CN116930522A

CN116930522A - Sample analysis system and concentration detection method

Info

Publication number: CN116930522A
Application number: CN202210333966.1A
Authority: CN
Inventors: 吴舒晨; 李学荣; 刘隐明
Original assignee: Shenzhen Mindray Bio Medical Electronics Co Ltd
Current assignee: Shenzhen Mindray Bio Medical Electronics Co Ltd
Priority date: 2022-03-30
Filing date: 2022-03-30
Publication date: 2023-10-24

Abstract

A sample analysis system, a method for detecting the concentration of a diluent for measuring a blood sample, and a method for detecting the concentration of a first reagent for measuring a biological sample are provided: measuring a first liquid and a second liquid; mixing the measured first liquid and second liquid uniformly to form a mixed liquid so as to prepare a first reagent with a specific concentration, and supplying the first reagent with the specific concentration to a sample analysis device; controlling the sample analysis device to perform first item measurement on the biological sample to obtain a measurement result of the first item of the biological sample; the first item is an item in which the sample analysis device uses the first reagent when performing item visualization on a living being; determining whether or not the concentration of the first reagent supplied to the sample analysis device is abnormal based on the measurement result of the first item of the biological sample. The invention provides a brand-new technical route for judging whether the concentration of the first reagent prepared by the reagent preparation device is abnormal.

Description

Sample analysis system and concentration detection method

Technical Field

The present invention relates to a sample analysis system and a concentration detection method, and more particularly, to a sample analysis system, a concentration detection method of a diluent for measuring a blood sample, and a concentration detection method of a first reagent for measuring a biological sample.

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.

The inputs to the solution reduction apparatus typically include pure water and a concentrated solution, and the interior typically includes: a quantifying system and a mixing 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 mixing the quantitative pure water and the concentrated solution uniformly to form a solution with a specific concentration for a subsequent sample analysis device.

When there is a deviation in the concentration of the solution prepared by the solution reduction apparatus, a prompt is required.

Disclosure of Invention

In order to solve the above problems, the present invention provides a sample analysis system, a method for detecting the concentration of a diluent for measuring a blood sample, and a method for detecting the concentration of a first reagent for measuring a biological sample, which will be described in detail below.

According to a first aspect, there is provided in one embodiment a sample analysis system comprising:

one or more sample analysis devices for measuring a blood sample;

a sample introduction part for carrying a blood sample to be measured to supply the blood sample to be measured to the sample analysis device;

the reagent preparation device is used for quantitatively measuring a first liquid and a second liquid, wherein the first liquid is a stock solution of a diluent, and the second liquid is used for diluting the stock solution of the diluent; the reagent preparation device is used for uniformly mixing the first liquid and the second liquid which are measured in quantity to form a mixed solution so as to prepare a diluent with a specific concentration, and supplying the diluent with the specific concentration to the sample analysis device;

a control device for controlling the sample analysis device to perform measurement of a first item on a blood sample formed by the blood sample and the diluent having a specific concentration, to obtain measurement data of the blood sample with respect to the first item, and to obtain a measurement result of the first item of the blood sample based on the measurement data; the control device determines whether or not the concentration of the diluent supplied from the reagent preparing device is abnormal based on the measurement result of the first item of the blood sample.

In some embodiments, the control device determines whether the concentration of the diluent supplied by the reagent preparing device is abnormal according to the measurement result of the first item of the blood sample, including:

the blood sample is a quality control sample;

the control device obtains a measurement result of the first item of the quality control sample;

the control device judges whether the concentration of the diluent supplied by the reagent preparation device is abnormal according to the measurement result of the first item of the quality control sample.

In some embodiments, the control device determines whether the concentration of the diluent supplied by the reagent preparation device is abnormal according to the measurement result of the first item of the quality control sample, including:

the control device obtains a calibration value of the first item of the quality control sample;

the control device compares the calibration value of the first item of the quality control sample with a measurement result to judge whether the concentration of the diluent supplied by the reagent preparation device is abnormal.

In some embodiments, the control device corrects the calibration value of the first item of the quality control sample before comparing the calibration value of the first item with the measurement result.

In some embodiments, the control device corrects the calibration value of the first item of the quality control sample based on the unsealing time of the quality control sample and/or the measurement result of the first item of the quality control sample history.

the control device judges whether the concentration of the diluent supplied by the reagent preparation device is abnormal according to the measurement result of the first item of the quality control sample and the measurement result of the first item of the quality control sample history.

In some embodiments, the measurement of the first item of the quality control sample history is the measurement of the first item of the quality control sample previous time.

In some embodiments, the control device determines whether the concentration of the diluent supplied by the reagent preparing device is abnormal according to the measurement result of the first item, including:

the control device obtains a set value of the first item;

the control device obtains measurement results of the first items of the plurality of blood samples to be measured;

The control device calculates a mean value of the measurement results of the first item according to the measurement results of the first item of the plurality of blood samples;

the control device determines whether or not the concentration of the diluent supplied from the reagent preparing device is abnormal based on the set value of the first item and the calculated average value of the measurement results of the first item.

In some embodiments, the control device calculates a mean value of the measurement results of the first item from the measurement results of the first item of the plurality of blood samples, including:

the control device removes blood samples that do not meet statistical conditions from the plurality of blood samples;

the control device calculates a mean value of the measurement results of the first item of the remaining blood sample as a mean value of the measurement results of the first item.

In some embodiments, the non-statistically compliant blood sample comprises: for the abnormal sample of the first item and/or the blood sample with the mean deviation of the measurement result of the first item larger than a preset value from the plurality of blood samples.

In some embodiments, the number of remaining blood samples is greater than a preset number.

In some embodiments, the first item is an item detected based on an electrical impedance method.

In some embodiments, the first item is an item for determining a volume-related parameter of a particular cell in the blood sample.

In some embodiments, the term for determining a volume-related parameter of a particular cell in the blood sample is a term for a volume-related parameter of a red blood cell; the items of the erythrocyte volume related parameter include at least one of average erythrocyte volume, hematocrit, erythrocyte distribution width variation coefficient, erythrocyte distribution width standard deviation.

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

one or more sample analysis devices for assaying a biological sample;

a sample introduction part for carrying a biological sample to be measured to supply the biological sample to be measured to the sample analysis device;

a reagent preparing means for preparing a first reagent having a specific concentration to supply the first reagent having a specific concentration to the sample analyzing means; the method comprises the steps of,

a control device; wherein:

the sample analysis device performs measurement of a first item on a biological sample to obtain a measurement result of the first item of the biological sample; the first item is an item in which the sample analysis device uses the first reagent when performing item visualization on a living being;

The control device determines whether or not the concentration of the first reagent supplied from the reagent preparing device is abnormal based on the measurement result of the first item of the biological sample.

