of the troponin I hypersensitivity assay kit with and without a reflective element, according to an embodiment; and
[0025] Figure 4(b) shows a graph of the light received at the PMT when using different volumes of the troponin I hypersensitivity assay kit with and without a reflective element, according to an embodiment. Detailed Implementation
[0026] The detailed description set forth below with reference to the accompanying drawings is intended as a description of various embodiments and is not intended to represent the only embodiments in which the invention can be practiced. Each embodiment described in this disclosure is provided only as an example or illustration of the invention and should not necessarily be construed as being more preferred or advantageous than other embodiments. The detailed description includes specific details for the purpose of providing a full understanding of the invention. However, it will be apparent to those skilled in the art that the invention can be practiced without these specific details.
[0027] This embodiment relates to a system for performing an immunoassay. The system may be a chemiluminescent immunoassay analyzer that utilizes a photometer to measure one or more parameters associated with a human test sample. The photometer may include a cuvette holder for accommodating cuvettes carrying a test sample conjugated with a reagent, such as a photogenerating reagent. The photometer may also include an optical detector for collecting light generated due to the chemiluminescent reaction between the test sample and the photogenerating reagent. To guide the light toward the PMT (phosphorescent immunoassay), the inner surface of the cuvette holder has reflective elements for guiding the light toward the optical detector. The reflective elements may be positioned on the bottom and side surfaces of each cuvette holder, excluding the side facing the optical detector. One or more parameters associated with the test sample can be measured based on the amount of light collected by the optical detector.
[0028] Figure 1 A top view of a photometer 100 for detecting light emitted from a test sample, according to an embodiment, is shown. The photometer 100 may include a photometer ring 102 comprising a plurality of cuvette holders. The photometer ring 102 may be a circular insulated track rotatable in a predefined direction. Each of the plurality of cuvette holders 104 may be made of a transparent material such as glass or plastic. Each cuvette holder 104 has a reflective element 114 on its inner surface. More specifically, the reflective element 114 may be present on the bottom surface and three inner surfaces of each cuvette holder 104. The reflective element 114 may be a reflective coating, a shiny metallic surface, or a treated surface. In one implementation, a plane mirror or a flat chrome strip may be mounted on the inner surface of each cuvette holder 104. In another implementation, the inner surface of each cuvette holder 104 may be coated with a reflective coating.
[0029] Each cuvette holder 104 can separately accommodate a cuvette 106. Although in Figure 1 A cubic cuvette is shown, but it should be understood that cuvette 106 can be any other shape, such as a cylinder. Therefore, the cuvette holder 104 can also be cubic, cylindrical, or any other shape. Cuvette 106 can be made of a material transparent to a wide range of wavelengths of light emitted during the chemiluminescent reaction. Cuvette 106 can be made of glass or Teflon®. Cuvette 106 can include a test sample. The test sample can be a blood sample, a urine sample, or bodily fluids extracted from the human body. The test sample can contain an analyte of interest in the form of an antigen or antibody. A luminescent reagent can be added to cuvette 106. The luminescent reagent can be a class of acridinium esters (AEs). Subsequently, other reagents containing antibodies and a solid-phase medium are added to cuvette 106 to form a solution. The solution can be treated, and acids and bases can then be added to the solution to generate light through a chemiluminescent reaction between the antibody present in the other reagents and the antigen present in the test sample.
[0030] Cuvette 106 can be placed inside cuvette holder 104 at inlet position 108 of photometer ring 102. In one implementation, a cuvette loader can be used to place cuvette 106 inside cuvette holder 104. Photometer ring 102 can advance multiple positions of cuvette holder 104. In one implementation, photometer ring 102 can rotate in a circular direction. Cuvette 106 can be removed from cuvette holder at outlet position 110 of photometer ring 102. In one implementation, cuvette remover can be used to remove cuvette 106 from cuvette holder. Cuvette 106 can move at the opening of photometer ring 102 when the luminescent reagent reacts with the test sample to emit light through cuvette 106.
