JP2017032500A - Automatic analyzer - Google Patents

Abstract

An object of the present invention is to automatically determine and identify the replacement timing and cleaning timing of a limited-life component considering the usage status of each user. A first storage unit that stores, for each reaction container, a set of the last measured value and the latest measured value of water blank absorbance measured using the same reaction container, and the latest A first threshold for the measured value, a second storage for storing a second threshold for the difference between the immediately preceding measured value and the latest measured value, and the immediately preceding stored value for the same reaction vessel. The automatic analyzer includes a multi-determination unit that determines the quality of the reaction vessel and the lamp based on the measured value and the latest measured value. [Selection] Figure 2

Description

  The present invention relates to a technique for automatically determining the state of contamination of a reaction vessel used in an automatic analyzer, the presence or absence of scratches, and the state of lamp deterioration.

  In an automatic analyzer that performs biochemical analysis or immunological component analysis of blood or urine, a reaction vessel (also referred to as “cell”) or lamp made of plastic or glass is generally used. These are consumables having a lifetime and require regular cleaning and replacement work. For example, in the case of a reaction container, cleaning once a week by the user is required. By the way, the cleaning of the reaction vessel is performed as a part of the maintenance function. For this reason, it is necessary to temporarily stop the measurement of the specimen once during the cleaning.

  However, emergency hospitals and inspection centers operate automatic analyzers continuously for 24 hours and always perform inspections without interruption. In addition, in such a use environment, since the measurement of the sample is always prioritized, it is not possible to secure the cleaning time of the reaction container that accompanies the measurement stop of the sample. However, failure to clean the reaction vessel may increase the potential for data failure.

  In many cases, manufacturers of automatic analyzers uniformly set the maintenance cycle of consumables regardless of the user's usage environment and the degree of wear. For example, the cleaning cycle of the reaction vessel is set to one week, the replacement cycle of the reaction vessel is set to one month, and the replacement cycle of the lamp is set to half a year. However, the progress of the deterioration of the reaction vessel and the lamp depends on the type of reagent used for measurement by each user, the number of times of specimen measurement, and the like, and is not necessarily uniform. Incidentally, the manufacturer defines the replacement period of consumables on the premise that it is used for 5 hours a day. For this reason, in a facility that operates an automatic analyzer continuously for 24 hours, the replacement timing comes earlier than the maintenance cycle determined by the manufacturer.

  Patent Document 1 describes a method of using measurement light having different wavelengths for sample measurement (cell blank measurement) and verification of contamination of the reaction container.

Japanese Patent Laid-Open No. 3-181862

  As described above, the manufacturer uniformly sets the replacement period and the cleaning period of the consumables without considering the use environment of each user. Therefore, for example, a lamp life (replacement cycle) is naturally different between a facility used for 5 hours a day and a facility used for 10 hours a day. In other words, depending on the maintenance cycle determined by the manufacturer, it is not possible to accurately manage the replacement cycle or cleaning cycle of consumables. In addition, a user who uses a lot of reagents that easily deposit in the reaction container is expected to have a replacement cycle that is earlier than the maintenance cycle determined by the manufacturer. For this reason, it is important to grasp the execution timing of maintenance in consideration of the use environment of each user.

  In order to solve the above problems, the present invention employs, for example, the configurations described in the claims. The present specification includes a plurality of means for solving the above-described problems. To give an example, “the last measured value of the water blank absorbance measured using the same reaction vessel and the latest measured value are used. A first storage unit that stores a set of measurement values for each reaction vessel, a first threshold value for the latest measurement value, and a difference between the measurement value of the previous time and the latest measurement value On the basis of the second storage unit that stores the second threshold value, and the previous measurement value and the latest measurement value stored for the same reaction container, the quality of the reaction container and the lamp is determined. And an automatic analyzer having a multi-determination unit for determining “.

  According to the present invention, it is possible to automatically determine the replacement timing and cleaning timing of consumables in consideration of the usage environment of each user. Problems, configurations, and effects other than those described above will become apparent from the following description of embodiments.

The figure which shows the example of whole structure of an automatic analyzer. The figure explaining the conceptual structure of a multi determination part. The figure explaining the determination matrix which a multi determination part uses. The flowchart which shows an example of the analysis operation | movement by an automatic analyzer.

  Hereinafter, embodiments of the present invention will be described with reference to the drawings. The embodiment of the present invention is not limited to the embodiments described later, and various modifications are possible within the scope of the technical idea.

(1) Form example Here, the automatic analyzer used for biochemical analysis or immunological component analysis is demonstrated. The automatic analyzer according to the embodiment uses the water blank absorbance information to automatically determine the state of contamination of the plastic or glass reaction vessel, the presence or absence of scratches, and the deterioration of the lamp. When the dirt is judged, only the corresponding reaction container is automatically cleaned using a special detergent. If the reaction container is damaged or the lamp is deteriorated, the user uses a dedicated monitor attached to the device to that effect. To inform.

(2) Overall Configuration FIG. 1 shows the overall configuration of an automatic analyzer 100 according to an embodiment. The automatic analyzer 100 includes a sample disk 1, a computer 3, a sampling mechanism 5, a reaction disk 9, a reagent pipetting mechanism 10, a reagent disk 12, a stirring mechanism 13, a lamp 14, a photometry unit 15, and a reaction vessel cleaning system 20. ing.

