CN115280155A

CN115280155A - Sample analysis device and method

Info

Publication number: CN115280155A
Application number: CN202080098311.XA
Authority: CN
Inventors: 孙骁; 郭文恒; 杨雨; 武振兴; 李鑫
Original assignee: Shenzhen Mindray Bio Medical Electronics Co Ltd; Beijing Shen Mindray Medical Electronics Technology Research Institute Co Ltd
Current assignee: Shenzhen Mindray Bio Medical Electronics Co Ltd; Beijing Shen Mindray Medical Electronics Technology Research Institute Co Ltd
Priority date: 2020-04-13
Filing date: 2020-04-13
Publication date: 2022-11-01
Also published as: WO2021207898A1

Abstract

A sample analyzer and method, wherein a light irradiation unit (50) irradiates a first container containing a measurement sample prepared from a sample to be measured and a detection reagent at a sample measurement site; wherein the illumination component (50) is capable of providing light of a first intensity and light of a second intensity to the sample measurement location, the first intensity being less than the second intensity.

Description

Sample analysis device and method

Technical Field

The present invention relates to a sample analysis device and method.

Background

A sample analysis apparatus is a type of apparatus for analyzing biochemical characteristics of a sample, which is widely used in the field of clinical medicine to help medical staff diagnose a patient's condition. Taking a hemagglutination instrument as an example, the hemagglutination instrument can measure the blood coagulation time and the concentration or activity of related substances contained in the blood; the hemagglutination meter can detect coagulation items by adopting an optical method, and specifically, the hemagglutination meter irradiates light to a reaction cup solution in the reaction process and analyzes scattered or transmitted light to obtain optical information such as absorbance of the solution and the like, so as to obtain coagulation time or concentration of a substance to be detected and the like.

The optical method detects the coagulation item through optical information of scattering, reflection or transmission of light by the reaction solution, so that when a sample has an interfering substance, the scattering, reflection or transmission property of the reaction solution to the light changes, which affects the measurement, and the detection result is inaccurate, and even the detection result cannot be obtained under severe conditions.

Summary of The Invention

Technical problem

The present invention generally provides a sample analysis apparatus and method, and is described in detail below.

Solution to the problem

Technical solution

According to a first aspect, there is provided in an embodiment a sample analysis device comprising:

the illumination component is used for illuminating a first container which is positioned at a sample measuring position and is filled with a measuring sample, and the measuring sample is prepared from a sample to be measured and a detection reagent; wherein the illumination component is capable of providing a first intensity of light and a second intensity of light to the sample measurement location, the first intensity being less than the second intensity;

an optical detection unit including a first detector adjacent to the sample measurement site for receiving an output optical signal of the first container irradiated by the illumination unit to obtain optical detection information of the measurement sample, the optical detection information including first optical detection information corresponding to light of a first intensity and second optical detection information corresponding to light of a second intensity;

and the analysis component is used for selecting second optical detection information corresponding to the light with the second intensity to analyze the sample detection item when the interferent of the sample to be detected exceeds a preset threshold value, and selecting first optical detection information corresponding to the light with the first intensity to analyze the sample detection item when the interferent of the sample to be detected does not exceed the preset threshold value.

In one embodiment, the illumination component provides a first intensity of light and a second intensity of light to the sample measurement location during each illumination cycle.

In one embodiment, the illumination component includes a multi-wavelength light source, and sequentially outputs different illumination lights according to a predetermined sequence in each illumination period, where the different illumination lights in each illumination period include lights of a first wavelength and a first intensity and lights of a first wavelength and a second intensity, or include lights of the first wavelength and the first intensity and lights of the second wavelength and the second intensity.

In one embodiment, the first intensity of light provided by the illumination component comprises: at least one of light of a first wavelength for measurement by a chromogenic substrate method, light of a second wavelength for measurement by an immunoturbidimetric method, and light of a third wavelength for measurement by a coagulation method; preferably, the first wavelength is in the range of 340nm to 420nm, the second wavelength is in the range of 520nm to 590nm, and the third wavelength is in the range of 660nm to 800nm.

In one embodiment, the illumination component sequentially 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 sequence in each illumination period, wherein the first wavelength is less than the second wavelength and less than the third wavelength and less than or equal to the fourth wavelength.

In one embodiment, the sample analysis device further comprises an interferent detection means comprising at least one interferent detection bit and a second detector adjacent to the interferent detection bit; the illumination component is used for illuminating a second container which is positioned at an interfering object detection position and at least contains a sample, and the second detector is used for receiving an output optical signal of the second container after the second container is illuminated by the illumination component so as to obtain interfering object detection information of the sample to be detected; the interferent detection information is used for indicating whether the interferent of the sample to be detected exceeds a preset threshold value.

In one embodiment, the illumination component irradiates a first container containing a measurement sample at the sample measurement position with light with a first intensity, and the first detector is configured to receive an output optical signal of the first container irradiated by the illumination component, so as to obtain detection information of an interfering object of the sample to be measured; and the interferent detection information is used for judging whether the interferent of the sample to be detected exceeds a preset threshold value.

In one embodiment, the sample analyzer further includes a dispensing mechanism and a controller, and the controller is configured to control the dispensing mechanism to dispense a part of the sample and a diluent into the second container or control the dispensing mechanism to dispense the sample and a detection reagent into the first container.

In one embodiment, the sample to be tested is blood, and the interferent comprises at least one of hemoglobin, bilirubin, and chyle.

In one embodiment, there are a plurality of said sample measurement locations; the illumination component includes a light source and a one-to-many fiber bundle including a plurality of optical fibers respectively corresponding to the sample measurement locations, each optical fiber for providing the light of the first intensity and the light of the second intensity to the corresponding sample measurement location.

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, and the light of the first wavelength, the second wavelength and the third wavelength are all of a first intensity.

In one embodiment, the illumination assembly further comprises 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-sharing manner during an illumination period.

In one embodiment, the illumination component further includes a driving circuit, and the driving circuit is connected to the first light source, the second light source, the third light source and the fourth light source, and is configured to provide a first driving current to drive the first light source, the second light source and the third light source to generate light with the first intensity; according to a first aspect, there is provided in one embodiment a sample analysis device further configured to time-divisionally provide a first drive current and a second drive current to drive the fourth power supply to generate the first drive current, comprising:

an illumination unit for illuminating a first container located at a sample measurement site and containing a measurement sample prepared from a sample to be measured and a detection reagent; wherein the illumination component is capable of providing a first intensity of light and a second intensity of light to the sample measurement location, the first intensity being less than the second intensity;

and the analysis component is used for selecting the second optical detection information corresponding to the light with the second intensity to analyze the sample detection item when the interferent of the sample to be detected exceeds a preset threshold value, and selecting the first optical detection information corresponding to the light with the first intensity to analyze the sample detection item when the interferent of the sample to be detected does not exceed the preset threshold value.

In one embodiment, the illumination assembly provides light of a first intensity and light of a second intensity to the sample side location during each illumination cycle.

In one embodiment, the first intensity of light provided by the illumination component comprises: at least one of light of a first wavelength for measurement by a chromogenic substrate method, light of a second wavelength for measurement by an immunoturbidimetric method, and light of a third wavelength for measurement by a coagulation method; preferably, the first wavelength is in the range of 340nm-420nm, the second wavelength is in the range of 520nm-590nm, and the third wavelength is in the range of 660nm-800nm.

In one embodiment, the illumination component sequentially outputs light with a first wavelength and a first intensity, light with a second wavelength and a first intensity, light with a third wavelength and a first intensity, light with a fourth wavelength and a first intensity, and light with a fourth wavelength and a second intensity in a preset sequence in each illumination period, wherein the first wavelength is less than the second wavelength and less than the third wavelength and less than the fourth wavelength.

In one embodiment, the sample analysis device further comprises an interferent detection means comprising at least one interferent detection bit and a second detector adjacent to the interferent detection bit; the illumination component is used for illuminating a second container which is positioned at an interfering object detection position and at least contains a sample, and the second detector is used for receiving an output optical signal of the second container after the second container is illuminated by the illumination component so as to obtain interfering object detection information of the sample to be detected; the interferent detection information is used for indicating whether interferents of the sample to be detected exceed a preset threshold value.

In one embodiment, the sample to be tested is blood and the interferent comprises at least one of hemoglobin, bilirubin, and chyle.

In one embodiment, there are a plurality of said sample measurement locations; the illumination component comprises a light source and a light splitting and multiple optical fiber bundle, wherein the light splitting and multiple optical fiber bundle comprises a plurality of optical fibers respectively corresponding to the sample measuring positions, and each optical fiber is used for providing the light with the first intensity and the light with the second intensity to the corresponding sample measuring position.

