JP6503261B2 - Automatic analyzer - Google Patents

Description

  The present invention relates to a technique for automatically determining the status of stains and scratches on a reaction container used in an automatic analyzer and the status of lamp degradation.

  Generally, plastic or glass reaction containers (also referred to as "cells") and lamps are used in automatic analyzers for biochemical analysis or immunological component analysis of blood or urine. These are consumables that have a lifetime and require regular cleaning and replacement work. For example, if it is a reaction vessel, weekly cleaning by the user is required. By the way, cleaning of the reaction vessel is performed as part of the maintenance function. For this reason, while the cleaning is being performed, it is necessary to once stop the measurement of the sample.

  However, in emergency hospitals and inspection centers, automatic analyzers are operated continuously for 24 hours, and inspections are always conducted continuously at night. In addition, in such a usage environment, since the measurement of the sample is always prioritized, it is impossible to secure the cleaning time of the reaction container accompanied by the stop of the measurement of the sample. However, failure to clean the reaction vessel can increase the potential for data failure.

  In many cases, manufacturers of automatic analyzers uniformly set the maintenance cycle of consumables regardless of the use environment of the user and the degree of consumption. For example, the cleaning cycle of the reaction vessel is set to one week, the exchange cycle of the reaction vessel is set to one month, and the lamp exchange cycle is set to half a year. However, the progress of the deterioration of the reaction container and the lamp depends on the type of reagent used by each user for the measurement, the number of times of measurement of the sample, and the like, and is not necessarily uniform. By the way, the manufacturer defines the replacement cycle of consumables on the assumption that it is used for 5 hours a day. For this reason, at a facility operating an automatic analyzer for 24 hours continuously, the replacement timing comes earlier than the maintenance cycle defined by the manufacturer.

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

Unexamined-Japanese-Patent No. 3-181862 gazette

  As described above, the manufacturer uniformly defines the replacement cycle and cleaning cycle of consumables without considering the use environment of each user. Therefore, for example, the service life (replacement cycle) of the lamp naturally differs between a facility used five hours a day and a facility used ten hours a day. That is, depending on the maintenance cycle defined by the manufacturer, the replacement cycle and the cleaning cycle of consumables can not be managed properly. In addition, for a user who uses a large amount of reagent that tends to deposit in the reaction container, it is expected that the replacement cycle will come earlier than the maintenance cycle defined by the manufacturer. Therefore, it is important to understand the maintenance execution timing taking into consideration the usage environment of each user.

  In order to solve the above problems, the present invention adopts, for example, the configuration described in the claims. Although the present specification includes a plurality of means for solving the above problems, to mention one example, “the immediately preceding measurement value of the water blank absorbance measured using the same above-mentioned reaction vessel and the latest cycle A first storage unit for storing a set of measurement values for each of the reaction vessels, a first threshold value for the latest measurement value, and a difference between the previous measurement value and the latest measurement value The quality of the reaction container and the lamp is determined based on a second storage unit that stores a second threshold value, the previous measurement value stored for the same reaction container, and the latest measurement value. An automatic analyzer having a multi determination unit that determines

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

The figure which shows the example of a whole structure of an automatic analyzer. The figure explaining the conceptual composition of a multi judgment 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 based on the drawings. In addition, the aspect of implementation of this invention is not limited to the form example mentioned later, In the range of the technical thought, various deformation | transformation are possible.

(1) Form Example Here, an automatic analyzer used for biochemical analysis or immunological component analysis will be described. The automatic analyzer according to the embodiment uses the water blank absorbance information to automatically determine the state of dirt, damage, and deterioration of the lamp or the reaction container made of plastic or glass, When the contamination is judged, only the corresponding reaction container is automatically cleaned using a special detergent, and if there is a scratch on the reaction container or deterioration of the lamp, the user is notified using a dedicated monitor etc. attached to the device. Alert to

(2) Overall Configuration FIG. 1 shows the overall configuration of the automatic analyzer 100 according to the embodiment. The automatic analyzer 100 comprises 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 container cleaning system 20. ing.