  The sample disk 1 is a mechanism that can mount a plurality of sample cups (hereinafter referred to as “sample containers”) 1A for holding a sample, and is arranged on the front side of the reaction disk 9. The computer 3 is a control unit that executes control of the entire mechanical system, calculation of the concentration of the sample, multi-determination processing described later, and the like, and provides these data processing through execution of the program. The sampling mechanism 5 includes a sample probe (hereinafter also referred to as “analyte probe”), and sucks a predetermined amount of the analyte from the sample cup 1A using the sample probe, and directly measures the reaction container 6 for photometry (hereinafter simply referred to as “reaction container”). It is also a mechanism for discharging (dispensing). The reaction vessel 6 also serves as a cuvette for mixing and reacting the specimen and the reagent and a cell for measuring absorbance, and is made of, for example, plastic or glass. The reaction disk 9 is a mechanism that can mount a plurality of reaction vessels 6.

  The reagent pipetting mechanism 10 is a mechanism for collecting a predetermined amount of a reagent from a reagent container installed on the reagent disk 12 and dispensing it into the reaction container 6. The reagent disk 12 is a mechanism that can mount a plurality of reagent containers that hold reagents. In the case of this embodiment, the reagent disk 12 is also provided with one or a plurality of reagent containers holding a cleaning liquid used for cleaning the reaction container 6. The stirring mechanism 13 is a mechanism used for stirring the solution dispensed into the reaction vessel 6. The lamp 14 can switch and output the wavelength of the measurement light used for measuring the water blank absorbance. The photometry unit 15 is disposed at a position facing the lamp 14 with the reaction vessel 6 interposed therebetween, and is configured by a plurality of detectors (multi-wavelength photometers) that receive measurement light that has passed through the reaction vessel 6. The reaction container cleaning system 20 is used for cleaning the reaction container 6. The reaction container cleaning system 20 is disposed between the position where the light flux from the lamp 14 reaches and the position where the specimen is discharged.

  In addition, the automatic analyzer 100 includes an interface 4, a sample pump 7, a motor 8, a reagent pump 11, a keyboard 16, a printer 17, a CRT screen 18, a reagent barcode reader 19, a multiplexer 21, an FD drive 22, and a hard disk. A drive (HD) 23 is provided. The interface 4 provides a communication path that interconnects the components constituting the automatic analyzer 100. The sample pump 7 is used to dispense the specimen into the sample cup 1A. The motor 8 is used to drive the reaction disk 9. The reagent pump 11 is used to dispense a reagent into a reagent container. The keyboard 16 is one of input devices for the computer 3, and through the operation, the start of cleaning of the reaction container 6 by the reaction container cleaning system 20 and the measurement of the water blank absorbance can be instructed. The printer 17 is one of output devices used for outputting analysis results by the computer 3.

  The CRT screen 18 is used to display a user interface screen, and an instruction to the computer 3 is input through the user interface screen. In addition, the CRT screen 18 displays information on the deterioration of the lamp 14 that is a lifespan component, the scratch on the reaction vessel 6, and the presence or absence of deterioration as alarms.

  The reagent barcode reader 19 is used to read the barcode printed on the reagent container. Although not shown, an identification device such as a barcode reader for identifying the reaction vessel 6 is also mounted. The multiplexer 21 is used to select a wavelength used for measuring the water blank absorbance. The FD drive 22 is a drive for reading and writing data from and to a floppy disk as an external storage medium. The external storage medium may be a USB memory, an SD card, or other semiconductor memory. In this case, a drive according to the standard of the external storage medium is used instead of the FD drive 22. The hard disk drive (HD) 23 is a hard disk drive as an internal storage medium. A measurement result obtained by the automatic analyzer 100 is used to store a threshold value (cell blank measurement value application range, previous allowable error) used for determination to be described later.

  The automatic analyzer 100 having these structures performs an analysis operation according to the following procedure under the control of the computer 3. The automatic analyzer 100 first executes a multi-judgment process, which will be described later, and measures the concentration of the sample using the corresponding reaction vessel 6 and lamp 14 only when no abnormality is found in the reaction vessel 6 or the lamp 14. Transition to processing.

  The automatic analyzer 100 that has shifted to the concentration measurement process sucks a predetermined amount of the sample from the sample cup 1 </ b> A installed on the sample disk 1 by the sample probe, and discharges the sucked sample to the reaction container 6. Next, the automatic analyzer 100 sucks a certain amount of reagent from the reagent container installed on the reagent disk 12 by the reagent probe, and discharges the sucked reagent into the reaction container 6 from which the sample has been discharged in a predetermined amount. Thereafter, the automatic analyzer 100 agitates the sample and the reagent injected into the reaction vessel 6 by the agitation mechanism 13. The automatic analyzer 100 measures the water blank absorbance for the reaction vessel 6 that has been agitated, and measures the concentration of the specimen.

  Note that the reaction disk 9 rotates in one direction by one half rotation + one reaction container for each cycle of measurement and temporarily stops. In this case, the position of the reaction vessel 6 installed on the reaction disk 9 is one reaction vessel in the counterclockwise direction from the point symmetrical with respect to the start position of the previous measurement cycle at the start of the next measurement cycle. It is in a shifted position. The reaction disk 9 facing the lamp 14 rotates, so that the light beam of the measurement light emitted from the lamp 14 sequentially passes through the rows of the reaction containers 6 and is detected by the photometry unit 15.