In one embodiment, the illumination component further includes a driving circuit, and the driving circuit is connected to the first light source, the second light source, the third light source and the fourth light source, and is configured to provide a first driving current to drive the first light source, the second light source and the third light source to generate light with the first intensity; the fourth power supply is used for supplying a first driving current and a second driving current in a time-sharing manner to drive the fourth power supply to generate light with the first intensity and the second intensity, and the second driving current is larger than the first driving current.

In one embodiment, the illumination component includes a multi-wavelength light source and a rotary filter, the rotary filter includes a filter and an attenuation sheet, and the illumination component is configured to provide light with different wavelengths and different intensities in a time-sharing manner when the rotary filter rotates.

In one embodiment, the illumination component includes a plurality of multi-wavelength light sources respectively corresponding to the plurality of sample measurement sites.

According to a second aspect, there is provided in an embodiment a sample analysis device comprising:

and the analysis component is used for selecting first optical detection information corresponding to the light with the first intensity or second optical detection information corresponding to the light with the second intensity according to a preset condition and analyzing the detection result of the sample.

In one embodiment, the preset condition is a condition related to sample interferent detection information, and the analysis component is configured to select second optical detection information corresponding to light of a second intensity for analysis when the interferent of the sample to be detected exceeds a preset threshold; and when the interferent of the sample to be detected does not exceed the preset threshold value, selecting first optical detection information corresponding to the light with the first intensity for analysis.

In one embodiment, the sample interferent detection information includes at least one of absorbance or luminous flux of the sample to be detected.

In one embodiment, the illumination component includes a multi-wavelength light source, and sequentially outputs different illumination lights according to a preset sequence in each illumination period, where the different illumination lights in each illumination period include lights with a first wavelength and a first intensity provided in a time-sharing manner and lights with a first wavelength and a second intensity provided in a time-sharing manner, or include lights with a first wavelength and a first intensity provided in a time-sharing manner and lights with a second wavelength and a second intensity provided in a time-sharing manner.

In one embodiment, the first intensity of light provided by the illumination component comprises: at least one of light of a first wavelength for measurement by a chromogenic substrate method, light of a second wavelength for measurement by immunoturbidimetry, and light of a third wavelength for measurement by a coagulation method; preferably, the first wavelength is in the range of 340nm-420nm, the second wavelength is in the range of 520nm-590nm, and the third wavelength is in the range of 660nm-800nm.

In an embodiment, the light of the second intensity provided by the illumination component includes light of a fourth wavelength, and the fourth wavelength is not less than any one of the first wavelength, the second wavelength or the third wavelength.

According to a third aspect, an embodiment provides a method of sample analysis, comprising:

illuminating a first container located at a sample measurement position and containing a measurement sample with light of a first intensity and light of a second intensity during an illumination period; the determination sample is prepared from a sample to be detected and a detection reagent;

acquiring optical detection information corresponding to the light with the first intensity and the light with the second intensity;

obtaining the detection information of an interferent of a sample to be detected;

if the interferent of the sample to be detected exceeds a preset threshold value, selecting optical detection information corresponding to light with second intensity;

if the interferent of the sample to be detected does not exceed the preset threshold value, selecting optical detection information corresponding to the light with the first intensity; and

and analyzing the detection result of the sample according to the selected optical detection information.

In one embodiment, the irradiating the first container, which is located at the sample measuring position and contains the measurement sample, with the first intensity of light and the second intensity of light comprises:

within an illumination period, illuminating a measurement sample at a sample measurement position with light of a first wavelength and a first intensity and light of a first wavelength and a second intensity in a time-sharing manner; or within one illumination period, the light with the first wavelength and the first intensity and the light with the second wavelength and the second intensity are irradiated to the measurement sample of the sample measurement position in a time-sharing manner.

In one embodiment, the irradiating the first container located at the sample measuring position and containing the measurement sample with the first intensity of light and the second intensity of light comprises:

within an illumination period, illuminating a measurement sample at a sample measurement position with 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 time-sharing manner, wherein the first wavelength is less than the second wavelength and less than the third wavelength and less than or equal to the fourth wavelength;

preferably, the first wavelength is in the range of 340nm-420nm, the second wavelength is in the range of 520nm-590nm, and the third wavelength is in the range of 660nm-800nm.

In one embodiment, the obtaining of the detection information of the interferent of the sample to be detected includes dispensing a part of the sample to be detected and the diluent into the second container.

In one embodiment, the sample analysis method further comprises dispensing another portion of the sample to be measured and a detection reagent into the first container to prepare the assay sample; and transporting the first container to the sample testing location.

In one embodiment, the obtaining of the interferent detection information of the sample to be detected includes performing interferent detection on the sample to be detected before preparing the measurement sample.

In one embodiment, the obtaining of the interferent detection information of the sample to be detected includes performing interferent detection on the measurement sample located by the sample detection using the light with the first intensity.

In one embodiment, the sample analysis method further includes outputting the sample detection result and the interferent detection information after analyzing the sample detection result.

In an embodiment, the interferent detection information includes at least one of an absorbance of light with a predetermined wavelength by a sample to be detected or a luminous flux of the sample to be detected.

According to a fourth aspect, an embodiment provides a computer readable storage medium comprising a program executable by a processor to implement the method of any of the embodiments herein.

Advantageous effects of the invention

Brief description of the drawings

Drawings

FIG. 1 is a schematic diagram showing absorption spectra of three interferents of hemoglobin, bilirubin and chyle for light in each wavelength range;

FIG. 2 is a schematic structural diagram of a sample analyzer according to an embodiment;

FIG. 3 is a schematic structural view of a sample analyzer according to another embodiment;

FIG. 4 is a schematic structural view of a sample analyzer according to yet another embodiment;

FIG. 5 (a) is a schematic view of the light provided by the illumination component during an illumination cycle; FIG. 5 (b) is another schematic view of the light provided by the illumination component during an illumination cycle;

FIG. 6 (a) is a schematic view of the light provided by the illumination component during an illumination cycle; FIG. 6 (b) is another schematic view of the light provided by the illumination component during an illumination cycle;

FIG. 7 is a schematic structural diagram of an illumination component according to an embodiment;

FIG. 8 is a schematic view of a structure of a lighting unit according to another embodiment;

fig. 9 is a schematic structural view of a lighting unit according to still another embodiment;

FIG. 10 is a schematic structural view of an illumination unit according to still another embodiment

FIG. 11 is a schematic view of a structure of a lighting unit according to still another embodiment

FIG. 12 is a schematic view of a structure of a lighting unit according to still another embodiment;

FIG. 13 is a schematic structural view of a sample analyzer according to still another embodiment;

FIG. 14 is a schematic flow chart of a sample analysis method according to an embodiment;

FIG. 15 is a schematic flow chart of a sample analysis method according to another embodiment;

FIG. 16 is a schematic flow chart of a sample analysis method according to yet another embodiment;

fig. 17 is a schematic flow chart of a sample analysis method according to still another embodiment.

Examples of the invention

Modes for carrying out the invention

The present invention will be described in further detail with reference to the following detailed description and accompanying drawings. Wherein like elements in different embodiments are numbered with like associated elements. In the following description, numerous details are set forth in order to provide a better understanding of the present application. However, those skilled in the art will readily recognize that some of the features may be omitted or replaced with other elements, materials, methods in different instances. In some instances, certain operations related to the present application have not been shown or described in detail in order to avoid obscuring the core of the present application from excessive description, and it is not necessary for those skilled in the art to describe these operations in detail, so that they may be fully understood from the description in the specification and the general knowledge in the art.

Furthermore, the described features, operations, or characteristics may be combined in any suitable manner to form various embodiments. Also, the various steps or actions in the description of the methods may be transposed or transposed in order, as will be apparent to a person skilled in the art. Thus, the various sequences in the specification and drawings are for the purpose of describing certain embodiments only and are not intended to imply a required sequence unless otherwise indicated where such sequence must be followed.

The ordinal numbers used herein for the components, such as "first," "second," etc., are used merely to distinguish between the objects described, and do not have any sequential or technical meaning. The term "connected" and "coupled" as used herein includes both direct and indirect connections (couplings), unless otherwise specified.

