CN116380612A

CN116380612A - Reagent preparation device, sample analysis system and calibration method

Info

Publication number: CN116380612A
Application number: CN202211678846.1A
Authority: CN
Inventors: 吴舒晨; 刘隐明; 李学荣
Original assignee: Shenzhen Mindray Bio Medical Electronics Co Ltd
Current assignee: Shenzhen Mindray Bio Medical Electronics Co Ltd
Priority date: 2021-12-30
Filing date: 2022-12-26
Publication date: 2023-07-04

Abstract

A reagent preparing apparatus, a sample analyzing system and a calibration method, which prepares a reagent having a specific concentration by a first liquid and a second liquid; detecting the reagent having the specific concentration by a first concentration detection means to obtain a first value for characterizing the concentration of the reagent; detecting the reagent having the specific concentration by a second concentration detection means which is a standard detection means, to obtain a second value for characterizing the concentration of the reagent; and adjusting the calibration coefficient of the first concentration detection component according to the first value and the second value so that the difference between the first value and the second value is within a preset range. The invention provides a novel reagent preparation device, a sample analysis system and a calibration method.

Description

Reagent preparation device, sample analysis system and calibration method

Technical Field

The present invention relates to the field of sample analysis, and in particular, to a reagent preparation device, a sample analysis system, and a calibration method.

Background

The application of solution reduction equipment is becoming wider and wider, for example, in the medical instrument industry, the diluent of a blood cell analyzer, the cleaning solution of an immune instrument and the like are larger in the usage amount of the instrument, and the container volume and the replacement frequency are larger, so that the workload of doctors is increased, and the use experience of the instrument is reduced. Therefore, an instrument for reducing the concentrated solution into the normal concentration solution is designed, the replacement frequency of the solution is greatly reduced, and the use experience of doctors is improved.

Because the concentration of the reducing solution prepared by the reducing instrument may deviate, when the deviation exceeds a certain degree, the reporting parameters of the subsequent instrument are affected, and therefore, the output end of the reducing instrument is generally provided with a concentration detecting component for detecting whether the concentration of the solution meets the concentration requirement of the instrument.

The concentration detecting means may be affected by aging or the like, so that the detection accuracy thereof is lowered, and the detection result is inaccurate, thereby causing an error, such as a possibility that a solution which does not meet the concentration requirement passes the detection. The concentration detection means generally needs to be calibrated regularly to ensure the accuracy of its detection.

Disclosure of Invention

In order to solve the above problems, the present invention provides a reagent preparing apparatus, a sample analyzing system and a calibration method, which are described in detail below.

According to a first aspect, there is provided in one embodiment a reagent preparation device comprising a first liquid supply part, a second liquid supply part, a dosing part, a mixing part, a reagent line, a liquid line interface and a processor;

the first liquid supply part is used for storing and supplying a first liquid;

the second liquid supply part is used for storing and supplying a second liquid;

The quantitative component is used for measuring the first liquid from the first liquid supply component and conveying the measured first liquid to the mixing component, and measuring the second liquid from the second liquid supply component and conveying the measured second liquid to the mixing component;

the mixing component is used for uniformly mixing the measured first liquid and the measured second liquid to prepare a reagent with a specific concentration; the specific concentration of the reagent prepared by the mixing component is detected by a first concentration detection component, so that a first value for representing the concentration of the reagent is obtained;

the reagent pipeline is used for conveying the reagent with the specific concentration after being uniformly mixed by the uniformly mixing component;

the liquid path interface is used for being connected with a second concentration detection component so that the second concentration detection component can detect the reagent with the specific concentration to obtain a second value used for representing the concentration of the reagent; the second concentration detection part is a standard concentration detection part;

the processor is used for adjusting the calibration coefficient of the first concentration detection component according to the first value and the second value of the reagent prepared at the same time, so that the difference between the first value and the second value of the reagent prepared at the same time is detected within a preset range.

In one embodiment, the liquid path interface is disposed on the reagent path.

In one embodiment, the reagent preparing apparatus further comprises: and a liquid path interface for accessing the first concentration detection component.

The liquid path interface for accessing the first concentration detection component is arranged on the reagent pipeline.

In one embodiment, the liquid path interface is configured such that: when the first concentration detecting member and the second concentration detecting member are connected, the first concentration detecting member and the second concentration detecting member are in a series relationship on the liquid path.

In one embodiment:

the reagent pipeline comprises a first branch, a second branch and a third branch; a first end of the first branch is used for receiving the reagent with the specific concentration, and a second end of the third branch is used for outputting the reagent with the specific concentration; alternatively, the second end of the third branch is configured to receive the reagent having the specific concentration, and the first end of the first branch is configured to output the reagent having the specific concentration;

the second end of the first branch and the first end of the second branch are used as the liquid path interface for being connected with the first concentration detection component, and when being connected with the first concentration detection component, the second end of the first branch is used for being connected with the first end of the first concentration detection component;

The second end of the second branch and the first end of the third branch are used as the liquid path interfaces for being connected with the second concentration detection component, and when being connected with the second concentration detection component, the second end of the second branch is used for being connected with the first end of the second concentration detection component, and the first end of the third branch is used for being connected with the second end of the second concentration detection component; the second end of the second branch can be connected to the first end of the third branch when the second concentration detection means is not connected.

In one embodiment:

the reagent pipeline comprises a first branch and a third branch; a first end of the first branch is used for receiving the reagent with the specific concentration, and a second end of the third branch is used for outputting the reagent with the specific concentration; alternatively, the second end of the third branch is configured to receive the reagent having the specific concentration, and the first end of the first branch is configured to output the reagent having the specific concentration;

the second end of the first branch and the first end of the third branch are used as the liquid path interfaces;

when the first concentration detection part and the second concentration detection part are connected, the second end of the first branch is used for being connected with the first end of the first concentration detection part, the first end of the third branch is used for being connected with the second end of the second concentration detection part, and the second end of the first concentration detection part is used for being connected with the first end of the second concentration detection part;

When the first concentration detection part is connected and the second concentration detection part is not connected, the second end of the first branch is used for being connected with the first end of the first concentration detection part, and the first end of the third branch is used for being connected with the second end of the first concentration detection part.