[0031] Photometer 100 includes an optical detector 112 positioned (e.g., located) in front of an opening in photometer ring 102. The optical detector 112 may be a photomultiplier tube (PMT), a silicon photomultiplier tube (SiPM), an avalanche photodiode (APD), or a single-photon avalanche photodiode (SPAD). In one implementation, photometer 100 may include a PMT. A PMT is a highly sensitive optical detector that utilizes the photoelectric effect combined with secondary emission to convert light into an electrical signal. The PMT can measure light in the ultraviolet, visible, and near-infrared range of the electromagnetic spectrum. The PMT receives light emitted from cuvette 106 through an opening. A reflective element 114, present on the inner surface of cuvette holder 104, guides the light toward the PMT. For example, when cuvette holder 104 is cylindrical or spherical, the reflective element 114 may be positioned on the bottom and curved surfaces of each cuvette holder 104. Alternatively, when the cuvette holder 104 is cubic in shape, the reflective element 114 can be positioned on the bottom, rear, left, and right surfaces of each cuvette holder 104. However, it should be understood that the reflective element 114 is not positioned on the side of the cuvette holder 104 facing the optical detector 112 (e.g., in the direction in which light travels toward the PMT 112). Since most of the light is directed toward the optical detector 112 by using the reflective element 114, the amount of light received at the optical detector 112 (e.g., relative light units (RLU)) is increased. One or more parameters associated with the test sample are determined based on the amount of light received at the optical detector 112.
[0032] Figure 2 A front view of a photometer 100 according to an embodiment is shown. The photometer 100 includes an opening 202 for allowing light generated from a test sample to reach the PMT.
[0033] A photometer with and without a reflective element 114 are used to perform immunoassays on the test samples. Various luminescent reagents can be used to perform the immunoassays. In one implementation, different concentrations of luminescent reagents corresponding to a troponin I hypersensitive assay kit and luminescent reagents corresponding to a third-generation thyroid-stimulating hormone (TSH) hypersensitive assay kit are used to perform the immunoassays. The third-generation TSH hypersensitive assay kit may include a test sample, a luminescent reagent corresponding to the third-generation TSH hypersensitive assay, and other reagents. Similarly, the troponin I hypersensitive assay kit may include a test sample, a luminescent reagent corresponding to the troponin I hypersensitive assay, and other reagents. As shown in Figures 3(a), 3(b), 4(a), and 4(b), the counts of RLUs captured by the PMT of the photometer with and without the reflective element 114 are plotted. Specific details and explanations of the figures are provided subsequently.
[0034] Figure 3(a) shows a comparative analysis of the amount of light received at the PMT when using different concentrations of the third-generation thyroid-stimulating hormone (TSH) ultrasensitive assay kit with and without the reflective element 114. For the analysis, the third-generation thyroid-stimulating hormone (TSH) ultrasensitive assay kit was used with and without the reflective element 114, at concentrations of 0 µl U / ml and 0.148 µl U / ml. When the reflective element 114 was not used, a signal-to-noise ratio (SNR) of 12.89 ± 1.08 was observed. Furthermore, when the reflective element 114 was used, an SNR of 12.75 ± 0.73 was observed. Without changing the SNR value, an increase of at least 170% in the RLU count was observed due to the use of the reflective element 114.
[0035] Figure 3(b) shows a comparative analysis of the amount of light received at the PMT when using different concentrations of the troponin I hypersensitivity assay kit with and without the reflective element 114. For the analysis, troponin I hypersensitivity assay kits at concentrations of 0 ng / ml and 0.048 ng / ml were used with and without the reflective element 114. When using the 0 ng / ml troponin I hypersensitivity assay kit, a 204% increase in RLU count was observed, while when using the 0.048 ng / ml troponin I hypersensitivity assay kit, a 197% increase in RLU count was observed. An SNR of 5.32 ± 0.50 was observed without the reflective element 114. Furthermore, an SNR of 5.18 ± 0.47 was observed when the reflective element 114 was used. Without changing the SNR value, an increase of at least 190% in RLU count was observed due to the use of the reflective element 114.
