1. Field of the Invention
The present invention relates to a washing technique of a portion contacted by a biological sample in a biological sample measurement device or a biological sample measurement system.
2. Description of the Related Art
In a biological sample measurement device, when the concentration of a component contained in one biological sample is high, there are cases where the measurement result of the next biological sample is affected with a washing method in which a flow path of the biological sample and the like are uniformly washed with the same condition. In order to solve this problem, conventionally, the way of washing a portion contacted by the biological sample is changed based on the measurement result of a predetermined component contained in the biological sample.
For example, Japanese Patent Application Laid-open No. H10-293132 describes a measurement method of a biological sample that performs additional washing before measurement of the next biological sample in the case where the concentration of a component contained in the biological sample is high. Specifically, it is judged that the concentration of glucose in one biological sample is high from a relationship with measurement time, and necessity for the additional washing is determined for the measurement of the next biological sample.
However, the above related art has had the following problem.
That is, in Japanese Patent Application Laid-open No. H10-293132, it is determined whether or not the additional washing is performed after the measurement of one biological sample is completed. As a result, there has been a problem that the throughput of a device is reduced with this method.
The present invention has been devised in view of the above circumstances, and an object thereof is to provide a biological sample measurement device, a biological sample measurement system, and a biological sample measurement method each having a high throughput obtained by being capable of early determining whether or not change of a washing condition is necessary.
In order to solve the above problem, the present invention adopts the following technical means.
A biological sample measurement device provided by a first aspect of the present invention is a biological sample measurement device including a measurement section that performs measurement of a biological sample, a washing section that washes a biological sample contact portion, the biological sample contact portion contacting the biological sample during the measurement, a characteristic judgment section that judges a characteristic of the biological sample before the measurement by the measurement section is completed, and a washing control section that determines a washing method by the washing section based on the characteristic judged by the characteristic judgment section.
Preferably, the measurement section performs the measurement of a plurality of types of biological samples sequentially.
Preferably, the characteristic judgment section determines the type of the biological sample as the characteristic, and the washing control section determines the washing method based on the type.
Preferably, the type is one of urine and feces, and the characteristic judgment section determines whether the type is the urine or the feces as the characteristic.
Preferably, in a case where the measurement section performs the measurement of the feces subsequently to the measurement of the urine, the washing control section causes the washing section to wash the biological sample contact portion contacted by the urine under a condition in which a washing liquid quantity or washing time is increased.
Preferably, the biological sample measurement device further includes a measurement control section that controls a measurement method in the measurement section, the measurement section measures an occult blood, and the measurement control section uses a common measurement reagent irrespective of the type.
Preferably, the biological sample is contained in a sample container on which subject identification information is recorded, the biological sample measurement device further includes a reading section that reads the subject identification information, and a storage section that stores in advance pair information in which the subject identification information is paired with the type associated with the subject identification information, and the characteristic judgment section refers to the pair information based on the subject identification information read by the reading section to determine the type as the characteristic.
Preferably, the storage section stores a measurement schedule table in which a schedule of the measurement of the biological sample is described, the measurement schedule table includes the pair information, and, in a case where, subsequently to the measurement of a first biological sample of a predetermined type, the measurement of a second biological sample of a predetermined type different from the first biological sample is scheduled to be performed in the measurement schedule table, the washing control section determines the washing method of the biological sample contact portion contacted by the first biological sample in accordance with a combination of the first biological sample and the second biological sample.
Preferably, the biological sample is contained in a sample container on which subject identification information is recorded, the biological sample measurement device further includes a reading section that reads the subject identification information, the type is also recorded in the sample container, the reading section is capable of reading the type, and the characteristic judgment section determines the type of the biological sample read by the reading section as the characteristic.
Preferably, in a case where, subsequently to the measurement of a first biological sample of a predetermined type, the measurement of a second biological sample of a predetermined type different from the first biological sample is scheduled to be performed, the washing control section determines the washing method of the biological sample contact portion contacted by the first biological sample in accordance with a combination of the first biological sample and the second biological sample.
A biological sample measurement system provided by a second aspect of the present invention is a biological measurement system including the biological sample measurement device provided by the first aspect of the present invention, and external equipment connected to the biological sample measurement device, and the characteristic judgment section acquires the characteristic from the external equipment.
Preferably, at least one biological sample is urine, and the external equipment is a urine qualitative measurement device that performs urine qualitative measurement on the urine by using a urine test paper to acquire a urine qualitative measurement result of a predetermined measurement item.
Preferably, the characteristic judgment section receives the urine qualitative measurement result from the urine qualitative measurement device and determines a level of the urine qualitative measurement result as the characteristic, and the washing control section determines a washing method of the biological sample contact portion by the washing section based on the level.
Preferably, the predetermined measurement item is an occult blood, the characteristic judgment section determines the urine qualitative measurement result as the characteristic, and, in a case where the characteristic judgment section determines that the urine qualitative measurement result of the occult blood is not less than a preset first threshold value, the washing control section causes the washing section to wash the biological sample contact portion with a condition in which a washing liquid quantity or washing time is increased.
Preferably, the biological sample measurement system further includes a measurement control section that controls a measurement method in the measurement section, the predetermined measurement item is an occult blood, the measurement section is capable of further performing urine occult blood quantitative measurement on the urine on which the urine qualitative measurement of the occult blood has been performed in the urine qualitative measurement device, and the measurement control section causes the measurement section to perform the urine occult blood quantitative measurement in a case where the urine qualitative measurement result of the occult blood is not less than a preset second threshold value.