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

  The reagent pipetting mechanism 10 is a mechanism for collecting a predetermined amount of reagent from a reagent container mounted on the reagent disk 12 and dispensing the reagent into the reaction container 6. The reagent disk 12 is a mechanism capable of establishing a plurality of reagent containers for holding reagents. In the case of this embodiment, the reagent disc 12 also has one or more reagent containers for holding the washing liquid used to wash the reaction container 6. The stirring mechanism 13 is a mechanism used to stir the solution dispensed into the reaction vessel 6. The lamp 14 can switch and output the wavelength of the measurement light used to measure the water blank absorbance. The photometry unit 15 is disposed at a position facing the lamp 14 with the reaction container 6 interposed therebetween, and is configured of a plurality of detectors (multi-wavelength photometers) that receive measurement light having passed through the reaction container 6. The reaction container cleaning system 20 is used to clean the reaction container 6. The reaction container cleaning system 20 is disposed between the position where the luminous flux from the lamp 14 reaches and the position where the sample 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 bar code reader 19, a multiplexer 21, an FD drive 22 and a hard disk. It has a drive (HD) 23. The interface 4 provides a communication path which mutually connects between each part which comprises the autoanalyzer 100. The sample pump 7 is used to dispense the sample into the sample cup 1A. The motor 8 is used to drive the reaction disk 9. The reagent pump 11 is used to dispense the reagent into the reagent container. The keyboard 16 is one of the input devices to the computer 3, and through its operation, it is possible to instruct the start of washing of the reaction vessel 6 by the reaction vessel washing system 20 and the measurement of the water blank absorbance. The printer 17 is one of output devices used to output an analysis result 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. Further, on the CRT screen 18, information on the deterioration of the lamp 14 which is a limited-life part, the scratch of the reaction container 6, and the presence or absence of deterioration is displayed as an alarm.

  The reagent barcode reader 19 is used to read a barcode printed on a reagent container. Although not shown, an identification device such as a bar code reader for identifying the reaction container 6 is also mounted. The multiplexer 21 is used to select the wavelength used to measure 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 another semiconductor memory, in which case the 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 drive of a hard disk as an internal storage medium. The measurement result by the automatic analyzer 100 is used to store a threshold (cell blank measurement value application range, previous tolerance) used for determination described later.

  Under the control of the computer 3, the automatic analyzer 100 having these structures executes the analysis operation in the following procedure. The automatic analyzer 100 first executes multi-determination processing described later, and measures the concentration of the sample using the corresponding reaction container 6 and the lamp 14 only when no abnormality is found in the reaction container 6 or the lamp 14. Transfer to processing.

  The automatic analyzer 100 transferred to the concentration measurement process sucks a certain amount of sample from the sample cup 1A mounted on the sample disk 1 by the sample probe, and discharges the aspirated sample to the reaction container 6. Next, the automatic analyzer 100 sucks a fixed amount of the reagent from the reagent container mounted on the reagent disc 12 by the reagent probe, and discharges the fixed amount of the sucked reagent to the reaction container 6 which has previously discharged the sample. Thereafter, the automatic analyzer 100 causes the stirring mechanism 13 to stir the sample and the reagent injected into the reaction container 6. The automatic analyzer 100 measures the water blank absorbance of the reaction vessel 6 for which the stirring is completed, and measures the concentration of the sample.

  The reaction disk 9 rotates in one direction by one half rotation + one reaction container every measurement of one cycle, and is temporarily stopped. In this case, at the start of the next measurement cycle, the position of the reaction container 6 mounted on the reaction disc 9 is one reaction container in the counterclockwise direction from the point symmetrical position with respect to the start position of the previous measurement cycle. It is in the wrong position. When the reaction disk 9 facing the lamp 14 is rotated, the luminous flux of the measurement light emitted from the lamp 14 passes through the line of the reaction containers 6 in order, and is detected by the photometry unit 15.

(3) Multi Determination Processing Subsequently, the multi determination processing executed before measuring the concentration of the sample will be described. The multi-determination process is provided by the computer 3 through the execution of the program as described above. Hereinafter, the computer 3 as an 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. As shown in FIG. 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 in the photometry unit 15. The measurement of water blank absorbance is performed for each of 12 wavelengths selected from the range of 340 nm to 800 nm for each reaction vessel 6. Thus, twelve measurements of water blank absorbance are obtained for one reaction vessel 6. However, the number of wavelengths used for measurement is an example, and may be, for example, 11 or another number. In the water blank absorbance storage unit 26, the measurement values of the water blank absorbance of 12 wavelengths measured immediately before for the reaction vessel number and the reaction vessel 6 having the same reaction vessel number, and the latest time for the same reaction vessel 6 It is stored in association with the measured values of the water blank absorbance measured for 12 wavelengths.