In one embodiment, the liquid path interface is configured such that: when the first concentration detection part and the second concentration detection part are connected, the first concentration detection part and the second concentration detection part are in parallel connection on a liquid path.

In one embodiment:

the reagent pipeline comprises a first branch, a second branch, a third branch and a fourth branch;

the first end of the first branch is connected with the first end of the third branch and is used for receiving the reagent with the specific concentration, and the second end of the second branch is connected with the second end of the fourth branch and is used for outputting the reagent with the specific concentration; or, the second end of the second branch is connected with the second end of the fourth branch, so as to receive the reagent with the specific concentration, and the first end of the first branch is connected with the first end of the third branch, so as to output the reagent with the specific concentration;

The second end of the first branch and the first end of the second branch are used as the liquid path interface for being connected with the first concentration detection component, and when the first concentration detection component is connected, the second end of the first branch is used for being connected with the first end of the first concentration detection component, and the first end of the second branch is used for being connected with the second end of the first concentration detection component;

the second end of the third branch and the first end of the fourth branch are used as the liquid path interfaces for being connected with the second concentration detection component, and when being connected with the second concentration detection component, the second end of the third branch is used for being connected with the first end of the second concentration detection component, and the first end of the fourth branch is used for being connected with the second end of the second concentration detection component; when the second concentration detection means is not accessed, the third and/or fourth branch is/are closed.

In one embodiment, the liquid path interface is detachably connected to the second concentration detection member.

In an embodiment, the liquid path interface for accessing the first concentration detection component is detachably connected with the first concentration detection component.

In one embodiment, the liquid path interface may be capable of being independently connected to any one of the second concentration detection means and the first concentration detection means.

In one embodiment, the liquid path interface is detachably connected with the first concentration detection component; the liquid path interface is detachably connected with the second concentration detection component.

In an embodiment, the reagent preparation device further comprises a second electrical interface for electrically connecting with the second concentration detection means for signal connection of the first concentration detection means with the processor such that the processor obtains the second value for characterizing reagent concentration from the second concentration detection means via the second electrical interface.

In one embodiment, the second electrical interface is detachably connected to the second concentration detection means.

In an embodiment, the reagent preparation device further comprises a first electrical interface for electrically connecting with the first concentration detection means for signal connection of the first concentration detection means with the processor such that the processor obtains the first value for characterizing the concentration of reagent from the first concentration detection means via the first electrical interface.

In one embodiment, the first electrical interface is detachably connected to the first concentration detection means.

In an embodiment, the first liquid is a stock solution of the reagent, and the second liquid is a dilution solution for diluting the stock solution of the reagent.

In an embodiment, the processor further controls the dosing unit to take the second liquid from the second liquid supply unit and to deliver the taken second liquid to the mixing unit for cleaning the first concentration detection unit and the second concentration detection unit.

In one embodiment, the processor adjusts the calibration coefficients of the first concentration detection component according to a plurality of sets of the first value and the second value; wherein after the first concentration detecting means and the second concentration detecting means detect to obtain a set of the first value and the second value, the processor controls to empty the reagent in the first concentration detecting means and the second concentration detecting means so that the first concentration detecting means and the second concentration detecting means perform next detection to obtain a next set of the first value and the second value.

In one embodiment, the first concentration detecting means and the second concentration detecting means are means for detecting conductivity.

According to a second aspect, an embodiment provides a sample analysis system comprising:

a plurality of sample analysis modules for measuring samples;

a track for connecting the sample analysis modules;

scheduling means for scheduling samples transmitted through the tracks to the corresponding sample analysis modules;

a reagent preparation device according to any of the embodiments herein for supplying a reagent to the sample analysis module.

According to a third aspect, an embodiment provides a method of calibrating a reagent preparation device, comprising:

preparing a reagent having a specific concentration from the first liquid and the second liquid;

detecting the reagent having the specific concentration by a first concentration detection means to obtain a first value for characterizing the concentration of the reagent;

detecting the reagent having the specific concentration by a second concentration detection means which is a standard detection means, to obtain a second value for characterizing the concentration of the reagent;

and adjusting the calibration coefficient of the first concentration detection component according to the first value and the second value so that the difference between the first value and the second value is within a preset range.

In an embodiment, the calibration method further determines whether the difference between the first value and the second value exceeds a preset range, and when the difference exceeds the preset range, determines that the first concentration detection component needs to be replaced.

In one embodiment, the first concentration detection means detects the reagent having a specific concentration by accessing a liquid path interface; the second concentration detection means detects the reagent having a specific concentration by accessing another liquid path interface.

In one embodiment, when the first concentration detection means is replaced, the first concentration detection means is detached from the fluid path interface for accessing the first concentration detection means to free the fluid path interface for connecting a new means for detecting the concentration of the reagent.

In one embodiment, the first concentration detecting means detects the reagent having a specific concentration by being connected to a liquid path interface, and the second concentration detecting means detects the reagent having a specific concentration by being connected to the liquid path interface; wherein the liquid path interface is not connected to the second concentration detection part when connected to the first concentration detection part, and is not connected to the first concentration detection part when connected to the second concentration detection part.

In one embodiment, when the first concentration detection means is replaced, the first concentration detection means is removed from the fluid path interface to free the fluid path interface for connection to a new means for detecting the concentration of the reagent.

According to the reagent preparing apparatus, the sample analyzing system and the calibration method of the above embodiments, a new reagent preparing apparatus, sample analyzing system and calibration method are provided.