A biological sample measurement method provided by a third aspect of the present invention is a biological sample measurement method including a measurement step of performing measurement of a biological sample, a washing step of washing a biological sample contact portion, the biological sample contact portion contacting the biological sample during the measurement, a judgment step of judging a characteristic of the biological sample before the measurement is completed, and a determination step of determining a washing method of the biological sample contact portion based on the characteristic judged in the judgment step.
Preferably, the measurement of a plurality of types of biological samples can be performed in the measurement step, the type of the biological sample is determined as the characteristic in the judgment step, and the washing method is determined based on the type in the determination step.
Preferably, the biological sample measurement method further includes an acquisition step of performing urine qualitative measurement on urine by using a urine test paper to acquire a urine qualitative measurement result of a predetermined measurement item, a level of the urine qualitative measurement result of the predetermined measurement item is determined as the characteristic in the judgment step, and the washing method is determined based on the level of the urine qualitative measurement result of the predetermined measurement item in the determination step.
According to the adoption of the aspect of the present invention, it is possible to provide the biological sample measurement device, the biological sample measurement system, and the biological sample measurement method each having the high throughput obtained by being capable of early determining whether or not the change of the washing condition is necessary.
Other features and advantages of the present invention will become more apparent from the description of embodiments made below with reference to the accompanying drawings.
Hereinbelow, preferred embodiments of the present invention will be described specifically with reference to the drawings.
Each of
The biological sample measurement device M1 can be used alone, and can also be used by being connected to other information processing devices and biological sample measurement devices via communication that uses a local area network (LAN) constructed in the hospital or a line such as the Internet.
The biological sample measurement device M1 is configured to be capable of performing quantitative measurement of a plurality of types of biological samples S sequentially, and performing the quantitative measurement of a plurality of measurement items of each biological sample S sequentially. Examples of the biological sample S that can be measured include blood serum, blood plasma, and whole blood in addition to urine and feces. With regard to the feces, a liquid obtained by filtering a suspension in which the feces are suspended is used as the sample. As shown in
As shown in
The sample container 30 is held upright in a rack 3. As the rack 3, for example, a rack 3A for the urine container 30A and a rack 3B for the feces container 30B are prepared. The racks 3A and 3B are also provided with information recording sections 3Aa and 3Ba. Each of the information recording sections 3Aa and 3Ba is configured by using, e.g., a label on which a bar code is printed. It is possible to record information on the type of the biological sample S in the information recording sections 3Aa and 3Ba.
It is possible to include the information on the type of the biological sample S in the information recording section 31. The type of the biological sample S corresponds to an example of a characteristic in the present invention. In this case, it is possible to adopt a configuration in which the urine container 30A and the feces container 30B are held upright in a state in which the urine container 30A and the feces container 30B are held in the same rack 3.
The biological sample measurement device M1 is a device for performing the quantitative measurement on a plurality of types of the biological samples S. The type of the biological sample S is always input at the time of the measurement in order to identify the type of the biological sample S. The information on the type of the biological sample S is input manually by an examiner, or is automatically read from the information recording section 31 of the sample container 30, the information recording section 3Aa of the rack 3A, or the information recording section 3Ba of the rack 3B by an ID reading section 11.
As shown in
As shown in
The adjustment section 10 is provided for adjusting a reaction liquid for measuring a component contained in the biological sample S in a reaction cell 13b described later. As shown in
The sample collection nozzle 10A is provided for sucking and collecting a predetermined quantity of the biological sample S from the sample container 30 having passed the front of the ID reading section 11. As shown in
The ID reading section 11 is, e.g., a bar code reader and, as shown in
The reagent supply section 10B is provided for supplying a dilution liquid for diluting the biological sample S and a liquid reagent to the reaction cell 13b. As shown in
The dispensing quantity of the biological sample S to the reaction cell 13b is configured to be changeable. The dispensing quantity of the dilution liquid or the liquid reagent to the reaction cell 13b is also configured to be changeable. It is possible to change a dilution factor of the biological sample S in the reaction liquid by changing at least one of the dispensing quantities of the biological sample S, the dilution liquid, and the liquid reagent. By changing the dilution factor, it is possible to change a measurement range of the measurement item as a target.
The cell stirring section 10C is provided for stirring the reaction liquid including the biological sample S, the dilution liquid, and the liquid reagent dispensed to the reaction cell 13b using a stirring blade 10Ca.
As shown in
The liquid reagent is configured to react with a predetermined component contained in the biological sample S, and develop a color of a degree corresponding to the concentration of the component. As shown in
As shown in
The operation of the washing section 12 is controlled by a washing control section 19b described later.
As shown in
After the biological sample S is dispensed to the reaction cell 13b, the sample collection nozzle 10A moves to a position over the sample collection nozzle washing tank 12e, descends, and is accommodated in the sample collection nozzle washing tank 12e. Subsequently, the washing control section 19b switches the connection of the sample collection nozzle 10A from the connection to the spotting pump 10Aa to connection to the washing liquid supply driving section 12d to discharge the washing liquid into the sample collection nozzle washing tank 12e. With this, the inside of the sample collection nozzle 10A is washed. In addition, an outer wall of the sample collection nozzle 10A is also washed with the washing liquid stored in the sample collection nozzle washing tank 12e. On the other hand, after completion of washing of the sample collection nozzle 10A, the washing control section 19b drives the washing liquid discharge driving section 12f to discard the washing liquid into the waste liquid tank 12g.
