A sample analysis device and method
By providing a combination of two light intensities and a multi-wavelength light source, the influence of interfering substances in the sample on optical detection is resolved, enabling accurate sample analysis at different levels of interfering substances. This method is applicable to sample analysis devices such as blood coagulation analyzers.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- SHENZHEN MINDRAY BIO MEDICAL ELECTRONICS CO LTD
- Filing Date
- 2020-04-13
- Publication Date
- 2026-05-19
AI Technical Summary
When there are interfering substances in the sample, the optical sample analysis device may produce inaccurate or undetectable results. In particular, the strong absorption of light by interfering substances such as hemoglobin, bilirubin, and chyle affects the accuracy of the measurement.
The system employs an illumination component to provide two light intensities: low-intensity light for situations with no or few interfering objects, and high-intensity light for situations with many interfering objects. It also combines a multi-wavelength light source and an interfering object detection component to select appropriate optical detection information for analysis.
It improves the accuracy and reliability of sample detection, and can provide accurate detection results at different levels of interference. It is applicable to a variety of detection items such as coagulation method, immunoturbidimetric method and chromogenic substrate method.
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Figure CN115280155B_ABST
Abstract
Description
Technical Field
[0001] This invention relates to a sample analysis apparatus and method. Background Technology
[0002] Sample analysis devices are used to analyze the biochemical characteristics of samples. They are widely used in clinical medicine to help medical personnel diagnose patients' conditions. Taking a blood coagulation analyzer as an example, it can measure blood clotting time and the concentration or activity of related substances. Blood coagulation analyzers can use optical methods to detect coagulation parameters. Specifically, the analyzer irradiates the solution in the reaction vessel during the reaction process with light and analyzes the scattered or transmitted light to obtain optical information such as the absorbance of the solution, thereby obtaining information such as clotting time or the concentration of the analyte.
[0003] Optical methods detect coagulation parameters by detecting the optical information of light scattering, reflection, or transmission through the reaction solution. Therefore, when there are interfering substances in the sample that change the properties of light scattering, reflection, or transmission through the reaction solution, it will affect the measurement, making the test results inaccurate. In severe cases, no test results may be obtained at all. Invention Overview
[0005] Technical issues
[0006] This invention mainly provides a sample analysis device and method, which are described in detail below.
[0007] Solution to the problem
[0008] Technical solutions
[0009] According to a first aspect, one embodiment provides a sample analysis apparatus, comprising:
[0010] An illumination component is used to illuminate a first container located at a sample measurement position and containing a test sample, the test sample being prepared from a sample to be tested and a detection reagent; wherein the illumination component is capable of providing light of a first intensity and light of a second intensity to the sample measurement position, the first intensity being less than the second intensity;
[0011] An optical detection component includes a first detector adjacent to the sample measurement position, used to receive the output light signal after the illumination component illuminates the first container, so as to obtain optical detection information of the measured sample, wherein the optical detection information includes first optical detection information corresponding to light of a first intensity and second optical detection information corresponding to light of a second intensity;
[0012] An analysis component is used to select second optical detection information corresponding to a second intensity of light to analyze sample detection items when the interference in the sample under test exceeds a preset threshold, and to select first optical detection information corresponding to a first intensity of light to analyze sample detection items when the interference in the sample under test does not exceed the preset threshold.
[0013] In one embodiment, the illumination component provides light of a first intensity and light of a second intensity to the sample measurement position during each illumination cycle.
[0014] In one embodiment, the illumination component includes a multi-wavelength light source, which outputs different illumination lights in a preset order during each illumination cycle. The different illumination lights during each illumination cycle include light with a first wavelength and a first intensity and light with a first wavelength and a second intensity, or light with a first wavelength and a first intensity and light with a second wavelength and a second intensity.
[0015] In one embodiment, the light provided by the illumination component of the first intensity includes at least one of light of a first wavelength for determination by chromogenic substrate method, light of a second wavelength for determination by immunoturbidimetric method, and light of a third wavelength for determination by coagulation method; preferably, the range of the first wavelength is 340nm-420nm, the range of the second wavelength is 520nm-590nm, and the range of the third wavelength is 660nm-800nm.
[0016] In one embodiment, the illumination component outputs light of a first wavelength and a first intensity, light of a second wavelength and a first intensity, light of a third wavelength and a first intensity, light of a fourth wavelength and a first intensity, and light of a fourth wavelength and a second intensity in a preset order during each illumination cycle, wherein the first wavelength < the second wavelength < the third wavelength ≤ the fourth wavelength.
[0017] In one embodiment, the sample analysis device further includes an interference detection component, which includes at least one interference detection position and a second detector adjacent to the interference detection position; the illumination component is used to illuminate a second container located at the interference detection position and containing at least one sample, and the second detector is used to receive the output light signal of the second container after it is illuminated by the illumination component, so as to obtain interference detection information of the sample to be tested; the interference detection information is used to indicate whether the interference of the sample to be tested exceeds a preset threshold.
[0018] In one embodiment, the illumination component illuminates a first container containing a test sample at the sample measurement position with light of a first intensity. The first detector is used to receive the output light signal of the first container after it is illuminated by the illumination component, so as to obtain interference detection information of the test sample. The interference detection information is used to determine whether the interference of the test sample exceeds a preset threshold.
[0019] In one embodiment, the sample analysis device further includes a dispensing mechanism and a controller. The controller is used to control the dispensing mechanism to dispense a portion of the sample to be tested and the diluent into the second container or to control the dispensing mechanism to dispense the sample to be tested and the test reagent into the first container.
[0020] In one embodiment, the sample to be tested is blood, and the interfering agent includes at least one of hemoglobin, bilirubin, and chyle.
[0021] In one embodiment, there are multiple sample measurement positions; the illumination component includes a light source and a multi-fiber optic bundle, the multi-fiber optic bundle including multiple optical fibers corresponding to the sample measurement positions respectively, each optical fiber being used to provide light of the first intensity and light of the second intensity to the corresponding sample measurement position.
[0022] In one embodiment, the light source includes a first light source, a second light source, and a third light source, which respectively provide light of a first wavelength, a second wavelength, and a third wavelength, wherein the light of the first wavelength, the second wavelength, and the third wavelength are all of a first intensity.
[0023] In one embodiment, the illumination component further includes a fourth light source for providing light of a fourth wavelength and a first intensity and light of a fourth wavelength and a second intensity in a time-division manner within an illumination cycle.
[0024] In one embodiment, the illumination component further includes a driving circuit connected to the first light source, the second light source, the third light source, and the fourth light source, for providing a first driving current to drive the first light source, the second light source, and the third light source to generate light of the first intensity; and for providing the first driving current and the second driving current in a time-division manner to drive the fourth light source to generate light of the first intensity. According to a first aspect, one embodiment provides a sample analysis device, including:
[0025] An illumination component is used to illuminate a first container located at a sample measurement position and containing a test sample, the test sample being prepared from a sample to be tested and a detection reagent; wherein the illumination component is capable of providing light of a first intensity and light of a second intensity to the sample measurement position, the first intensity being less than the second intensity;
[0026] An optical detection component includes a first detector adjacent to the sample measurement position, used to receive the output light signal after the illumination component illuminates the first container, so as to obtain optical detection information of the measured sample, wherein the optical detection information includes first optical detection information corresponding to light of a first intensity and second optical detection information corresponding to light of a second intensity;
[0027] An analysis component is used to select second optical detection information corresponding to a second intensity of light to analyze sample detection items when the interference in the sample under test exceeds a preset threshold, and to select first optical detection information corresponding to a first intensity of light to analyze sample detection items when the interference in the sample under test does not exceed the preset threshold.
[0028] In one embodiment, the illumination component provides light of a first intensity and light of a second intensity to the sample measurement position during each illumination cycle.
[0029] In one embodiment, the illumination component includes a multi-wavelength light source, which outputs different illumination lights in a preset order during each illumination cycle. The different illumination lights during each illumination cycle include light with a first wavelength and a first intensity and light with a first wavelength and a second intensity, or light with a first wavelength and a first intensity and light with a second wavelength and a second intensity.
[0030] In one embodiment, the light provided by the illumination component of the first intensity includes at least one of light of a first wavelength for determination by chromogenic substrate method, light of a second wavelength for determination by immunoturbidimetric method, and light of a third wavelength for determination by coagulation method; preferably, the range of the first wavelength is 340nm-420nm, the range of the second wavelength is 520nm-590nm, and the range of the third wavelength is 660nm-800nm.
[0031] In one embodiment, the illumination component outputs light of a first wavelength and a first intensity, light of a second wavelength and a first intensity, light of a third wavelength and a first intensity, light of a fourth wavelength and a first intensity, and light of a fourth wavelength and a second intensity in a preset order during each illumination cycle, wherein the first wavelength < the second wavelength < the third wavelength ≤ the fourth wavelength.