Optical coagulation measurement can be generally classified into three methods: coagulation, immunoturbidimetry and chromogenic substrate methods. The chromogenic substrate method generally employs violet light or ultraviolet light AT 340nm to 420nm, and is generally used for the measurement of detection items such as antithrombin-III (AT-III or AT 3). Immunoturbidimetry usually uses yellow-green light at 520nm to 590nm, and immunoturbidimetry usually uses for measuring detection items such as D-dimer (DD), fibrin/Fibrinogen Degradation Product (FDP) and the like. The coagulation method generally employs red light or infrared light of 660nm to 800nm, and is generally used for measuring detection items such as thrombospondin time (PT), activated Partial Thromboplastin Time (APTT), thrombin Time (TT), and Fibrinogen (FIB).

In the optical method for measuring blood coagulation, whether the coagulation method, the immunoturbidimetry method or the chromogenic substrate method is adopted, when an interfering substance exists in a sample, the detection is interfered; for example, when interferents such as hemoglobin, bilirubin, and chyle are present in the sample plasma, these interferents may interfere with the detection of the sample due to their relatively strong absorption of light. Hemoglobin, bilirubin, and chyle can generally be collectively referred to as HIL interference, where H refers to hemoglobin, I refers to bilirubin, and L refers to chyle. Referring to fig. 1, it is a schematic diagram of absorption spectra of three interferents, namely hemoglobin, bilirubin and chyle, for light in each wavelength range, and it can be seen from the diagram that the three interferents have strong absorption for light in a small wavelength band, especially light below 600nm, which greatly reduces the light transmittance of a mixture of a sample and a detection reagent, and the actually received light is very small, which affects the accuracy and reliability of optical determination; sometimes the light that can be received is even almost zero, resulting in an unrecognizable course of reaction of the sample with the detection reagent.

One solution to the interferents is to provide light in a wavelength band that is not absorbed by the interferents in the sample for detection, e.g., to provide a larger wavelength such as 800nm to illuminate the mixture of sample and detection reagent, as is evident from the figure, hemoglobin and bilirubin have little absorption of light at wavelengths greater than 800nm, while chyle has relatively little absorption of light at wavelengths greater than 800nm. This solution has some drawbacks, such as that although chyle has a relatively small absorption of light at wavelengths greater than 800nm, these absorptions of light by chyle are still not negligible for the case where the detection results require a relatively precise one; in addition, when the concentration of chyle in a sample is relatively high, even in a case where the accuracy of the detection result requires general (for example, physical examination test) and the like, the absorption of light by chyle is still not negligible, and the accuracy of the detection result is still seriously affected by chyle; finally, the provision of light of a larger wavelength, for example, 800nm, is not applicable to items such as detection by the chromogenic substrate method, which is a method in which, in principle, only the aforementioned violet light or ultraviolet light of 340nm to 420nm is generally used, and light of other wavelength bands is not used, because the substance in the sample is displaced by the detection reagent after the reaction between the sample and the detection reagent, and the displaced substance absorbs only in the ultraviolet and violet wavelength bands, whereas the coagulation method and immunoturbidimetric method can theoretically use light of other wavelength band ranges for detection in addition to the light of the respective wavelength band ranges mentioned above.

The applicant researches the above problems and proposes another solution to solve the problem of the interference in the sample caused by the item detection by increasing the light intensity to compensate the influence of the low luminous flux caused by the interference. Specifically, when the sample has no interferent or has a low interferent content, the light with normal light intensity is used for detection, and when the sample has a high interferent content, the light with high light intensity is used for detection. The present invention will be explained below.

In some embodiments, a sample analysis device is disclosed. A sample analysis device is an instrument for analyzing and measuring a sample. The test flow of the sample analyzer is not illustrated by way of example in the case of a blood coagulation analyzer (i.e., a blood coagulation analyzer referred to herein). The test procedure for coagulation analyzers is generally as follows: the coagulation analyzer can irradiate the measurement sample in the cuvette with, for example, light of multiple wavelengths, and analyze the measurement sample by a coagulation method, an immunoturbidimetry method, a chromogenic substrate method, or the like to obtain a coagulation reaction curve of the measurement sample with time, thereby further calculating the coagulation time or other coagulation-related performance parameters of the measurement sample.

In the sample analyzer, at the stage of measuring a measurement sample, a core member is a member for providing light, a member for receiving light transmitted, reflected, scattered, or the like from the measurement sample, and a member for analyzing information of the received light. Therefore, referring to fig. 2, the sample analysis apparatus in some embodiments may include an illumination component 50, an optical detection component 60, and an analysis component 70. Referring to fig. 3 and 4, the sample analyzer in some embodiments may further include one or more of a sample cell 10, a reagent cell 20, a dispensing mechanism 30, a controller 40, and the like.

The sample cell 10 is used to carry a sample. In some examples, the Sample unit 10 may include a Sample Delivery Module (SDM) and a front end track; in other examples, the sample cell 10 may be a sample tray-for example, fig. 4 is an example, the sample tray includes a plurality of sample sites for placing containers, and the sample tray can dispatch the sample to a corresponding position, for example, a position for the dispensing mechanism 30 to suck the sample, by rotating the tray structure.

The reagent unit 20 is used to carry reagents. In an embodiment, the reagent unit 20 is disposed in a disk-shaped structure, the reagent unit 20 has a plurality of positions for carrying reagent containers, and the reagent unit 20 can rotate and drive the reagent containers carried by the reagent unit to rotate for rotating the reagent containers to a reagent sucking position, so that the dispensing mechanism 30 sucks the reagent. The number of the reagent unit 20 may be one or more.

The dispensing mechanism 30 is used to aspirate and discharge a sample or a reagent. In some embodiments, the dispensing mechanism 30 may include a sample dispensing mechanism 31 and a reagent dispensing mechanism 33. The sample dispensing mechanism 31 is used to aspirate and discharge a sample into a container to be loaded. In some embodiments, the sample dispensing mechanism 31 may include a sample needle that is spatially moved in two or three dimensions by a two or three dimensional driving mechanism, so that the sample needle can be moved to aspirate a sample carried by the sample cell 10 and to a position of a container to be loaded and discharge the sample into the container. In some embodiments, the reagent dispensing mechanism 33 may include a reagent needle that performs two-dimensional or three-dimensional motion in space by a two-dimensional or three-dimensional driving mechanism, so that the reagent needle can move to aspirate a reagent carried by the reagent unit 20 and to a position of a container to which the reagent is to be added and discharge the reagent to the container. In some embodiments, the sample dispensing mechanism 31 and the reagent dispensing mechanism 33 may also share a set of driving mechanism and a needle, and when the sample dispensing mechanism 31 and the reagent dispensing mechanism 33 share a set of driving mechanism and a needle, cleaning of the needle is required when a sample and a reagent are sucked, so as to avoid cross contamination and other problems.

In fig. 4, the reaction member 41 is used to carry an assay sample prepared from a sample and a detection reagent. In one example, the reaction component 41 is configured in a disc-shaped structure, and has a plurality of placing positions for placing a first container, such as a reaction cup, and the reaction component 41 can rotate and drive the reaction cup in the placing position to rotate for scheduling the reaction cup in the reaction tray and incubating a mixed solution in the reaction cup. The sample detection site may be on the reaction part 41, i.e. some placement sites on the reaction part 41 are sample detection sites; the sample detection site may also be provided independently of the reaction part 41, i.e., at a position close to the reaction part 41, for example.

The light irradiation unit 50 is used to supply light for measurement. In some embodiments, the illumination component 50 is capable of providing two intensities of light, for example, a first intensity of light and a second intensity of light, wherein the first intensity is less than the second intensity. The light of the first intensity may be the intensity of light normally used for measuring a sample, and the light of the second intensity may be light having a higher intensity than the light of the first intensity, and may be used for measuring a sample containing an interfering substance in the present invention. Specifically, the illumination section 50 is for illuminating a first container (e.g., cuvette) which is located at a sample measurement site and which contains a measurement sample prepared from a sample to be measured and a detection reagent, as described above; the illumination component 50 is capable of providing a first intensity of light and a second intensity of light to the sample measurement site.

In some embodiments, the illumination component 50 provides the first intensity of light and the second intensity of light to the sample measurement site during each illumination cycle, for example, referring to fig. 5 (a), the first wavelength and the first intensity of light, the first wavelength and the second intensity of light are sequentially output according to a predetermined compliance during each illumination cycle; alternatively, referring to fig. 5 (b), the light with the first wavelength and the first intensity and the light with the second wavelength and the second intensity are sequentially output according to a predetermined compliance in each illumination period.