The washing control section 19b changes a washing liquid quantity and washing time by changing a driving amount of the washing liquid supply driving section 12d. The washing time is changed and washing performance is adjusted by changing a time period in which the washing liquid is stored in the sample collection nozzle washing tank 12e. The washing performance is enhanced by increasing the number of times of the driving of the washing liquid supply driving section 12d.
The stirring blade washing section 12b is provided for washing the stirring blade 10Ca of the cell stirring section 10C. As shown in
The washing control section 19b changes the washing performance of the stirring blade washing section 12b by changing the washing liquid quantity. The washing time is changed and the washing performance is adjusted by changing a time period in which the washing liquid is stored in the stirring blade washing tank 12h. In addition, the washing performance is adjusted by increasing or decreasing the number of times of the supply of the washing liquid.
The washing control section 19b can also be configured to adjust the washing performance of the stirring blade washing section 12b by changing the type of the washing liquid. In this case, in the washing section 12, a plurality of types of the washing liquids obtained by changing the type of a contained washing agent or changing the concentration of the washing agent are prepared. In the case where the concentration of the washing agent is changed, a configuration may also be adopted in which a dilution liquid for the washing liquid is additionally prepared and the dilution factor is automatically changed on an as needed basis.
In
The control section 19 is configured by using, e.g., a microcomputer, and includes a characteristic judgment section 19a and the washing control section 19b in particular.
The characteristic judgment section 19a is a section that judges the characteristic of the biological sample S. An example of the characteristic of the biological sample S includes the type of the biological sample S. Specifically, the characteristic judgment section 19a judges, e.g., that the biological sample S is “the urine S1” or “the feces S2”.
The judgment of the characteristic by the characteristic judgment section 19a is performed at least before the measurement on the biological sample S to be washed is completed. The completion of the measurement denotes the completion of the measurement of the absorbance of the reaction liquid (the same applies to the following description). Alternatively, the judgment thereof is performed at least before the measurement of the biological sample S to be washed is started. The start of the measurement denotes the start of the reaction between the specific component in the biological sample S and the reagent in the reaction liquid (the same applies to the following description). Alternatively, the judgment thereof is performed at least before the biological sample S to be washed is dispensed to the reaction cell 13b. Alternatively, the judgment thereof is performed at least before the stirring of the reaction liquid in the reaction cell 13b is completed.
The washing control section 19b is a section for determining a washing method by the washing section 12 based on the characteristic judged by the characteristic judgment section 19a. Specifically, the washing control section 19b determines the washing method by the washing section 12 based on the type of the biological sample S. The washing control section 19b changes the washing liquid quantity, the washing time, or the type of the washing liquid based on the determined washing method, and causes the washing section 12 to wash the biological sample contact portion.
The determination of the washing method by the washing control section 19b is performed at least before the measurement of the biological sample S to be washed is completed. Alternatively, the determination thereof is performed at least before the measurement of the biological sample S to be washed is started. Alternatively, the determination thereof is performed at least before the biological sample S to be washed is dispensed to the reaction cell 13b. Alternatively, the determination thereof is performed at least before the stirring of the reaction liquid in the reaction cell 13b is completed.
The control section 19 performs control of an operation process of the main body portion 1 or the transfer device 2, management of the quantitative measurement value acquired by the measurement section 13, and management of output of the quantitative measurement value.
The storage section 18 is configured by using, e.g., a memory, an HDD, or an SSD, and includes a measurement schedule table storage section 18a and a washing schedule table storage section 18b in particular. In addition to them, the storage section 18 stores programs and various data sets for causing the control section 19 to execute operation control of the individual sections of the biological sample measurement device M1 and various data processes. For example, the storage section 18 stores the calibration curve and the quantitative measurement value of each measurement item.
In the measurement schedule table T1, in the case where the biological sample S is the urine S1, as the measurement items, glucose (GLU), occult blood (BLD), protein (PRO), creatinine (CRE), albumin (ALB), amylase (AMY), 13-D-N acetylglucosaminidase (NAG), β2-microglobulin (BMG), urinary protein/creatinine ratio (P/C), and albumin/creatinine ratio (A/C) are measured. On the other hand, in the case where the biological sample S is the feces S2, occult blood (BLD) is measured as the measurement item.
A urine occult blood test is a test for determining the presence or absence of hemorrhage in a kidney•urinary tract system with a hemoglobin concentration in the urine S1 used as an index. The urine occult blood test is used as indexes of an inflammation, tumor, and stone in a kidney, ureter, bladder, urethra, and prostate. In contrast to this, a fecal occult blood test is a test for determining the presence or absence of hemorrhage in the digestive tract with the hemoglobin concentration in the feces S2 used as an index. The fecal occult blood test is performed mainly for the purpose of early detection of colorectal cancer.
In the present embodiment, in the measurement of the urine occult blood and the fecal occult blood, the common adjustment section 10, the common washing section 12, the common measurement section 13, and the common reagent are used. However, it is well known that the concentration of the occult blood in the urine S1 is 1000 or more times higher than the concentration thereof in the feces S2. Accordingly, in the washing with a usual condition, there are cases where a blood component of the urine S1 remains in the biological sample contact portion such as the flow path of the biological sample S. In particular, in the case where the fecal occult blood is measured subsequently to the measurement of the urine occult blood, it is feared that false determination (false-positive) occurs. In this case, it is necessary to perform the washing with an additional condition in which the washing performance is enhanced.
For example, in the washing schedule table T2 in
Next, when attention is paid to the biological sample types of washing orders 3 and 4, the feces S2 are measured subsequently to the measurement of the urine S1. In this case, the urine S1 of a sample number 0003 is washed with the additional condition. As described above, this is because the concentration of the fecal occult blood is lower than the concentration of the urine occult blood and the clinically accurate measurement is required.