[0032] In one embodiment, the sample analysis device further includes an interference detection component, which includes at least one interference detection position and a second detector adjacent to the interference detection position; the illumination component is used to illuminate a second container located at the interference detection position and containing at least one sample, and the second detector is used to receive the output light signal of the second container after it is illuminated by the illumination component, so as to obtain interference detection information of the sample to be tested; the interference detection information is used to indicate whether the interference of the sample to be tested exceeds a preset threshold.
[0033] In one embodiment, the illumination component illuminates a first container containing a test sample at the sample measurement position with light of a first intensity. The first detector is used to receive the output light signal of the first container after it is illuminated by the illumination component, so as to obtain interference detection information of the test sample. The interference detection information is used to determine whether the interference of the test sample exceeds a preset threshold.
[0034] In one embodiment, the sample analysis device further includes a dispensing mechanism and a controller. The controller is used to control the dispensing mechanism to dispense a portion of the sample to be tested and the diluent into the second container or to control the dispensing mechanism to dispense the sample to be tested and the test reagent into the first container.
[0035] In one embodiment, the sample to be tested is blood, and the interfering agent includes at least one of hemoglobin, bilirubin, and chyle.
[0036] In one embodiment, there are multiple sample measurement positions; the illumination component includes a light source and a multi-fiber optic bundle, the multi-fiber optic bundle including multiple optical fibers corresponding to the sample measurement positions respectively, each optical fiber being used to provide light of the first intensity and light of the second intensity to the corresponding sample measurement position.
[0037] In one embodiment, the light source includes a first light source, a second light source, and a third light source, which respectively provide light of a first wavelength, a second wavelength, and a third wavelength, wherein the light of the first wavelength, the second wavelength, and the third wavelength are all of a first intensity.
[0038] In one embodiment, the illumination component further includes a fourth light source for providing light of a fourth wavelength and a first intensity and light of a fourth wavelength and a second intensity in a time-division manner within an illumination cycle.
[0039] In one embodiment, the illumination component further includes a driving circuit connected to the first light source, the second light source, the third light source, and the fourth light source. The driving circuit is used to provide a first driving current to drive the first light source, the second light source, and the third light source to generate light of the first intensity; and is also used to provide the first driving current and the second driving current in a time-division manner to drive the fourth light source to generate light of the first intensity and the second intensity, wherein the second driving current is greater than the first driving current.
[0040] In one embodiment, the illumination component includes a multi-wavelength light source and a rotating filter. The rotating filter includes a filter and an attenuator. The illumination component is used to provide light of different wavelengths and intensities in a time-division manner as the rotating filter rotates.
[0041] In one embodiment, the illumination component includes multiple multi-wavelength light sources, each corresponding to one of the multiple sample measurement positions.
[0042] According to a second aspect, one embodiment provides a sample analysis apparatus, comprising:
[0043] An illumination component is used to illuminate a first container located at a sample measurement position and containing a test sample, the test sample being prepared from a sample to be tested and a detection reagent; wherein the illumination component is capable of providing light of a first intensity and light of a second intensity to the sample measurement position, the first intensity being less than the second intensity;
[0044] An optical detection component includes a first detector adjacent to the sample measurement position, used to receive the output light signal after the illumination component illuminates the first container, so as to obtain optical detection information of the measured sample, wherein the optical detection information includes first optical detection information corresponding to light of a first intensity and second optical detection information corresponding to light of a second intensity;
[0045] The analysis component is used to select, based on preset conditions, first optical detection information corresponding to light of a first intensity or second optical detection information corresponding to light of a second intensity, and to analyze the sample detection results.
[0046] In one embodiment, the preset condition is a condition related to the detection information of interference in the sample. The analysis component is used to select second optical detection information corresponding to the second intensity of light for analysis when the interference in the sample under test exceeds a preset threshold; and to select first optical detection information corresponding to the first intensity of light for analysis when the interference in the sample under test does not exceed the preset threshold.
[0047] In one embodiment, the sample interference detection information includes at least one of the absorbance or luminous flux of the sample to be tested.
[0048] In one embodiment, the illumination component includes a multi-wavelength light source, which sequentially outputs different illumination lights in a preset order during each illumination cycle. The different illumination lights during each illumination cycle include light with a first wavelength and a first intensity and light with a first wavelength and a second intensity provided in a time-division manner, or light with a first wavelength and a first intensity and light with a second wavelength and a second intensity provided in a time-division manner.
[0049] In one embodiment, the light provided by the illumination component of the first intensity includes at least one of light of a first wavelength for determination by chromogenic substrate method, light of a second wavelength for determination by immunoturbidimetric method, and light of a third wavelength for determination by coagulation method; preferably, the range of the first wavelength is 340nm-420nm, the range of the second wavelength is 520nm-590nm, and the range of the third wavelength is 660nm-800nm.
[0050] In one embodiment, the second intensity of light provided by the illumination component includes light of a fourth wavelength, the fourth wavelength being not less than any one of the first wavelength, the second wavelength, or the third wavelength.
[0051] According to a third aspect, one embodiment provides a method for sample analysis, comprising:
[0052] In one illumination cycle, a first container located at the sample measurement position and containing the measurement sample is irradiated with light of a first intensity and light of a second intensity; the measurement sample is prepared from the sample to be tested and the detection reagent.
[0053] Acquire optical detection information corresponding to light of first intensity and light of second intensity;
[0054] Obtain interference detection information for the sample to be tested;
[0055] If the interference in the sample to be tested exceeds the preset threshold, select the optical detection information corresponding to the second intensity of light;
[0056] If the interference in the sample to be tested does not exceed the preset threshold, select the optical detection information corresponding to the light of the first intensity; and
[0057] Based on the selected optical detection information, the sample detection results are analyzed.
[0058] In one embodiment, irradiating a first container located at the sample measurement position and containing the measurement sample with light of a first intensity and light of a second intensity includes:
[0059] Within one illumination cycle, the sample at the measurement site is irradiated with light of a first wavelength and a first intensity, and light of a first wavelength and a second intensity at different times; or within one illumination cycle, the sample at the measurement site is irradiated with light of a first wavelength and a first intensity, and light of a second wavelength and a second intensity at different times.
[0060] In one embodiment, irradiating a first container located at the sample measurement position and containing the measurement sample with light of a first intensity and light of a second intensity includes:
[0061] Within one illumination cycle, the sample at the measurement site is irradiated with light of the first wavelength and first intensity, light of the second wavelength and first intensity, light of the third wavelength and first intensity, light of the fourth wavelength and first intensity, and light of the fourth wavelength and second intensity at different times, wherein the first wavelength < the second wavelength < the third wavelength ≤ the fourth wavelength.
[0062] Preferably, the first wavelength ranges from 340nm to 420nm, the second wavelength ranges from 520nm to 590nm, and the third wavelength ranges from 660nm to 800nm.
[0063] In one embodiment, obtaining interference detection information of the sample to be tested includes dispensing a portion of the sample to be tested and a diluent into a second container.
[0064] In one embodiment, the sample analysis method further includes dispensing another portion of the sample to be tested and the detection reagent into the first container to prepare the test sample; and transporting the first container to the sample measurement site.
[0065] In one embodiment, obtaining interference detection information of the sample to be tested includes detecting interference in the sample to be tested before preparing the test sample.
[0066] In one embodiment, obtaining interference detection information of the sample to be tested includes using light of a first intensity to detect interference on the test sample at the test site.
[0067] In one embodiment, the sample analysis method further includes outputting sample detection results and interfering substance detection information after analyzing the sample detection results.
[0068] In one embodiment, the interference detection information includes at least one of the absorbance of the sample to light of a preset wavelength or the luminous flux of the sample.
[0069] In one embodiment, the sample to be tested is blood, and the interfering agent includes at least one of hemoglobin, bilirubin, and chyle.
[0070] According to a fourth aspect, one embodiment provides a computer-readable storage medium including a program that can be executed by a processor to implement the methods described in any of the embodiments herein.
[0071] Beneficial effects of the invention
[0072] Brief description of the accompanying drawings Attached Figure Description
[0073] Figure 1 This is a schematic diagram of the absorption spectra of light in various wavelength ranges for the three interfering substances: hemoglobin, bilirubin, and chyle.
[0074] Figure 2 This is a schematic diagram of the structure of a sample analysis device according to one embodiment;
[0075] Figure 3 This is a schematic diagram of the sample analysis device according to another embodiment;
[0076] Figure 4 This is a schematic diagram of the sample analysis device according to another embodiment;
[0077] Figure 5(a) is a schematic diagram of the light provided by the illumination component during the illumination cycle; Figure 5(b) is another schematic diagram of the light provided by the illumination component during the illumination cycle.
[0078] Figure 6(a) is a schematic diagram of the light provided by the illumination component during the illumination cycle; Figure 6(b) is another schematic diagram of the light provided by the illumination component during the illumination cycle.
[0079] Figure 7 This is a schematic diagram of the structure of a lighting component according to one embodiment;
[0080] Figure 8 This is a schematic diagram of the structure of a lighting component according to another embodiment;
[0081] Figure 9 This is a schematic diagram of the structure of a lighting component according to another embodiment;
[0082] Figure 10 A schematic diagram of the structure of a lighting component in one embodiment.