[0036] Figure 4(a) shows a graph of the light received at the PMT when using different volumes of the third-generation thyroid-stimulating hormone (TSH) hypersensitivity assay kit with and without the reflective element 114. For the test, standard volumes of the third-generation thyroid-stimulating hormone (TSH) hypersensitivity assay kit with concentrations of 0 µl U / ml and 0.148 µl U / ml were used with and without the reflective element 114. Furthermore, the test was performed with a volume reduction of only 1 / 3 or 33% of the total reaction volume (e.g., all components except acids and bases) of the third-generation thyroid-stimulating hormone (TSH) hypersensitivity assay kit with the reflective element 114. It was observed that despite the 2 / 3 volume reduction, the RLU count received by the PMT with the reflective element 114 was equal to the RLU count received by the PMT without the reflective element 114. Therefore, the total reaction volume was reduced by 66%. When the reflective element 114 was not used, an SNR value of 10.55 ± 0.84 was observed. When using reflective element 114, an SNR value of 10.83 ± 1.10 was observed. Furthermore, when using reflective element 114 with a reduced volume, an SNR value of 9.10 ± 1.11 was observed.
[0037] Figure 4(b) shows a graph of the light received at the PMT when using different volumes of the troponin I hypersensitivity assay kit with and without the reflective element 114. For the test, standard volumes of the troponin I hypersensitivity assay kit with concentrations of 0 ng / ml and 0.48 ng / ml were used with and without the reflective element 114. Furthermore, the test was performed with a volume reduction of only 1 / 3 or 33% of the total reaction volume (e.g., all components except acids and bases) of the troponin I hypersensitivity assay kit with the reflective element 114. It was observed that despite the 2 / 3 volume reduction, the RLU count received by the PMT with the reflective element 114 was equal to the RLU count received by the PMT without the reflective element 114. Therefore, the total reaction volume was reduced by 66%. An SNR value of 3.46 ± 0.42 was observed when the reflective element 114 was not used. An SNR value of 4.00 ± 0.31 was observed when the reflective element 114 was used. Furthermore, when the reflective element 114 was used with a reduced volume, an SNR value of 3.62 ± 0.59 was observed.
[0038] The above-described embodiments provide numerous technical advancements as mentioned below. The system for performing immunoassays utilizes a reflective element present on the inner surface of the cuvette holder of the photometer. The reflective element guides light generated by the chemiluminescent reaction between the test sample and the photogenerating reagent toward the optical detector of the photometer. Therefore, the count of RLUs captured by the optical detector is increased with minimal alteration to the existing shape or design of the photometer. Furthermore, the volume of test sample and reagent required to perform the immunoassay according to the invention is significantly reduced. Therefore, a greater number of immunoassays can now be performed using the same volume of test sample and reagent currently used to perform immunoassays. Consequently, the overall cost of performing immunoassays is reduced. Although the above-described treatment is for performing immunoassays, it should be noted that the above-described treatment can be used to perform any assay.
[0039] In light of the description of this disclosure, all changes, modifications, and variations within the meaning and scope of equivalents are considered to be within the scope and spirit of this invention. It should be understood that aspects and embodiments of the above disclosure can be used in any combination with each other. Many aspects and embodiments can be combined together to form further embodiments of this disclosure.
Claims
1. A system (100) for performing an immunoassay, the system comprising: A photometer ring (102) having a plurality of cuvette holders, each of the plurality of cuvette holders (104) being configured to contain a cuvette (106) comprising a test sample and a light-generating reagent, wherein the light-generating reagent reacts with the test sample and causes light emission through the cuvette (106); and An optical detector (112) is positioned in front of an opening (202) in the photometer ring (102), wherein the optical detector (112) is configured to receive light emitted through the cuvette (106) for determining one or more parameters of the test sample, wherein the inner surface of each of the plurality of cuvette holders (104) has a reflective element (114) for guiding the light toward the optical detector (112).
2. The system (100) according to claim 1, wherein, The reflective element (114) is positioned on the bottom and side surfaces of each of the plurality of cuvette holders (104).
3. The system (100) according to claim 1, wherein, The reflective element (114) is positioned on the bottom, rear, left and right surfaces of each of the plurality of cuvette holders (104).
4. The system (100) according to claim 1, wherein, The reflective element (114) is a reflective strip, a mirror, a reflective coating, a shiny metal surface, or a treated surface.
5. The system (100) according to claim 1, wherein, The optical detector (112) is a photomultiplier tube (PMT), silicon photomultiplier tube (SiPM), avalanche photodiode (APD), or single-photon avalanche photodiode (SPAD).
6. The system (100) according to claim 1, wherein, The cuvette (106) is made of a transparent material.
7. The system (100) according to claim 6, wherein, The transparent material is glass or Teflon®.