In some embodiments, the control device determines whether the concentration of the first reagent supplied by the reagent preparing device is abnormal according to the measurement result of the first item of the biological sample, including:

the biological sample is a quality control sample; the control device obtains a measurement result of the first item of the quality control sample; the control device judges whether the concentration of the first reagent supplied by the reagent preparation device is abnormal according to the measurement result of the first item of the quality control sample;

or alternatively, the process may be performed,

the control device obtains a set value of the first item; the control device obtains measurement results of the first item of a plurality of biological samples; the control device calculates the average value of the measurement results of the first item according to the measurement results of the first item of the biological samples; the control means compares the average value of the measurement results of the first item with the set value of the first item to determine whether the concentration of the first reagent supplied from the reagent preparing means is abnormal.

In some embodiments, the control device determines whether the concentration of the first reagent supplied by the reagent preparation device is abnormal according to the measurement result of the first item of the quality control sample, including:

the control device compares the calibration value of the first item of the quality control sample with a measurement result to judge whether the concentration of the first reagent supplied by the reagent preparation device is abnormal.

the control device judges whether the concentration of the first reagent supplied by the reagent preparation device is abnormal or not according to the measurement result of the first item of the quality control sample and the measurement result of the first item of the quality control sample history.

According to a third aspect, an embodiment provides a method for detecting a concentration of a diluent for measuring a blood sample, including:

measuring a first liquid and a second liquid, wherein the first liquid is a stock solution of a diluent, and the second liquid is used for diluting the stock solution of the diluent;

mixing the measured first liquid and second liquid uniformly to form a mixed liquid so as to prepare a diluent with a specific concentration, and supplying the diluent with the specific concentration to a sample analysis device;

controlling the sample analysis device to perform measurement of a first item on a blood sample and a blood sample formed by the diluent having a specific concentration, so as to obtain measurement data of the blood sample with respect to the first item, and obtaining a measurement result of the first item of the blood sample based on the measurement data;

based on the measurement result of the first item of the blood sample, it is determined whether or not the concentration of the diluent supplied to the sample analysis device is abnormal.

In some embodiments, the determining whether the concentration of the diluent supplied to the sample analysis device is abnormal according to the measurement result of the first item of the quality control sample includes:

The blood sample is a quality control sample; obtaining a measurement result of the first item of the quality control sample; acquiring a calibration value of the first item of the quality control sample; comparing the calibration value of the first item of the quality control sample with a measurement result to determine whether the concentration of the diluent supplied to the sample analysis device is abnormal;

or alternatively, the process may be performed,

the blood sample is a quality control sample; obtaining a measurement result of the first item of the quality control sample; judging whether the concentration of the diluent supplied to the sample analysis device is abnormal or not according to the measurement result of the first item of the quality control sample and the measurement result of the first item of the quality control sample history;

or alternatively, the process may be performed,

acquiring a set value of the first item; obtaining measurement results of the first item of a plurality of blood samples to be measured; calculating a mean value of the measurement results of the first item according to the measurement results of the first item of the plurality of blood samples; determining whether or not the concentration of the diluent supplied to the sample analysis device is abnormal based on the set value of the first item and the calculated average value of the measurement result of the first item.

In some embodiments, the first item is an item for determining a volume-related parameter of a particular cell in the blood sample; the items of the volume-related parameters of the specific cells in the blood sample are measured, and the items of the volume-related parameters of the red blood cells are measured; the items of the erythrocyte volume related parameter include at least one of average erythrocyte volume, hematocrit, erythrocyte distribution width variation coefficient, erythrocyte distribution width standard deviation.

According to a fourth aspect, an embodiment provides a method for detecting a concentration of a first reagent for biological sample measurement, including:

measuring a first liquid and a second liquid;

mixing the measured first liquid and second liquid uniformly to form a mixed liquid so as to prepare a first reagent with a specific concentration, and supplying the first reagent with the specific concentration to a sample analysis device;

controlling the sample analysis device to perform first item measurement on the biological sample to obtain a measurement result of the first item of the biological sample; the first item is an item in which the sample analysis device uses the first reagent when performing item visualization on a living being;

Determining whether or not the concentration of the first reagent supplied to the sample analysis device is abnormal based on the measurement result of the first item of the biological sample.

In some embodiments, the determining whether the concentration of the first reagent supplied to the sample analysis device is abnormal according to the measurement result of the first item of the biological sample includes:

the biological sample is a quality control sample; obtaining a measurement result of the first item of the quality control sample; judging whether the concentration of the first reagent supplied to the sample analysis device is abnormal or not according to the measurement result of the first item of the quality control sample;

or alternatively, the process may be performed,

acquiring a set value of the first item; obtaining measurement results of the first item of a plurality of biological samples; calculating a mean value of the measurement results of the first item according to the measurement results of the first item of the plurality of biological samples; comparing the average value of the measurement results of the first item with the set value of the first item to determine whether the concentration of the first reagent supplied to the sample analysis device is abnormal.

According to the sample analysis system, the method for detecting the concentration of the diluent for measuring the blood sample, and the method for detecting the concentration of the first reagent for measuring the biological sample of the above embodiments, it is determined whether the concentration of the first reagent supplied to the sample analysis device is abnormal or not based on the measurement result of the first item of the biological sample, and a brand-new technical path is provided to determine whether the concentration of the first reagent prepared by the reagent preparation device is abnormal or not.

Drawings

FIG. 1 is a schematic diagram of a sample analysis system according to one embodiment;

FIG. 2 is a schematic diagram of a sample analysis system according to one embodiment;

FIG. 3 is a schematic structural view of a reagent preparing apparatus according to an embodiment;

FIG. 4 is a schematic structural view of a reagent preparing apparatus according to an embodiment;

FIG. 5 is a schematic view showing the structure of a reagent preparing apparatus according to one embodiment;

FIG. 6 is a schematic diagram of detection of items detected based on electrical impedance methods according to one embodiment;

FIG. 7 is a schematic diagram of an item detected based on an electrical impedance method, according to an embodiment, the pulse voltage generated during the detection process;

FIG. 8 is a schematic diagram showing the comparison of pulse signals generated by the same red blood cell in different concentrations of dilutions according to one embodiment;

FIG. 9 is a schematic diagram showing a method for detecting the concentration of a first reagent for measuring a biological sample according to an embodiment;

fig. 10 is a schematic diagram showing a method for detecting the concentration of a diluent for measuring a blood sample according to an embodiment.

Detailed Description

The application 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, related operations of the present application have not been shown or described in the specification in order to avoid obscuring the core portions of the present application, and may be unnecessary to persons skilled in the art from a detailed description of the related operations, which may be presented in the description and 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 term "coupled" as used herein includes both direct and indirect coupling (coupling), unless otherwise indicated.

Reduction equipment can deviate from the intended concentration of the prepared and reduced solution due to various failure problems, aging, and batch of stock solution. In order to detect whether the concentration of the prepared and reduced solution deviates, in general, a concentration detection system may be introduced into the reduction device, the concentration detection system being used to detect whether the concentration of the solution after mixing meets the instrument concentration requirement, and if not, an alarm is given. For example, the concentration detection system is used for detecting the concentration of the reduced solution and comparing the concentration with the expected concentration, and when the deviation is found to exceed the set value, the concentration detection system is used for judging that the concentration of the solution prepared by the reduction equipment is abnormal and does not meet the requirements.