In order to allow the sample measuring site to perform a plurality of items of detection, i.e., to support items of detection such as measurement by coagulation, immunoturbidimetry, and chromogenic substrates, the light irradiation means 50 may include a multi-wavelength light source, i.e., may supply light of a plurality of wavelengths to the sample measuring site. For example, the first intensity of light provided by the illumination component 50 includes: at least one of, two of, or three of light of a first wavelength for measurement by a chromogenic substrate method, light of a second wavelength for measurement by immunoturbidimetry, and light of a third wavelength for measurement by a coagulation method; in some embodiments, the first wavelength is in the range of 340nm to 420nm, the second wavelength is in the range of 520nm to 590nm, and the third wavelength is in the range of 660nm to 800nm. Further, the light of the second intensity provided by the illumination component 50 may include light of a fourth wavelength, which is not less than any one of the first wavelength, the second wavelength or the third wavelength; in one example the first wavelength < the second wavelength < the third wavelength ≦ the fourth wavelength. In one specific example, the illumination component 50 can sequentially output 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 according to a predetermined compliance in each illumination period. In another specific example, the illumination component 50 may sequentially output light of a first wavelength and a first intensity, light of a third wavelength and a first intensity, light of a second wavelength and a first intensity, light of a fourth wavelength and a first intensity, and light of a fourth wavelength and a second intensity according to a predetermined compliance during each illumination period. In another embodiment, the illumination component 50 can sequentially output light of a first wavelength and a first intensity, light of a third wavelength and a first intensity, light of a second wavelength and a first intensity, light of a fourth wavelength and a first intensity, light of a first wavelength and a second intensity, light of a third wavelength and a second intensity, light of a second wavelength and a second intensity, and light of a fourth wavelength and a second intensity according to a predetermined compliance during each illumination period. Fig. 6 (a) and 6 (b) are two examples.

Referring to fig. 7, in order to simplify the structure, in some embodiments, the illumination component 50 may include a light source 51 and a one-to-many optical fiber bundle 59, such that the light source 51 can provide light to the plurality of sample measurement positions, and specifically, the one-to-many optical fiber bundle 59 includes a plurality of optical fibers respectively corresponding to the plurality of sample measurement positions, each of the optical fibers being used for providing the light of the first intensity and the light of the second intensity to the corresponding sample measurement position. Specifically, referring to fig. 8, the light source 51 may include a first light source 52, a second light source 53 and a third light source 54, wherein the first light source 52 provides light with a first wavelength, the second light source 53 provides light with a second wavelength, the third light source 54 provides light with a third wavelength, and the light with the first wavelength, the second wavelength and the third wavelength are all light with a first intensity. In some embodiments, the light source 51 may further include a fourth light source 55 for providing light of a fourth wavelength and a first intensity and light of a fourth wavelength and a second intensity in a time-sharing manner during an illumination cycle; i.e. the fourth light source 55 may provide light of a fourth wavelength of two photometric levels. It is understood that, in order to improve the performance of light, some optical components for focusing, such as a focusing lens, etc., may be further added between the light source 51 and the one-to-many fiber bundle 59; an associated collimating lens may also be added between the one-to-many fiber bundle 59 and each sample-side location to improve the performance of the light directed to the sample-side location.

The light source 51 providing light of the above wavelengths and intensities may be implemented in a number of configurations, as described in more detail below.

In some embodiments, referring to fig. 9, the illumination component 50 further includes a driving circuit 56, the driving circuit 56 is connected to the first light source 52, the second light source 53, the third light source 54 and the fourth light source 55, and is configured to provide 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 with a first intensity; and also for providing a first driving current and a second driving current in a time-sharing manner to drive the fourth power supply 55 to generate light with a first intensity and a second intensity, wherein the second driving current is greater than the first driving current. By supplying different driving currents to the fourth light source 55, the fourth light source 55 generates light with different intensities. For example, as shown in fig. 6 (a), the first light source 52, the second light source 53, the third light source 54 and the fourth light source 55 are controlled by the driving circuit 56 to flash in time division during one illumination period to ensure that each time the cuvette is illuminated with a specific wavelength; during driving, in one illumination period, the LEDs of the first light source 52, the second light source 53, and the third light source 54 each blink once, the fourth light source 55 blinks twice, and the two times of the fourth light source 55 are lit with different driving currents, that is, the light sources blink five times in one period; the first four illumination sources in one illumination cycle are used for normal testing of the undisturbed sample and the last four illumination sources 55 with a greater drive current are used for testing of the disturbed sample. One illumination period in this context may be 0.1s.

Similarly, in some embodiments, the driving circuit 56 may also cause the first light source 52 to generate light of different intensities by providing different driving currents to the first light source 52; in some embodiments, the driving circuit 56 may also cause the second light source 53 to generate light of different intensities by providing different driving currents to the second light source 53; in some embodiments, the driving circuit 56 may also cause the third light source 54 to generate light of different intensities by providing different driving currents to the third light source 54.

In some embodiments, referring to FIG. 10, the light source 51 may also be implemented by a multi-wavelength light source 57 and a rotating filter 58. The multi-wavelength light source 57 provides light of a plurality of wavelengths, such as light of a first wavelength, light of a second wavelength, light of a third wavelength, and light of a fourth wavelength. In some examples, the multi-wavelength light source 57 may be implemented using a halogen lamp. The rotating filter 58 includes a filter and an attenuator, and the light irradiation unit 50 is configured to provide light with different wavelengths and different intensities in a time-sharing manner when the rotating filter 58 rotates, for example, light with a first wavelength and a first intensity, light with a second wavelength and a first intensity, light with a third wavelength and a first intensity, light with a fourth wavelength and a first intensity, and light with a fourth wavelength and a second intensity. The light may then be provided to a plurality of sample measurement locations by passing through a one-to-many fiber optic bundle 59. It will be appreciated that optical components, such as lens assemblies, may be added between the multi-wavelength light source 57 and the rotary filter 58 to improve the illumination performance.

The above is an example in which the light irradiation section 50 supplies light of different wavelengths and different intensities to a plurality of samples at the time of measuring the position through the one-to-many optical fiber bundle 59.

In some examples, the illumination assembly 50 may also be configured with a multi-wavelength light source for each sample measurement site, each multi-wavelength light source capable of providing light of a different wavelength and at a different intensity to the corresponding sample measurement site.

Referring to fig. 11, in some examples, the illumination component 50 may also be configured to provide a single-wavelength light source for each sample measurement site, each of the single-wavelength light sources being capable of providing light of a single wavelength and different intensities to the corresponding sample measurement site. For example, some sample assay sites are provided with a light source of a first wavelength capable of providing light of a first wavelength and a first intensity to the corresponding sample assay site, and light of the first wavelength and a second intensity, the different intensities of light being realized by different drive currents or attenuation sheets, and the sample assay sites can be assayed for detection items supporting the chromogenic substrate method; similarly, some sample measurement locations are configured with a light source of a second wavelength capable of providing a light of a second wavelength and a first intensity, and a light of a second wavelength and a second intensity, to the corresponding sample measurement location at which an immunoturbidimetric assay-supporting test item can be determined; a light source of a third wavelength is arranged at some of the sample measurement sites, and the light source of the third wavelength is capable of supplying light of the third wavelength and the first intensity and light of the third wavelength and the second intensity to the corresponding sample measurement sites, and the detection items supporting the coagulation method can be measured at the sample measurement sites.

In some examples, the sample analysis device also provides interferent detection sites, as will be further described below. The illumination means 50 may also provide illumination to the perturber detection site, for example by a one-to-many fiber optic bundle 59, so that the illumination means 50 illuminates the sample detection site and the perturber detection site the same, as is the case in fig. 12. In the figure, the violet LED provides 405nm light, the green LED provides 575nm light, the red LED provides 660nm light, and the infrared LED provides 800nm light, which are coupled together into the optical fiber of the one-component optical fiber bundle 59 by three dichroic mirror bundles, wherein the one-component optical fiber bundle 59 is divided into a plurality of small fiber ends, one of which can be used for illuminating a second container (such as a colorimetric cell or a reaction cup) at the interference detection position for detecting the interferent in the sample, such as the type and content of the interferent, and the other small fiber ends are used for illuminating a first container (such as a reaction cup) of the contained measurement sample, although the LED light source in the figure can be replaced by other types of light sources, such as an LD light source or a halogen lamp. In some examples, the illumination component 50 may also independently provide illumination to the sample detection site and the interferent detection.

The above is some description of the light irradiation means 50, and the following description is made of the optical detection means 60.