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

  The multi-determination unit 25 uses the measurement value of the water blank absorbance stored in the water blank absorbance storage unit 26, the cell blank measurement value application range 28 input in the analysis parameter input unit 27, and the previous tolerance error 29. Then, it is determined whether the reaction container 6 and the lamp 14 are good or bad. As a result of the judgment, (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, (4) the lamp is deteriorated .

  When it is determined that the reaction container 6 needs to be cleaned, the multi-determination unit 25 sucks a fixed amount of detergent (cleaning solution) 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 container 6 is performed. This cleaning is performed in one measurement cycle as in the normal operation. For this reason, the detergent is kept in the reaction vessel 6 for about 10 minutes. After the end of the individual cleaning operation, the reaction container cleaning system 20 sucks the detergent and prepares for the next measurement cycle.

  By mounting the individual cleaning operation function, the automatic analyzer 100 can clean only the specific reaction container 6 in which the contamination is recognized while performing the measurement of the sample continuously for 24 hours. That is, the automatic analyzer 100 according to the embodiment does not have to stop the operation of the entire apparatus as in 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 measurement value application range 28 is a range in which the measurement value of water blank absorbance measured in each reaction vessel 6 before measurement is good (effect by contamination with dirt, scratches, etc. normal range without deterioration of the lamp 14 )give. The last tolerance 29 is a range for checking the difference between the latest measurement value of the water blank absorbance performed before the measurement and the immediately preceding measurement value measured in the same reaction container 6.

  As described above, the automatic analyzer 100 according to the embodiment measures, for one reaction container 6, twelve water blank absorbances corresponding to twelve wavelengths set in advance. This is because there are stains not detected depending on the wavelength. The multi-determination 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 tolerance 29 to clean and replace the consumable reaction container 6, lamp 14. Accurately determine the deterioration state of the

  Table 1 shows a specific example of the determination operation performed by the multi determination unit 25. In Table 1, 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 tolerance error 29 corresponding to the same wavelength is “100”. Shows the determination result patterns 1 to 4 in the case of.

In the case of judgment result pattern 1:
In the case of this pattern, since the latest measurement value of the water blank absorbance is “8030”, the cell blank measurement value coverage 28 (14000) is satisfied. Furthermore, the difference from the immediately preceding measurement value "8000" measured using the same wavelength for the same reaction vessel 6 is "30" (= 8030-8000), so it is smaller than the previous tolerance 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 container 6 is free from contamination and scratches, and that the lamp 14 is not deteriorated. Therefore, the multi-determination unit 25 instructs (permits) the start of sample measurement to continue to use the corresponding reaction container 6.

In the case of judgment result pattern 2:
In the case of this pattern, since the measurement value of the latest water blank absorbance is “7700”, the cell blank measurement value coverage 28 (14000) is satisfied. On the other hand, the difference from the immediately preceding measurement value “7500” measured using the same wavelength for the same reaction container 6 is “200” (= 7700-7500), which is larger than the previous tolerance error 29. In this case, the multi determining unit 25 determines that the cause of the increase in the water blank absorbance is deterioration of the lamp 14. In this case, the multi determination unit 25 determines that correct measurement can not be performed under the present circumstances, stops sampling of the sample to the reaction container 6 used for measuring the water blank absorbance, and shifts to processing of the next reaction container 6. In addition, the multi-determination unit 25 determines that the life of the lamp 14 is near to expire, and displays an alarm on the screen to prompt the user to replace the lamp 14. When the determination result is continuously generated for the five reaction containers 6, the multi-determination unit 25 stops the sample measurement by the automatic analyzer 100.

In the case of judgment result pattern 3:
In the case of this pattern, the latest water blank absorbance measurement value is "14500", which is larger than the cell blank measurement value coverage 28 (14000). Further, the difference between the same reaction container 6 and the immediately preceding measurement value “13000” measured using the same wavelength is “1500” (= 14500−13000), so it is larger than the previous tolerance 29 (100). In this case, the multi-determination unit 25 determines that the cause of the increase in the water blank absorbance is because the reaction container 6 is contaminated, and instructs the execution of the individual cleaning operation of the relevant reaction container 6. The determination result means that at the same time, the reaction container 6 is not damaged or deteriorated, and the lamp 14 is not deteriorated. In the individual cleaning operation, after a fixed amount of the reagent held in the reagent container mounted on the reagent disc 12 is aspirated by the reagent probe, the reagent is discharged to the reaction container 6 to be cleaned, and the individual cleaning of the reaction container 6 is performed. The action is performed. After completion of the individual cleaning operation, the detergent solution in the reaction vessel 6 is aspirated using the reaction vessel cleaning system 20.