Next, when attention is paid to the biological sample types of washing orders 5 and 6, the urine S1 is measured subsequently to the measurement of the feces S2. In this case, the feces S2 of a sample number 0005 is washed with the standard condition. The concentration of the fecal occult blood is lower than the concentration of the urine occult blood, and hence standard washing is adequate.
Further, when attention is paid to the biological sample types of washing orders 7 and 8, the feces S2 are measured subsequently to the measurement of the feces S2. In this case, the feces S2 of a sample number 0007 is washed with the standard condition. Similarly to the above case, the concentration of the fecal occult blood is lower than the concentration of the urine occult blood, and hence the standard washing is adequate.
It goes without saying that the washing control section 19b can determine the washing condition based on the type of the biological sample S without considering the relationship with the type of the biological sample S that is measured next.
Next, a description will be given of an example of operation process procedures of the biological sample measurement device M1 by the control section 19 with reference to flowcharts shown in
As shown in the flowchart in
Next, the washing control section 19b refers to the washing schedule table T2 to confirm the type of the biological sample S (S302). In the case where the type of the biological sample S is the urine S1, the type of the biological sample that is measured next is confirmed (S303: YES, S304). In the case where the type of the next biological sample S is the feces S2, the washing control section 19b determines the execution of the washing with the additional condition, and writes the determination into the washing schedule table T2 (S305: YES, S306, S307).
In the case where the washing control section 19b refers to the washing schedule table T2 to determine that the type of the biological sample S is not the urine S1 (i.e., the feces S2), the washing control section 19b determines the execution of the washing with the standard condition, and writes the determination into the washing schedule table T2 (S303: NO, S308, S307). In addition, in the case where the washing control section 19b determines that the type of the next biological sample S is not the feces S2 (i.e., the urine S1), the washing control section 19b determines the execution of the washing with the standard condition, and writes the determination into the washing schedule table T2 (S305: NO, S308, S307). When the above processes are completed, the procedures return to the flowchart shown in
Next, the sample collection nozzle 10A moves to the measurement section 13 and dispenses the biological sample S to the reaction cell 13b after the sample collection nozzle 10A collects the biological sample S in the biological sample collection section 27 (S4). Next, the reagent dispensing nozzle 10Ba dispenses the dilution liquid and the liquid reagent to the reaction cell 13b (S5). Next, the cell stirring section 10C stirs a liquid mixture in the reaction cell (S6).
Next, the washing control section 19b refers to the washing schedule table T2 to cause the washing section 12 to wash the sample collection nozzle 10A and the stirring blade 10Ca that have contacted the biological sample S (S7). The washing section 12 can start the washing before the measurement of the biological sample S is completed. For example, the washing of the sample collection nozzle 10A is started at the point of time when the washing method of the biological sample S is determined and the dispensing to the reaction cell 13b is completed. In addition, the washing of the stirring blade 10Ca is started at the point of time when the washing method of the biological sample S is determined and the stirring of the reaction liquid of the reaction cell 13b is completed.
Next, as described above, the measurement section 13 performs the quantitative measurement of the measurement item specified for each biological sample S (S8).
When the quantitative measurement of each measurement item of the biological sample S is completed, the printer 14 prints the quantitative measurement value in association with the subject identification information (S9).
According to the present embodiment, the type of the biological sample S is adopted as the characteristic when the washing control section 19b determines the washing method. The type of the biological sample S is information that can be acquired before the measurement of the biological sample S is performed. Accordingly, the washing control section 19b can early determine whether or not additional washing of the biological sample contact portion is necessary. In addition, the washing control section 19b can select the proper washing condition in accordance with the type of the biological sample S instead of using the uniform washing condition. With this, it is possible to achieve acceleration of the measurement while maintaining accuracy in the measurement by the measurement section 13.
According to the present embodiment, the type of the biological sample S is adopted as the characteristic of the biological sample S. In the biological sample measurement device M1, the type of the biological sample S is always input at the time of the measurement. The characteristic judgment section 19a uses the information when the characteristic judgment section 19a judges the characteristic of the biological sample S. Accordingly, it is not necessary to add a new detection device or the like in order to obtain the characteristic. With this, it is possible to prevent an increase in the manufacturing cost of the biological sample measurement device M1.
Each of
A measurement system MS1 is installed in, e.g., a laboratory of a hospital, and is used to perform the urine quantitative measurement successively after urine qualitative measurement is performed. As shown in
In the following description, a description will be given of the case where the urine S1 and the feces S2 are measured as examples of the biological sample S. (The urine S1 and the feces S2 are the same as those described in the first embodiment.)
The urine qualitative measurement device M2 and the biological sample measurement device M3 are directly connected to each other via a communication line L. Note that the urine qualitative measurement device M2 and the biological sample measurement device M3 may be capable of data communication mutually between them appropriately, and they can be configured to be connected to each other via communication that uses a local area network (LAN) constructed in, e.g., the hospital or a line such as the Internet.
As shown in
As shown in
Note that the external equipment is not limited to the urine qualitative measurement device M2. The external equipment may also be an information processing device such as a personal computer that is directly connected to the biological sample measurement device M3. In addition, the external equipment may also be an information processing device such as a server that is connected to a local area network (LAN) constructed in the hospital or the Internet.