The optical detection part 60 is fitted with the illumination part 50. In some embodiments, the optical detection component 60 includes a first detector 61 adjacent to the sample measurement site. The first detector 61 is configured to receive an output optical signal of the first container irradiated with the light from the light irradiation unit 50, and acquire optical detection information of the measurement sample, where 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 light irradiation means 50 irradiates the first container containing the measurement sample at the sample measurement position with light of the first intensity, the first detector 61 obtains first optical detection information corresponding to the light of the first intensity by sensing transmission, reflection, scattered light, or the like of the first container containing the measurement sample to the light of the first intensity; similarly, after the light irradiation section 50 irradiates the first container containing the measurement sample at the sample measurement position with light of the second intensity, the first detector 61 acquires second optical detection information corresponding to the light of the second intensity by sensing transmission, reflection, scattered light, or the like of the light of the second intensity by the first container containing the measurement sample. In some examples, the first detector 61 detects the transmitted light transmitted through the measurement sample. In some examples, the first detector 61 may be implemented by a component capable of converting an optical signal into an electrical signal, such as a photodetector, and in particular, may 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 type detector ICCD, an electron multiplication type EMCCD, or the like. It will be appreciated that typically a sample measurement site is provided with a first detector 61, i.e. there is a corresponding first detector 61 for each sample measurement site.

The analyzing section 70 analyzes the sample detection item through one of the first optical detection information and the second optical detection information. In some embodiments, the analysis component 70 selects the first optical detection information corresponding to the light with the first intensity or the second optical detection information corresponding to the light with the second intensity according to a preset condition to perform the sample detection result analysis. The preset condition may be a condition related to the detection information of the sample interferent, and the analyzing unit 70 is configured to select the second optical detection information corresponding to the light of the second intensity for analysis when the interferent of the sample to be detected exceeds a preset threshold; and when the interferent of the sample to be detected does not exceed the preset threshold value, selecting first optical detection information corresponding to the light with the first intensity for analysis. In some embodiments, the sample interferent detection information comprises at least one of absorbance or luminous flux of the sample to be detected; the absorbance of the sample to be detected represents the absorption degree of the sample to be detected to light when the sample to be detected is irradiated by the light; if the absorbance of the sample to be detected to the preset wavelength exceeds a preset absorbance threshold, for example, the absorbance of at least one of 405nm, 575nm, 660nm and 800nm exceeds a corresponding absorbance threshold, it indicates that the interferent of the sample to be detected exceeds the preset threshold, and anti-interference detection needs to be performed by increasing the light intensity or other methods; the luminous flux of the sample to be detected represents the degree of light passing through the sample to be detected when the sample to be detected is irradiated by light, and the luminous flux of the sample to be detected can be the initial luminous flux detected before the sample to be detected is subjected to formal coagulation item detection; if the initial luminous flux of the sample to be detected is lower than a preset luminous flux threshold value, the fact that the interferent of the sample to be detected exceeds the preset threshold value is indicated, and anti-interference detection needs to be carried out in a mode of improving light intensity.

The above are some descriptions of the sample analyzing apparatus. It can be seen that two links are involved, namely, the detection of the interferent on the sample to be detected, and the analysis of the sample detection item by selecting the optical detection information corresponding to the light with the proper intensity from the two light intensities. The following are described separately.

Referring to fig. 13, in some embodiments, the sample analyzer may further include an interferent detection part 80, and the interferent detection part 80 includes at least one interferent detection bit and a second detector 81 adjacent to the interferent detection bit. The second detector 81 may be implemented by a component capable of converting an optical signal into an electrical signal, such as a photodetector or the like, and specifically may 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 type detector ICCD, an electron multiplication type EMCCD, or the like. The illumination means 50 is for illuminating a second container (e.g., a reaction cup or a cuvette, etc.) containing at least the specimen at the interfering substance detection site, for example, the illumination means 50 is illuminated by light of a first intensity; the second detector 81 is configured to receive an output optical signal of the second container irradiated by the illumination component 50 to obtain detection information of an interfering object of the sample to be detected; the interferent detection information is used for indicating whether the interferent of the sample to be detected exceeds a preset threshold value. Therefore, from the viewpoint of the test flow, the controller 40 may be configured to control the dispensing mechanism 30 to dispense a part of the sample to be tested and the diluent to the second container so as to perform the interferent detection of the sample at the interferent detection site, and then the controller may control the dispensing mechanism 30 to dispense the remaining part of the sample to be tested and the detection reagent to the first container so as to perform the analysis of the sample detection item at the sample detection site; then, at the sample detection site, the illumination unit 50 may sequentially provide the first intensity of light and the second intensity of light to the sample detection site, or may provide only one intensity of light according to the detection information of the interfering object, for example, when the interfering object of the sample detected at the interfering object detection site does not exceed a preset threshold, then the sample is detected at the sample detection site, only the first intensity of light may be provided; when the interferent detected at the interferent detection site of the sample exceeds the preset threshold, the light may be provided at only the second intensity when the sample is subsequently detected at the sample detection site.

The introduction of the interference detection component 80 can detect the interferent in the sample to be detected, and obtain the detection information of the sample interferent. In other embodiments, the interferent detection site may not be additionally provided, but the interferent detection on the sample to be detected is realized while the sample is determined by the sample measurement site, which is described in detail below.

In some embodiments, the illumination component 50 illuminates a first container containing a measurement sample at a sample measurement position through light of a first intensity, and the first detector 61 is configured to receive an output optical signal of the first container illuminated by the illumination component 50 to obtain detection information of an interfering object of the sample to be measured; the interferent detection information is used for judging whether interferents of the sample to be detected exceed a preset threshold value; specifically, if the analyzing unit 50 determines that the interfering substance of the sample to be measured does not exceed the preset threshold value through the first optical detection information corresponding to the light of the first intensity, the first optical detection information is directly used to analyze the sample measurement item, and the subsequent illuminating unit 50 may also continue to illuminate the first container containing the measurement sample at the sample measurement position without using the light of the second intensity; on the contrary, if the analyzing part 50 judges that the interfering substance of the sample to be measured exceeds the preset threshold value through the first optical detection information corresponding to the light of the first intensity, the illuminating part 50 then continues to illuminate the first container containing the measurement sample at the sample measurement position with the light of the second intensity, and selects the second optical detection information corresponding to the light of the second intensity to perform the analysis of the sample detection item. Of course, the illumination unit 50 may provide the first intensity light and the second intensity light to the sample measurement site in sequence in one illumination period, acquire the first optical detection information corresponding to the first intensity light and the second optical detection information corresponding to the second intensity light, determine whether the interferent of the sample to be measured exceeds the preset threshold value through the first optical detection information, and select one of the first optical detection information and the second optical detection information according to the determination result to analyze the sample detection item. Therefore, in view of the test flow, the controller 40 can directly control the dispensing mechanism 30 to dispense the sample to be tested and the detection reagent into the first container so that the detection of the interfering substance and the analysis of the sample detection item are performed at the sample detection site, instead of controlling the dispensing mechanism 30 to dispense the part of the sample to be tested and the diluent into the second container to perform the detection of the interfering substance at the interfering substance detection site.

Of course, in other embodiments, the interferent detection information may be obtained using the average light flux over the time period after the first container containing the assay sample is placed in the sample testing position and before the test is initiated. In one example, when the sample is added to the last step of the trigger reagent, the mixing and moving of the mixture to the sample measurement position may be completed within generally 3s, and then the detection is started at 10s, and at 7s between 3s and 10s, the illumination component 50 irradiates a first container containing the measurement sample at the sample measurement position with light of a first intensity, and the first detector 61 is configured to receive an output optical signal of the first container irradiated by the illumination component 50, for example, an average light flux minimum light transmission amount during the period, so as to obtain the interferent detection information of the sample to be detected. If the analyzing part 50 judges that the interferent of the sample to be measured does not exceed the preset threshold value through the interferent detection information, the illuminating part 50 still illuminates the measurement sample with light of the first intensity, and the analyzing part 50 analyzes the sample detection item through first optical detection information corresponding to the light of the first intensity; if the analyzing part 50 judges that the interfering substance of the sample to be measured exceeds the preset threshold value through the interfering substance detection information, the illuminating part 50 then illuminates the measurement sample with light of the second intensity, and the analyzing part 50 performs analysis of the sample detection item through the second optical detection information corresponding to the light of the second intensity.

In the above embodiments of detecting a sample interfering substance, it can be understood that a person skilled in the art may also use other methods to detect a sample interfering substance, for example, by taking a picture of a sample to be detected, obtaining an image of the sample to be detected, and then analyzing the image by a method such as machine learning, so as to obtain the detecting information of the sample to be detected.