Drawings

FIG. 1 is a schematic view showing the structure of a reagent preparing apparatus according to one embodiment;

FIG. 2 is a schematic structural view of a reagent preparing apparatus according to an embodiment;

FIG. 3 is a schematic diagram showing a first concentration detection means for detecting the concentration of a reagent according to one embodiment;

FIG. 4 (a) is a schematic view of a reagent preparing apparatus according to an embodiment with respect to a liquid path interface and an electrical interface of a first concentration detecting means, and FIG. 4 (a) is a schematic view of the first concentration detecting means not connected to the reagent preparing apparatus; FIG. 4 (b) is a schematic view of a reagent preparing apparatus according to one embodiment with respect to a liquid path interface and an electrical interface of a first concentration detecting section, and FIG. 4 (b) is a schematic view of the first concentration detecting section connected to the reagent preparing apparatus;

FIG. 5 (a) is a schematic view of a reagent preparing apparatus according to an embodiment with respect to a liquid path interface and an electrical interface of a second concentration detecting section, and FIG. 5 (a) is a schematic view of the second concentration detecting section not connected to the reagent preparing apparatus; FIG. 5 (b) is a schematic view of a reagent preparing apparatus according to one embodiment with respect to the liquid path interface and the electrical interface of the second concentration detecting section, and FIG. 5 (b) is a schematic view of the second concentration detecting section accessing the reagent preparing apparatus;

FIG. 6 is a schematic diagram showing a first concentration detection means and a second concentration detection means of an embodiment in a serial relationship on a liquid path;

FIG. 7 is a schematic diagram showing a first concentration detection means and a second concentration detection means of an embodiment in a serial relationship on a liquid path;

FIG. 8 is a schematic diagram showing a first concentration detection means and a second concentration detection means in a parallel relationship on a liquid path according to an embodiment;

FIG. 9 is a schematic diagram of a sample analysis system according to one embodiment;

FIG. 10 is a flow chart of a method of calibrating a reagent preparing apparatus according to one embodiment;

FIG. 11 is a flow chart of a method of calibrating a reagent preparing apparatus according to one embodiment;

Detailed Description

The invention will be described in further detail below with reference to the drawings by means of specific embodiments. Wherein like elements in different embodiments are numbered alike in association. In the following embodiments, numerous specific details are set forth in order to provide a better understanding of the present application. However, one skilled in the art will readily recognize that some of the features may be omitted, or replaced by other elements, materials, or methods in different situations. In some instances, some operations associated with the present application have not been shown or described in the specification to avoid obscuring the core portions of the present application, and may not be necessary for a person skilled in the art to describe in detail the relevant operations based on the description herein and the general knowledge of one skilled in the art.

Furthermore, the described features, operations, or characteristics of the description may be combined in any suitable manner in various embodiments. Also, various steps or acts in the method descriptions may be interchanged or modified in a manner apparent to those of ordinary skill in the art. Thus, the various orders in the description and drawings are for clarity of description of only certain embodiments, and are not meant to be required orders unless otherwise indicated.

The numbering of the components itself, e.g. "first", "second", etc., is used herein merely to distinguish between the described objects and does not have any sequential or technical meaning. The terms "coupled" and "connected," as used herein, are intended to encompass both direct and indirect coupling (coupling), unless otherwise indicated.

Calibration of the concentration detection means of the solution reduction apparatus or reagent preparation device is generally performed by using a standard solution in the prior art; the standard solution is a solution with known concentration, and the detection value obtained by detecting the standard solution by the concentration detection component is compared with the value calibrated by the standard solution, so that the calibration of the concentration detection component is completed. There are problems with using standard solutions to calibrate the concentration detection components of reagent preparation devices: the price of the standard solution is high, if other solutions are assigned, performance verification such as stability and consistency is required, the verification time is long, and the investment is large; the solution is inconvenient to take by clothing, and if the operation is not standard in the calibration process, calibration deviation is easy to cause.

In some embodiments of the present invention, a new calibration scheme is presented that requires only one standard concentration detection component for calibration; in some embodiments, the calibration process is basically fully automated, and the reliability of calibration is high; in some embodiments, the standard concentration detection component is designed to be detachable from the reagent preparation device, facilitating calibration; in some embodiments, the original concentration detection member is designed to be detachable from the reagent preparing apparatus, facilitating maintenance and replacement.

The inputs to the solution reduction apparatus or reagent preparation device typically comprise pure water and concentrated solution, and the interior typically comprises: the quantitative system, the mixing system and the concentration detection system; wherein the quantifying system is operative to quantify a volume of purified water and a volume of concentrated solution, wherein the ratio of the volumes of purified water and the volume of concentrated solution is substantially a fixed value; the mixing system is used for uniformly mixing quantitative pure water and the concentrated solution into a solution with uniform concentration; the concentration detection system or the concentration detection component is used for detecting whether the concentration of the uniformly mixed solution meets the instrument concentration requirement, and if not, alarming and prompting are carried out.

In some embodiments of the present invention, an interface for connecting the standard concentration detection part is provided on the reagent preparation apparatus, and the standard concentration detection part and the liquid path of the concentration detection part to be calibrated are connected in series or in parallel; after that, the reagent preparing apparatus produces a reagent of a specific concentration and causes the prepared reagent to flow through the standard concentration detecting section and the concentration detecting section to be calibrated, and in some embodiments, it may be controlled such that the standard concentration detecting section and the concentration detecting section to be calibrated start detection at the same time, and the calibration coefficient of the concentration detecting section to be calibrated is adjusted with the measurement result of the standard concentration detecting section as the target value of the solution such that the measurement results of both are within a preset range or equal. In some embodiments, after calibration is completed, the standard concentration detection component and the concentration detection component to be calibrated are cleaned by the diluent or pure water used for preparing the reagent in the reagent preparation device, so that the calibration process is basically automated, and the work of cleaning the relevant concentration detection component by taking the calibration process is omitted.

A specific description will be given of the reagent preparing apparatus.

Referring to fig. 1, the reagent preparing apparatus in some embodiments includes a first liquid supplying part 10, a second liquid supplying part 11, a dosing part 20, a mixing part 30, a reagent line 40, and a processor 50.

In some embodiments, the first liquid supply 10 is used to store and supply a first liquid. In some embodiments, the first liquid is a stock solution of the reagent, such as a high concentration of the reagent.

In some embodiments, the second liquid supply part 11 is used to store and supply the second liquid. In some embodiments, the second liquid is a diluent, such as pure water, that dilutes the stock solution of the reagent.

In some embodiments, the dosing assembly 20 is configured to take a first liquid from the first liquid supply assembly 10 and deliver the taken first liquid to the mixing assembly 30, and to take a second liquid from the second liquid supply assembly 11 and deliver the taken second liquid to the mixing assembly 30.