(3) Multi-determination process Subsequently, the multi-determination process executed before measuring the concentration of the specimen will be described. As described above, the multi-determination process is provided by the computer 3 through the execution of the program. Hereinafter, the computer 3 as the execution subject of the multi-determination process is referred to as a multi-determination unit.

  FIG. 2 shows a functional configuration of the multi-determination unit 25. The multi determination unit 25 includes a water blank absorbance storage unit 26 and an analysis parameter input unit 27. The water blank absorbance storage unit 26 is used to store the water blank absorbance measured by the photometry unit 15. The measurement of the water blank absorbance is performed for each of the twelve wavelengths selected from the range of 340 [nm] to 800 [nm] for each reaction vessel 6. Therefore, 12 measured values of water blank absorbance are obtained for one reaction vessel 6. However, the number of wavelengths used for the measurement is only an example, and may be, for example, 11 or any other number. In the water blank absorbance storage unit 26, the measured value of the water blank absorbance for 12 wavelengths measured immediately before for the reaction vessel 6 having the same reaction vessel number and the latest reaction for the same reaction vessel 6 are stored. The measured values of the measured water blank absorbance for 12 wavelengths are stored in association with each other.

  The analysis parameter input unit 27 stores a cell blank measurement value application range 28 and a previous allowable error 29. The cell blank measurement value application range 28 and the previous allowable error 29 are set in advance by the manufacturer or individually input by the user through the user interface. The cell blank measured value application range 28 provides a range (first threshold value) in which the measured value is good. For example, an upper limit of allowable measurement values is given. The previous allowable error 29 gives a range (second threshold) in which the difference between the last measured value and the latest measured value is good. For example, an upper limit of an allowable difference is given. In the case of this embodiment, the cell blank measurement value application range 28 and the previous allowable error 29 are prepared for each of the 12 wavelengths used for the measurement of the water blank absorbance. That is, 12 sets of cell blank measurement value application range 28 and previous allowable error 29 are prepared. Note that only one set of the cell blank measurement value application range 28 and the previous allowable error 29 may be prepared for 12 wavelengths.

  The multi determination unit 25 uses the measured value of the water blank absorbance stored in the water blank absorbance storage unit 26, the cell blank measured value application range 28 and the previous allowable error 29 input to the analysis parameter input unit 27. Then, the quality of the reaction vessel 6 and the lamp 14 is judged. As a result of the determination, (1) the reaction vessel 6 and the lamp 14 are both normal, (2) the reaction vessel 6 needs to be cleaned, (3) the reaction vessel 6 needs to be replaced, and (4) the lamp is deteriorated. .

  When the multi-determination unit 25 determines that the reaction container 6 needs to be cleaned, the multi-determination unit 25 sucks a certain amount of detergent (cleaning liquid) stored in the reagent disk 12 using the reagent probe, and the corresponding reaction container 6 And the individual cleaning operation of the corresponding reaction vessel 6 is executed. This cleaning is performed in one measurement cycle as in normal operation. For this reason, the detergent is kept in the reaction vessel 6 for about 10 minutes. After completion of the individual cleaning operation, the reaction container cleaning system 20 sucks the detergent and prepares for the next measurement cycle.

  By mounting this individual cleaning operation function, the automatic analyzer 100 can clean only the specific reaction container 6 in which the contamination is recognized in parallel while executing the measurement of the sample continuously for 24 hours. That is, the automatic analyzer 100 according to the embodiment does not need to stop the operation of the entire apparatus unlike the maintenance function, and can basically measure the sample continuously for 24 hours.

  The description of the multi determination unit 25 will be continued. The cell blank measured value application range 28 is a range in which the measured value of the water blank absorbance measured in each reaction vessel 6 before measurement is good (normal range in which there is no influence of contamination, scratches, etc. due to contaminants, or deterioration of the lamp 14). )give. The previous allowable error 29 is a range in which the difference between the latest measurement value of the water blank absorbance performed before the measurement and the previous measurement value measured in the same reaction vessel 6 is checked.

  As described above, the automatic analyzer 100 according to the embodiment measures 12 water blank absorbances corresponding to 12 wavelengths set in advance for one reaction vessel 6. This is because there is dirt that cannot be detected depending on the wavelength. The multi-judgment unit 25 combines the cell blank measurement value application range 28 corresponding to the wavelength used for the measurement of the water blank absorbance and the previous allowable error 29 to clean and replace the reaction container 6 that is a consumable, the lamp 14 Accurately determine the state of deterioration.