The above is a sample analysis device according to some embodiments of the present invention.

Referring to fig. 14 and 15, in some embodiments of the present invention, a method for analyzing a sample is further provided, including the following steps:

step 110: irradiating a first container located at a sample measurement site and containing a measurement sample with light of a first intensity and light of a second intensity during an illumination period; the determination sample is prepared from a sample to be detected and a detection reagent.

In some embodiments, the step 110 sequentially outputs the light of the first wavelength and the first intensity, the light of the first wavelength and the light of the second intensity according to a preset compliance in one illumination period; or, the light with the first wavelength and the first intensity and the light with the second wavelength and the second intensity are output in turn according to a preset compliance in each illumination period.

In order to allow the sample assay site to perform a plurality of items of detection, i.e., to support items of detection such as those determined by coagulation, immunoturbidimetry, and chromogenic substrates, step 110 may provide light at multiple wavelengths to the sample assay site. For example, the first intensity of light provided at step 110 includes: at least one of, two of, or three of light of a first wavelength for measurement by a chromogenic substrate method, light of a second wavelength for measurement by an immunoturbidimetric method, and light of a third wavelength for measurement by a coagulation method; in some embodiments, the first wavelength is in the range of 340nm-420nm, the second wavelength is in the range of 520nm-590nm, and the third wavelength is in the range of 660nm-800nm. Further, the light of the second intensity provided in step 110 may include light of a fourth wavelength, where the fourth wavelength is not less than any of the first wavelength, the second wavelength, or the third wavelength; in one example the first wavelength < the second wavelength < the third wavelength ≦ the fourth wavelength. In one specific example, step 110 may sequentially output 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 according to a predetermined compliance during each illumination period. In another embodiment, step 110 may sequentially output the light of the first wavelength and the first intensity, the light of the third wavelength and the first intensity, the light of the second wavelength and the first intensity, the light of the fourth wavelength and the first intensity, and the light of the fourth wavelength and the second intensity according to a predetermined compliance during each illumination period. In another embodiment, step 110 may sequentially output light of a first wavelength and a first intensity, light of a third wavelength and a first intensity, light of a second wavelength and a first intensity, light of a fourth wavelength and a first intensity, light of a first wavelength and a second intensity, light of a third wavelength and a second intensity, light of a second wavelength and a second intensity, and light of a fourth wavelength and a second intensity according to a predetermined compliance during each illumination period.

Step 120: and acquiring optical detection information corresponding to the light with the first intensity and the light with the second intensity.

For example, after the first container containing the measurement sample and located at the sample measurement position is irradiated with light of the first intensity in step 110, step 120 acquires first optical detection information corresponding to the light of the first intensity by sensing transmission, reflection, or scattered light, etc. of the light of the first intensity by the first container containing the measurement sample; similarly, after the first container containing the measurement sample and located at the sample measurement site is irradiated with light of the second intensity in step 110, second optical detection information corresponding to the light of the second intensity is acquired by sensing transmission, reflection, scattering light, or the like of the light of the second intensity by the first container containing the measurement sample in step 120. In some examples, step 120 detects transmitted light transmitted through the assay sample.

Step 130: and obtaining the detection information of the interferent of the sample to be detected.

In some embodiments, the interferent detection information includes at least one of an absorbance of the light of the predetermined wavelength by the sample to be detected or a luminous flux of the sample to be detected. The absorbance of the sample to be detected represents the absorption degree of the sample to be detected to light when the sample to be detected is irradiated by light; if the absorbance of the sample to be detected to the preset wavelength exceeds a preset absorbance threshold, for example, the absorbance of at least one of 405nm, 575nm, 660nm and 800nm exceeds a corresponding absorbance threshold, it indicates that the interferent of the sample to be detected exceeds the preset threshold, and anti-interference detection needs to be performed by increasing the light intensity or other methods; the luminous flux of the sample to be detected represents the degree of light passing through the sample to be detected when the sample to be detected is irradiated by light, and the luminous flux of the sample to be detected can be the initial luminous flux detected before the sample to be detected is subjected to formal coagulation item detection; if the initial luminous flux of the sample to be detected is lower than a preset luminous flux threshold value, the fact that the interferent of the sample to be detected exceeds the preset threshold value is indicated, and anti-interference detection needs to be carried out in a mode of improving light intensity.

Step 140: and if the interferent of the sample to be detected exceeds a preset threshold value, selecting optical detection information corresponding to the light with the second intensity.

Step 150: and if the interferent of the sample to be detected does not exceed the preset threshold value, selecting optical detection information corresponding to the light with the first intensity.

Step 160: and analyzing the detection result of the sample according to the selected optical detection information.

Step 170: and outputting a sample detection result and detection information of the interferent.

The above is a flow chart of some of the steps of the method of sample analysis. Next, how to obtain the interferent detection information of the sample to be detected in step 130 is described.

In some embodiments, the interferent detection information of the sample to be detected may be obtained by introducing interferent detection bits that are distinct from the sample detection bits to perform interferent detection on the sample. The specific process can be that a part of the sample to be detected and the diluent are separately injected into a second container; in some cases, the second container may be a cuvette. Accordingly, another portion of the sample to be measured and the detection reagent may then be dispensed into the first container to prepare the assay sample, and the first container may then be transported to the sample measurement location. In this method, the analyte is detected in the sample before the preparation of the measurement sample. The detailed description of how to perform the interferent detection on the sample at the interferent detection site is given above, and will not be repeated herein.

In other embodiments, the interferent detection may be performed on the sample at the sample measurement site to obtain interferent detection information of the sample to be measured, for example, the interferent detection may be performed on the measurement sample at the sample measurement site by using the light with the first intensity.

Specifically, the detection information of the interfering object of the sample to be detected is obtained through first optical detection information corresponding to the light with the first intensity, when the interfering object of the sample to be detected is judged not to exceed a preset threshold value, the first optical detection information is directly used for analyzing the sample detection item, and the first container which is provided with the detection sample at the sample detection position can be continuously irradiated by the light with the second intensity subsequently; on the contrary, if it is determined that the interfering substance of the sample to be measured exceeds the preset threshold value through the first optical detection information corresponding to the light of the first intensity, the first container containing the measurement sample at the sample measurement position is continuously irradiated with the light of the second intensity, and the second optical detection information corresponding to the light of the second intensity is selected to analyze the sample detection item. Of course, the first intensity light and the second intensity light may be sequentially provided to the sample measurement site in one illumination period, the first optical detection information corresponding to the first intensity light and the second optical detection information corresponding to the second intensity light are acquired, then the first optical detection information is used as the interferent detection information to determine whether the interferent of the sample to be measured exceeds the preset threshold, and then one of the first optical detection information and the second optical detection information is selected according to the determination result to analyze the sample detection item. Therefore, in the test flow, the sample and the detection reagent can be directly dispensed into the first container so as to detect the interfering substance and analyze the sample detection item at the sample detection site, without controlling the dispensing mechanism 30 to dispense a part of the sample and the diluent into the second container to detect the interfering substance at the interfering substance detection site.

Referring to fig. 16, a sample analysis method according to some embodiments includes the following steps:

step 210: and obtaining the detection information of the interferent of the sample to be detected.

Step 210 is to obtain the interferent detection information of the sample to be tested, which may refer to the above description of step 130, for example, step 210 may be to introduce interferent detection bits different from the sample detection location to perform interferent detection on the sample, or may be to perform interferent detection on the sample at the sample detection location, for example, to obtain the interferent detection information by obtaining the initial light flux detected at the sample detection location before the sample to be tested is subjected to the detection of the formal coagulation item.

Step 220: and judging whether the interferent of the sample to be detected exceeds a preset threshold value according to the acquired interferent detection information of the sample to be detected.

Step 230: and if the interferent of the sample to be detected does not exceed the preset threshold value, driving the illumination component by the first driving current. The illumination means, like the first light source, the second light source, the third light source, and even the fourth light source, are driven with a first drive current, for example by a drive circuit, to provide light of a first intensity to the sample assay site.

Step 240: and if the interferent of the sample to be detected exceeds a preset threshold value, driving the illumination component by using a second driving current. The illumination means, like the fourth light source, is driven with a second drive current, for example by a drive circuit, even in addition to the first light source, the second light source and the third light source, to provide light of a second intensity to the sample measuring location. It will be appreciated that the second drive current is greater than the first drive current, such that the second intensity is greater than the first intensity.