Since the concentration and the conductivity of the solution have a linear relationship in a certain range, the concentration detection system can be realized by a conductivity detection device: and detecting the conductivity of the reduced solution, so as to monitor whether the concentration of the reduced solution meets the use requirement.

The above-described manner is a common method for detecting whether the concentration of a solution prepared by a reduction apparatus is abnormal.

In practical use, the conductivity detection device may be degraded due to aging or impurity influence, and the detection accuracy may be reduced, so that misjudgment or missed judgment exists, and the solution which does not meet the concentration requirement passes through the detection and is further provided for a subsequent sample analysis device to be used, thereby influencing the measurement result of a subsequent sample.

The application provides a brand-new technical route for judging whether the concentration of a solution prepared by reduction equipment is abnormal or not: in general, when the concentration of the solution prepared by the reduction apparatus deviates from the expected value, the measurement result of the subsequent sample may be affected, and one intuitive scheme is to reversely determine whether the concentration of the solution prepared by the reduction apparatus is abnormal or not through the measurement result of the subsequent sample; however, as described above, in the current technical route, the conductivity detection device is disposed at the reduction device to directly detect whether the concentration of the solution meets the requirement, and the determination result of the subsequent sample is not considered to reversely determine whether the concentration of the solution prepared by the reduction device is abnormal; this is because there are various samples such as a trouble of the sample analyzing apparatus itself, such as abnormality of the sample itself (e.g., bubbles, contaminated, etc.), which are factors that cause abnormality of the measurement result of the sample, and thus, in the prior art, the skilled person would not think of reversely judging whether the concentration of the solution prepared by the reduction apparatus is abnormal or not by the measurement result of the subsequent sample; the present application proposes a technical route that is feasible, and that can determine whether or not the solution of the solution prepared by the reduction apparatus is abnormal by using the measurement result of the item of the solution prepared by the reduction apparatus.

Referring to fig. 1, a sample analysis system in some embodiments includes a sample analysis device 10, a sample introduction part 20, a reagent preparation device 30, and a control device 40, which are described in detail below.

The sample analysis device 10 is used for assaying a biological sample. In some embodiments, the biological sample is a blood sample.

The number of sample analysis devices 10 may be one or more. In order to improve efficiency and test throughput, in general, a sample analysis system may have a plurality of sample analysis apparatuses 10, and these sample analysis apparatuses 10 may be the same sample analysis apparatuses, i.e., may be used to measure the same item, or may be different sample analysis apparatuses, i.e., may be used to measure different items, which may be configured according to the needs of users and departments.

The sample introduction part 20 serves to carry a biological sample to be measured to supply the biological sample to be measured to the sample analysis device 10.

When the sample analysis system includes a plurality of sample analysis devices 10, the sample analysis system is actually a pipeline system, in such a system, the sample introduction part 20 is generally an area where a biological sample is placed by a user, and when the pipeline system works, the sample introduction part 20 can automatically scan codes, sort samples and the like for the biological sample placed therein to be processed by a next link, for example, the sample analysis device 10. Referring to fig. 2, in the pipeline system, the sample analysis system may further include a rail 90 and a dispatching device 91, the rail 90 is used for connecting each sample analysis device 10, and the dispatching device 91 is used for dispatching the biological samples transmitted through the rail 90 to the corresponding sample analysis devices 10 for measurement; by such a pipelined system, the speed of measurement of biological samples can be greatly increased.

The reagent preparing apparatus 30 is used to prepare a first reagent having a specific concentration to supply the first reagent having the specific concentration to the sample analyzing apparatus 10. In some embodiments, the first reagent may be a diluent; in such an embodiment, the reagent preparing apparatus 30 is used to quantitatively measure a first liquid and a second liquid, wherein the first liquid is a stock solution of a dilution liquid, and the second liquid is a stock solution for diluting the dilution liquid, for example, the second liquid may be pure water; the reagent preparing apparatus 30 is configured to mix a predetermined amount of the first liquid and the second liquid to prepare a mixed liquid, prepare a diluent having a specific concentration, and supply the diluent having the specific concentration to the sample analyzing apparatus 10.

A more detailed description of the reagent preparing apparatus 30 follows.

Referring to fig. 3, the reagent preparing apparatus 30 in some embodiments includes a dosing part 31 and a mixing part 38; in some embodiments, the reagent preparing apparatus further includes a concentration detecting section 39, which will be described in detail below.

The dosing unit 31 is used for dosing the first liquid and the second liquid. For example, the dosing means 31 is for dosing the first liquid and the second liquid according to dosing parameters; the quantitative parameter is used to characterize the amount of the first liquid and/or the second liquid that needs to be measured. In some embodiments, the first liquid is a stock solution of a first reagent; in some embodiments, the second liquid is a diluent for diluting the first liquid, i.e., the second liquid is a diluent for diluting the stock solution of the first reagent, for example, the second liquid may be pure water. The mixing part 38 is used for mixing the first liquid and the second liquid measured by the quantitative part 31 to form a mixed liquid to prepare a reagent. In the embodiment in which the reagent preparing apparatus 30 has the concentration detecting section 39, the concentration detecting section 39 is used to detect whether the concentration of the reagent prepared by the mixing section 38 meets the requirement. The reagent preparing apparatus 30 can prepare the first reagent having a specific concentration by performing operations such as quantifying and mixing the liquid, for example, by diluting the stock solution of the first reagent to a specific concentration.

Referring to fig. 4, in some embodiments, the dosing unit 31 includes a first dosing container 32, a first infusion line 32a and a first drain line 32b, the first dosing container 32 is used for dosing a first liquid and/or a second liquid, and the first infusion line 32a is connected to the first dosing container 32 for delivering the liquid to be dosed to the first dosing container 32; the first drain line 32b is connected between the first dosing vessel 32 and the mixing part 38 for discharging the liquid dosed by the first dosing vessel 32 to the mixing part 38. For example, the first metering container 32 is used only for metering the first liquid, specifically, the first liquid is delivered to the first metering container 32 through the first infusion line 32a, the first metering container 32 is used for metering the first liquid, and then the metered first liquid is discharged to the mixing part 38 through the first liquid discharge line 32 b. For another example, the first metering container 32 is only used for metering the second liquid, specifically, the second liquid is delivered to the first metering container 32 through the first infusion line 32a, the first metering container 32 is used for metering the second liquid, and then the metered second liquid is discharged to the mixing part 38 through the first liquid discharge line 32 b. For another example, the first metering container 32 may time-divisionally meter the first liquid and the second liquid, for example, meter the first liquid, then discharge the first liquid to the mixing part 38, then meter the second liquid, then discharge the second liquid to the mixing part 38, or may meter the second liquid, then discharge the second liquid to the mixing part 38, then meter the first liquid, and then discharge the first liquid to the mixing part 38; in such an example, the first liquid and the second liquid are measured in a common first measuring container 32.