  Table 1 shows a specific example of the determination operation executed in the multi determination unit 25. Table 1 shows that the wavelength of light used for measurement is 340 [nm], the cell blank measurement value application range 28 corresponding to the wavelength is “14000”, and the previous allowable error 29 corresponding to the same wavelength is “100”. Determination result patterns 1 to 4 in the case of

For judgment result pattern 1:
In the case of this pattern, since the latest measured value of the water blank absorbance is “8030”, the cell blank measured value application range 28 (14000) is satisfied. Furthermore, since the difference from the last measured value “8000” measured using the same wavelength for the same reaction vessel 6 is “30” (= 8030−8000), it is smaller than the previous allowable error 29 (100). In this case, the multi-determination unit 25 determines that the measured value of the water blank absorbance for the reaction container 6 is stably changing. This determination result means that the reaction vessel 6 is not contaminated or scratched, and the lamp 14 is not deteriorated. Therefore, the multi-determination unit 25 instructs (permits) the start of the sample measurement that continuously uses the corresponding reaction container 6.

For judgment result pattern 2:
In the case of this pattern, since the latest measurement value of the water blank absorbance is “7700”, the cell blank measurement value application range 28 (14000) is satisfied. On the other hand, the difference from the previous measurement value “7500” measured using the same wavelength for the same reaction vessel 6 is “200” (= 7700-7500), which is larger than the previous allowable error 29. In this case, the multi determination unit 25 determines that the cause of the increase in the water blank absorbance is the deterioration of the lamp 14. In this case, the multi-determination unit 25 determines that correct measurement cannot be performed at present, stops sampling of the specimen for the reaction container 6 used for the measurement of the water blank absorbance, and shifts to the next process of the reaction container 6. In addition, the multi-determination unit 25 determines that the life of the lamp 14 will almost expire, displays an alarm (alarm) on the screen, and prompts the user to replace the lamp 14. When this determination result is continuously generated for the five reaction vessels 6, the multi determination unit 25 stops the sample measurement by the automatic analyzer 100.

For judgment result pattern 3:
In the case of this pattern, the latest measured value of the water blank absorbance is “14500”, which is larger than the cell blank measured value application range 28 (14000). Further, since the difference from the previous measurement value “13000” measured using the same wavelength for the same reaction vessel 6 is “1500” (= 14500-13000), it is larger than the previous allowable error 29 (100). In this case, the multi determination unit 25 determines that the cause of the increase in the water blank absorbance is that the reaction container 6 is contaminated, and instructs the execution of the individual cleaning operation of the corresponding reaction container 6. This determination result means that the reaction vessel 6 is not damaged or deteriorated, and the lamp 14 is not deteriorated. In the individual cleaning operation, a predetermined amount of the reagent held in the reagent container mounted on the reagent disk 12 is aspirated by the reagent probe, and then is discharged into the reaction container 6 to be cleaned, and the individual cleaning of the reaction container 6 is performed. The action is executed. After completion of the individual cleaning operation, the detergent liquid in the reaction container 6 is sucked using the reaction container cleaning system 20.

For judgment result pattern 4:
In the case of this pattern, the measured value of the latest water blank absorbance is “14650”, which is larger than the cell blank measured value application range 28 (14000). On the other hand, the difference from the last measured value “14600” measured using the same wavelength for the same reaction vessel 6 is “50” (= 14650-14600), and is smaller than the previous allowable error 29 (100). However, since the last measurement value “14600” is already larger than the cell blank measurement value application range 28 (14000), it is estimated that the reaction vessel 6 has already been cleaned at the last measurement. Despite the last washing, no decrease was observed in the measured value of the water blank absorbance. As described above, when the measurement value exceeds the cell blank measurement value application range 28 (14000) twice in succession for the same reaction vessel 6, the multi-determination unit 25 causes the reaction vessel 6 to deteriorate due to the increase in water blank absorbance. It is determined that there is. In this case, the multi-determination unit 25 determines that correct measurement cannot be performed at present, stops sampling of the specimen for the reaction container 6 used for the measurement of the water blank absorbance, and shifts to the next process of the reaction container 6. In addition, the multi-determination unit 25 displays on the screen an alarm (alarm) that recommends replacement of the reaction container 6 and that the reaction container 6 has been excluded from the measurement of the sample due to an abnormality in the measurement value.

  FIG. 3 shows a processing matrix that the multi-determination unit 25 refers to when making a determination. The above-described processing patterns 1 to 4 match the contents of these processing matrices.

(4) Outline of Analysis Operation Next, an outline of the analysis operation executed in the automatic analyzer 100 will be described. First, the user operates the start display portion of the user interface displayed on the CRT screen 18 through the keyboard 16. For example, the start display unit is clicked by the mouse pointer or touched by the user. With this operation as a trigger, the reaction container cleaning system 20 starts cleaning the reaction container 6. Moreover, the automatic analyzer 100 starts measuring the water blank absorbance. At this time, the automatic analyzer 100 irradiates each of the reaction containers 6 used for measuring the sample while switching 12 wavelengths selected from the range of 340 [nm] to 800 [nm], and water is used for all 12 wavelengths. Measure the blank absorbance. The measured value here is used as a reference value in subsequent measurements.

  The measurement of water blank absorbance is carried out by the following procedure. When the measurement of the water blank absorbance is started, the sample cup 1A installed on the sample disk 1 is moved to the sampling position of the specimen. Similarly, the two reagent disks 12 also rotate and move to the reagent pipetting positions, respectively. During this time, a multi-judgment process is executed, and it is confirmed whether or not the reaction container 6 and the amplifier 14 are in a state that can be used for the sample. If no abnormality is found in the reaction vessel 6 or the amplifier 14, the sampling mechanism 5 sucks, for example, a sample (specimen) of an amount necessary for the analysis item A from the sample cup 1A, and the normality is confirmed in the reaction vessel 6. Discharge. At the same time, the reagent pipetting mechanism 10 sucks the first reagent for the analysis item A from the reagent container installed on the reagent disk 12, and discharges it to the reaction container 6 from which the sample for the analysis item A has been discharged. After that, the outer and inner walls of the reagent probe used for dispensing are washed in the probe washing tank to prepare for dispensing of the first reagent for the next analysis item B.