Step 250: and analyzing the detection result of the sample according to the optical detection information. It is understood that if the driving is performed with the first driving current in step 230, the optical detection information corresponding to the light with the first intensity can be obtained, and the sample detection result analysis is performed with the optical detection information corresponding to the light with the first intensity in step 250; if the driving is performed at the second driving current in step 230, the optical detection information corresponding to the second intensity of light can be obtained, and the analysis of the detection result of the sample is performed in step 250 according to the optical detection information corresponding to the second intensity of light.

Of course, after the sample detection result is analyzed in step 250, the detection result may be output, and even the detection information of the interferent of the sample to be detected may be output.

Referring to fig. 17, a sample analysis method according to some embodiments includes the following steps:

step 310: and acquiring the luminous flux of the sample to be detected.

In some examples, the light flux of the sample to be measured may be obtained at a detection site distinct from the sample measurement site. The specific process can be that a part of the sample to be detected and the diluent are separately injected into a second container; the second container is conveyed to the detection position, and then the detection position is irradiated through the illumination component, for example, the first intensity of light can be provided, and the luminous flux of the second container after being irradiated by the illumination component is obtained; at the same time, another part of the sample to be measured and the detection reagent may be dispensed into the first container to prepare the measurement sample, and then the first container may be transported to the sample measurement site.

In other examples, the light flux of the sample to be measured may be an initial light flux detected before the sample to be measured is subjected to the detection of the formal coagulation item, for example, before the measurement sample is prepared and the detection of the formal coagulation item is started at the sample measurement site, the measurement sample is irradiated with light, which is irradiated to the measurement site by the light irradiation means, to provide light of a first intensity, and then the light flux after the light passes through the measurement sample is obtained.

Step 320: and judging whether the luminous flux of the sample to be detected exceeds a threshold value.

Step 330: if the luminous flux of the sample to be measured exceeds the threshold value, the illumination part is driven by the first driving current. The illumination means, like the first light source, the second light source, the third light source, and even the fourth light source, are driven at a first drive current, for example by a drive circuit, to provide light of a first intensity to the sample assay site.

Step 340: and if the luminous flux of the sample to be measured does not exceed the threshold value, driving the illumination component by using a second driving current. The illumination means, like the fourth light source, is driven with a second drive current, for example by a drive circuit, even in addition to the first light source, the second light source and the third light source, to provide light of a second intensity to the sample measuring location. It will be appreciated that the second drive current is greater than the first drive current, such that the second intensity is greater than the first intensity.

Step 350: and analyzing the detection result of the sample according to the optical detection information. It is understood that if the driving is performed with the first driving current in step 330, the optical detection information corresponding to the light with the first intensity can be obtained, and the analysis of the detection result of the sample is performed with the optical detection information corresponding to the light with the first intensity in step 350; if the driving is performed at the second driving current in step 330, the optical detection information corresponding to the light of the second intensity can be obtained, and the analysis of the detection result of the sample is performed at step 350 according to the optical detection information corresponding to the light of the second intensity.

Of course, after the analysis of the detection result of the sample is performed in step 350, the detection result may also be output, and even the data of the light flux of the sample to be detected may also be output.

Herein, the sample to be tested may be blood, and the interferent includes at least one of hemoglobin, bilirubin, and chyle.

The sample with the interferent is tested by the stronger light, in some cases even the stronger light has larger wavelength, so that the influence of the interferent on the sample determination can be effectively reduced; however, when a sample with no or less interferent is measured normally, the degree of normal light intensity is still used, because if a sample with no or less interferent is measured with stronger light, the received light detection information is oversaturated, and the measurement cannot be performed normally. In specific implementation, the light with large light intensity can be added in one illumination period, so that the test of a sample with an interferent and a sample without the interferent can be completed by sample test positioning, specifically, the optical detection information corresponding to the light with which intensity is selected to carry out sample analysis according to the detection result of the interferent, the influence of the interferent on the test is effectively solved, and the test flow is simplified.

In summary, the present invention can adjust the light intensity when measuring the sample according to the detection information of the interferent, adjust the light intensity when judging that the interferent of the sample to be measured does not exceed the preset threshold, irradiate the measurement sample with the light of the first intensity to perform item detection on the sample, and adjust the light intensity when judging that the interferent of the sample to be measured exceeds the preset threshold, irradiate the measurement sample with the light of the second intensity to perform item detection on the sample. Alternatively, the present invention may analyze the sample detection items by irradiating the measurement sample with light of the first intensity and light of the second intensity sequentially in one light irradiation cycle, and then selecting optical detection information corresponding to one of the intensities of light from the interfering object detection information of the sample.

In other embodiments, the illumination component 50 may provide a first intensity of light to test the sample during the normal test, and the illumination component 50 provides a second intensity of light to test the sample when the analysis component 70 or the user determines that the retest is required, that is, when the retest of the sample is performed.

Reference is made herein to various exemplary embodiments. However, those skilled in the art will recognize that changes and modifications may be made to the exemplary embodiments without departing from the scope hereof. For example, the various operational steps, as well as the components used to perform the operational steps, may be implemented in differing ways depending upon the particular application or consideration of any number of cost functions associated with operation of the system (e.g., one or more steps may be deleted, modified or incorporated into other steps).

In the above embodiments, it may be implemented in whole or in part by software, hardware, firmware, or any combination thereof. Additionally, as will be appreciated by one skilled in the art, the principles herein may be reflected in a computer program product on a computer readable storage medium, which is 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-to-ROM, DVD, blu-Ray discs, etc.), flash memory, and/or the like. These computer program instructions may be loaded onto a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions which execute on the computer or other programmable data processing apparatus create means for implementing the functions specified. These computer program instructions may also be stored in a computer-readable memory that can direct a computer or other programmable data processing apparatus to function in a particular manner, such that the instructions stored in the computer-readable memory produce an article of manufacture including means for implementing the function specified. The computer program instructions may also be loaded onto a computer or other programmable data processing apparatus to cause a series of operational steps to be performed on the computer or other programmable apparatus to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide steps for implementing the functions specified.

While the principles herein have been illustrated in various embodiments, many modifications of structure, arrangement, proportions, elements, materials, and components particularly adapted to specific environments and operative requirements may be employed without departing from the principles and scope of the present disclosure. The above modifications and other changes or modifications are intended to be included within the scope of this document.

The foregoing detailed description has been described with reference to various embodiments. However, one skilled in the art will recognize that various modifications and changes may be made without departing from the scope of the present disclosure. Accordingly, the disclosure is to be considered in an illustrative and not a restrictive sense, and all such modifications are intended to be included within the scope thereof. Also, advantages, other advantages, and solutions to problems have been described above with regard to various embodiments. However, the benefits, advantages, solutions to problems, and any element(s) that may cause any benefit, advantage, or solution to occur or become more pronounced are not to be construed as critical, required, or essential. As used herein, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, system, article, or apparatus. Furthermore, the term "coupled," and any other variation thereof, as used herein, refers to a physical connection, an electrical connection, a magnetic connection, an optical connection, a communicative connection, a functional connection, and/or any other connection.

Those having skill in the art will recognize that many changes may be made to the details of the above-described embodiments without departing from the underlying principles of the invention. The scope of the invention should, therefore, be determined only by the following claims.

Claims

A sample analysis device, comprising:

the illumination component is used for illuminating a first container which is positioned at a sample measuring position and is filled with a measuring sample, and the measuring sample is prepared from a sample to be measured and a detection reagent; wherein the illumination component is capable of providing a first intensity of light and a second intensity of light to the sample measurement location, the first intensity being less than the second intensity;

an optical detection unit including a first detector adjacent to the sample measurement site for receiving an output optical signal of the first container irradiated by the illumination unit to obtain optical detection information of the measurement sample, the optical detection information including first optical detection information corresponding to light of a first intensity and second optical detection information corresponding to light of a second intensity;