[0083] Figure 11 A schematic diagram of the structure of the illumination component in another embodiment.
[0084] Figure 12 This is a schematic diagram of the structure of a lighting component according to another embodiment;
[0085] Figure 13 This is a schematic diagram of the sample analysis device according to another embodiment;
[0086] Figure 14 This is a flowchart illustrating a sample analysis method according to one embodiment;
[0087] Figure 15 A flowchart illustrating a sample analysis method according to another embodiment;
[0088] Figure 16 This is a flowchart illustrating a sample analysis method according to yet another embodiment;
[0089] Figure 17 This is a flowchart illustrating a sample analysis method according to another embodiment.
[0090] Invention Embodiments
[0091] Embodiments of the present invention
[0092] The present invention will now be described in further detail with reference to specific embodiments and accompanying drawings. Similar elements in different embodiments are referred to by associated similar element reference numerals. In the following embodiments, many details are described to facilitate a better understanding of this application. However, those skilled in the art will readily recognize that some features may be omitted in different situations, or may be replaced by other elements, materials, or methods. In some cases, certain operations related to this application are not shown or described in the specification. This is to avoid obscuring the core parts of this application with excessive description. For those skilled in the art, detailed description of these related operations is not necessary; they can fully understand the related operations based on the description in the specification and general technical knowledge in the art.
[0093] Furthermore, the features, operations, or characteristics described in the specification can be combined in any suitable manner to form various embodiments. At the same time, the steps or actions in the method description can be rearranged or adjusted in a manner obvious to those skilled in the art. Therefore, the various orders in the specification and drawings are only for the clear description of a particular embodiment and do not imply a necessary order, unless otherwise stated that a particular order must be followed.
[0094] The serial numbers assigned to components in this document, such as "first" and "second," are used only to distinguish the described objects and have no sequential or technical meaning. The terms "connection" and "linkage" used in this application, unless otherwise specified, include both direct and indirect connections (linkages).
[0095] Optical methods for coagulation testing can generally be divided into three types: coagulation assays, immunoturbidimetric assays, and chromogenic substrate assays. Chromogenic substrate assays typically use violet or ultraviolet light (340nm-420nm) and are commonly used to measure parameters such as antithrombin-III (AT-III or AT3). Immunoturbidimetric assays typically use yellow-green light (520nm-590nm) and are commonly used to measure parameters such as D-dimer (DD) and fibrin / fibrinogen degradation products (FDP). Coagulation assays typically use red or infrared light (660nm-800nm) and are commonly used to measure parameters such as thrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), and fibrinogen (FIB).
[0096] Regardless of whether it's a coagulation method, immunoturbidimetric assay, or chromogenic substrate method, in optical coagulation determinations, the presence of interfering substances in the sample can interfere with the detection. For example, when plasma samples contain interfering substances such as hemoglobin, bilirubin, and chyle, these substances strongly absorb light, thus interfering with the sample detection. Hemoglobin, bilirubin, and chyle are generally referred to as HIL interference, where H stands for hemoglobin, I for bilirubin, and L for chyle. Please refer to [reference needed]. Figure 1 This diagram illustrates the absorption spectra of hemoglobin, bilirubin, and chyle—three interfering substances—to light in various wavelength ranges. As can be seen from the diagram, these three interfering substances exhibit strong absorption of light in the lower wavelength range, especially below 600 nm. This significantly reduces the transmittance of the mixture of sample and reagent, resulting in very little light that can actually be received, affecting the accuracy and reliability of optical measurements. Sometimes, the amount of light that can be received is almost zero, making it impossible to identify the reaction process between the sample and reagent.
[0097] One solution to address interfering substances is to provide light in a wavelength range that is not absorbed by the interfering substances in the sample for detection. For example, a larger wavelength, such as 800nm, can be used to illuminate the mixture of sample and detection reagent. As can be clearly seen from the figure, hemoglobin and bilirubin have almost no absorption of light with wavelengths greater than 800nm, while chyle also has relatively little absorption of light with wavelengths greater than 800nm. This approach has some drawbacks. For example, although chyle absorbs relatively little light with wavelengths greater than 800nm, this absorption is still significant for applications requiring high accuracy. Furthermore, when the concentration of chyle in the sample is high, even in applications with moderate accuracy requirements (such as physical examinations), this absorption still significantly impacts the accuracy of the results. Finally, providing larger wavelengths, such as 800nm, is unsuitable for tests using chromogenic substrate methods. This is because, in chromogenic substrate methods, the reagent displaces substances from the sample after the reaction. These displaced substances only absorb in the ultraviolet (UV) and violet (Ultraviolet) ranges. Therefore, only the aforementioned 340nm-420nm UV or Ultraviolet light can be used; other wavelengths are not permitted. In contrast, coagulation and immunoturbidimetric methods, besides using their respective wavelength ranges, theoretically can also utilize other wavelength ranges for detection.
[0098] The applicant has researched the above-mentioned problems and proposed an alternative solution: compensating for the low light flux caused by interfering substances by increasing light intensity, thereby resolving the impact of interfering substances in the sample on the project detection. Specifically, when there are no interfering substances in the sample or the content of interfering substances is low, normal light intensity is used for detection; when the content of interfering substances in the sample is high, higher light intensity is used for detection. The invention is described below.
[0099] Some embodiments of the present invention disclose a sample analysis device. A sample analysis device is an instrument used to analyze and measure samples. Taking a coagulation analyzer (i.e., a coagulation analyzer mentioned herein) as an example, the testing procedure of the sample analysis device will be illustrated. The testing procedure of a coagulation analyzer is generally as follows: A sample, such as blood or plasma, and a test reagent are added to a container, such as a reaction cup, to prepare a test sample (or mixture, reaction solution, etc.). After incubating the test sample, the reaction cup is placed in a preset position, such as the sample measurement position. The coagulation analyzer can irradiate the test sample in the reaction cup with light of, for example, multiple wavelengths, and analyze it using methods such as coagulation, immunoturbidimetry, or chromogenic substrate methods to obtain the coagulation reaction curve of the test sample over time, thereby further calculating the coagulation time or other coagulation-related performance parameters of the test sample.
[0100] In the sample analysis device, during the measurement of the test sample, the core components are: a component that provides illumination, a component that receives light transmitted, reflected, or scattered by the test sample, and a component that analyzes the information from the received light. Therefore, please refer to... Figure 2 In some embodiments, the sample analysis apparatus may include an illumination component 50, an optical detection component 60, and an analysis component 70. Please refer to... Figure 3 and Figure 4 In some embodiments, the sample analysis apparatus may also include one or more of the following: sample unit 10, reagent unit 20, dispensing mechanism 30, and controller 40.
[0101] Sample unit 10 is used to carry samples. In some examples, sample unit 10 may include a sample delivery module (SDM) and a front-end track; in other examples, sample unit 10 may also be a sample disk—for example... Figure 4 In such an example, the sample tray includes multiple sample positions where containers can be placed. By rotating its tray structure, the sample can be moved to the appropriate position, such as the position where the dispensing mechanism 30 can pick up the sample.
[0102] The reagent unit 20 is used to hold reagents. In one embodiment, the reagent unit 20 is arranged in a disk-shaped structure and has multiple positions for holding reagent containers. The reagent unit 20 is rotatable and drives the reagent containers it holds to rotate, so as to rotate the reagent containers to the reagent aspiration position for the dispensing mechanism 30 to aspirate the reagents. The number of reagent units 20 can be one or more.
[0103] Dispensing mechanism 30 is used to aspirate and dispense samples or reagents. In some embodiments, dispensing mechanism 30 may include sample dispensing mechanism 31 and reagent dispensing mechanism 33. Sample dispensing mechanism 31 is used to aspirate samples and dispense them into a container to be dispensed. In some embodiments, sample dispensing mechanism 31 may include a sample needle, which moves in two or three dimensions in space via a two-dimensional or three-dimensional driving mechanism, thereby moving the sample needle to aspirate the sample carried by sample unit 10 and to the position of the container to be dispensed, and dispensing the sample into the container. In some embodiments, reagent dispensing mechanism 33 may include a reagent needle, which moves in two or three dimensions in space via a two-dimensional or three-dimensional driving mechanism, thereby moving the reagent needle to aspirate the reagent carried by reagent unit 20 and to the position of the container to be dispensed, and dispensing the reagent into the container. In some embodiments, the sample dispensing mechanism 31 and the reagent dispensing mechanism 33 may share a set of drive mechanism and needle. When the sample dispensing mechanism 31 and the reagent dispensing mechanism 33 share a set of drive mechanism and needle, the needle needs to be cleaned when aspirating the sample and the reagent to avoid cross-contamination and other problems.