Referring to fig. 2, in some embodiments, the dosing block 20 includes a first dosing vessel 21, a first infusion line 21a, a first drain line 21b, a second dosing vessel 22, a second infusion line 22a, and a second drain line 22b. The first liquid supply part 10 supplies the first liquid to the first metering container 21 through the first liquid supply line 21a, the first metering container 21 is used for metering the first liquid, and the first liquid discharge line 21b is connected between the first metering container 21 and the mixing part 30 for delivering the first liquid metered by the first metering container 21 to the mixing part 30. The second liquid supply part 11 supplies the second liquid to the second dosing container 22 through the second liquid supply line 22a, the second dosing container 22 is used for measuring the second liquid, and the second liquid discharge line 22b is connected between the second dosing container 22 and the mixing part 30 for delivering the second liquid measured by the second dosing container 22 to the mixing part 30.

Shown in fig. 2 is an example in which the dosing unit 20 comprises two dosing containers, namely a first dosing container 21 and a second dosing container 22; one or both of these dosing containers may be of a thin-top-down-thick shape, for example comprising a first body portion and a mouth portion, chi Zuibu being provided above and in communication with the body portion, the body portion having an inner diameter greater than the inner diameter of Chi Zuibu, such a thin-top-down-thick shape being such that fluctuations in the level dosing have a small effect on the percentage of the dosing volume; of course, the quantitative container may have other shapes as long as the quantitative function is achieved. It will be appreciated that in some examples where the dosing unit 20 comprises two dosing containers, the two dosing containers may be identical in shape and structure or may be different. In addition, fig. 2 shows an example in which the quantitative part 20 includes two quantitative containers; in other examples, the dosing unit 20 may include only one dosing container, for example, the dosing unit 20 includes a first dosing container 21, where the first dosing container 21 is used to measure the first liquid and the second liquid in a time-sharing manner, for example, measure the first liquid first, then discharge the first liquid measured to the mixing unit 30, then measure the second liquid measured to the mixing unit 30, or measure the second liquid first, then discharge the second liquid measured to the mixing unit 30, then measure the first liquid measured to the mixing unit 30; in such an example, the first liquid and the second liquid are measured by sharing a first measuring container 11; it will be appreciated that in such an example, both the first liquid supply part 10 and the second liquid supply part 11 are used for supplying liquid to this first metering container 11, and therefore, the first drain line 21b of this first metering container 11 is connected to the first liquid supply part 10 and the second liquid supply part 11, respectively, the first liquid supply part 10 supplies the first liquid to the first metering container 11 through the first drain line 21b, and the second liquid supply part 11 also supplies the second liquid to the same first metering container 11 through the first drain line 21 b. In some embodiments, the mixing component 30 is used to mix the first liquid and the second liquid to prepare a particular concentration of the reagent. In some embodiments, the reagent line 40 is used to transport the above-mentioned reagent having a specific concentration after being mixed by the mixing part 30. In some embodiments, the reagent line 40 is used to transfer a specific concentration of reagent prepared by the mixing component 30 to a subsequent sample analysis module requiring the use of the reagent. In some embodiments, the reagent line 40 may also deliver a specific concentration of reagent prepared by the mixing component 30 to a reservoir capable of storing the reagent, and then deliver the reagent received and stored by the reservoir to a subsequent sample analysis module requiring use of the reagent.

The specific concentration of reagent prepared by the mixing section 30 needs to be checked to determine if the demand is met. Thus, referring to fig. 3, in some embodiments, a specific concentration of a reagent prepared by the mixing component 30 is detected by the first concentration detecting component 01, and the first concentration detecting component 01 may output a first value for characterizing the concentration of the reagent. In some embodiments, the processor 50 is configured to be electrically connected to the first concentration detection means 01, and the processor 50 is capable of obtaining the first value from the first concentration detection means 01. In some embodiments, the processor 50 determines whether the concentration of the reagent prepared by the mixing component 30 meets or meets the requirements according to the first value, and if not, the processor 50 may generate an alarm message.

In some embodiments, the first concentration detection component 01 may be disposed within the mixing component 30. In some embodiments, the first concentration detection component 01 may be disposed in the reagent line 40. In some embodiments, the first concentration detection member 01 may be provided in the liquid storage container described above.

The first concentration detecting member 01 will be further described with reference to fig. 4 (a) and 4 (b).

In some embodiments, the reagent preparation device further comprises a fluid connection 41, the fluid connection 41 being adapted to access the first concentration detection means 01. The reagent prepared by the mixing section 30 is enabled to flow through the first concentration detecting section 01 through the liquid path interface 41, so that the first concentration detecting section 01 detects the reagent to obtain a first value for characterizing the concentration of the reagent. In some embodiments, the fluid line interface 41 is disposed on the reagent line 40 described above.

In some embodiments, the liquid path interface 41 is detachably connected to the first concentration detection member 01, which may facilitate maintenance and replacement of the first concentration detection member 01, etc.

In some embodiments, the reagent preparation device further comprises a first electrical interface 43, the first electrical interface 43 being for electrical connection with the first concentration detection means 01 for signal connection of the first concentration detection means 01 with the processor 50, such that the processor 50 obtains a first value for characterizing the concentration of the reagent from the first concentration detection means 01 via the first electrical interface 43. In some embodiments, the first electrical interface 43 is detachably connected to the first concentration detection means 01, which may facilitate maintenance and replacement of the first concentration detection means 01, etc.

Fig. 4 (a) is a schematic view of the first concentration detection means 01 not connected to the reagent preparing apparatus, for example, not connected to the liquid path interface 41 and the first electrical interface 43, and fig. 4 (b) is a schematic view of the first concentration detection means 01 connected to the reagent preparing apparatus, for example, connected to the liquid path interface 41 and the first electrical interface 43.

In some embodiments, the reagent preparation device may comprise a first concentration detection component 01.

In some embodiments, the first concentration detection means 01 is a means for detecting conductivity.

The above are some descriptions of the first concentration detecting means 01. When calibration of the first density detecting means 01 is required, this can be accomplished by a standard density detecting means. Further description will be given below with reference to fig. 5 (a) and 5 (b).