and the analysis component is used for selecting second optical detection information corresponding to the light with the second intensity to analyze the sample detection item when the interferent of the sample to be detected exceeds a preset threshold value, and selecting first optical detection information corresponding to the light with the first intensity to analyze the sample detection item when the interferent of the sample to be detected does not exceed the preset threshold value.
The sample analysis device of claim 1, wherein the illumination component provides a first intensity of light and a second intensity of light to the sample measurement location during each illumination cycle.
The sample analyzer of claim 2, wherein the illumination component comprises a multi-wavelength light source, and different illumination lights are sequentially output in a predetermined sequence in each illumination cycle, and the different illumination lights in each illumination cycle comprise a first wavelength and a first intensity of light and a first wavelength and a second intensity of light, or comprise a first wavelength and a first intensity of light and a second wavelength and a second intensity of light.
The sample analysis device of any of claims 1 to 3, wherein the first intensity of light provided by the illumination component comprises: at least one of light of a first wavelength for measurement by a chromogenic substrate method, light of a second wavelength for measurement by immunoturbidimetry, and light of a third wavelength for measurement by a coagulation method; preferably, the first wavelength is in the range of 340nm to 420nm, the second wavelength is in the range of 520nm to 590nm, and the third wavelength is in the range of 660nm to 800nm.
The sample analyzer of claim 1, 2, or 4, wherein the illumination component sequentially 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 predetermined order in each illumination cycle, wherein the first wavelength < the second wavelength < the third wavelength ≦ the fourth wavelength.
The sample analysis device of any one of claims 1-5, further comprising an interferent detection means comprising at least one interferent detection site and a second detector adjacent to the interferent detection site; the illumination component is used for illuminating a second container which is positioned at an interfering object detection position and at least contains a sample, and the second detector is used for receiving an output optical signal of the second container after the second container is illuminated by the illumination component so as to obtain interfering object detection information of the sample to be detected; the interferent detection information is used for indicating whether interferents of the sample to be detected exceed a preset threshold value.
The apparatus according to any one of claims 1 to 5, wherein the illumination means illuminates a first container containing the measurement sample at the measurement position of the sample with light of a first intensity, and the first detector is configured to receive an output optical signal of the first container illuminated by the illumination means to obtain the detection information of the interferent in the sample; and the interferent detection information is used for judging whether the interferent of the sample to be detected exceeds a preset threshold value.
The sample analyzer according to claim 6 or 7, further comprising a dispensing mechanism and a controller for controlling the dispensing mechanism to dispense a part of the sample and a diluent to the second container or controlling the dispensing mechanism to dispense the sample and a detection reagent to the first container.
The sample analyzing apparatus according to any one of claims 1 to 8, wherein the sample to be measured is blood, and the interfering substance includes at least one of hemoglobin, bilirubin, and chyle.
The sample analysis device of any of claims 1-9, wherein there are a plurality of sample testing sites; the illumination component includes a light source and a one-to-many fiber bundle including a plurality of optical fibers respectively corresponding to the sample measurement locations, each optical fiber for providing the light of the first intensity and the light of the second intensity to the corresponding sample measurement location.
The sample analysis device of claim 10, wherein the light source comprises a first light source, a second light source, and a third light source that provide light at a first wavelength, a second wavelength, and a third wavelength, respectively, wherein the light at the first wavelength, the second wavelength, and the third wavelength are all at a first intensity.
The sample analyzing apparatus of claim 11, wherein the illumination assembly further comprises 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-sharing manner during an illumination period.
The sample analysis device of claim 12, wherein the illumination component further comprises a driving circuit coupled to the first, second, third, and fourth light sources for providing a first driving current to drive the first, second, and third light sources to generate the first intensity of light; and the fourth power supply is used for providing a first driving current and a second driving current in a time-sharing manner to drive the fourth power supply to generate light with the first intensity and the second intensity, and the second driving current is greater than the first driving current.
The sample analyzer of claim 10 wherein the illumination means comprises a multi-wavelength light source and a rotating filter, the rotating filter comprising a filter and an attenuator, the illumination means for providing light of different wavelengths and different intensities in a time-shared manner as the rotating filter rotates.
The sample analyzer of any of claims 1-9 wherein the illumination means comprises a plurality of multi-wavelength light sources corresponding to the plurality of sample assay sites, respectively.
A sample analysis apparatus, comprising:

the illumination component is used for illuminating a first container which is positioned at a sample measuring position and is filled with a measuring sample, and the measuring sample is prepared from a sample to be measured and a detection reagent; wherein the illumination component is capable of providing a first intensity of light and a second intensity of light to the sample measurement location, the first intensity being less than the second intensity;

an optical detection unit including a first detector adjacent to the sample measurement site for receiving an output optical signal of the first container irradiated by the illumination unit to obtain optical detection information of the measurement sample, the optical detection information including first optical detection information corresponding to light of a first intensity and second optical detection information corresponding to light of a second intensity;

and the analysis component is used for selecting first optical detection information corresponding to the light with the first intensity or second optical detection information corresponding to the light with the second intensity according to a preset condition and analyzing the detection result of the sample.
The sample analyzing apparatus according to claim 16, wherein the predetermined condition is a condition related to sample interferent detection information, and the analyzing means is configured to select the second optical detection information corresponding to the light of the second intensity for analysis when the interferent of the sample to be measured exceeds a predetermined threshold; and when the interferent of the sample to be detected does not exceed the preset threshold value, selecting first optical detection information corresponding to the light with the first intensity for analysis.
The sample analysis device of claim 17, wherein the sample interferent detection information comprises at least one of an absorbance or a luminous flux of the sample to be detected.
The sample analyzer of any of claims 16-18, wherein the illumination means comprises a multi-wavelength light source for sequentially outputting different illumination lights in a predetermined sequence during each illumination cycle, the different illumination lights during each illumination cycle comprising lights of a first wavelength and a first intensity and lights of the first wavelength and a second intensity provided in a time-sharing manner, or comprising lights of the first wavelength and the first intensity and lights of the second wavelength and the second intensity provided in a time-sharing manner.
The sample analysis device of any of claims 16-19, wherein the first intensity of light provided by the illumination component comprises: at least one of light of a first wavelength for measurement by a chromogenic substrate method, light of a second wavelength for measurement by immunoturbidimetry, and light of a third wavelength for measurement by a coagulation method; preferably, the first wavelength is in the range of 340nm-420nm, the second wavelength is in the range of 520nm-590nm, and the third wavelength is in the range of 660nm-800nm.
The sample analysis device of claim 20, wherein the second intensity of light provided by the illumination component comprises light at a fourth wavelength that is not less than any of the first, second, or third wavelengths.
A method of sample analysis, comprising:

irradiating a first container located at a sample measurement site and containing a measurement sample with light of a first intensity and light of a second intensity during an illumination period; the determination sample is prepared from a sample to be detected and a detection reagent;

acquiring optical detection information corresponding to the light with the first intensity and the light with the second intensity;

obtaining detection information of an interfering object of a sample to be detected;

if the interferent of the sample to be detected exceeds a preset threshold value, selecting optical detection information corresponding to the light with the second intensity;

if the interferent of the sample to be detected does not exceed the preset threshold value, selecting optical detection information corresponding to the light with the first intensity; and

and analyzing the detection result of the sample according to the selected optical detection information.
The method of claim 22, wherein said illuminating a first container at the sample testing location containing the test sample with a first intensity of light and a second intensity of light comprises:

in an illumination period, illuminating the measurement sample at the sample measurement position with light of a first wavelength and a first intensity and light of a first wavelength and a second intensity in a time-sharing manner; or within one illumination period, the light with the first wavelength and the first intensity and the light with the second wavelength and the second intensity are irradiated to the measurement sample of the sample measurement position in a time-sharing manner.
The method of claim 23, wherein said illuminating a first container at a sample testing location containing a test sample with a first intensity of light and a second intensity of light comprises:

in an illumination period, illuminating a measurement sample positioned for sample measurement with 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 time-sharing manner, wherein the first wavelength is less than the second wavelength and less than the third wavelength and less than or equal to the fourth wavelength;

preferably, the first wavelength is in the range of 340nm-420nm, the second wavelength is in the range of 520nm-590nm, and the third wavelength is in the range of 660nm-800nm.
The method of claim 22, wherein obtaining interferent detection information for the test sample comprises dispensing a portion of the test sample and a diluent into a second container.
The method of claim 25, further comprising dispensing another portion of a sample to be tested and a detection reagent into the first container to prepare the assay sample; and transporting the first container to the sample testing location.
The method of claim 22, wherein obtaining interferent detection information for a test sample comprises performing interferent detection on the test sample prior to preparing the assay sample.
The method of claim 22, wherein obtaining interferent detection information for the sample to be tested comprises using the first intensity of light to interferent detect an assay sample at the sample testing location.
The method of any one of claims 22-28, further comprising outputting the sample detection result and the interferent detection information after performing the sample detection result analysis.
The method of any one of claims 22-29, wherein the interferent detection information comprises at least one of an absorbance of light of a predetermined wavelength by a sample to be tested or a luminous flux of the sample to be tested.
The sample analyzing apparatus according to claim 22, wherein the sample to be measured is blood, and the interferent comprises at least one of hemoglobin, bilirubin, and chyle.
A computer-readable storage medium, comprising a program executable by a processor to implement the method of any one of claims 22-31