[0104] Figure 4 The reaction component 41 is used to hold the assay sample prepared from the sample and detection reagents. In one example, the reaction component 41 is arranged in a disk-shaped structure with multiple placement positions for placing a first container, such as a reaction cup. The reaction component 41 is rotatable and drives the reaction cup in the placement positions to rotate, for distributing the reaction cup and incubating the mixture in the reaction cup within the reaction disk. Sample detection positions can be on the reaction component 41, i.e., some placement positions on the reaction component 41 are sample detection positions; sample detection positions can also be set independently of the reaction component 41, i.e., set at a position, for example, close to the reaction component 41.
[0105] The illumination component 50 is used to provide light for measurement. In some embodiments, the illumination component 50 is capable of providing light of two intensities, such as a first intensity and a second intensity, wherein the first intensity is less than the second intensity. The first intensity can be the intensity of light typically used for measuring samples, and the second intensity is light stronger than the first intensity, which can be used in this invention to measure samples containing interfering substances. Specifically, the illumination component 50 is used to illuminate a first container (e.g., a reaction cup) located at the sample measurement site and containing the measurement sample—as described above, the measurement sample is prepared from the sample to be tested and the detection reagent; the illumination component 50 is capable of providing light of both the first and second intensities to the sample measurement site.
[0106] In some embodiments, the illumination component 50 provides light of a first intensity and light of a second intensity to the sample measurement position in each illumination cycle. For example, referring to FIG5(a), light of a first wavelength and a first intensity, and light of a first wavelength and a second intensity are output sequentially according to a preset conformation in each illumination cycle; or, referring to FIG5(b), light of a first wavelength and a first intensity, and light of a second wavelength and a second intensity are output sequentially according to a preset conformation in each illumination cycle.
[0107] To enable the sample measurement site to perform a wide range of detections, such as those using coagulation, immunoturbidimetry, and chromogenic substrates, the illumination component 50 may include a multi-wavelength light source, providing light of multiple wavelengths to the sample measurement site. For example, the first intensity of light provided by the illumination component 50 may include at least one of the following: light of a first wavelength used for chromogenic substrate assays, light of a second wavelength used for immunoturbidimetry, and light of a third wavelength used for coagulation assays; that is, one, two, or all three. In some embodiments, the first wavelength ranges from 340 nm to 420 nm, the second wavelength ranges from 520 nm to 590 nm, and the third wavelength ranges from 660 nm to 800 nm. Further, the second intensity of light provided by the illumination component 50 may include a fourth wavelength, which is not less than any one of the first, second, or third wavelengths; in one example, the first wavelength < the second wavelength < the third wavelength ≤ the fourth wavelength. In one specific example, the illumination component 50 can output light of a first wavelength and a first intensity, a second wavelength and a first intensity, a third wavelength and a first intensity, a fourth wavelength and a first intensity, and a fourth wavelength and a second intensity in a preset sequence within each illumination cycle. In another specific example, the illumination component 50 can output light of a first wavelength and a first intensity, a third wavelength and a first intensity, a second wavelength and a first intensity, a fourth wavelength and a first intensity, and a fourth wavelength and a second intensity in a preset sequence within each illumination cycle. Figures 6(a) and 6(b) illustrate these two examples.
[0108] To simplify the structure, please refer to Figure 7 In some embodiments, the illumination component 50 may include a light source 51 and a multi-fiber bundle 59, so that the light source 51 can provide light to multiple sample measurement positions. Specifically, the multi-fiber bundle 59 includes multiple optical fibers corresponding to multiple sample measurement positions, each optical fiber being used to provide light of a first intensity and light of a second intensity to the corresponding sample measurement position. For details, please refer to... Figure 8The light source 51 may include a first light source 52, a second light source 53, and a third light source 54. The first light source 52 provides light of a first wavelength, the second light source 53 provides light of a second wavelength, and the third light source 54 provides light of a third wavelength. The first, second, and third wavelengths of light all have a first intensity. In some embodiments, the light source 51 may also include a fourth light source 55, which provides light of a fourth wavelength and a first intensity and light of a fourth wavelength and a second intensity in a time-division multiplexing process within one illumination cycle; that is, the fourth light source 55 can provide light of a fourth wavelength with two intensities. Understandably, to improve the performance of the light, some optical components for focusing, such as focusing lenses, may be added between the light source 51 and the multi-fiber bundle 59; collimating lenses may also be added between the multi-fiber bundle 59 and each sample measurement position to improve the performance of the light directed toward the sample measurement position.
[0109] The light source 51 provides light of the aforementioned wavelength and intensity through many structures, which will be explained in detail below.
[0110] In some embodiments, please refer to Figure 9 The illumination component 50 also includes a driving circuit 56, which is connected to the first light source 52, the second light source 53, the third light source 54, and the fourth light source 55. The driving circuit 56 provides a first driving current to drive the first light source 52, the second light source 53, and the third light source 54 to generate light of a first intensity; and also provides the first driving current and the second driving current in a time-division manner to drive the fourth light source 55 to generate light of a first intensity and a second intensity, respectively, wherein the second driving current is greater than the first driving current. By providing different driving currents to the fourth light source 55, the fourth light source 55 generates light of different intensities. Taking Figure 6(a) above as an example, within one illumination cycle, the driving circuit 56 controls the first light source 52, the second light source 53, the third light source 54, and the fourth light source 55 to blink in a time-division manner, ensuring that each irradiation of the reaction cup is at a specified wavelength. During driving, within one illumination cycle, the LEDs of the first light source 52, the second light source 53, and the third light source 54 each blink once, and the fourth light source 55 blinks twice. These two illuminations of the fourth light source 55 use different driving currents, meaning that the light source blinks a total of five times within one cycle. The first four illuminations of the light source within one illumination cycle are used for normal testing of samples without interference, while the final illumination of the fourth light source 55 with a larger driving current is used for testing samples with interference. One illumination cycle in this paper can be 0.1s.
[0111] Similarly, in some embodiments, the driving circuit 56 can also provide different driving currents to the first light source 52, thereby causing the first light source 52 to produce light of different intensities; in some embodiments, the driving circuit 56 can also provide different driving currents to the second light source 53, thereby causing the second light source 53 to produce light of different intensities; in some embodiments, the driving circuit 56 can also provide different driving currents to the third light source 54, thereby causing the third light source 54 to produce light of different intensities.
[0112] In some embodiments, please refer to Figure 10 The light source 51 can also be implemented using a multi-wavelength light source 57 and a rotating filter 58. The multi-wavelength light source 57 provides light of multiple wavelengths, such as a first wavelength, a second wavelength, a third wavelength, and a fourth wavelength. In some examples, the multi-wavelength light source 57 can be implemented using a halogen lamp. The rotating filter 58 includes a filter and an attenuator. The illumination component 50 is used to provide light of different wavelengths and intensities in a time-division manner as the rotating filter 58 rotates, for example, providing light of a first wavelength and a first intensity, a second wavelength and a first intensity, a third wavelength and a first intensity, a fourth wavelength and a first intensity, and a fourth wavelength and a second intensity. Then, the light can be provided to multiple sample measurement positions through a multi-fiber bundle 59. Understandably, some optical components that improve the performance of the illumination light, such as lens groups, can be added between the multi-wavelength light source 57 and the rotating filter 58.
[0113] The above is an example of how the illumination component 50 provides light of different wavelengths and intensities to multiple samples through a multi-fiber bundle 59 for position division.
[0114] In some examples, the illumination component 50 can also equip each sample measurement position with a multi-wavelength light source, each multi-wavelength light source being able to provide light of different wavelengths and intensities to the corresponding sample measurement position.
[0115] Please refer to Figure 11In some examples, the illumination component 50 can also equip each sample measurement position with a single-wavelength light source, each single-wavelength light source capable of providing light of a single wavelength and different intensities to the corresponding sample measurement position. For example, some sample measurement positions are equipped with a first-wavelength light source, which can provide light of a first wavelength and a first intensity, and light of a first wavelength and a second intensity to the corresponding sample measurement position. Different intensities of light can be achieved through different driving currents or attenuators. Detection items supporting chromogenic substrate methods can be measured at these sample measurement positions. Similarly, some sample measurement positions are equipped with a second-wavelength light source, which can provide light of a second wavelength and a first intensity, and light of a second wavelength and a second intensity to the corresponding sample measurement position. Detection items supporting immunoturbidimetric methods can be measured at these sample measurement positions. Some sample measurement positions are equipped with a third-wavelength light source, which can provide light of a third wavelength and a first intensity, and light of a third wavelength and a second intensity to the corresponding sample measurement position. Detection items supporting coagulation methods can be measured at these sample measurement positions.