In some embodiments, the reagent preparing apparatus further comprises a liquid path interface 42, and the liquid path interface 42 is configured to be connected to the second concentration detecting component 02, so that the second concentration detecting component 02 can detect the reagent with the specific concentration, and obtain a second value for characterizing the concentration of the reagent. It can be seen that the reagent prepared by the mixing component 30 is enabled to flow through the second concentration detection component 02 via the liquid path interface 42, such that detection of the reagent by the second concentration detection component 02 results in a second value indicative of the concentration of the reagent. In some embodiments, the fluid line interface 42 is disposed in the reagent line 40 described above.

The second concentration detection means 02 in the present invention is a standard concentration detection means, in other words, the second concentration detection means 02 can accurately detect the concentration of the reagent, and the obtained second value for characterizing the concentration of the reagent is an accurate value or a standard value. The second concentration detection means 02 may be a standard substance specifically produced by a manufacturer for calibration, and in some examples, a completely new concentration detection means that is acceptable to the manufacturer may be used as the second concentration detection means 02. In some embodiments, the second concentration detection member 02 is a completely new concentration detection member that is configured identically to the second concentration detection member 01 and that is acceptable to the factory.

In some embodiments, the second concentration detection means 02 is a means for detecting conductivity. In some examples, the second concentration detection means 02 is a standard concentration detection means, which may also be a standard conductivity measurement instrument.

In some embodiments, the liquid path interface 42 is detachably connected to the second concentration detection component 02, when the first concentration detection component 01 needs to be calibrated, the second concentration detection component 02 is connected to the liquid path interface 42, and in other situations, the second concentration detection component 02 can be detached from the liquid path interface 42.

In some embodiments, the reagent preparation device further comprises a second electrical interface 44, the second electrical interface 44 being for electrical connection with the second concentration detection means 02 for signal connection of the second concentration detection means 02 with the processor 50, such that the processor 50 obtains a second value from the second concentration detection means 02 for characterizing the concentration of the reagent via the second electrical interface 44. In some embodiments, the second electrical interface 44 is detachably connected to the second concentration detection component 02, and when the first concentration detection component 01 needs to be calibrated, the second concentration detection component 02 is accessed through the second electrical interface 44, and in other situations, the second concentration detection component 02 can be detached from the second electrical interface 44.

Fig. 5 (a) is a schematic view of the second concentration detection means 02 not connected to the reagent preparing apparatus, for example, not connected to the liquid path interface 42 and the second electrical interface 44, and fig. 5 (b) is a schematic view of the second concentration detection means 02 connected to the reagent preparing apparatus, for example, connected to the liquid path interface 42 and the second electrical interface 44.

In some embodiments, the second concentration detecting means 02 may be provided with a display screen, for displaying the second value detected by the second concentration detecting means 02, and then the second value is input into the reagent preparing apparatus by the user through an input means such as a keyboard, etc., so that the processor 50 can obtain the second value.

In some embodiments, the reagent preparation device may comprise a second concentration detection component 02.

In some embodiments, the liquid path interface is configured such that: when the first concentration detecting means 01 and the second concentration detecting means 02 are connected, the first concentration detecting means 01 and the second concentration detecting means 02 are in a series relationship on the liquid path. Specifically, the liquid path interface 41 and the liquid path interface 42 are arranged such that: when the first concentration detecting means 01 is connected to the liquid path interface 41 and the second concentration detecting means 02 is connected to the liquid path interface 42, the first concentration detecting means 01 and the second concentration detecting means 02 are connected in series on the liquid path.

Fig. 6 shows an example in which the first concentration detecting means 01 and the second concentration detecting means 02 are connected in series on the liquid path. In some embodiments, the reagent line 40 includes a first leg 40a, a second leg 40b, and a third leg 40c. In some embodiments, the first end of the first branch 40a is configured to receive the reagent having the specific concentration, and the second end of the third branch 40c is configured to output the reagent having the specific concentration, that is, the reagent flows in from the first end of the first branch 40a and finally flows out from the second end of the third branch 40 c; alternatively, the second end of the third leg 40c is adapted to receive a reagent having a specific concentration, and the first end of the first leg 40a is adapted to output a reagent having a specific concentration, i.e., reagent flows in from the second end of the third leg 40c and ultimately out from the first end of the first leg 40 a.

In some embodiments, the second end of the first branch 40a and the first end of the second branch 40b serve as a fluid path interface 41 for accessing the first concentration detection means 01, and when accessing the first concentration detection means 01, the second end of the first branch 40a is adapted to be connected to the first end of the first concentration detection means 01, and the first end of the second branch 40b is adapted to be connected to the second end of the first concentration detection means, such that a reagent may flow through the first concentration detection means 01.

In some embodiments, the second end of the second branch 40b and the first end of the third branch 40c serve as a fluid path interface 42 for accessing the second concentration detection means 02, and when accessing the second concentration detection means 02, the second end of the second branch 40b is adapted to be connected to the first end of the second concentration detection means 02, and the first end of the third branch 40c is adapted to be connected to the second end of the second concentration detection means 02; when the second concentration detection means 02 is not connected, the second end of the second branch 40b can be connected to the first end of the third branch 40c.

Fig. 7 shows another example in which the first concentration detecting means 01 and the second concentration detecting means 02 are connected in series on the liquid path. In some embodiments, the reagent line 40 includes a first leg 40a and a third leg 40c. In some embodiments, the first end of the first branch 40a is configured to receive the reagent having the specific concentration, and the second end of the third branch 40c is configured to output the reagent having the specific concentration, that is, the reagent flows in from the first end of the first branch 40a and finally flows out from the second end of the third branch 40 c; alternatively, the second end of the third leg 40c is adapted to receive a reagent having a specific concentration, and the first end of the first leg 40a is adapted to output a reagent having a specific concentration, i.e., reagent flows in from the second end of the third leg 40c and ultimately out from the first end of the first leg 40 a.

In some embodiments, the second end of the first leg 40a and the first end of the third leg 40c function as fluid path interfaces described above, such as fluid path interface 41 and/or fluid path interface 42. When the first concentration detecting means 01 and the second concentration detecting means 02 are connected, the second end of the first branch 40a is used for being connected with the first end of the first concentration detecting means 01, the first end of the third branch 40c is used for being connected with the second end of the second concentration detecting means 02, and the second end of the first concentration detecting means 01 is used for being connected with the first end of the second concentration detecting means 02; when the first concentration detecting means 01 is connected and the second concentration detecting means 02 is not connected, the second end of the first branch 40a is adapted to be connected to the first end of the first concentration detecting means 01, and the first end of the third branch 40c is adapted to be connected to the second end of the first concentration detecting means 01.