In some examples, the dosing assembly 31 may comprise only one first dosing reservoir 32, the first dosing reservoir 32 being as described above, and the first liquid and the second liquid may be measured in time-sharing fashion-for example, fig. 4 is an example. In other examples, the dosing assembly 31 may comprise a plurality of first dosing containers 32, e.g. two, one first dosing container 32 for dosing a first liquid and one first dosing container 32 for dosing a second liquid, e.g. fig. 5 is an example. In some examples, the two first metering containers 32 included in fig. 5 may be identical in construction, but may be sized according to the requirements, such as two first metering containers 32 one by one.

The above are some illustrations of reagent preparation devices.

Next, how to determine whether or not the concentration of the first reagent supplied from the reagent preparing apparatus 30 is abnormal will be described.

In some embodiments, the sample analysis device 10 performs the first item of measurement on the biological sample to obtain the first item of measurement result of the biological sample; the control device 40 may control the sample analyzer 10 to perform the measurement of the first item on the biological sample, and obtain the measurement result of the first item of the biological sample. In some embodiments, the first item is an item of sample analysis device 30 that uses the first reagent described above in performing item visual determinations on the living being. The control device 40 determines whether or not the concentration of the first reagent supplied from the reagent preparing apparatus 30 is abnormal based on the measurement result of the first item of the biological sample.

The term "abnormality" in the context of determining whether or not the concentration of the first reagent supplied from the reagent preparing apparatus 30 is abnormal refers to that the concentration deviates from the expected value, i.e., is not satisfactory, for example, the first reagent having a specific concentration is originally prepared, but if the deviation between the actual concentration of the first reagent and the specific concentration is within a predetermined range, the deviation is normal, otherwise, the deviation is abnormal.

In some embodiments, whether the concentration of the first reagent supplied from the reagent preparing apparatus 30 is abnormal may be judged by the measurement result of the first item of the quality control sample.

The quality control sample is also called a quality control product, and is a standard sample for industrial production, and is used for quality control of the sample analysis device 10. In some embodiments, the quality control samples have three values, low, medium, and high; generally, the sample analyzer 10 needs to perform quality control daily, for example, running quality control samples with three different values daily to monitor the operation of the sample analyzer 10, so as to ensure the reliability of the measurement results of the project. The quality control sample is generally contained in a sample bottle, and after the sample bottle is opened, the sample analysis device 10 may draw the quality control sample from the sample bottle of the quality control sample to perform measurement or quality control, and generally, a brand new sample bottle is filled with a quality control sample amount capable of providing multiple quality control, for example, 50 times; in general, the sample bottle is also calibrated with a quality control value or calibration value when the quality control sample is used for measuring the corresponding item, and when the measured value obtained when the quality control sample is used for measuring the corresponding item is not matched with the calibration value, the sample analysis device is possibly out of control.

Thus, in some embodiments, it may be determined whether the concentration of the first reagent supplied from the reagent preparing apparatus 30 is abnormal by controlling the measurement result of the first item of the sample; since many other factors can be generally excluded when the measurement result of the quality control sample is abnormal, it is also reasonable to consider the abnormality of the reagent as one of the main factors, and it is also a very effective way to determine whether the concentration of the first reagent supplied from the reagent preparing apparatus 30 is abnormal or not in the actual implementation process.

Thus, in some embodiments, the biological sample is a quality control sample; the control device 40 obtains the measurement result of the first item of the quality control sample; the control device 40 determines whether or not the concentration of the first reagent supplied from the reagent preparing apparatus 30 is abnormal based on the measurement result of the first item of the quality control sample.

In some embodiments, the control device 40 determines whether the concentration of the first reagent supplied by the reagent preparing apparatus 30 is abnormal according to the measurement result of the first item of the quality control sample, including: the control device 40 obtains a calibration value of a first item of the quality control sample; the control device 40 compares the calibration value of the first item of the quality control sample with the measurement result to determine whether the concentration of the first reagent supplied from the reagent preparing device 30 is abnormal.

Considering that the quality control sample has a drift problem, that is, after the sample bottle is opened, there is a deviation between the actual value of the quality control sample and the calibration value, where the calibration value cannot truly represent the actual value of the quality control sample, in some embodiments, the control device 40 corrects the calibration value of the first item of the quality control sample before comparing the calibration value of the first item of the quality control sample with the measurement result, for example, the control device 40 corrects the calibration value of the first item of the quality control sample based on the opening time of the quality control sample (i.e., the opening time of the sample bottle in which the quality control sample is located) and/or the measurement result of the first item of the quality control sample history.

In some embodiments, the control device 40 determines whether the concentration of the first reagent supplied by the reagent preparing apparatus 30 is abnormal according to the measurement result of the first item of the quality control sample, including: the control device 40 determines whether or not the concentration of the first reagent supplied from the reagent preparing apparatus 30 is abnormal based on the measurement result of the first item of the quality control sample and the measurement result of the first item of the quality control sample history. In some embodiments, the measurement result of the first item of the quality control sample history may be the measurement result of the first item of the previous time of the quality control sample, that is, the control device 40 determines whether the concentration of the first reagent supplied by the reagent preparation device 30 is abnormal according to the measurement result of the first item of the adjacent two times of the quality control sample, and determines that the concentration of the first reagent supplied by the reagent preparation device 30 is abnormal when the deviation of the measurement result of the first item of the adjacent two times of the quality control sample exceeds a preset value.

In some embodiments, it is also possible to determine whether the concentration of the first reagent supplied from the reagent preparing apparatus 30 is abnormal by counting the average value of the first items of the considerable number of biological samples.

When the number of biological samples measured by the sample analysis device is large, the average value of the measurement results of the first item thereof is stabilized within a small range, so that it can be used to monitor whether the concentration of the first reagent supplied from the reagent preparing apparatus 30 is abnormal.

In some embodiments, control device 40 obtains an assay result for a first item of a plurality of biological samples; the control device 40 calculates the average value of the measurement results of the first item based on the measurement results of the first item of the plurality of biological samples; the control device 40 determines whether the concentration of the first reagent supplied from the reagent preparing apparatus 30 is abnormal based on the calculated average value of the measurement results of the first item, for example, the control device 40 acquires the set value of the first item and compares the average value of the measurement results of the first item with the set value of the first item to determine whether the concentration of the first reagent supplied from the reagent preparing apparatus 30 is abnormal.

In order to make the calculated average value of the measurement results of the first item more representative, when the control device 40 calculates the average value of the measurement results of the first item from the measurement results of the first items of the plurality of biological samples, it is possible to first remove biological samples that do not meet the statistical condition from the plurality of biological samples, and then calculate the average value of the measurement results of the first item for the remaining biological samples as the average value of the measurement results of the first item. In some embodiments, the non-statistically compliant biological sample comprises at least one of:

(1) An anomaly sample for the first item; this sample appears as: when the first item is measured on the sample, the measurement result is not significant, because the actual value of the first item of the sample is abnormal and is not in the normal range; for example, when the first item is a red blood cell volume-related parameter, such as an average red blood cell volume or a red blood cell backlog, the biological sample is an original cell sample, a immature cell sample, or a small red blood cell sample, which are referred to as abnormal samples for the red blood cell volume-related parameter, and thus the measurement result is not significant when the red blood cell volume-related parameter is measured for these samples, because the original cell sample, the immature cell sample, or the small red blood cell sample, etc., their average red blood cell volume or red blood cell backlog, etc., deviate from the normal range by themselves.