[0116] In some examples, the sample analysis apparatus also provides an interference detection position, which will be further mentioned below. The illumination component 50 can also provide illumination to the interference detection position, for example, through a multi-fiber bundle 59, so that the light illuminating the sample detection position and the interference detection position by the illumination component 50 is the same. Figure 12 Here's an example. In the diagram, a violet LED provides 405nm light, a green LED provides 575nm light, a red LED provides 660nm light, and an infrared LED provides 800nm light. These are combined through three dichroic mirrors and coupled together into the optical fiber of a multi-fiber bundle 59. The multi-fiber bundle 59 splits into multiple fiber ends. One of these fiber ends can be used to illuminate the second container (e.g., a cuvette or reaction vessel) at the interference detection site to detect interfering substances in the sample, such as their type and concentration. The remaining fiber ends are used to illuminate the first container (e.g., a reaction vessel) containing the sample. Of course, the LED light source in the diagram can be replaced with other types of light sources, such as an LD light source or a halogen lamp. In some examples, the illumination component 50 can also independently provide illumination to the sample detection site and the interference detection site.
[0117] The above is a description of the illumination component 50. The optical detection component 60 will be described below.
[0118] The optical detection component 60 cooperates with the illumination component 50. In some embodiments, the optical detection component 60 includes a first detector 61 adjacent to the sample measurement position. The first detector 61 is used to receive the output light signal after the illumination component 50 illuminates the first container to obtain optical detection information of the measurement sample. The optical detection information includes first optical detection information corresponding to light of a first intensity and second optical detection information corresponding to light of a second intensity. That is, after the illumination component 50 illuminates the first container located at the sample measurement position and containing the measurement sample with light of a first intensity, the first detector 61 obtains the first optical detection information corresponding to the first intensity of light by sensing the transmitted, reflected, or scattered light of the first container containing the measurement sample to the first intensity of light. Similarly, after the illumination component 50 illuminates the first container located at the sample measurement position and containing the measurement sample with light of a second intensity, the first detector 61 obtains the second optical detection information corresponding to the second intensity of light by sensing the transmitted, reflected, or scattered light of the first container containing the measurement sample to the second intensity of light. In some examples, the first detector 61 detects the transmitted light that passes through the measurement sample. In some examples, the first detector 61 can be implemented by a component capable of converting optical signals into electrical signals, such as a photodetector. Specifically, it can be a photodiode (PD), a photomultiplier tube (PMT), an avalanche photodiode (APD), a charge-coupled device (CCD), a complementary metal-oxide-semiconductor (CMOS), an image enhancement detector (ICCD), or an electron multiplier detector (EMCCD), etc. Understandably, one first detector 61 is typically provided for each sample measurement position; that is, each sample measurement position has a corresponding first detector 61.
[0119] The analysis unit 70 analyzes the sample detection items using either first optical detection information or second optical detection information. In some embodiments, the analysis unit 70 selects either first optical detection information corresponding to light of a first intensity or second optical detection information corresponding to light of a second intensity based on preset conditions to analyze the sample detection results. The preset conditions may be conditions related to the sample interference detection information. The analysis unit 70 selects the second optical detection information corresponding to light of a second intensity for analysis when the interference in the sample exceeds a preset threshold; and selects the first optical detection information corresponding to light of a first intensity for analysis when the interference in the sample does not exceed the preset threshold. In some embodiments, the sample interference detection information includes at least one of the absorbance or luminous flux of the sample under test. The absorbance of the sample under test represents the degree to which the sample absorbs light when illuminated. If the absorbance of the sample under test at a preset wavelength exceeds a preset absorbance threshold, for example, the absorbance at at least one of 405nm, 575nm, 660nm, and 800nm exceeds the corresponding absorbance threshold, it indicates that the interference of the sample under test exceeds the preset threshold, and anti-interference detection is required by increasing the light intensity or other methods. The luminous flux of the sample under test represents the degree to which light can pass through the sample when illuminated. The luminous flux of the sample under test can be the initial luminous flux detected before the formal coagulation test. If the initial luminous flux of the sample under test is lower than a preset luminous flux threshold, it indicates that the interference of the sample under test exceeds the preset threshold, and anti-interference detection is required by increasing the light intensity.
[0120] The above is a description of the sample analysis device. As you can see, it involves two steps: first, detecting interference in the sample; and second, analyzing the optical detection information corresponding to an appropriate light intensity from two light sources for the sample detection items. These will be explained separately below.
[0121] Please refer to Figure 13In some embodiments, the sample analysis apparatus may further include an interference detection component 80, which includes at least one interference detection position and a second detector 81 adjacent to the interference detection position. The second detector 81 may be implemented by a component capable of converting light signals into electrical signals, such as a photodetector, specifically a photodiode (PD), a photomultiplier tube (PMT), an avalanche photodiode (APD), a charge-coupled device (CCD), a complementary metal-oxide-semiconductor (CMOS), an image enhancement detector (ICCD), or an electron multiplier type detector (EMCCD). The illumination component 50 is used to illuminate a second container (e.g., a reaction cup or a colorimetric cell) located at the interference detection position and containing at least one sample—for example, the illumination component 50 is illuminated by light of a first intensity; the second detector 81 is used to receive the output light signal of the second container after it has been illuminated by the illumination component 50, to obtain interference detection information of the sample to be tested; this interference detection information is used to indicate whether the interference in the sample to be tested exceeds a preset threshold. Therefore, from the perspective of the testing process, the controller 40 can be used to control the dispensing mechanism 30 to dispense a portion of the sample to be tested and the diluent into the second container for interference detection at the interference detection position. Then, the controller can control the dispensing mechanism 30 to dispense the remaining portion of the sample to be tested and the test reagent into the first container for analysis of the sample test items at the sample detection position. Next, at the sample detection position, the illumination component 50 can sequentially provide light of a first intensity and light of a second intensity to the sample detection position, or it can provide only one intensity of light according to the interference detection information. For example, if the interference detected at the interference detection position does not exceed the preset threshold, then only the first intensity of light can be provided when the sample is tested at the sample detection position. If the interference detected at the interference detection position exceeds the preset threshold, then only the second intensity of light can be provided when the sample is tested at the sample detection position.
[0122] By introducing the interference detection component 80, interference can be detected in the sample to be tested, and the interference detection information can be obtained. In some other embodiments, instead of setting up a separate interference detection position, the interference detection of the sample to be tested can be achieved at the same time as the sample measurement position, which will be described in detail below.
[0123] In some embodiments, the illumination component 50 illuminates a first container containing a test sample at the sample measurement position with light of a first intensity. A first detector 61 receives the output light signal of the first container after it has been illuminated by the illumination component 50 to obtain interference detection information of the sample to be tested. This interference detection information is used to determine whether the interference in the sample to be tested exceeds a preset threshold. Specifically, if the analysis component 50 determines that the interference in the sample to be tested does not exceed the preset threshold based on the first optical detection information corresponding to the first intensity of light, it directly uses the first optical detection information to analyze the sample detection items, and the illumination component 50 may not use the second intensity of light to continue illuminating the first container containing the test sample at the sample measurement position. Conversely, if the analysis component 50 determines that the interference in the sample to be tested exceeds the preset threshold based on the first optical detection information corresponding to the first intensity of light, the illumination component 50 then uses the second intensity of light to continue illuminating the first container containing the test sample at the sample measurement position, and selects the second optical detection information corresponding to the second intensity of light to analyze the sample detection items. Of course, the illumination component 50 can also sequentially provide light of first intensity and light of second intensity to the sample measurement position in one illumination cycle, acquiring first optical detection information corresponding to the first intensity light and second optical detection information corresponding to the second intensity light. Then, it determines whether the interference in the sample exceeds a preset threshold based on the first optical detection information, and selects one of the first and second optical detection information to perform sample detection analysis based on the judgment result. Therefore, from the perspective of the testing process, the controller 40 does not need to control the dispensing mechanism 30 to dispense a portion of the sample and diluent into the second container for interference detection at the interference detection position. Instead, it can directly control the dispensing mechanism 30 to dispense the sample and detection reagent into the first container for interference detection and sample analysis at the sample detection position.
[0124] Of course, in other embodiments, the average luminous flux during the period between when the first container containing the test sample is placed at the sample measurement position and before the test begins can also be used to obtain interference detection information. In one example, timing begins after the sample is added to the final step trigger reagent. Generally, the mixing of the mixture and its movement to the sample measurement position can be completed within 3 seconds. Then, the detection begins at the 10th second. During the 7 seconds between the 3rd and 10th seconds, the illumination component 50 illuminates the first container containing the test sample at the sample measurement position with light of a first intensity. The first detector 61 is used to receive the output light signal of the first container after it is illuminated by the illumination component 50—for example, the average luminous flux and minimum transmittance during this period—to obtain the interference detection information of the sample to be tested. If the analysis component 50 determines, based on the interference detection information, that the interference in the sample to be tested does not exceed a preset threshold, then the illumination component 50 continues to irradiate the sample with light of the first intensity, and the analysis component 50 performs analysis of the sample detection items using the first optical detection information corresponding to the first intensity of light; if the analysis component 50 determines, based on the interference detection information, that the interference in the sample to be tested exceeds a preset threshold, then the illumination component 50 continues to irradiate the sample with light of the second intensity, and the analysis component 50 performs analysis of the sample detection items using the second optical detection information corresponding to the second intensity of light.