In some embodiments, the liquid path interface is configured such that: when the first concentration detecting means 01 and the second concentration detecting means 02 are connected, the first concentration detecting means 01 and the second concentration detecting means 02 are in a parallel relationship on the liquid path. Specifically, the liquid path interface 41 and the liquid path interface 42 are arranged such that: when the first concentration detecting means 01 is connected to the liquid path interface 41 and the second concentration detecting means 02 is connected to the liquid path interface 42, the first concentration detecting means 01 and the second concentration detecting means 02 are connected in parallel on the liquid path.

Fig. 8 shows an example of a parallel relationship between the first concentration detection member 01 and the second concentration detection member 02 in the liquid path. In some embodiments, the reagent line 40 includes a first leg 40a, a second leg 40b, a third leg 40c, and a fourth leg 40d. In some embodiments, a first end of the first leg 40a is connected to a first end of the third leg 40c for receiving a reagent having a particular concentration, and a second end of the second leg 40b is connected to a second end of the fourth leg 40d for outputting a reagent having a particular concentration; alternatively, the second end of the second branch 40b is connected to the second end of the fourth branch 40d for receiving a reagent having a specific concentration, and the first end of the first branch 40a is connected to the first end of the third branch 40c for outputting a reagent having a specific concentration.

In some embodiments, the second end of the first branch 40a and the first end of the second branch 40b serve as a fluid path interface 41 for accessing the first concentration detection means 01, and when the first concentration detection means is accessed, the second end of the first branch 40a is used for connecting with the first end of the first concentration detection means 01, and the first end of the second branch 40b is used for connecting with the second end of the first concentration detection means 01. In some embodiments, the second end of the third branch 40c and the first end of the fourth branch 40d serve as a fluid path interface 42 for accessing the second concentration detection means 02, and when accessing the second concentration detection means 02, the second end of the third branch 40c is adapted to be connected to the first end of the second concentration detection means 02, and the first end of the fourth branch 40d is adapted to be connected to the second end of the second concentration detection means 02; when the second concentration detection means 02 is not engaged, the third branch 40c and/or the fourth branch 40d are closed, with the effect that the reagent does not flow out through the second end of the third branch 40c and/or the first end of the fourth branch.

In some embodiments, fluid port 41 and fluid port 42 are the same fluid port. The liquid path interface, for example, the liquid path interface 41 or the liquid path interface 42, can be connected to either the second concentration detection means 02 or the first concentration detection means 01 alone. Alternatively, the liquid path interface 41 is multiplexed into the liquid path interface 42, and the liquid path interface 41 may be connected to either the first concentration detection means 01 or the first concentration detection means 02, and both may be connected to the liquid path interface 41 alternatively; the liquid path interface 41 is not connected to the second concentration detection means 02 when connected to the first concentration detection means 01, and is not connected to the first concentration detection means 01 when connected to the second concentration detection means 02; that is, the first concentration detecting means 01 and the first concentration detecting means 02 cannot simultaneously access the liquid path interface 41, and only one concentration detecting means can access the liquid path interface 41 at a time. In other words, the liquid path interface 42 is multiplexed into the liquid path interface 42, and the liquid path interface 42 may be connected to either the first concentration detection means 01 or the first concentration detection means 02, and both may be connected to the liquid path interface 42 alternatively; the liquid path interface 42 is not connected to the second concentration detection means 02 when connected to the first concentration detection means 01, and is not connected to the first concentration detection means 01 when connected to the second concentration detection means 02; that is, the first concentration detecting means 01 and the first concentration detecting means 02 cannot simultaneously access the liquid path interface 42, and only one concentration detecting means can access the liquid path interface 42 at a time. In this embodiment, when calibration is required, the first concentration detection component 01 is connected to the liquid path interface, and a first value is obtained through detection; then the first concentration detection part 01 is taken down, the second concentration detection part 02 is accessed, and a second value is obtained through detection; it can be understood that the second concentration detection means 02 may be connected to the liquid path interface to obtain the second value by detection; and then the second concentration detection part 02 is removed, the first concentration detection part 01 is connected, and the first value is obtained through detection. In such an embodiment, the first electrical interface 43 and the second electrical interface 44 may also be the same electrical interface; in such an embodiment, it is also possible to still leave two electrical interfaces, namely a first electrical interface 43 for electrically accessing the first concentration detection means 01 and a second electrical interface 44 for electrically accessing the second concentration detection means 02; in such an embodiment, it is also possible that only the first electrical interface 43 is provided, and the second electrical interface 44 is not provided, in which case the second concentration detecting means 02 may be provided with a display screen for displaying the second value detected by the second concentration detecting means 02, and the second value is then entered into the reagent preparing apparatus by the user via an input means, such as a keyboard or the like, so that the processor 50 can obtain the second value.

The first concentration detecting means 01, the second concentration detecting means 02, and the related liquid path interfaces, electric interfaces, and the like are described above. In some embodiments, the processor is configured to adjust the calibration coefficient of the first concentration detection means 01 according to detecting the first value and the second value of the reagent prepared at the same time so that a difference between the first value and the second value of the reagent prepared at the same time is detected within a preset range.

In consideration of the fact that the detection result of the concentration detection part may be affected by bubbles, repeatability and the like, bubbles and repeatability effects can be removed by detecting for a plurality of times in the calibration process, and the reagent detected last time can be emptied from the first concentration detection part 01 and the second concentration detection part 02 for the next detection in each detection; the results of each detection by the first concentration detecting means 01 and the second concentration detecting means 02 may be divided to remove the maximum and minimum values, and after the average value of the remaining detection results is calculated, the calibration coefficient of the first concentration detecting means 01 may be adjusted according to the calculated average value, thereby completing the calibration.

In some embodiments, a first value indicative of the concentration of the reagent may be obtained from the signal obtained by the detection of the reagent by the first concentration detection component 01 and the calibration factor.