The transfer device 2A is a device similar to the transfer device 2 described above, and transfers the rack 3 in directions indicated by arrows N5 to N7 sequentially. Reading of the bar code of the urine container 30A and the collection of the urine S1 are performed in the process of transferring the rack 3 in the direction indicated by the arrow N6. The transfer device 2A is connected to a transfer device 2B of the biological sample measurement device M3 described later via a connection member 5. The pusher 26 reciprocates along a front surface of the frame portion 21 in a direction indicated by an arrow N10 to move the rack 3. The rack 3 moves to the transfer device 2B through a transfer path 50 of the connection member 5 as indicated by the arrow N4 by being pushed by the pusher 26. Note that the rack 3 that holds the feces container 30B in which the feces S2 are contained upright may be put in the transfer device 2A. In addition, the rack 3B dedicated to the feces container 30B may also be transferred. In these cases, by identifying the type of the biological sample S, collection of the feces S2 from the feces container 30B is prevented in the urine qualitative measurement device M2.
As shown in
As shown in
According to the multi-item test piece 6, with different reagents contained in the individual reagent pads 60, it is possible to perform the urine qualitative measurement of a plurality of measurement items simultaneously. Examples of the measurement item that can be measured by using the multi-item test piece 6 include glucose (GLU), protein (PRO), urobilinogen (URO), bilirubin (BIL), creatinine (CRE), pH, occult blood (BLD), ketone body (KET), nitrite (NIT), leukocyte (LEU), albumin (ALB), urinary protein/creatinine ratio (P/C), and albumin/creatinine ratio (A/C). The measurement of each measurement item is performed by using, e.g., a generally known measurement principle. With the use of the multi-item test piece 6, it is possible to acquire qualitative values or semi-quantitative values of these measurement items. The qualitative value and the semi-quantitative value correspond to examples of a urine qualitative measurement result in the present invention.
The ID reading section 41 is, e.g., a bar code reader and, as shown in
As shown in
The control section 49 is configured by using, e.g., a microcomputer. The control section 49 is provided for controlling operation processes of the individual sections of the urine qualitative measurement device M2. The storage section 48 is configured by using, e.g., a memory, an HDD, or an SSD, and stores programs and various data sets for causing the control section 49 to execute operation control of the individual sections of the urine qualitative measurement device M2 and various data processes. In addition, the storage section 48 temporarily stores, e.g., the urine qualitative measurement result acquired by the measurement section 43.
The printer 44, the display section 45, and the operation section 46 are elements having functions identical or similar to those of the printer 14, the display section 15, and the operation section 16 in the biological sample measurement device M1 in the first embodiment described above. Therefore, herein, the description thereof will be omitted.
The biological sample measurement device M3 is provided for performing the quantitative measurement process of the urine S1 or the feces S2, and, as shown in
The transfer device 2B is also a device similar to the transfer device 2 described above, and transfers the rack 3 pushed out of the transfer device 2A in directions indicated by arrows N1 to N3 sequentially. The rack 3 reaches an end area Ea of the transfer path 20B finally. Similarly to the transfer device 2, the reading of the bar code of the urine container 30A and the collection of the urine S1 are performed in the process of transferring the rack 3 in the direction indicated by the arrow N2. The rack 3 is pushed out of the transfer device 2B by the pusher 26 finally. In the transfer device 2B, the feces container 30B is also transferred similarly. In addition, the transfer device 2B is configured such that the biological sample S that is measured only in the biological sample measurement device M3 can be put into the transfer device 2B.
As shown in
Note that, similarly to the case of the biological sample measurement device M1, the dispensing quantity of the biological sample S to the reaction cell 13b by the sample collection nozzle 10A in the adjustment section 10 is configured to be changeable. In addition, the dispensing quantity of the dilution liquid or the liquid reagent to the reaction cell 13b is also configured to be changeable. Therefore, it is possible to change the dilution factor of the biological sample S in the reaction liquid by changing at least one of the dispensing quantities of the biological sample S, the dilution liquid, and the liquid reagent. In the biological sample measurement device M3 as well, it is possible to change the measurement range of the measurement item as a target by changing the dilution factor.
The control section 19A is configured by using, e.g., a microcomputer and, as shown in
The characteristic judgment section 19Aa is provided for, e.g., judging the characteristic of the biological sample S. An example of the characteristic includes the type of the biological sample S. Specifically, the characteristic judgment section 19Aa determines the urine S1 or the feces S2 as the characteristic of the biological sample S. In addition to this, an example of the additional characteristic includes the urine qualitative measurement result acquired in the urine qualitative measurement device M2. Further, specifically, an example thereof includes a level of the urine qualitative measurement result. The level of the urine qualitative measurement result is represented by the qualitative value or the semi-quantitative value. The level of the urine qualitative measurement result also corresponds to an example of the characteristic of the biological sample in the present invention.
The judgment of the characteristic by the characteristic judgment section 19Aa is performed at least before the measurement of the urine S1 or the feces S2 to be washed is completed. Alternatively, the judgment thereof is performed at least before the measurement of the urine S1 or the feces S2 to be washed is started. Alternatively, the judgment thereof is performed at least before the urine S1 or the feces S2 to be washed is dispensed to the reaction cell 13b. Alternatively, the judgment thereof is performed at least before the stirring of the reaction liquid including the urine S1 or the feces S2 to be washed, the dilution liquid, and the liquid reagent is completed.
The washing control section 19Ab is a section for determining the washing method by the washing section 12 based on the characteristic judged by the characteristic judgment section 19Aa. Specifically, the washing control section 19Ab is a section for determining the washing method by the washing section 12 based on the type of the biological sample S. In addition, the washing control section 19Ab is a section for determining the washing method by the washing section 12 based on the level of the urine qualitative measurement result obtained from the urine S1. In the case where the level of the urine qualitative measurement result is not less than a predetermined threshold value, the washing control section 19Ab causes the washing section 12 to wash the biological sample contact portion with a condition in which the washing liquid quantity or the washing time is changed.