[0125] The above are some embodiments of sample interference detection. It is understood that those skilled in the art can also use other methods to detect sample interference, such as taking a picture of the sample to be tested to obtain an image of the sample to be tested, and then analyzing the image through methods such as machine learning to obtain interference detection information of the sample to be tested.
[0126] The above are some embodiments of the sample analysis device of the present invention.
[0127] Please refer to Figure 14 and Figure 15 Some embodiments of the present invention also provide a method for sample analysis, comprising the following steps:
[0128] Step 110: In one illumination cycle, a first container located at the sample measurement position and containing the measurement sample is irradiated with light of a first intensity and light of a second intensity; the measurement sample is prepared from the sample to be tested and the detection reagent.
[0129] In some embodiments, in step 110, light of a first wavelength and a first intensity, and light of a first wavelength and a second intensity are output sequentially according to a preset conformance within one illumination cycle; or, light of a first wavelength and a first intensity, and light of a second wavelength and a second intensity are output sequentially according to a preset conformance within each illumination cycle.
[0130] To enable the sample measurement site to perform a wide range of detections, such as those using coagulation, immunoturbidimetry, and chromogenic substrates, step 110 may provide light of multiple wavelengths to the sample measurement site. For example, the first intensity of light provided in step 110 may include at least one of the following: light of a first wavelength used for chromogenic substrate assays, light of a second wavelength used for immunoturbidimetry, and light of a third wavelength used for coagulation assays; that is, one, two, or all three. In some embodiments, the first wavelength ranges from 340 nm to 420 nm, the second wavelength ranges from 520 nm to 590 nm, and the third wavelength ranges from 660 nm to 800 nm. Further, the second intensity of light provided in step 110 may include a fourth wavelength, which is not less than any one of the first, second, or third wavelengths; in one example, the first wavelength < the second wavelength < the third wavelength ≤ the fourth wavelength. In one specific example, step 110 may output light of a first wavelength and a first intensity, a second wavelength and a first intensity, a third wavelength and a first intensity, a fourth wavelength and a first intensity, and a fourth wavelength and a second intensity in a preset compliant sequence within each illumination cycle. In another specific example, step 110 may output light of a first wavelength and a first intensity, a third wavelength and a first intensity, a second wavelength and a first intensity, a fourth wavelength and a first intensity, and a fourth wavelength and a second intensity in a preset compliant sequence within each illumination cycle. In yet another specific example, step 110 may output light of a first wavelength and a first intensity, a third wavelength and a first intensity, a second wavelength and a first intensity, a fourth wavelength and a first intensity, a first wavelength and a second intensity, a third wavelength and a second intensity, a second wavelength and a second intensity, and a fourth wavelength and a second intensity in a preset compliant sequence within each illumination cycle.
[0131] Step 120: Obtain the optical detection information corresponding to the first intensity light and the second intensity light.
[0132] For example, after step 110 irradiates the first container containing the test sample at the sample measurement position with light of a first intensity, step 120 obtains first optical detection information corresponding to the first intensity of light by sensing the transmitted, reflected, or scattered light of the first container containing the test sample through the first intensity of light. Similarly, after step 110 irradiates the first container containing the test sample at the sample measurement position with light of a second intensity, step 120 obtains second optical detection information corresponding to the second intensity of light by sensing the transmitted, reflected, or scattered light of the first container containing the test sample through the second intensity of light. In some examples, step 120 detects the transmitted light passing through the test sample.
[0133] Step 130: Obtain the interference detection information of the sample to be tested.
[0134] In some embodiments, the interference detection information includes at least one of the absorbance of the sample to a preset wavelength or the luminous flux of the sample. The absorbance of the sample represents the degree to which the sample absorbs light when illuminated. If the absorbance of the sample to a preset wavelength exceeds a preset absorbance threshold, for example, if the absorbance at least one of 405nm, 575nm, 660nm, and 800nm exceeds the corresponding absorbance threshold, it indicates that the interference in the sample exceeds the preset threshold, and anti-interference detection is required by increasing the light intensity or other methods. The luminous flux of the sample represents the degree to which light can pass through the sample when illuminated. The luminous flux can be the initial luminous flux detected before the formal coagulation test. If the initial luminous flux of the sample is lower than a preset luminous flux threshold, it indicates that the interference in the sample exceeds the preset threshold, and anti-interference detection is required by increasing the light intensity.
[0135] Step 140: If the interference in the sample to be tested exceeds the preset threshold, select the optical detection information corresponding to the second intensity of light.
[0136] Step 150: If the interference in the sample to be tested does not exceed the preset threshold, select the optical detection information corresponding to the light of the first intensity.
[0137] Step 160: Analyze the sample detection results based on the selected optical detection information.
[0138] Step 170: Output sample detection results and interference detection information.
[0139] The above is a flowchart of some steps in the sample analysis method. The following explains how to obtain interference detection information for the sample under test in step 130.
[0140] In some embodiments, an interference detection site distinct from the sample measurement site may be introduced to detect interference in the sample, providing interference detection information for the sample to be tested. Specifically, a portion of the sample to be tested and the diluent may be dispensed into a second container; in some cases, the second container may be a colorimetric cell. Correspondingly, another portion of the sample to be tested and the detection reagent may then be dispensed into the first container to prepare the test sample, after which the first container may be transported to the sample measurement site. In this method, interference detection is performed on the sample to be tested before the test sample is prepared. The method for detecting interference at the interference detection site has been described in detail above and will not be repeated here.
[0141] In other embodiments, interference detection can be performed on the sample at the sample measurement site to obtain interference detection information of the sample to be tested. For example, interference detection can be performed on the measurement sample at the sample measurement site using light of a first intensity.
[0142] Specifically, interference detection information of the sample to be tested is obtained through first optical detection information corresponding to light of first intensity. If it is determined that the interference of the sample to be tested does not exceed a preset threshold, the first optical detection information is directly used for sample detection analysis, and the second intensity light is no longer needed to continue illuminating the first container containing the test sample at the sample measurement position. Conversely, if the first optical detection information corresponding to light of first intensity indicates that the interference of the sample to be tested exceeds the preset threshold, the second intensity light is then used to continue illuminating the first container containing the test sample at the sample measurement position, and the second optical detection information corresponding to the second intensity light is selected for sample detection analysis. Alternatively, light of first intensity and light of second intensity can be sequentially provided to the sample measurement position in one illumination cycle to obtain first optical detection information corresponding to the first intensity light and second optical detection information corresponding to the second intensity light. The first optical detection information is then used as interference detection information to determine whether the interference of the sample to be tested exceeds the preset threshold, and based on the determination result, one of the first optical detection information and the second optical detection information is selected for sample detection analysis. Therefore, from the perspective of the testing process, instead of controlling the dispensing mechanism 30 to dispense a portion of the sample to be tested and the diluent into the second container for interference detection at the interference detection site, the sample to be tested and the test reagent can be directly dispensed into the first container for interference detection and analysis of the sample test items at the sample detection site.
[0143] Please refer to Figure 16 Some embodiments of the sample analysis method include the following steps:
[0144] Step 210: Obtain the interference detection information of the sample to be tested.
[0145] Step 210 obtains the interference detection information of the sample to be tested. You can refer to the description of obtaining the interference detection information of the sample to be tested in step 130 above. For example, step 210 can introduce an interference detection position that is different from the sample measurement position to detect interference in the sample, or it can detect interference in the sample at the sample measurement position. For example, obtain the initial light flux detected at the sample measurement position before the sample to be tested is subjected to the formal coagulation test to obtain the interference detection information.
[0146] Step 220: Based on the obtained interference detection information of the sample to be tested, determine whether the interference of the sample to be tested exceeds the preset threshold.
[0147] Step 230: If the interference in the sample to be tested does not exceed a preset threshold, then drive the illumination component with a first driving current. For example, drive the illumination component—such as a first light source, a second light source, a third light source, or even a fourth light source—with the first driving current through a driving circuit to provide light of a first intensity to the sample measurement location.
[0148] Step 240: If the interference in the sample exceeds a preset threshold, the illumination component is driven with a second driving current. For example, the illumination component—like a fourth light source, or even combined with a first, second, and third light source—is driven by a driving circuit with a second driving current to provide light of a second intensity to the sample measurement location. Understandably, the second driving current is greater than the first driving current, thus making the second intensity greater than the first intensity.
[0149] Step 250: Analyze the sample detection results based on the optical detection information. Understandably, if the first driving current is used in step 230, then optical detection information corresponding to the first intensity of light can be obtained, and in step 250, the sample detection results are analyzed based on this first intensity of light; if the second driving current is used in step 230, then optical detection information corresponding to the second intensity of light can be obtained, and in step 250, the sample detection results are analyzed based on this second intensity of light.
[0150] Of course, after analyzing the sample detection results in step 250, the detection results can be output, and even the interference detection information of the sample to be tested can be output.