(2) And a biological sample having a mean deviation from the measurement result of the first item of the plurality of biological samples of more than a preset value. For example, when the control device 40 calculates the average value of the measurement results of the first item from the measurement results of the first item of the N biological samples; the method comprises the steps of directly calculating the average value (not limited to an initial average value) of the measurement results of the first items of the N biological samples, comparing the measurement results of the first items of the N biological samples with the initial average value, removing the biological samples which deviate from the initial average value by more than a preset value, and calculating the average value of the measurement results of the final first item.

After removing the biological samples that do not meet the statistical condition, the control device 40 calculates a mean value of the measurement results of the first item of the remaining biological samples, and the calculated mean value is more representative; in some embodiments, the number of remaining biological samples needs to be greater than a preset number in order for the calculated mean to be more representative of the overall mean. In some embodiments, the predetermined number takes a value between 100 and 200, such as 100, 120, 140, 160, 180, or 200.

The above are some descriptions of how to judge whether or not the concentration of the first reagent supplied from the reagent preparing apparatus 30 is abnormal. When it is determined that there is an abnormality in the concentration of the first reagent supplied from the reagent preparing apparatus 30, the control apparatus 40 may generate a prompt or alarm to alert the user that there is a possibility that the concentration of the first reagent supplied from the reagent preparing apparatus 30 is abnormal, requiring the user to pay attention; or the control device 40 reminds the user of the need to pay attention to and check whether or not the abnormality is actually occurring in the concentration of the first reagent supplied from the current reagent preparing device 30, as one of the important causes of the occurrence of the prompt or alarm that the abnormality is likely to occur in the concentration of the first reagent supplied from the reagent preparing device 30.

The first reagent may be used as a diluent.

The diluent plays a very important role in a sample analysis device 10 for measuring blood samples, such as a blood cell analysis device, which provides a stable solution environment for blood cells during blood cell detection, dilutes the blood sample and provides a conductive environment, and performs cell classification, counting and hemoglobin measurement in combination with electrical impedance methods, colorimetry, laser scattering methods and flow cytometry of fluorescent staining. Because the usage amount of the diluent is large, when the blood sample amount is large, the barreled volume and the replacement frequency of the diluent are large, which increases the workload of doctors and reduces the usage experience of the blood cell analyzer, so that the diluent with a specific concentration needs to be prepared by the reagent preparation device and supplied to the sample analysis device 10 for use.

In some embodiments, by monitoring the daily quality control of the blood cell analysis device or the deviation of the detected blood sample such as the red blood cell volume related parameter (e.g. average red blood cell volume, red blood cell backlog, red blood cell distribution width variation coefficient and/or red blood cell distribution width standard deviation, etc.), the concentration deviation of the diluted solution reduced by the reagent preparation device is monitored, and when the deviation of the red blood cell volume related parameter exceeds a certain value, the system prompts and alarms, thereby avoiding the inaccuracy of the report parameter of the blood cell analysis device caused by the deviation of the concentration of the diluted solution, and improving the reliability of the measurement system.

Thus, in some embodiments, the control device 40 is configured to control the sample analysis device 10 to perform measurement of a first item on a blood sample and a blood sample formed from a diluent having a specific concentration supplied from the reagent preparation device 30, to obtain measurement data of the blood sample with respect to the first item, and to obtain a measurement result of the first item of the blood sample based on the measurement data; the control device 40 determines whether or not the concentration of the diluent supplied from the reagent preparing apparatus 30 is abnormal based on the measurement result of the first item of the blood sample.

As described above, the quality control sample is also referred to as a quality control sample, which is a standard sample for industrial production, and is used to control the quality of the sample analyzer 10. Generally, a sample of whole blood is an industrially produced whole blood product corresponding to a blood sample, or a quality control sample of the sample analysis device 10 for measuring a blood sample.

When there is a deviation in the concentration of the reduced or prepared diluent in the reagent preparing apparatus 30, it will affect parameters such as the volume of red blood cells (e.g. average red blood cell volume, hematocrit, coefficient of variation of distribution width of red blood cells, standard deviation of distribution width of red blood cells, etc.) in the quality control, and the concentration of the reduced diluent in the reagent preparing apparatus 30 can be monitored by monitoring parameters such as the volume of red blood cells in the quality control, and when the deviation of the parameters exceeds a certain value, prompt and alarm are given to avoid inaccuracy of the report parameters of the blood cell analyzing apparatus due to the deviation of the concentration of the diluent.

Thus, in some embodiments, the blood sample is a quality control sample; the control device 40 obtains the measurement result of the first item of the quality control sample; the control device 40 determines whether or not the concentration of the first reagent supplied from the reagent preparing apparatus 30 is abnormal based on the measurement result of the first item of the quality control sample.

In some embodiments, it is also possible to determine whether the concentration of the first reagent supplied from the reagent preparing apparatus 30 is abnormal by counting the average value of the first items of the considerable number of blood samples.

When the number of blood samples measured by the sample analyzing device is large, the average value of the measurement results of the first item thereof is stabilized within a small range, so that it can be used to monitor whether the concentration of the first reagent supplied from the reagent preparing device 30 is abnormal.

In some embodiments, control device 40 obtains a measurement of a first item of a plurality of blood samples; the control device 40 calculates the average value of the measurement results of the first item based on the measurement results of the first item of the plurality of blood samples; the control device 40 determines whether the concentration of the first reagent supplied from the reagent preparing apparatus 30 is abnormal based on the calculated average value of the measurement results of the first item, for example, the control device 40 acquires the set value of the first item and compares the average value of the measurement results of the first item with the set value of the first item to determine whether the concentration of the first reagent supplied from the reagent preparing apparatus 30 is abnormal.

In order to make the calculated average value of the measurement results of the first item more representative, when the control device 40 calculates the average value of the measurement results of the first item from the measurement results of the first items of the plurality of blood samples, it is possible to first remove the blood sample that does not meet the statistical condition from the plurality of blood samples, and then calculate the average value of the measurement results of the first item for the remaining blood samples as the average value of the measurement results of the first item. In some embodiments, the non-statistically compliant blood sample comprises at least one of:

(1) An anomaly sample for the first item; this sample appears as: in the case of the measurement of the first item on the blood sample, the measurement result is not significant because the actual value of the first item of the blood sample itself is abnormal and not within the normal range; for example, when the first item is a red blood cell volume-related parameter such as an average red blood cell volume or a red blood cell backlog, and when the blood sample is an original cell sample, a immature cell sample, or a small red blood cell sample, etc., these blood samples are referred to as abnormal samples for the red blood cell volume-related parameter, the measurement result is not significant because the original cell sample, the immature cell sample, or the small red blood cell sample, etc., their average red blood cell volume or red blood cell backlog, etc., deviate from the normal range.