  The reaction disk 9 rotates by half rotation + 1 reaction container in one cycle and temporarily stops, so that it rotates by 1 rotation + 2 reaction containers in the 2-cycle operation. Each time the reaction disk 9 makes one revolution, the reaction vessel 6 passes in front of the lamp 14. When the reaction vessel 6 crosses the optical axis of the light emitted from the lamp 14, the water blank absorbance of the reaction vessel 6 is measured. If the time required for one cycle is 12 seconds, the photometry is performed 25 times during a reaction time of 10 minutes. After completion of photometry, the reaction vessel 6 is washed by the reaction vessel washing system 20 to prepare for the next sample (specimen) measurement. The measured water blank absorbance is used for concentration calculation by the computer 3, and the analysis result is output from the printer 17.

(5) Multi-judgment operation The multi-judgment operation is executed immediately before dispensing the specimen into the reaction container 6. The multi-judgment operation is executed 12 times for one reaction vessel 6. The twelve multi-judgment operations are executed for each of twelve different wavelengths selected from the range of 340 [nm] to 800 [nm]. In other words, the multi-determination operation is executed each time the water blank absorbance is measured by the photometry unit 15 for each wavelength.

  The measurement result is transmitted from the photometry unit 15 to the water blank absorbance storage unit 26 in the multi-determination unit 25 and recorded. The water blank absorbance storage unit 26 includes the reaction vessel number used for the measurement, the measured value of the water blank absorbance for the 12 wavelengths measured for the last time for the reaction vessel 6 having the same reaction vessel number, and the same reaction vessel. 6 and the measured value of the water blank absorbance for 12 wavelengths measured in the latest round is stored.

  The multi-determination unit 25 determines whether the latest measurement value of the water blank absorbance is within the cell blank measurement value application range 28 (is smaller than the set value), and the previous measurement measured in the same reaction vessel 6. A process of determining whether the difference between the value and the latest measured value is within the previous allowable error 29 (is smaller than the set value) is executed. When the latest measurement value is within the cell blank measurement value application range 28 and the difference between the previous measurement value and the latest measurement value is within the previous allowable error 29, the multi-determination unit 25 It is determined that the reaction vessel 6 is in a good state free from contamination and scratches, and the light quantity of the lamp 14 is stable, and the shift to the sample sampling operation is permitted.

  On the other hand, even if the latest measurement value is within the cell blank measurement value application range 28, if the difference between the previous measurement value and the latest measurement value is larger than the previous allowable error 29, the multi-determination unit 25 Since the random fluctuation range is large, it is estimated that the light amount of the lamp 14 is unstable. That is, the multi-determination unit 25 determines that the lamp 14 has deteriorated, and displays a recommendation to replace the lamp 14 on the CRT screen 18 as an alarm. Note that the corresponding reaction vessel 6 is not used for measurement of a sample (specimen) (measurement is skipped). Furthermore, when the same determination result continues for five different reaction containers 6 (that is, when the same determination result continues five times), the multi-determination unit 25 determines that the deterioration of the lamp 14 has progressed, and the specimen Automatically stops the measurement operation.

  When the latest measurement value is larger than the cell blank measurement value application range 28 and the difference between the previous measurement value and the latest measurement value is larger than the previous allowable error 29, the multi-determination unit 25 determines whether or not the reaction container 6, it is determined that the contamination of the reaction vessel 6 has progressed, and the washing process of the reaction vessel 6 is performed without dispensing the sample into the corresponding reaction vessel 6. The cleaning liquid used for the cleaning process is held in a reagent container installed on the reagent disk 12. Therefore, a predetermined amount (for example, 200 [μL]) of the cleaning liquid is sucked from the reagent container using the reagent pipetting mechanism 10 and discharged to the reaction container 6 to be cleaned. The dispensed washing liquid is maintained in the reaction vessel 6 for the same time as the normal analysis time, and is aspirated by the reaction vessel washing system 20 after 10 minutes have elapsed since dispensing.

  Further, when the latest measurement value is larger than the cell blank measurement value application range 28 and the difference between the previous measurement value and the latest measurement value is within the previous allowable error 29 (water blank of the same reaction vessel 6). When the measured value of the absorbance is out of the range twice in succession), the multi-determination unit 25 determines that the cause of the increase in the measured value is not due to dirt, but the reaction container 6 is progressing in scratches and deterioration. . In this case, since it is considered that the cleaning of the reaction vessel 6 again is ineffective, the multi-determination unit 25 displays a recommendation for replacement of the reaction vessel 6 on the CRT screen 18 as an alarm. Note that the reaction vessel 6 is not used for measurement of the specimen. That is, the sampling of the sample into the reaction container 6 is skipped.