The determination of the washing method by the washing control section 19Ab is performed at least before the measurement of the urine S1 or the feces S2 to be washed is completed. Alternatively, the determination thereof is performed at least before the measurement of the urine S1 or the feces S2 to be washed is started. Alternatively, the determination thereof is performed at least before the urine S1 or the feces S2 to be washed are dispensed to the reaction cell 13b. Alternatively, the determination thereof is performed at least before the stirring of the reaction liquid including the urine S1 or the feces S2 to be washed, the dilution liquid, and the liquid reagent is completed.
The measurement control section 19Ac is provided for controlling the measurement in the measurement section 13. For example, in the case where the level of the urine qualitative measurement result acquired by the urine qualitative measurement device M2 is not less than the predetermined threshold value, the measurement control section 19Ac causes the measurement section to perform the quantitative measurement.
The measurement section 13 is configured to use a common measurement reagent irrespective of the urine qualitative measurement result acquired by the urine qualitative measurement device M2 or irrespective of the type of the biological sample S. The measurement control section 19Ac controls the measurement method of the quantitative measurement in the measurement section 13 based on the level of the urine qualitative measurement result acquired by the urine qualitative measurement device M2. For example, when attention is paid to the occult blood (BLD), the common liquid reagent is used for the urine S1 and the feces S2. In addition, with regard to BLD of urine S1, the measurement method of the quantitative measurement is controlled based on the level of the urine qualitative measurement result.
The arithmetic operation section 19Ad corrects the absorbance or the quantitative measurement concentration acquired by the biological sample measurement device M3 based on an arithmetic operation parameter stored in an arithmetic operation parameter storage section 18Ah described later. In the present embodiment, the absorbance and the quantitative measurement concentration are collectively referred to as the quantitative measurement values.
In addition to this, the control section 19A performs control of an operation process of the main body portion 1A or the transfer device 2B, management of the quantitative measurement value acquired by the measurement section 13, and management of output of the quantitative measurement value.
The storage section 18A is configured by using, e.g., a memory, an HDD, or an SSD and, in particular, the storage section 18A includes a measurement item comparison table storage section 18Aa, a urine quantitative measurement necessity determination table storage section 18Ab, a quantitative measurement schedule table storage section 18Ac, an additional washing necessity determination table storage section 18Ad, a washing schedule table storage section 18Ae, a quantitative measurement item classification table storage section 18Af, a quantitative sample adjustment criterion storage section 18Ag, and the arithmetic operation parameter storage section 18Ah. In addition to these, the storage section 18A stores programs and various data sets for causing the control section 19A to execute the operation control of the individual sections of the biological sample measurement device M3 and various data processes. For example, the storage section 18A stores the calibration curve, the absorbance, and the quantitative measurement concentration of each measurement item.
Note that the quantitative measurement schedule table T5 shows a state before the measurement order in the biological sample measurement device M3 is determined. The measurement order is determined in accordance with, e.g., the order in which the subject identification information recorded in the urine container 30A is read by the ID reading section 11.
Information on the type of the biological sample S is not limited to information directly input by the examiner, and may also be information received from the urine qualitative measurement device M2. In addition, the information thereon may also be information that is automatically read by the ID reading section 11 from the information recording section 31 of the sample container 30, the information recording section 3Aa of the rack 3A, or the information recording section 3Ba of the rack 3B.
For example, in the washing schedule table T7 in
Next, when attention is paid to the biological sample types of washing orders 7 and 8, the feces S2 of a sample number 0008 are measured subsequently to the measurement of the urine S1 of a sample number 0007. In addition, the urine qualitative measurement result of the urine S1 of the sample number 0007 is not more than the threshold value. In this case, the urine S1 of the sample number 0007 is washed with the standard condition. From the urine qualitative measurement result, it is predicted that the concentration of the urine occult blood is low, and an influence on the quantitative measurement of the feces S2 of the sample number 0008 is small, and hence standard washing is considered to be adequate.
Next, when attention is paid to the biological sample types of washing orders 5 and 6, the urine S1 of a sample number 0006 is measured subsequently to the measurement of the urine S1 of a sample number 0005. The urine qualitative measurement result of the urine S1 of the sample number 0005 is not less than the threshold value but, in this case, the washing is performed with the standard condition. In such a case, it is considered that the clinically accurate washing is not required.
It goes without saying that the washing control section 19Ab can determine the washing condition based on the type of the biological sample S or based on the type of the biological sample S and the urine qualitative measurement result without considering the relationship with the type of the biological sample S that is measured next.
When attention is paid to BLD in this table, in the urine qualitative measurement device M2, BLD measurement is performed by a method for detecting a peroxidase-like activity of hemoglobin using a test piece including tetramethylbenzidine and cumene hydroperoxide. In contrast to this, in the biological sample measurement device M3, the BLD measurement is performed by latex agglutination turbidimetry that detects agglutination of latex particles by an antigen-antibody reaction. In this case, as is apparent from
Further, with regard to PRO, in the biological sample measurement device M3, the quantitative measurement is performed by using a phenomenon in which, when red bromopyrogallol red-indium complex combines with protein under an acid condition, the maximum absorption wave length shifts to the side of a long wave length and the color is changed to purple. It is well known that, in the case where the quantitative measurement is performed by using this measurement principle, a prozone-like phenomenon can occur. In the case where the quantitative measurement is performed under the condition that the prozone-like phenomenon can occur, there are cases where the measurement result is not displayed as an abnormal value, which leads to a problem.