[0151] Please refer to Figure 17 Some embodiments of the sample analysis method include the following steps:
[0152] Step 310: Obtain the luminous flux of the sample to be tested.
[0153] In some examples, the light flux of the sample to be tested can be obtained at a detection position distinct from the sample measurement position. Specifically, a portion of the sample to be tested and the diluent can be dispensed into a second container; the second container can be transported to the aforementioned detection position, and then the detection position can be irradiated by, for example, a light irradiation component—for example, providing light of a first intensity—and the light flux of the second container after irradiation can be obtained; simultaneously, another portion of the sample to be tested and the detection reagent can be dispensed into the first container to prepare the test sample, and then the first container can be transported to the sample measurement position.
[0154] In other examples, the light flux of the test sample can also be the initial light flux detected before the formal coagulation test is performed on the test sample. For example, before the test sample is prepared and the formal coagulation test is started at the test sample measurement position, the test sample is illuminated. This can be done by providing light of a first intensity to the test position through an illumination component, and then acquiring the light flux after the light passes through the test sample.
[0155] Step 320: Determine whether the light flux of the sample to be tested exceeds a threshold.
[0156] Step 330: If the luminous flux of the sample to be tested exceeds the above threshold, the illumination component is driven with a first driving current. For example, the illumination component—such as a first light source, a second light source, a third light source, or even a fourth light source—is driven by a driving circuit with the first driving current to provide light of a first intensity to the sample measurement location.
[0157] Step 340: If the luminous flux of the sample under test does not exceed the aforementioned threshold, the illumination component is driven with a second driving current. For example, the illumination component—like a fourth light source, or even combined with a first, second, and third light source—is driven by a driving circuit with a second driving current to provide light of a second intensity to the sample measurement location. Understandably, the second driving current is greater than the first driving current, thus making the second intensity greater than the first intensity.
[0158] Step 350: Analyze the sample detection results based on the optical detection information. Understandably, if the first driving current is used in step 330, then optical detection information corresponding to the first intensity of light can be obtained, and in step 350, the sample detection results are analyzed based on this first intensity of light; if the second driving current is used in step 330, then optical detection information corresponding to the second intensity of light can be obtained, and in step 350, the sample detection results are analyzed based on this second intensity of light.
[0159] Of course, after analyzing the sample detection results in step 350, the detection results can be output, and even the light flux data of the sample to be tested can be output.
[0160] The sample to be tested in this article can be blood, and the interfering substances include at least one of hemoglobin, bilirubin and chyle.
[0161] This paper uses stronger light—in some cases even with a longer wavelength—to test samples with interfering substances, effectively reducing the impact of these substances on sample measurement. However, when measuring samples without interfering substances or with low levels of interfering substances, the normal light intensity is still used. This is because using stronger light for samples with no or low levels of interfering substances would result in oversaturated optical detection information, making normal measurement impossible. In practice, a higher intensity light can be added within a single illumination cycle. This allows the sample measurement unit to test both samples with and without interfering substances. Specifically, based on the interfering substance detection results, the appropriate light intensity corresponding to the optical detection information is selected for sample analysis, effectively solving the problem of interfering substances affecting the test and simplifying the testing process.
[0162] In summary, this invention can adjust the light intensity during sample measurement based on interference detection information. If the interference level in the sample does not exceed a preset threshold, the light intensity is adjusted, and the sample is irradiated with light of a first intensity for testing. If the interference level exceeds the preset threshold, the light intensity is adjusted, and the sample is irradiated with light of a second intensity for testing. Alternatively, this invention can sequentially irradiate the sample with light of a first intensity and light of a second intensity within one illumination cycle, and then select the optical detection information corresponding to one of the light intensities based on the interference detection information of the sample to analyze the sample's testing parameters.
[0163] In other embodiments, during normal testing, the illumination component 50 provides light of a first intensity to test the sample, and when the analysis component 70 or the user determines that a retest is required, i.e. when the sample is being retested, the illumination component 50 provides light of a second intensity to test the sample.
[0164] This document describes various exemplary embodiments with reference to them. However, those skilled in the art will recognize that changes and modifications can be made to the exemplary embodiments without departing from the scope of this document. For example, various operational steps and components for performing operational steps can be implemented in different ways depending on the specific application or considering any number of cost functions associated with the operation of the system (e.g., one or more steps can be deleted, modified, or combined with other steps).
[0165] In the above embodiments, implementation can be achieved, in whole or in part, by software, hardware, firmware, or any combination thereof. Furthermore, as those skilled in the art will understand, the principles herein can be reflected in a computer program product on a computer-readable storage medium pre-loaded with computer-readable program code. Any tangible, non-transitory computer-readable storage medium may be used, including magnetic storage devices (hard disks, floppy disks, etc.), optical storage devices (CD-ROMs, DVDs, Blu-ray discs, etc.), flash memory, and / or the like. These computer program instructions can be loaded onto a general-purpose computer, special-purpose computer, or other programmable data processing apparatus to form a machine, such that instructions executing on the computer or other programmable data processing apparatus can generate means for implementing a specified function. These computer program instructions can also be stored in a computer-readable storage medium that can instruct the computer or other programmable data processing apparatus to operate in a particular manner, such that instructions stored in the computer-readable storage medium can form an article of manufacture including means for implementing the specified function. The computer program instructions can also be loaded onto a computer or other programmable data processing apparatus to perform a series of operational steps on the computer or other programmable apparatus to produce a computer-implemented process, such that instructions executing on the computer or other programmable apparatus can provide steps for implementing the specified function.
[0166] While the principles herein have been illustrated in various embodiments, numerous modifications to the structure, arrangement, proportions, elements, materials, and components, particularly suited to specific environmental and operational requirements, may be used without departing from the principles and scope of this disclosure. These modifications and other alterations or alterations will be included within the scope of this document.
[0167] The foregoing specific descriptions have been described with reference to various embodiments. However, those skilled in the art will recognize that various modifications and changes can be made without departing from the scope of this disclosure. Therefore, considerations for this disclosure are to be illustrative rather than restrictive, and all such modifications are to be included within its scope. Similarly, advantages, other advantages, and solutions to problems with respect to various embodiments have been described above. However, benefits, advantages, solutions to problems, and any elements that produce these, or make them more explicit, should not be construed as critical, essential, or necessary. The term “comprising” and any other variations thereof as used herein are non-exclusive inclusion, meaning that a process, method, article, or apparatus that includes a list of elements includes not only those elements but also other elements not expressly listed or not part of the process, method, system, article, or apparatus. Furthermore, the term “coupled” and any other variations thereof as used herein refer to physical connections, electrical connections, magnetic connections, optical connections, communication connections, functional connections, and / or any other connections.
[0168] Those skilled in the art will recognize that many changes can be made to the details of the above embodiments without departing from the basic principles of the invention. Therefore, the scope of the invention should be determined only by the claims.
Claims
1. A sample analysis device, characterized in that, include: An illumination component for illuminating a first container located at a sample measurement position and containing a test sample, the test sample being prepared from a sample to be tested and a detection reagent; The illumination component is capable of providing light of a first intensity and light of a second intensity to the sample measurement site, wherein the first intensity is less than the second intensity; An optical detection component includes a first detector adjacent to the sample measurement position, used to receive the output light signal after the illumination component illuminates the first container, so as to obtain optical detection information of the measured sample, wherein the optical detection information includes first optical detection information corresponding to light of a first intensity and second optical detection information corresponding to light of a second intensity; An analysis component is configured to analyze sample detection items based on the acquired interference detection information of the sample to be tested, wherein the interference detection information indicates whether the interference of the sample to be tested exceeds a preset threshold; when the interference detection information indicates that the interference of the sample to be tested exceeds the preset threshold, the component selects second optical detection information corresponding to a second intensity of light to analyze the sample detection items; and when the interference detection information indicates that the interference of the sample to be tested does not exceed the preset threshold, the component selects first optical detection information corresponding to a first intensity of light to analyze the sample detection items.
2. The sample analysis apparatus as described in claim 1, characterized in that, The illumination component provides light of a first intensity and light of a second intensity to the sample measurement position during each illumination cycle.
3. The sample analysis device as described in claim 2, characterized in that, The illumination component includes a multi-wavelength light source, which outputs different illumination lights in a preset order during each illumination cycle. The different illumination lights during each illumination cycle include light with a first wavelength and a first intensity and light with a first wavelength and a second intensity, or light with a first wavelength and a first intensity and light with a second wavelength and a second intensity.
4. The sample analysis apparatus as described in claim 1, characterized in that, The first intensity of light provided by the illumination component includes at least one of: light of a first wavelength for determination by chromogenic substrate method, light of a second wavelength for determination by immunoturbidimetric method, and light of a third wavelength for determination by coagulation method.
5. The sample analysis apparatus as described in claim 4, characterized in that, The first wavelength ranges from 340nm to 420nm, the second wavelength ranges from 520nm to 590nm, and the third wavelength ranges from 660nm to 800nm.