  Note that when the same reaction vessel 6 is continuously washed 5 times (that is, when sampling of the sample is skipped 5 times for the same reaction vessel 6), the multi-determination unit 25 The measurement may be automatically stopped, although the number of consecutive times is not limited to 5. In addition, when washing is performed cumulatively 5 times for the same reaction vessel 6 (that is, for the same reaction vessel 6 When skipping of sampling is intermittently executed five times), the multi-determination unit 25 may automatically stop sampling of the specimen, although the number of consecutive times is not limited to five.

  In addition, when sample sampling is skipped for five consecutive cycles for different reaction vessels 6, the multi-determination unit 25 determines that many reaction vessels 6 are scratched or deteriorated and automatically performs sample measurement. You may stop. In addition, when there is no measurement value of the last time measured for the same reaction vessel 6, the multi-determination unit 25 uses only the latest measurement value and compares it with the cell blank measurement value application range 28 for comparison. The necessity of cleaning is determined according to the result.

(6) Specific Example of Multi Determination Operation FIG. 4 shows a specific example of the multi determination operation. In the case of this embodiment, the multi-determination operation shown in FIG. 4 is executed for each wavelength. Therefore, at each determination to be described later, the cell blank measurement value application range and the previous allowable error set or input for the wavelength to be used are used. When the measurement of the sample is started by the computer 3 (multi-determination unit 25) (step SP1), the reaction container 6 used for the measurement is washed, and then the water blank absorbance is measured (step SP2). The computer 3 (multi-determination unit 25) stores the latest measurement value for each reaction container 6 in the water blank absorbance storage unit 26 together with the corresponding previous measurement value (step SP3).

  The computer 3 (multi-determination unit 25) confirms the use history of the reaction vessel 6 that has measured the water blank absorbance, and determines whether or not the reaction vessel 6 is used for the first time (step SP4). The reaction vessel 6 in which the measurement value of the previous time is not stored is the reaction vessel 6 for the first use. When the reaction container 6 is used for the first time, the computer 3 (multi-determination unit 25) cannot compare the measured value of the same reaction container 6 with the previous measurement value. Therefore, the computer 3 (multi-determination unit 25) determines whether or not the latest measurement value of the water blank absorbance exceeds the cell blank measurement value application range (step SP5).

  When a positive result is obtained in step SP5 (when the latest measurement value exceeds the cell blank measurement value application range), the computer 3 (multi-determination unit 25) individually cleans the corresponding reaction vessel 6 (step SP6). ). When a negative result is obtained in step SP5 (when the latest measurement value is within the cell blank measurement value application range), the computer 3 (multi-determination unit 25) starts sampling of the sample (step SP9), and thereafter Reagent dispensing (step SP10), water blank absorbance measurement (step SP11), and measurement result reporting (step SP12) are sequentially executed. Subsequently, when there is another measurement sample (positive result in step SP13), the computer 3 (multi-determination unit 25) returns to step SP2. On the other hand, when a negative result is obtained in step SP13, the computer 3 (multi-determination unit 25) automatically stops the sample measurement operation by the automatic analyzer 100 (step SP14).

  When a negative result is obtained in step SP4 (when it is not the first use), the computer 3 (multi-determination unit 25) determines whether or not the measured value of the water blank absorbance is smaller than the cell blank measured value application range 28 ( Step SP7). When an affirmative result is obtained in step SP7 (when it is within the applicable range), the computer 3 (multi-determination unit 25) has a difference between the latest measurement value and the previous measurement value smaller than the previous allowable error 29. (Step SP8). When an affirmative result is obtained in step SP8 (when the difference is within the previous allowable error), the computer 3 (multi-determination unit 25) determines that there is no problem in the reaction vessel 6 and the lamp 14, and the sample (specimen) is determined. Sampling is started (step SP9). Thereafter, the computer 3 (multi-determination unit 25) sequentially executes reagent dispensing (step SP10), absorbance measurement (step SP11), and measurement result reporting (step SP12). If there is another measurement sample (step SP13), the computer 3 (multi-determination unit 25) returns to step SP2.

  When a negative result is obtained in step SP8 (when the difference exceeds the previous allowable error), the computer 3 (multi-determination unit 25) has a random variation in absorbance change (deterioration of the lamp has occurred). ) And “Lamp deterioration” is displayed on the alarm screen (step SP15). Further, the computer 3 (multi-determination unit 25) stops the sampling of the specimen into the reaction container 6 (step SP16). Subsequently, the computer 3 (multi-determination unit 25) determines whether or not alarms caused by lamp degradation are continuously output for five reaction vessels 6 (step SP17). If a negative result is obtained in step SP17, the computer 3 (multi-determination unit 25) returns to step SP2 when “YES” via step SP13. On the other hand, when a positive result is obtained in step SP17, the computer 3 (multi-determination unit 25) automatically stops the sample measurement operation by the automatic analyzer 100 (step SP14).

  When a negative result is obtained in step SP7 (when the latest measurement value satisfies the cell blank measurement value application range), the computer 3 (multi-determination unit 25) determines the latest measurement value, the previous measurement value, It is determined whether or not the difference is smaller than the previous allowable error 29 (step SP18). When a negative result is obtained in step SP18 (when the difference is larger than the previous allowable error), the computer 3 (multi-determination unit 25) determines that the reaction container 6 is dirty and instructs to stop sampling of the sample ( Step SP19), and thereafter, individual cleaning of the reaction vessel 6 is instructed (step SP20).