Therefore, in the case where the measurement item is BLD, GLU or PRO, it is preferable to take measures by referring to the result of the urine qualitative measurement by the urine qualitative measurement device M2 before the quantitative measurement is performed.
On the other hand, as shown in
Based on the foregoing, the measurement item of the biological sample measurement device M3 can be classified as in, e.g., a quantitative measurement item classification table T8 shown in
In the case where the measurement item belongs to the first classification, the measurement control section 19Ac determines whether or not a quantitative sample adjustment condition is changed in accordance with the level of the urine qualitative measurement result performed in the urine qualitative measurement device M2.
The arithmetic operation parameter storage section 18Ah is a section that stores the arithmetic operation parameter. The arithmetic operation parameter constitutes part of the quantitative sample adjustment criterion T9. In the case where the urine S1 is adjusted with a changed adjustment condition, the arithmetic operation section 19Ad corrects the urine quantitative measurement value such that the urine quantitative measurement value becomes equal to that in the case where the urine S1 is adjusted with the usual adjustment condition. In the biological sample measurement device M3, the common measurement reagent is used irrespective of the type of the biological sample and the level of the urine qualitative measurement result acquired by the urine qualitative measurement device M2, and hence the above correction is required.
The communication sections 17 and 47 are connected to each other via the communication line L, and perform data exchange between the urine qualitative measurement device M2 and the biological sample measurement device M3.
Next, a description will be given of an example of operation process procedures by the control section 19A in the biological sample measurement system MS1 with reference to flowcharts shown in
As shown in the flowchart in
As shown in the flowchart in
On the other hand, in the case where the measurement control section 19Ac determines that the measurement item is not included in the measurement item of the biological sample measurement device M3, the procedures return to the flowchart in
Next, as shown in the flowchart in
Next, the control section 19A determines the washing method of the biological sample contact portion (S14). The determination of the washing method of the biological sample contact portion is performed in accordance with a subroutine shown in
First, the characteristic judgment section 19Aa refers to the quantitative measurement schedule table T5 to write the type of the biological sample S into the washing schedule table T7 as the characteristic. Further, the characteristic judgment section 19Aa determines that the level of the urine qualitative measurement result is not less than the predetermined threshold value or not more than the predetermined threshold value by using the level of the urine qualitative measurement result as the characteristic, and writes the determination result into the washing schedule table T7 (S1401).
Next, the washing control section 19Ab refers to the additional washing necessity determination table T6 to determine whether or not the additional washing of the urine S1 described in the quantitative measurement schedule table T5 is necessary (S1402). In the case where the urine qualitative measurement result of BLD is not less than the threshold value (the qualitative value 2+, the semi-quantitative value 0.2), and the next biological sample S is the feces S2, the washing control section 19Ab determines that the additional washing is necessary (S1403: YES). Next, the washing control section 19Ab records the execution of the washing with the additional condition for each corresponding urine S1 in the washing schedule table T7 (S1404).
On the other hand, in the case where the urine qualitative measurement result of BLD is not more than the threshold value (the qualitative value 1+, the semi-quantitative value 0.06), the washing control section 19Ab determines that the additional washing is not necessary (S1403: NO). Even when the urine qualitative measurement result of BLD is not less than the threshold value (the qualitative value 2+, the semi-quantitative value 0.2), in the case where the next biological sample S is the urine S1, the washing control section 19Ab determines that the additional washing is not necessary (S1403: NO). Next, the washing control section 19Ab records the execution of the washing with the standard condition for each corresponding urine S1 in the washing schedule table T7 (S1405). When the above processes are completed, the procedures return to the flowchart shown in
Next, the measurement control section 19Ac refers to the quantitative measurement schedule table T5 based on the subject identification information read by the ID reading section 11 to determine whether or not the quantitative measurement of BLD is scheduled to be performed (S16). In the case where the measurement control section 19Ac determines that the quantitative measurement is scheduled to be performed, the measurement control section 19Ac determines the quantitative measurement sample adjustment condition (S17: YES, S18). The determination of the quantitative sample adjustment condition is performed in accordance with a subroutine shown in
As shown in the flowchart in
The measurement control section 19Ac refers to the quantitative sample adjustment criterion T9 and, in the case where the level of the urine qualitative measurement result of BLD is not less than the threshold value (the qualitative value 2+, the semi-quantitative value 0.2), the measurement control section 19Ac determines that the changed adjustment condition is adopted (S1804: YES, S1805). Next, the measurement control section 19Ac causes the sample collection nozzle 10A to dispense the urine S1, the dilution liquid, and the liquid reagent to the reaction cell 13b based on the changed adjustment condition (S1806). With this, the dilution factor of the urine S1 is changed from the dilution factor of the usual adjustment condition. In contrast to this, in the case where the level of the urine qualitative measurement result of BLD is not more than the threshold value (the qualitative value 1+, the semi-quantitative value 0.06), the sample collection nozzle 10A dispenses the urine S1, the dilution liquid, and the liquid reagent based on the usual adjustment condition (S1804: NO, S1809).
Note that, in the case where the measurement item belongs to the second or third classification (S1802: NO), the dispensing based on the usual adjustment condition is also performed (S1807 to S1809). When the above processes are completed, the procedures return to the flowchart shown in
Next, as shown in the flowchart in
Next, the measurement section 13 performs transmitted light measurement to acquire the absorbance (S21). The arithmetic operation section 19Ad applies the absorbance to the calibration curve stored in the storage section to calculate the quantitative measurement concentration of BLD (S22). Further, the arithmetic operation section 19Ad corrects the quantitative measurement concentration by using the arithmetic operation parameter recorded in the quantitative sample adjustment criterion T9 (S23). Next, the printer 14 prints the corrected quantitative measurement concentration in association with the subject identification information (S24).