(2) And a blood sample having a mean deviation from the measurement result of the first item of the plurality of blood samples of more than a preset value among the plurality of blood samples. For example, when the control device 40 calculates the average value of the measurement results of the first item from the measurement results of the first item of the N blood samples; the average value (not limited to the initial average value) of the measurement results of the first items of the N blood samples is directly calculated, the measurement results of the first items of the N blood samples are compared with the initial average value, the blood samples with the deviation from the initial average value greater than the preset value are removed, and the average value of the measurement results of the final first item is calculated.

After removing the blood sample that does not meet the statistical condition, the control device 40 calculates the average value of the measurement results of the first item of the remaining blood sample, and the average value thus calculated is more representative; in some embodiments, the number of remaining blood samples needs to be greater than a preset number in order for the calculated mean to be more representative of the overall mean. In some embodiments, the predetermined number takes a value between 100 and 200, such as 100, 120, 140, 160, 180, or 200.

The above are some illustrations of the first reagent as a diluent. Some descriptions of the first item are provided below.

In some embodiments, the first item is an item detected based on electrical impedance methods.

An item to be detected based on the electrical impedance method, one principle of which is shown in fig. 6. Referring to fig. 6, the detection system of the electrical impedance method includes: the device comprises an impedance pool 1, two detection electrodes 2, a detection small hole 3, a constant current source and an analysis circuit 4; wherein, two detection electrodes 2 are respectively arranged at two sides of the detection small hole 3, and the detection electrodes 2 are connected with a constant current source and a constant current source in an analysis circuit 4 in the detection process; the detection process of the electrical impedance method comprises the following steps: the blood sample is diluted by the diluent and then enters the impedance pool 1, the blood sample formed by the blood sample and the diluent passes through the detection aperture 3 under the action of constant negative pressure, and because the cells have the characteristic of poor conductors, when the cells in the blood sample pass through the detection aperture 3, the direct current resistance between the two detection electrodes 2 is changed, so that a pulse signal which is proportional to the cell volume is formed at the two ends of the detection electrodes 2, as shown in fig. 7; the pulse signal is amplified and collected, and the blood cell analysis device calculates the cell volume according to the pulse voltage amplitude, so that the project of the volume related parameters of the specific cells of the blood sample is calculated.

When the concentration of the diluent changes, the osmotic pressure of the diluent also changes, and the osmotic pressure of the diluent is in direct proportion to the concentration; the greater the osmotic pressure of the solution, the smaller the volume of the cells after entering the solution, i.e., the higher the concentration of the diluent, the more the cells lose water. Thus, when the concentration of the diluent is higher, the osmotic pressure of the solution increases, the volume of the cell after entering the solution is smaller (i.e. smaller than normal), when the cell passes through the detection aperture 3, the variation between the two measurement electrodes is smaller than normal, the amplitude of the generated pulse signal decreases, and after the pulse signal is processed, the corresponding cell volume decreases, for example the average red blood cell volume decreases. Similarly, when the concentration of the diluent is smaller, the osmotic pressure of the solution is reduced, the volume of the cell after entering the solution is increased (i.e. larger than normal), when the cell passes through the detection aperture 3, the variation between the two measurement electrodes is increased, the amplitude of the generated pulse signal is increased, so that the corresponding cell volume is increased, for example, the average red cell volume is increased after the pulse signal is processed; FIG. 8 is a comparison of pulse signals generated by the same red blood cell at different concentrations of diluent.

In some embodiments, the first item is an item for determining a volume-related parameter of a particular cell in a blood sample. In some embodiments, the term for determining a volume-related parameter of a particular cell in the blood sample is a term for a volume-related parameter of a red blood cell. In some embodiments, the term of the red blood cell volume related parameter includes at least one of average red blood cell volume, red blood cell hematocrit, red blood cell distribution width coefficient of variation, and red blood cell distribution width standard deviation.

In some embodiments, the first item is an item of a volume-related parameter of a specific cell in the blood sample based on electrical impedance methods, such as an item of a red blood cell volume-related parameter.

In some embodiments of the present invention, a concentration detection method (hereinafter, simply referred to as concentration detection method) of a first reagent for biological sample measurement is provided, which is used to detect the concentration of the first reagent for biological sample measurement, and is described in detail below.

Referring to fig. 9, the concentration detection method of some embodiments includes the following steps:

step 100: the first liquid and the second liquid are measured. In some embodiments, the first liquid is a stock solution of a first reagent; in some embodiments, the second liquid is a diluent, such as pure water, for diluting the first liquid.

Step 110: the measured first liquid and the measured second liquid are uniformly mixed to form a mixed liquid so as to prepare the first reagent with specific concentration, and the first reagent with specific concentration is supplied to a sample analysis device.

Step 120: controlling a sample analysis device to perform measurement of a first item on a biological sample to obtain a measurement result of the first item of the biological sample; wherein the first item is an item in which the sample analysis device uses the first reagent in performing item visual determination on the living being.

Step 130: based on the measurement result of the first item of the biological sample, it is determined whether or not the concentration of the first reagent supplied to the sample analyzer is abnormal.

In some embodiments, step 130 may determine whether the concentration of the first reagent supplied to the sample analysis device is abnormal by controlling the measurement result of the first item of the sample.

Thus, step 130 may be implemented in some embodiments as follows: the biological sample is a quality control sample; step 130, obtaining a measurement result of a first item of a quality control sample; step 130 determines whether the concentration of the first reagent supplied to the sample analyzer is abnormal according to the measurement result of the first item of the quality control sample.

In some embodiments, the step 130 of determining whether the concentration of the first reagent supplied to the sample analysis device is abnormal according to the measurement result of the first item of the quality control sample includes: step 130, obtaining a calibration value of a first item of a quality control sample; step 130 compares the calibration value of the first item of the quality control sample with the measurement result to determine whether the concentration of the first reagent supplied to the sample analysis device is abnormal.

Considering that the quality control sample has a drift problem, that is, after the sample bottle is opened, there is a deviation between the actual value of the quality control sample and the calibration value with the lapse of time, and the calibration value cannot truly represent the actual value of the quality control sample, in some embodiments, the calibration value of the first item of the quality control sample is corrected in step 130 before comparing the calibration value of the first item of the quality control sample with the measurement result, for example, the calibration value of the first item of the quality control sample is corrected in step 130 based on the opening time of the quality control sample (that is, the opening time of the sample bottle in which the quality control sample is located) and/or the measurement result of the first item of the quality control sample history.

In some embodiments, the step 130 of determining whether the concentration of the first reagent supplied to the sample analysis device is abnormal according to the measurement result of the first item of the quality control sample includes: step 130 determines whether the concentration of the first reagent supplied to the sample analyzer is abnormal based on the measurement result of the first item of the quality control sample and the measurement result of the first item of the quality control sample history. In some embodiments, the measurement result of the first item of the quality control sample history may be the measurement result of the first item of the previous time of the quality control sample, that is, step 130 determines whether the concentration of the first reagent supplied to the sample analysis device is abnormal according to the measurement result of the first item of the adjacent two times of the quality control sample, and determines that the concentration of the first reagent supplied to the sample analysis device is abnormal when the deviation of the measurement result of the first item of the adjacent two times of the quality control sample exceeds a preset value.