For example, if the first concentration detection means 01 is a means for detecting conductivity, the calibration coefficient may be an electrode constant thereof.

In some embodiments, processor 50 adjusts the calibration system of first concentration detection component 01 based on multiple sets of the first and second values described above; wherein after the first concentration detecting means 01 and the second concentration detecting means 02 detect a set of the first value and the second value (herein, a set of the first value and the second value, which are understood to mean detecting the first value and the second value of the reagent prepared at the same time), the processor 50 controls to empty the reagent in the first concentration detecting means 01 and the second concentration detecting means 02 so that the first concentration detecting means 01 and the second concentration detecting means 02 perform the next detection, resulting in the next set of the first value and the second value.

In some embodiments, the processor 50 also controls the dosing unit 20 to take the second liquid from the second liquid supply unit 11 and deliver the taken second liquid to the mixing unit 30 for cleaning the first concentration detecting unit 01 and the second concentration detecting unit 02. For example, in the embodiment having two different liquid path interfaces, i.e., the liquid path interface 41 and the liquid path interface 42, after the calibration is completed, the internal piping of the first concentration detection means 01 and the second concentration detection means 02 may be cleaned by the second liquid, e.g., pure water. For another example, in the case where the liquid path interface 41 and the liquid path interface 42 are the same liquid path interface, in the calibration process, after the first concentration detection part 01 completes detection to obtain the first value, the internal pipe of the first concentration detection part 01 may be cleaned by the second liquid such as pure water; and/or, after the second concentration detection means 02 completes the detection to obtain the first value, the internal piping of the first concentration detection means 01 may be cleaned by the second liquid such as pure water

A sample analysis system is also disclosed in some embodiments of the invention. Referring to fig. 9, a sample analysis system of some embodiments includes a plurality of sample analysis modules 80, a track 90, a scheduler 91, and a reagent preparation apparatus as described in any of the embodiments herein.

The sample analysis module 80 is used for determining a sample; the track 90 is used for connecting the sample analysis modules 80 together, and the scheduling means 91 is used for scheduling the samples transmitted through the track 90 to the respective sample analysis modules 80; the sample measuring speed can be greatly improved through the pipelining system; in this process, the reagent preparation device is used to supply reagents to the sample analysis module 80.

The invention also discloses a calibration method of the reagent preparation device in some embodiments; the reagent preparation device involved in the calibration method may be the reagent preparation device described in any of the embodiments herein.

Referring to fig. 10, the calibration method in some embodiments includes the following steps:

step 110: a reagent having a specific concentration is prepared from the first liquid and the second liquid.

In some embodiments, the first liquid is a stock solution of the reagent, such as a high concentration of the reagent.

In some embodiments, the second liquid is a diluent, such as pure water, that dilutes the stock solution of the reagent.

Step 120: detecting the reagent having the specific concentration by a first concentration detecting means to obtain a first value for characterizing the concentration of the reagent;

step 130: detecting the reagent having the specific concentration by a second concentration detecting section which is a standard detecting section, to obtain a second value for characterizing the concentration of the reagent;

step 140: and adjusting the calibration coefficient of the first concentration detection component according to the first value and the second value so that the difference between the first value and the second value is within a preset range.

Referring to fig. 11, the calibration method in some embodiments further includes step 150: it is determined whether the first concentration detection member needs to be replaced. For example, step 150 determines whether the difference between the first value and the second value exceeds a preset range, and when the difference exceeds the preset range, determines that the first concentration detecting component needs to be replaced.

In some embodiments of the calibration method, the first concentration detection means detects the reagent having the specific concentration by accessing a liquid path interface, such as liquid path interface 41 described above; the second concentration detection means detects the above-described reagent having a specific concentration by accessing another liquid path interface, such as the liquid path interface 42 above. When the first concentration detecting means needs to be replaced, the first concentration detecting means may be detached from the liquid path interface for accessing the first concentration detecting means to free the liquid path interface for connecting a new means for detecting the concentration of the reagent.

In some embodiments of the calibration method, the first concentration detection means detects a reagent having a specific concentration by accessing a fluid path interface, and the second concentration detection means also detects a reagent having a specific concentration by accessing the fluid path interface; the liquid path interface is not connected with the second concentration detection component when connected with the first concentration detection component, and is not connected with the first concentration detection component when connected with the second concentration detection component; this is also the case where the liquid path interface 41 and the liquid path interface 42 are the same liquid path interface as described above; when the first concentration detection means is to be replaced, the first concentration detection means may be detached from the liquid path interface to free the liquid path interface for connection of a new means for detecting the concentration of the reagent.

In some embodiments of the calibration method, the processor 50 may obtain the first and second values through, for example, the first and second electrical interfaces 43, 44.

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

While the principles herein have been shown in various embodiments, many modifications of structure, arrangement, proportions, elements, materials, and components, which are particularly adapted to specific environments and operative requirements, may be used 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, those 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 present disclosure is to be considered as illustrative and not restrictive in character, 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. 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 a critical, required, or essential feature. 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 "couple" and any other variants thereof are used herein to refer to physical connections, electrical connections, magnetic connections, optical connections, communication connections, functional connections, and/or any other connection.

Those skilled 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. Accordingly, the scope of the invention should be determined only by the following claims.

Claims

1. A reagent preparing apparatus, comprising a first liquid supplying part, a second liquid supplying part, a quantifying part, a mixing part, a first concentration detecting part, and a processor; the reagent preparation device is operable to detachably access a second concentration detection component, wherein:

the first liquid supply part is used for storing and supplying a first liquid;

the mixing component is used for uniformly mixing the measured first liquid and the measured second liquid to form a mixed liquid so as to prepare a reagent with a specific concentration; the specific concentration of the reagent prepared by the mixing component is detected by a first concentration detection component, so that a first value for representing the concentration of the reagent is obtained;

When the reagent preparing apparatus is connected to the second concentration detecting means, the second concentration detecting means can be enabled to detect the reagent having a specific concentration, resulting in a second value for characterizing the concentration of the reagent; the second concentration detection part is a standard concentration detection part;

the processor is configured to:

controlling the dosing part to measure the first liquid from the first liquid supply part and convey the measured first liquid to the mixing part;

controlling the dosing part to measure the second liquid from the second liquid supply part and convey the measured second liquid to the mixing part;

controlling the mixing component to uniformly mix the measured first liquid and the measured second liquid to form a mixed liquid so as to prepare a reagent with a specific concentration;

acquiring a first value obtained by detecting the prepared reagent by the first concentration detecting section, and acquiring a second value obtained by detecting the same prepared reagent by the second concentration detecting section;

and adjusting the calibration coefficient of the first concentration detection part according to the acquired first value and second value so as to detect the difference between the first value and the second value of the reagent prepared at the same time to be within a preset range.