According to the present embodiment, as the characteristic of the urine S1, the urine qualitative measurement result acquired by the urine qualitative measurement device M2 is adopted. The urine qualitative measurement result is information that can be acquired in the biological sample measurement device M3 without performing the measurement on the urine S1. Accordingly, the washing control section 19Ab can early determine whether or not the additional washing of the biological sample contact portion is necessary. In addition, the washing control section 19Ab can select the proper washing condition in accordance with the level of the urine qualitative measurement result instead of using the uniform washing condition. With this, it is possible to achieve acceleration of the measurement while maintaining accuracy in the measurement by the measurement section 13.
According to the present embodiment, as the characteristic of the urine S1, the urine qualitative measurement result acquired by the urine qualitative measurement device M2 is adopted in addition to the type of the biological sample S. Accordingly, the washing control section 19Ab can set the washing condition of the biological sample contact portion minutely and properly. With this, it is possible to achieve acceleration of the measurement while maintaining accuracy in the measurement by the measurement section 13.
According to the present embodiment, as the characteristic of the urine S1, the urine qualitative measurement result acquired by the urine qualitative measurement device M2 is adopted. The characteristic judgment section 19Aa of the biological sample measurement device M3 uses the information when the characteristic judgment section 19Aa judges the characteristic of the urine S1. Accordingly, it is not necessary to add a new detection device or the like to the biological sample measurement device M3 in order to obtain the characteristic. With this, it is possible to prevent an increase in the manufacturing cost of the biological sample measurement system MS1.
According to the present embodiment, when the measurement item in the biological sample measurement device M3 is the occult blood, in the case where the characteristic judgment section 19Aa determines that the level of the urine qualitative measurement result is not less than the preset first threshold value, the washing control section 19Ab causes the washing section 12 to wash the biological sample contact portion with the condition in which the washing liquid quantity or the washing time is increased. Since the washing liquid quantity or the washing time is increased as the washing condition, it is not necessary to add a new washing device or the like. With this, it is possible to prevent an increase in the manufacturing cost of the biological sample measurement system MS1.
According to the present embodiment, in the case where the urine qualitative measurement result of the occult blood is not less than the preset second threshold value, the measurement control section 19Ac causes the measurement section 13 to automatically perform the urine occult blood quantitative measurement. Accordingly, it is possible to prevent execution of unnecessary measurement in the biological sample measurement device M3. With this, it is possible to achieve acceleration of the measurement and prevent an increase in measurement cost in the biological sample measurement system MS1.
According to the present embodiment, the measurement section 13 is configured to use the common measurement reagent in the urine occult blood quantitative measurement in the biological sample measurement device M3 irrespective of the urine qualitative measurement result of the occult blood. The measurement control section 19Ac controls the measurement method of the occult blood quantitative measurement in the measurement section 13 based on the level of the urine qualitative measurement result of the occult blood in the urine qualitative measurement device M2. Accordingly, it is possible to reduce the frequency of re-measurement in the measurement section 13. With this, it is possible to achieve acceleration of the measurement and a reduction in measurement cost.
According to the present embodiment, the measurement items of the biological sample measurement device M3 are classified as the first to third classifications in advance. In the case where the measurement item belongs to the first classification, the measurement control section 19Ac determines whether or not the quantitative sample adjustment condition is changed based on the level of the urine qualitative measurement result. With this, it is not necessary to determine the necessity to change the quantitative sample adjustment condition on all of the measurement items, and hence it is possible to reduce the burden of the measurement control section 19Ac.
The present invention is not limited to the contents of the embodiments described above. The specific configurations of the individual sections of the biological sample measurement device and the biological sample measurement system according to the present invention can be modified in design in various ways. In addition, the specific configurations of the individual steps of the biological sample measurement method of the sample according to the present invention can be modified in various ways.
As described in the first embodiment, the sample container 30 can also be configured such that the type of the biological sample S is recorded together with the subject identification information. In this case, the ID reading section 11 is configured to be capable of reading the type of the biological sample S. The characteristic judgment section 19a determines the type of the biological sample S read by the ID reading section 11 as the characteristic of the biological sample S. With this configuration, the type of the biological sample S is directly recorded in the sample container 30 in which the biological sample S is contained, and hence the judgment of the characteristic by the characteristic judgment section 19 Aa becomes more reliable. With this, the washing control section 19Ab can reliably select the washing condition of the biological sample contact portion.
In the first embodiment, the sample container 30 can be set such that its height and shape vary by the type of the biological sample S, and the sample container 30 can be identified by a shape detection sensor. In this case, the characteristic judgment section 19a determines the type of the biological sample S as the characteristic by detecting a difference in the shape of the sample container 30. Accordingly, it is possible to early determine whether or not the change of the washing condition is necessary. With this, it is possible to achieve acceleration of the measurement and a reduction in measurement cost.
In the second embodiment, in the case where the urine qualitative measurement result is not less than the second threshold value, it is also possible to cancel the occult blood measurement instead of changing the sample adjustment condition of the urine S1. With this configuration, it becomes possible to prevent the execution of the unnecessary measurement. With this, it is possible to achieve acceleration of the measurement and prevent an increase in measurement cost in the biological sample measurement device M3.
Number | Date | Country | Kind |
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2015-082192 | Apr 2015 | JP | national |