In some embodiments, it is also possible to determine whether the concentration of the first reagent supplied to the sample analysis device is abnormal by counting the average value of the first items of the considerable number of biological samples.

When the number of biological samples measured by the sample analysis device is large, the average value of the measurement results of the first item thereof is stabilized within a small range, so that the sample analysis device can be used for monitoring whether the concentration of the first reagent supplied to the sample analysis device is abnormal.

In some embodiments, step 130 obtains an assay result for a first item of a plurality of biological samples; step 130, calculating a mean value of the measurement results of the first item according to the measurement results of the first item of the plurality of biological samples; step 130 determines whether the concentration of the first reagent supplied to the sample analysis device is abnormal according to the calculated average value of the measurement result of the first item, for example, step 130 obtains a set value of the first item, and compares the average value of the measurement result of the first item with the set value of the first item to determine whether the concentration of the first reagent supplied to the sample analysis device is abnormal.

In order to make the calculated average value of the measurement results of the first item more representative, when calculating the average value of the measurement results of the first item according to the measurement results of the first items of the plurality of biological samples in step 130, biological samples that do not meet the statistical condition may be removed from the plurality of biological samples, and then the average value of the measurement results of the first item of the remaining biological samples may be calculated as the average value of the measurement results of the first item. In some embodiments, the non-statistically compliant biological sample comprises at least one of:

(2) And a biological sample having a mean deviation from the measurement result of the first item of the plurality of biological samples of more than a preset value. For example, when the average value of the measurement results of the first item is calculated according to the measurement results of the first item of the N biological samples in step 130; the method comprises the steps of directly calculating the average value (not limited to an initial average value) of the measurement results of the first items of the N biological samples, comparing the measurement results of the first items of the N biological samples with the initial average value, removing the biological samples which deviate from the initial average value by more than a preset value, and calculating the average value of the measurement results of the final first item.

Step 130, after removing the biological samples which do not meet the statistical conditions, calculating a mean value of the measurement results of the first item of the remaining biological samples, wherein the calculated mean value is more representative; in some embodiments, the number of remaining biological samples needs to be greater than a preset number in order for the calculated mean to be more representative of the overall mean. In some embodiments, the predetermined number takes a value between 100 and 200, such as 100, 120, 140, 160, 180, or 200.

The above are some descriptions of how to determine whether or not the concentration of the first reagent supplied to the sample analysis device is abnormal. When it is determined that the concentration of the first reagent supplied to the sample analysis device is abnormal, step 130 may generate a prompt or alarm to alert the user that the concentration of the first reagent supplied to the sample analysis device is likely to be abnormal, requiring the user to pay attention; in other words, step 130 alerts the user to pay attention to and check whether the abnormality is actually occurring in the concentration of the first reagent currently supplied to the sample analyzer, which is one of the important reasons for the occurrence of the alarm or the prompt that the abnormality is likely to occur in the concentration of the first reagent supplied to the sample analyzer.

In some embodiments, the biological sample is a blood sample and the first reagent is a diluent; in the above examples, a concentration detection method (hereinafter, simply referred to as a concentration detection method) of a diluent for measuring a blood sample, that is, a concentration detection method for detecting a concentration of a diluent for measuring a blood sample, is disclosed, and will be described in detail.

Referring to fig. 10, the concentration detection method of some embodiments includes the following steps:

step 200: the first liquid and the second liquid are measured. In some embodiments, the first liquid is a stock solution of a diluent, and the second liquid is used to dilute the stock solution of the diluent, for example, the second liquid is pure water.

Step 210: the measured first liquid and the measured second liquid are uniformly mixed to form a mixed liquid so as to prepare a diluent with a specific concentration, and the diluent with the specific concentration is supplied to a sample analysis device.

Step 220: the sample analyzer is controlled to measure a first item of a blood sample and a blood sample formed of the diluent having a specific concentration, to obtain measurement data of the blood sample with respect to the first item, and to obtain a measurement result of the first item of the blood sample based on the measurement data.

Step 230: based on the measurement result of the first item of the blood sample, it is determined whether or not the concentration of the diluent supplied to the sample analyzer is abnormal.

In some embodiments, whether the concentration of the first reagent supplied to the sample analysis device is abnormal may be determined by the measurement result of the first item of the quality control sample.

As described above, the quality control sample is also called a quality control product, and is a standard sample for industrial production, and is used for quality control of the sample analysis device. Generally, a sample corresponding to a blood sample, or a quality control sample of a sample analysis device for measuring a blood sample, is an industrially produced whole blood product.

When there is a deviation in the concentration of the diluent supplied to the sample analysis device, it will affect parameters such as the volume of red blood cells (e.g., average red blood cell volume, red blood cell backlog, coefficient of variation in distribution width of red blood cells, and/or standard deviation of distribution width of red blood cells) in the quality control.

Thus, in some embodiments, the blood sample is a quality control sample; step 230, obtaining a measurement result of a first item of the quality control sample; step 230 determines whether the concentration of the first reagent supplied to the sample analyzer is abnormal according to the measurement result of the first item of the quality control sample.

In some embodiments, step 230 determines whether the concentration of the first reagent supplied to the sample analysis device is abnormal according to the measurement result of the first item of the quality control sample, including: step 230, obtaining a calibration value of a first item of a quality control sample; step 230 compares the calibration value of the first item of the quality control sample with the measurement result to determine whether the concentration of the first reagent supplied to the sample analysis device is abnormal.

Considering that the quality control sample has a drift problem, that is, after the sample bottle is opened, there is a deviation between the actual value of the quality control sample and the calibration value with the lapse of time, and the calibration value cannot truly represent the actual value of the quality control sample, in some embodiments, step 230 corrects the calibration value of the first item of the quality control sample before comparing the calibration value of the first item of the quality control sample with the measurement result, for example, step 230 corrects the calibration value of the first item of the quality control sample based on the opening time of the quality control sample (that is, the opening time of the sample bottle in which the quality control sample is located) and/or the measurement result of the first item of the quality control sample history.

In some embodiments, step 230 determines whether the concentration of the first reagent supplied to the sample analysis device is abnormal according to the measurement result of the first item of the quality control sample, including: step 230 determines whether the concentration of the first reagent supplied to the sample analyzer is abnormal according to the measurement result of the first item of the quality control sample and the measurement result of the first item of the quality control sample history. In some embodiments, the measurement result of the first item of the quality control sample history may be the measurement result of the first item of the previous time of the quality control sample, that is, step 230 determines whether the concentration of the first reagent supplied to the sample analysis device is abnormal according to the measurement result of the first item of the adjacent two times of the quality control sample, and determines that the concentration of the first reagent supplied to the sample analysis device is abnormal when the deviation of the measurement result of the first item of the adjacent two times of the quality control sample exceeds a preset value.