2. The reagent preparing apparatus of claim 1, further comprising a reagent line for transporting the reagent having the specific concentration after being mixed by the mixing part, wherein a liquid path interface for detachably connecting the second concentration detecting part is provided on the reagent line.

3. The reagent preparing apparatus of claim 1 or 2, further comprising: and a liquid path interface for accessing the first concentration detection component.

4. The reagent preparing apparatus of claim 3, wherein the liquid path port for accessing the first concentration detecting means is provided in the reagent path.

5. The reagent preparing apparatus of claim 4, wherein the liquid path interface is configured such that: when the first concentration detecting member and the second concentration detecting member are connected, the first concentration detecting member and the second concentration detecting member are in a series relationship on the liquid path.

6. The reagent preparing apparatus of claim 5, wherein:

7. The reagent preparing apparatus of claim 5, wherein:

when the first concentration detection part is connected but the second concentration detection part is not connected, the second end of the first branch is used for being connected with the first end of the first concentration detection part, and the first end of the third branch is used for being connected with the second end of the first concentration detection part.

8. The reagent preparing apparatus of claim 4, wherein the liquid path interface is configured such that: when the first concentration detection part and the second concentration detection part are connected, the first concentration detection part and the second concentration detection part are in parallel connection on a liquid path.

9. The reagent preparing apparatus of claim 8, wherein:

10. The reagent preparing apparatus of claim 3, wherein the liquid path interface for accessing the first concentration detecting means is detachably connected to the first concentration detecting means.

11. The reagent preparing apparatus of claim 2, wherein the liquid path interface is capable of being connected to either one of the second concentration detecting section and the first concentration detecting section independently.

12. The reagent preparing apparatus of claim 11, wherein the liquid path interface is detachably connected to the first concentration detecting member; the liquid path interface is detachably connected with the second concentration detection component.

13. The reagent preparation device according to any one of claims 1 to 12, further comprising a second electrical interface for electrically connecting with the second concentration detection means to signal the second concentration detection means to the processor such that the processor obtains the second value indicative of reagent concentration from the second concentration detection means via the second electrical interface.

14. The reagent preparing apparatus of claim 13, wherein the second electrical interface is detachably connected to the second concentration detecting member.

15. The reagent preparation device according to any one of claims 1 to 14, further comprising a first electrical interface for electrically connecting with the first concentration detection means to signal the first concentration detection means to the processor such that the processor obtains the first value indicative of reagent concentration from the first concentration detection means via the first electrical interface.

16. The reagent preparing apparatus of claim 15, wherein the first electrical interface is detachably connected to the first concentration detecting member.

17. The reagent preparing apparatus of any one of claims 1 to 16, wherein the first liquid is a stock solution of a reagent, and the second liquid is a dilution liquid that dilutes the stock solution of the reagent.

18. The reagent preparing apparatus of claim 17, wherein the processor further controls the quantitative part to take out the second liquid from the second liquid supply part and convey the taken out second liquid to the mixing part for cleaning the first concentration detecting part and the second concentration detecting part.

19. The reagent preparing apparatus of any one of claims 1 to 18, wherein the processor adjusts the calibration coefficient of the first concentration detecting means according to a plurality of sets of the first value and the second value; wherein after the first concentration detecting means and the second concentration detecting means detect to obtain a set of the first value and the second value, the processor controls to empty the reagent in the first concentration detecting means and the second concentration detecting means so that the first concentration detecting means and the second concentration detecting means perform next detection to obtain a next set of the first value and the second value.

20. The reagent preparing apparatus of any one of claims 1 to 19, wherein the first concentration detecting means and the second concentration detecting means are means for detecting electric conductivity.

21. A sample analysis system, comprising:

a plurality of sample analysis modules for measuring samples;

a track for connecting the sample analysis modules;

the reagent preparation device of any one of claims 1 to 21, for supplying reagents to the sample analysis module.

22. A method of calibrating a reagent preparation device, comprising:

measuring a first liquid;

measuring a second liquid;

preparing a reagent having a specific concentration by uniformly mixing the measured first liquid and second liquid to form a mixed liquid;

And adjusting the calibration coefficient of the first concentration detection component according to the first value and the second value so as to detect the difference between the first value and the second value of the reagent prepared at the same time to be within a preset range.

23. The method of calibrating according to claim 22, further comprising determining whether a difference between the first value and the second value exceeds a predetermined range, and when the difference exceeds the predetermined range, determining that the first concentration detection member needs to be replaced.

24. The calibration method according to claim 22 or 23, wherein the first concentration detection means detects the reagent having a specific concentration by accessing a liquid path interface; the second concentration detection means detects the reagent having a specific concentration by accessing another liquid path interface.

25. The method of calibrating according to claim 24, wherein when the first concentration detecting means is required to be replaced, the first concentration detecting means is detached from a liquid path interface for accessing the first concentration detecting means for connecting a new means for detecting the concentration of the reagent;

or when the first concentration detection part needs to be replaced, the first concentration detection part is detached and then replaced by the second concentration detection part.

26. The calibration method according to claim 22 or 23, wherein the first concentration detection means detects the reagent having a specific concentration by accessing a liquid path interface, and the second concentration detection means also detects the reagent having a specific concentration by accessing the liquid path interface; wherein the liquid path interface is not connected to the second concentration detection part when connected to the first concentration detection part, and is not connected to the first concentration detection part when connected to the second concentration detection part.

27. The method of calibrating according to claim 26, wherein when the first concentration detecting means is replaced, the first concentration detecting means is detached from the fluid path interface for connecting a new means for detecting the concentration of the reagent.