  Further, the computer 3 (multi-determination unit 25) determines whether or not the five different reaction vessels 6 have been successively washed (step SP21). When a negative result is obtained in step SP21, the computer 3 (multi-determination unit 25) returns to step SP2 when “YES” is obtained via step SP13, and automatically when a positive result is obtained in step SP21. The sample measurement operation by the analyzer 100 is automatically stopped.

  If an affirmative result is obtained in step SP18, the computer 3 (multi-determination unit 25) determines that there is no effect on the cleaning of the reaction vessel 6 (determines that the reaction vessel 6 needs to be replaced), and the reaction vessel The sampling of the sample (specimen) for 6 is stopped (step SP22). Thereafter, the computer 3 (multi-determination unit 25) displays a warning “reaction container needs to be replaced” on the alarm screen (step SP23), and then returns to step SP2 when “YES” via step SP13. .

(7) Effect realized by the embodiment According to the automatic analyzer 100 described above, the variation factor of the measured value of the water blank absorbance is caused by the contamination of the reaction vessel 6 or the surface of the reaction vessel 6 is caused by scratches. Or whether the life of the lamp 14 is due. For this reason, in the automatic analyzer 100, it is not necessary to wash the reaction vessel 6 as a part of the maintenance function unlike the current apparatus. That is, in the automatic analyzer 100, it is only necessary to perform individual cleaning only for the reaction container 6 that needs to be contaminated, and it is not necessary to completely stop the specimen measurement operation as in the current apparatus.

  Moreover, in the automatic analyzer 100, since it is not necessary to wash all reaction containers including reaction containers in which contamination has not progressed as in the current apparatus, the cleaning time can be shortened. Furthermore, the automatic analyzer 100 eliminates wasteful consumption of detergents, so that a cost reduction effect is also expected. Moreover, the cleaning of the reaction container 6 in the automatic analyzer 100 can be performed in parallel (within one cycle time) with the sample measurement operation using the other reaction container 6. That is, since the reaction container 6 can be washed without stopping the sample measurement operation, the automatic analyzer 100 can be operated continuously for 24 hours.

  In addition, the current apparatus is equipped with a function of skipping the measurement of the sample using the reaction container 6 when the measurement value of the water blank absorbance is disturbed before the sample measurement. Unlike the automatic analyzer 100 according to the above, the individual execution function of the cleaning operation is not mounted, and the replacement of the reaction vessel 6 and the lamp 14 cannot be determined. Thus, the automatic analyzer 100 can realize technical effects that cannot be realized with the current apparatus.

  Further, in the current apparatus, the confirmation of the abnormal reaction vessel 6 is performed using only the latest measurement value of each reaction vessel, whereas in the automatic analyzer 100, the previous measurement value and A method including a process of storing both of the latest measurement values and comparing the difference between these two measurement values is adopted. By employing this method, the automatic analyzer 100 can determine whether the cause of the increase in the measured value of the water blank absorbance is the contamination of the reaction vessel 6 or the deterioration of the reaction vessel 6 or the lamp 14.

  Furthermore, the automatic analyzer 100 can automatically isolate the cause from the measured value of the water blank absorbance of the reaction vessel 6 without stopping the operation of the apparatus with the maintenance function (that is, while continuing the measurement of the sample). .

  In addition, when it is determined that the cause of the increase in the measured value of the water blank absorbance is contamination of the reaction container, a dedicated detergent held in one of the reagent containers installed in the reagent disk 12 is used as a reagent probe. To the corresponding reaction vessel 6 and wash only the reaction vessel 6 individually. In general, the accumulation of scratches and dirt on the surface of the reaction vessel 6 and the deterioration of the reaction vessel 6 vary depending on the reagent used and the usage status of the user. In addition, the deterioration speed of the lamp 14 depends on the cumulative power-on time of the automatic analyzer 100. For this reason, although the time for replacing the reaction vessel 6 and the time for replacing the lamp 14 are different for each user, the automatic analyzer 100 does not have a uniform period determined by the manufacturer, but the time for replacement according to the actual situation and situation of use. It is possible to accurately determine and communicate the necessity to the user.

(8) Other Embodiments The present invention is not limited to the embodiment described above, and includes various modifications. For example, the above-described embodiments have been described in detail for easy understanding of the present invention, and it is not necessary to provide all the configurations described. For example, a part of the configuration of another embodiment can be added, deleted, or replaced with a part of the configuration of the embodiment.

  For example, in the above-described embodiment, it is assumed that the process shown in FIG. 4 is repeatedly executed for each of the 12 wavelengths, and in that case, measurement is performed as the cell blank measurement value application range and the previous allowable error value. Although a value specific to the wavelength of light is used, a value common to 12 wavelengths may be used as the cell blank measurement value application range and the previous allowable error value.

  In the above-described embodiment, the process shown in FIG. 4 has been described as being repeatedly executed for each of the 12 wavelengths. However, the measurement of the water blank absorbance corresponding to each of the 12 wavelengths is performed in step SP2. The determination using the immediately previous measurement value and the latest measurement value corresponding to each wavelength is executed in steps SP5, SP7, SP8, SP18, and conditions are set for the water blank absorbance corresponding to at least one wavelength. When not satisfy | filling, you may determine with not satisfy | filling the conditions of each step SP5, SP7, SP8, SP18.