In the case of judgment result pattern 4:
In the case of this pattern, the latest water blank absorbance measurement value is "14650", which is larger than the cell blank measurement value coverage 28 (14000). On the other hand, the difference from the immediately preceding measurement value “14600” measured using the same wavelength for the same reaction vessel 6 is “50” (= 14650-14600), so it is smaller than the previous tolerance 29 (100). However, since the immediately preceding measurement value “14600” is already larger than the cell blank measurement value application range 28 (14000), it is assumed that this reaction vessel 6 has already been cleaned in the immediately preceding measurement. Despite the last wash, no drop in the measured value of the water blank absorbance is seen. As described above, when the measurement value exceeds the cell blank measurement value application range 28 (14000) twice in a row for the same reaction container 6, the multi-judgment unit 25 causes the increase in the water blank absorbance to deteriorate in the reaction container 6. It is determined that there is. In this case, the multi determination unit 25 determines that correct measurement can not be performed under the present circumstances, stops sampling of the sample to the reaction container 6 used for measuring the water blank absorbance, and shifts to processing of the next reaction container 6. Further, the multi-determination unit 25 displays on the screen that the reaction container 6 is excluded from the measurement of the sample due to the abnormality of the measurement value, and an alarm (alarm) that recommends replacement of the reaction container 6.

  FIG. 3 shows a processing matrix to which the multi-determination unit 25 refers at the time of determination. The aforementioned processing patterns 1 to 4 match the contents of these processing matrices.

(4) Outline of Analysis Operation Next, an outline of the analysis operation performed 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. The reaction container cleaning system 20 starts cleaning the reaction container 6 using this operation as a trigger. The automatic analyzer 100 also starts measuring the water blank absorbance. Under the present circumstances, the automatic analyzer 100 irradiates, switching 12 wavelengths selected from the range of 340 [nm]-800 [nm] about each of the reaction container 6 used for the measurement of a sample, and water about all 12 wavelengths Measure blank absorbance. The measured value here is used as a reference value at the time of the subsequent measurement.

  The measurement of water blank absorbance is carried out according to the following procedure. When the measurement of the water blank absorbance is started, the sample cup 1A mounted on the sample disc 1 is moved to the sample sampling position. Similarly, the two reagent disks 12 also rotate and move to the pipetting positions of the reagents, respectively. During this time, multi-determination processing is executed to check whether the reaction container 6 and the amplifier 14 can be used for measurement of the sample. If no abnormality is found in the reaction container 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. Discharge. At the same time, the reagent pipetting mechanism 10 sucks the first reagent for the analysis item A from the reagent container mounted on the reagent disk 12 and discharges it to the reaction container 6 in which the sample for the analysis item A is discharged. Thereafter, the outer and inner walls of the reagent probe used for dispensing are cleaned in the probe cleaning tank to prepare for dispensing of the first reagent for the next analysis item B.

  The reaction disc 9 rotates by half a rotation + 1 reaction vessel in one cycle and is temporarily stopped, so it rotates by one rotation + 2 reaction vessel in two cycle operation. The reaction vessel 6 passes in front of the lamp 14 each time the reaction disc 9 makes one revolution. As the reaction vessel 6 traverses the optical axis of the light emitted from the lamp 14, the water blank absorbance of the reaction vessel 6 is measured. Assuming that the time required for one cycle is 12 seconds, 25 times of photometry are performed during the reaction time of 10 minutes. The reaction container 6 for which the photometry has ended is cleaned by the reaction container cleaning system 20 to prepare for the measurement of the next sample (specimen). The measured water blank absorbance is used for concentration calculation by the computer 3, and the printer 17 outputs an analysis result.

(5) Multi-determination operation The multi-determination operation is performed immediately before dispensing the sample into the reaction container 6. The multi-determination operation is performed twelve times for one reaction container 6. Twelve multi-decision operations are performed for each of 12 different wavelengths selected from the range of 340 [nm] to 800 [nm]. In other words, the multi-determination operation is performed 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-judgment unit 25 and recorded. In the water blank absorbance storage unit 26, the same reaction vessel number as the measurement value of the water blank absorbance of 12 wavelengths measured immediately before for the reaction vessel 6 having the same reaction vessel number and the reaction vessel number used for the measurement The measured values of the water blank absorbance of 12 wavelengths measured most recently for 6 are stored.