In some embodiments, it is also possible to determine whether the concentration of the first reagent supplied to the sample analysis device is abnormal by counting the average value of the first items of the considerable number of blood samples.

When the number of blood samples measured by the sample analysis device is large, the average value of the measurement results of the first item thereof is stabilized within a small range, so that the sample analysis device can be used for monitoring whether the concentration of the first reagent supplied to the sample analysis device is abnormal.

In some embodiments, step 230 obtains a measurement of a first item of a plurality of blood samples; step 230, calculating the average value of the measurement results of the first item according to the measurement results of the first item of the plurality of blood samples; step 230 determines whether the concentration of the first reagent supplied to the sample analysis device is abnormal according to the calculated average value of the measurement result of the first item, for example, step 230 obtains a set value of the first item, and compares the average value of the measurement result of the first item with the set value of the first item to determine whether the concentration of the first reagent supplied to the sample analysis device is abnormal.

In order to make the calculated average value of the measurement results of the first item more representative, when calculating the average value of the measurement results of the first item according to the measurement results of the first items of the plurality of blood samples in step 230, the blood sample that does not meet the statistical condition may be removed from the plurality of blood samples, and then the average value of the measurement results of the first item of the remaining blood samples may be calculated as the average value of the measurement results of the first item. In some embodiments, the non-statistically compliant blood sample comprises at least one of:

(2) And a blood sample having a mean deviation from the measurement result of the first item of the plurality of blood samples of more than a preset value among the plurality of blood samples. For example, when calculating the average value of the measurement results of the first item from the measurement results of the first item of the N blood samples in step 230; the average value (not limited to the initial average value) of the measurement results of the first items of the N blood samples is directly calculated, the measurement results of the first items of the N blood samples are compared with the initial average value, the blood samples with the deviation from the initial average value greater than the preset value are removed, and the average value of the measurement results of the final first item is calculated.

Step 230, after removing the blood sample which does not meet the statistical condition, calculating a mean value of the measurement results of the first item of the remaining blood sample, wherein the calculated mean value is more representative; in some embodiments, the number of remaining blood samples needs to be greater than a preset number in order for the calculated mean to be more representative of the overall mean. In some embodiments, the predetermined number takes a value between 100 and 200, such as 100, 120, 140, 160, 180, or 200.

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.

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 of skill in the art, the principles herein may be reflected in a computer program product on a computer readable storage medium preloaded 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 disks, 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 which implement 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 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 sample analysis system, comprising:

one or more sample analysis devices for measuring a blood sample;

2. The sample analysis system according to claim 1, wherein the control means for determining whether or not the concentration of the diluent supplied from the reagent preparing means is abnormal based on the measurement result of the first item of the blood sample, comprises:

the blood sample is a quality control sample;

3. The sample analysis system according to claim 2, wherein the control means for determining whether or not the concentration of the diluent supplied from the reagent preparing means is abnormal based on the measurement result of the first item of the quality control sample, comprises:

4. The sample analyzer of claim 2 wherein said control means modifies said calibration value of said first item of said quality control sample prior to comparing said calibration value of said first item with a measurement result.

5. The sample analyzer according to claim 4, wherein the control device corrects the calibration value of the first item of the quality control sample based on an unsealing time of the quality control sample and/or a measurement result of the first item of the quality control sample history.

6. The sample analysis system according to claim 2, wherein the control means for determining whether or not the concentration of the diluent supplied from the reagent preparing means is abnormal based on the measurement result of the first item of the quality control sample, comprises:

7. The sample analysis system of claim 6, wherein the measurement of the first item of the quality control sample history is the measurement of the first item of the quality control sample prior.

8. The sample analysis system according to claim 1, wherein the control means for determining whether or not the concentration of the diluent supplied from the reagent preparing means is abnormal based on the measurement result of the first item comprises:

The control device obtains a set value of the first item;

9. The sample analysis system of claim 8, wherein the control device calculates a mean value of the measurement results of the first item from the measurement results of the first item of the plurality of blood samples, comprising:

10. The sample analysis system of claim 9, wherein the non-statistically compliant blood sample comprises: for the abnormal sample of the first item and/or the blood sample with the mean deviation of the measurement result of the first item larger than a preset value from the plurality of blood samples.

11. The sample analysis system of claim 9, wherein the number of remaining blood samples is greater than a preset number.

12. The sample analysis system of any of claims 1 to 11, wherein the first item is an item detected based on an electrical impedance method.

13. The sample analysis system of any one of claims 1 to 11, wherein the first item is an item for determining a volume-related parameter of a specific cell in the blood sample.

14. The sample analysis system of claim 13, wherein the item for determining a volume-related parameter for a particular cell in the blood sample is an item for a volume-related parameter for red blood cells; the items of the erythrocyte volume related parameter include at least one of average erythrocyte volume, hematocrit, erythrocyte distribution width variation coefficient, erythrocyte distribution width standard deviation.

15. A sample analysis system, comprising:

one or more sample analysis devices for assaying a biological sample;

a control device; wherein:

16. The sample analysis system according to claim 15, wherein the control means for determining whether or not the concentration of the first reagent supplied from the reagent preparing means is abnormal based on the measurement result of the first item of the biological sample, comprises:

Or alternatively, the process may be performed,

17. The sample analysis system according to claim 16, wherein the control means for determining whether the concentration of the first reagent supplied from the reagent preparing means is abnormal based on the measurement result of the first item of the quality control sample, comprises:

18. The sample analysis system of claim 17, wherein the control device modifies the calibration value of the first item of the quality control sample prior to comparing the calibration value of the first item with the measurement result.

19. The sample analysis system according to claim 16, wherein the control means for determining whether the concentration of the first reagent supplied from the reagent preparing means is abnormal based on the measurement result of the first item of the quality control sample, comprises:

20. A method for detecting the concentration of a diluent for measuring a blood sample, comprising:

21. The method of detecting a concentration according to claim 20, wherein the determining whether the concentration of the diluent supplied to the sample analysis device is abnormal based on the measurement result of the first item of the quality control sample includes:

or alternatively, the process may be performed,

Or alternatively, the process may be performed,

22. The concentration detection method according to claim 20 or 21, wherein the first item is an item detected based on an electrical impedance method.

23. The concentration detection method according to claim 20 or 21, wherein the first item is an item for determining a volume-related parameter of a specific cell in the blood sample; the items of the volume-related parameters of the specific cells in the blood sample are measured, and the items of the volume-related parameters of the red blood cells are measured; the items of the erythrocyte volume related parameter include at least one of average erythrocyte volume, hematocrit, erythrocyte distribution width variation coefficient, erythrocyte distribution width standard deviation.

24. A method for detecting the concentration of a first reagent for measuring a biological sample, comprising:

measuring a first liquid and a second liquid;

25. The method of detecting concentration according to claim 24, wherein the determining whether the concentration of the first reagent supplied to the sample analysis device is abnormal based on the measurement result of the first item of the biological sample includes:

Or alternatively, the process may be performed,