  Each of the above-described configurations, functions, processing units, processing means, and the like may be realized by hardware by designing a part or all of them, for example, with an integrated circuit. Each of the above-described configurations, functions, and the like may be realized by the processor interpreting and executing a program that realizes each function (that is, in software). Information such as programs, tables, and files that realize each function can be stored in a storage device such as a memory, a hard disk, and an SSD (Solid State Drive), or a storage medium such as an IC card, an SD card, and a DVD. Control lines and information lines indicate what is considered necessary for the description, and do not represent all control lines and information lines necessary for the product. In practice, it can be considered that almost all components are connected to each other.

1 ... Sample disc 1A ... Sample cup (reaction vessel)
2 ... Sample barcode reader 3 ... Computer 4 ... Interface 5 ... Sampling mechanism 6 ... Reaction vessel 7 ... Sample pump 8 ... Motor 9 ... Reaction disk 10 ... Reagent probe 11 ... Reagent pump 12 ... Reagent disk 13 ... Agitating mechanism 14 ... Lamp 15 ... Metering unit 16 ... Keyboard 17 ... Printer 18 ... CRT screen 19 ... Reagent barcode reader 20 ... Reaction vessel washing tank system 21 ... Multiplexer 22 ... FD drive 23 ... HD drive 25 ... Multi determination part 26 ... Water blank absorbance Storage unit 27 ... analysis parameter input unit 28 ... cell blank measured value adaptive range 29 ... previous allowable error

Claims (11)

A sample probe for dispensing the sample into the reaction vessel;
A reagent probe for dispensing a reagent into the reaction vessel;
A sample disk for laying a container for holding the specimen;
A reaction disk for laying the reaction vessel;
A reagent disk for laying a container holding the reagent;
A photometric unit having a lamp and a light receiving unit and measuring the water blank absorbance of the reaction vessel;
A first storage unit that stores, for each reaction container, a set of the last measurement value and the latest measurement value of the water blank absorbance measured using the same reaction container;
A second storage unit for storing a first threshold value for the latest measurement value and a second threshold value for a difference between the immediately previous measurement value and the latest measurement value;
A multi-determination unit that determines the state of the reaction vessel and the state of the lamp based on the last measured value and the latest measured value stored for the same reaction vessel, and
The multi-determination unit
When the latest measurement value is smaller than the first threshold value and the difference is smaller than the second threshold value, it is determined that the reaction vessel and the lamp are both normal.
When the latest measurement value is smaller than the first threshold value and the difference is larger than the second threshold value, it is determined that the lamp has deteriorated,
When the latest measured value is greater than the first threshold and the difference is greater than the second threshold, it is determined that the reaction vessel should be washed;
When the latest measurement value is larger than the first threshold value and the difference is smaller than the second threshold value, it is determined that the reaction container should be replaced. The automatic analyzer. The automatic analyzer according to claim 1,
The multi-determination unit
An automatic analyzer characterized in that the reaction container determined to require cleaning is excluded from the sample dispensing target and designated as the cleaning target. The automatic analyzer according to claim 2,
The multi-determination unit
Using the reagent probe to aspirate detergent from one of the containers mounted on the reagent disk, and then dispensing the aspirated detergent into the reaction container that is determined to require cleaning. A featured automatic analyzer. The automatic analyzer according to claim 1,
The multi-determination unit
An automatic analyzer characterized in that the reaction container determined to be exchanged is excluded from the sample dispensing target and designated as a replacement target. The automatic analyzer according to claim 1,
The multi-determination unit
An automatic analyzer characterized in that, when it is determined that the same reaction container needs to be continuously washed a predetermined number of times, the measurement operation of the sample being executed is automatically stopped. The automatic analyzer according to claim 1,
The multi-determination unit
An automatic analyzer characterized in that, when the number of determinations that the same reaction container needs to be cleaned reaches a predetermined number, the measurement operation of the sample being executed is automatically stopped. The automatic analyzer according to claim 1,
The multi-determination unit
An automatic analyzer characterized in that, when it is determined that the different reaction containers need to be continuously washed a predetermined number of times, the measurement operation of the sample being executed is automatically stopped. The automatic analyzer according to claim 1,
The multi-determination unit
An automatic analyzer characterized in that, when it is determined that the lamp needs to be replaced continuously for a predetermined number of times, the measurement operation of the sample being executed is automatically stopped. The automatic analyzer according to claim 1,
The second storage unit stores one set of the first threshold value and the second threshold value for each of the wavelengths of the plurality of measurement light beams used for measuring the water blank absorbance. A featured automatic analyzer. The automatic analyzer according to claim 1,
An automatic analyzer further comprising an analysis parameter input unit for individually inputting the first threshold value and the second threshold value. The automatic analyzer according to claim 1,
The multi-determination unit
When it is determined that the reaction container needs to be cleaned, when it is determined that the reaction container needs to be replaced, or when it is determined that the lamp needs to be replaced, a message to that effect is displayed on the operation screen. An automatic analyzer characterized by display.

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