6. The sample analysis apparatus as described in claim 1, characterized in that, The illumination component outputs light of a first wavelength and a first intensity, light of a second wavelength and a first intensity, light of a third wavelength and a first intensity, light of a fourth wavelength and a first intensity, and light of a fourth wavelength and a second intensity in a preset order during each illumination cycle, wherein the first wavelength < the second wavelength < the third wavelength ≤ the fourth wavelength.
7. The sample analysis apparatus according to any one of claims 1-6, characterized in that, It also includes an interference detection component, which includes at least one interference detection position and a second detector adjacent to the interference detection position; the illumination component is used to illuminate a second container located at the interference detection position and containing at least a sample, and the second detector is used to receive the output light signal of the second container after it is illuminated by the illumination component, so as to obtain the interference detection information of the sample to be tested.
8. The sample analysis apparatus according to any one of claims 1-6, characterized in that, The illumination component illuminates the first container containing the test sample at the sample measurement position with light of a first intensity. The first detector is used to receive the output light signal of the first container after it is illuminated by the illumination component, so as to obtain the interference detection information of the test sample.
9. The sample analysis apparatus as described in claim 7, characterized in that, It also includes a dispensing mechanism and a controller, wherein the controller is used to control the dispensing mechanism to dispense a portion of the sample to be tested and the diluent into the second container or to control the dispensing mechanism to dispense the sample to be tested and the test reagent into the first container.
10. The sample analysis apparatus as described in claim 8, characterized in that, It also includes a dispensing mechanism and a controller, wherein the controller is used to control the dispensing mechanism to dispense a portion of the sample to be tested and the diluent into a second container located at the interference detection position and containing at least the sample, or to control the dispensing mechanism to dispense the sample to be tested and the detection reagent into the first container.
11. The sample analysis apparatus according to any one of claims 1-6, characterized in that, The sample to be tested is blood, and the interfering substances include at least one of hemoglobin, bilirubin, and chyle.
12. The sample analysis apparatus according to any one of claims 1-6, characterized in that, The sample measurement positions are multiple; the illumination component includes a light source and a multi-fiber bundle, the multi-fiber bundle includes multiple optical fibers corresponding to the sample measurement positions respectively, and each optical fiber is used to provide light of the first intensity and light of the second intensity to the corresponding sample measurement position.
13. The sample analysis apparatus as described in claim 12, characterized in that, The light source includes a first light source, a second light source, and a third light source, which respectively provide light of a first wavelength, a second wavelength, and a third wavelength, wherein the light of the first wavelength, the second wavelength, and the third wavelength are all of a first intensity.
14. The sample analysis apparatus as described in claim 13, characterized in that, The illumination component further includes a fourth light source for providing light of a fourth wavelength and a first intensity and light of a fourth wavelength and a second intensity in a time-division manner within an illumination cycle.
15. The sample analysis apparatus as described in claim 14, characterized in that, The illumination component further includes a driving circuit, which is connected to the first light source, the second light source, the third light source and the fourth light source, and is used to provide a first driving current to drive the first light source, the second light source and the third light source to generate light of the first intensity. It is also used to provide a first driving current and a second driving current in a time-division manner to drive the fourth light source to generate light of the first intensity and the second intensity, wherein the second driving current is greater than the first driving current.
16. The sample analysis apparatus as described in claim 12, characterized in that, The illumination component includes a multi-wavelength light source and a rotating filter. The rotating filter includes a filter and an attenuator. The illumination component is used to provide light of different wavelengths and intensities at different times as the rotating filter rotates.
17. The sample analysis apparatus according to any one of claims 1 to 6, characterized in that, The illumination component includes multiple multi-wavelength light sources, each corresponding to one of the multiple sample measurement positions.
18. A sample analysis device, characterized in that, include: An illumination component for illuminating a first container located at a sample measurement position and containing a test sample, the test sample being prepared from a sample to be tested and a detection reagent; The illumination component is capable of providing light of a first intensity and light of a second intensity to the sample measurement site, wherein the first intensity is less than the second intensity; An optical detection component includes a first detector adjacent to the sample measurement position, used to receive the output light signal after the illumination component illuminates the first container, so as to obtain optical detection information of the measured sample, wherein the optical detection information includes first optical detection information corresponding to light of a first intensity and second optical detection information corresponding to light of a second intensity; An analysis component is used to select, according to preset conditions, first optical detection information corresponding to light of a first intensity or second optical detection information corresponding to light of a second intensity, and to analyze the sample detection results. The preset conditions are conditions related to the detection information of interference in the sample. The analysis component is used to select the second optical detection information corresponding to the second intensity of light for analysis when the interference in the sample under test exceeds the preset threshold; and to select the first optical detection information corresponding to the first intensity of light for analysis when the interference in the sample under test does not exceed the preset threshold. The sample interference detection information includes at least one of the absorbance or luminous flux of the sample to be tested.
19. The sample analysis apparatus as described in claim 18, characterized in that, The illumination component includes a multi-wavelength light source, which outputs different illumination lights in a preset order during each illumination cycle. The different illumination lights during each illumination cycle include light with a first wavelength and a first intensity and light with a first wavelength and a second intensity provided in a time-division manner, or light with a first wavelength and a first intensity and light with a second wavelength and a second intensity provided in a time-division manner.
20. The sample analysis apparatus as described in claim 18, characterized in that, The first intensity of light provided by the illumination component includes at least one of: light of a first wavelength for determination by chromogenic substrate method, light of a second wavelength for determination by immunoturbidimetric method, and light of a third wavelength for determination by coagulation method.
21. The sample analysis apparatus as described in claim 20, characterized in that, The first wavelength ranges from 340nm to 420nm, the second wavelength ranges from 520nm to 590nm, and the third wavelength ranges from 660nm to 800nm.
22. The sample analysis apparatus as described in claim 20, characterized in that, The second intensity of light provided by the illumination component includes light of a fourth wavelength, which is not less than any one of the first wavelength, the second wavelength, or the third wavelength.
23. A method for sample analysis, characterized in that, include: In one illumination cycle, a first container located at the sample measurement position and containing the measurement sample is irradiated with light of a first intensity and light of a second intensity, wherein the first intensity is less than the second intensity; the measurement sample is prepared from the sample to be tested and the detection reagent. Acquire optical detection information corresponding to light of first intensity and light of second intensity; Obtain interference detection information for the sample to be tested; If the interference in the sample to be tested exceeds the preset threshold, select the optical detection information corresponding to the second intensity of light; If the interference in the sample to be tested does not exceed the preset threshold, select the optical detection information corresponding to the light of the first intensity; and Based on the selected optical detection information, the sample detection results are analyzed.
24. The method as described in claim 23, characterized in that, The illumination of the first container, located at the sample measurement position and containing the measurement sample, with light of a first intensity and light of a second intensity includes: Within one illumination cycle, the sample at the measurement site is irradiated with light of a first wavelength and a first intensity, and light of a first wavelength and a second intensity at different times; or within one illumination cycle, the sample at the measurement site is irradiated with light of a first wavelength and a first intensity, and light of a second wavelength and a second intensity at different times.
25. The method as described in claim 24, characterized in that, The illumination of the first container, located at the sample measurement position and containing the measurement sample, with light of a first intensity and light of a second intensity includes: Within one illumination cycle, the sample at the measurement site is irradiated with light of the first wavelength and first intensity, the second wavelength and first intensity, the third wavelength and first intensity, the fourth wavelength and first intensity, and the fourth wavelength and second intensity at different times, wherein the first wavelength < the second wavelength < the third wavelength ≤ the fourth wavelength.
26. The method as described in claim 25, characterized in that, The first wavelength ranges from 340nm to 420nm, the second wavelength ranges from 520nm to 590nm, and the third wavelength ranges from 660nm to 800nm.
27. The method as described in claim 23, characterized in that, The process of obtaining interference detection information of the sample to be tested includes dispensing a portion of the sample to be tested and the diluent into a second container.
28. The method as described in claim 27, characterized in that, It also includes dispensing another portion of the sample to be tested and the detection reagent into the first container to prepare the test sample; and transporting the first container to the sample testing site.
29. The method as described in claim 23, characterized in that, The acquisition of interference detection information of the sample to be tested includes detecting interference in the sample to be tested before preparing the test sample.
30. The method as described in claim 23, characterized in that, The process of obtaining interference detection information of the sample to be tested includes using light of a first intensity to detect interference on the test sample at the test site.
31. The method according to any one of claims 23-30, characterized in that, It also includes outputting sample detection results and interfering substance detection information after analyzing the sample detection results.
32. The method according to any one of claims 23-30, characterized in that, The interference detection information includes at least one of the absorbance of the sample to light of a preset wavelength or the luminous flux of the sample.
33. The sample analysis method as described in claim 23, characterized in that, The sample to be tested is blood, and the interfering substances include at least one of hemoglobin, bilirubin, and chyle.
34. A computer-readable storage medium, characterized in that, Includes a program that can be executed by a processor to implement the method as described in any one of claims 23-32.