  The multi-determination unit 25 performs processing to determine whether the latest measurement value of water blank absorbance is within the cell blank measurement value application range 28 (is smaller than the set value) and the measurement of the immediately preceding measurement measured in the same reaction vessel 6 A process is executed to determine whether the difference between the value and the latest measured value is within the previous tolerance 29 (is smaller than the set value). If the latest measurement value is within the cell blank measurement value application range 28 and the difference between the immediately preceding measurement value and the latest measurement value is within the previous tolerance error 29, the multi-judgment unit 25 The reaction container 6 is in a good condition free from contamination and scratches, and it is determined that the light intensity of the lamp 14 is stable, and the transition to the sampling operation of the sample 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 greater than the previous tolerance 29, the multi-determination unit 25 Since the random fluctuation range is large, it is estimated that the light quantity of the lamp 14 is unstable. That is, the multi-determination unit 25 determines that the lamp 14 is deteriorated, and displays the recommendation to replace the lamp 14 on the CRT screen 18 as an alarm. The corresponding reaction container 6 is not used for measurement of the sample (specimen) (skipping the measurement). Furthermore, in the case where the same determination result continues for five different reaction containers 6 (that is, the same determination result continues five times), the multi-determination unit 25 determines that the deterioration of the lamp 14 is progressing, and the specimen Stop the measurement operation automatically.

  In addition, when the latest measurement value is larger than the cell blank measurement value application range 28 and the difference between the immediately preceding measurement value and the latest measurement value is larger than the previous tolerance error 29, the multi-judgment unit 25 determines that the reaction container It is determined that the contamination of 6 is progressing, and the cleaning processing of the reaction container 6 is executed without dispensing the sample into the corresponding reaction container 6. The cleaning solution used for the cleaning process is held in a reagent container mounted on the reagent disk 12. Therefore, the reagent pipetting mechanism 10 is used to suck a certain amount (for example, 200 μL) of the cleaning solution from the reagent container and discharge it to the reaction container 6 to be cleaned. The dispensed washing solution is kept in the reaction vessel 6 for the same time as the normal analysis time, and is aspirated by the reaction vessel washing system 20 10 minutes after the dispensing.

  In addition, 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 tolerance 29 (water blank of the same reaction vessel 6 If the measured value of the absorbance is out of the range twice in a row), the multi-determination unit 25 determines that the cause of the increase in the measured value is not due to contamination but that the reaction container 6 is being scratched or deteriorated. . In this case, since it is considered that the washing of the reaction container 6 again is not effective, the multi-determination unit 25 displays the recommendation of the replacement of the reaction container 6 on the CRT screen 18 as an alarm. In addition, the said reaction container 6 is not used for the measurement of a test substance. That is, sampling of the sample into the reaction container 6 is skipped.

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

  In addition, when sampling of the sample is skipped for five consecutive cycles for different reaction containers 6, the multi-determination unit 25 determines that scratches and deterioration occur in many of the reaction containers 6, and automatically measures the sample. You may stop it. In addition, when there is no immediately preceding measurement value measured for the same reaction container 6, the multi-judgment unit 25 compares with the cell blank measurement value application range 28 using only the latest measurement value and compares them. Determine the need for cleaning depending on the results.

(6) Specific Example of Multi Determination Operation FIG. 4 shows a specific example of the multi determination operation. In the case of the present embodiment, it is assumed that the multi determination operation shown in FIG. 4 is performed for each wavelength. Therefore, in each determination to be described later, the cell blank measurement value application range set and input for the wavelength to be used and the previous tolerance are used. When the measurement of the sample is started by the computer 3 (multi judgment 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-judgment unit 25) stores the latest measurement value of each reaction container 6 in the water blank absorbance storage unit 26 together with the corresponding measurement value of the immediately preceding cycle (step SP3).

  The computer 3 (multi-determination unit 25) confirms the usage history of the reaction container 6 whose water blank absorbance has been measured, and determines whether it is the first-use reaction container 6 (step SP4). The reaction container 6 in which the immediately preceding measurement value is not stored is the first-use reaction container 6. In the case of the first-use reaction container 6, the computer 3 (multi-determination unit 25) can not compare with the immediately preceding measurement value of the same reaction container 6. 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).

  If an affirmative result is obtained in step SP5 (when the latest measurement value exceeds the cell blank measurement value application range), the computer 3 (multi-judgment unit 25) individually cleans the corresponding reaction container 6 (step SP6). ). If a negative result is obtained in step SP5 (when the latest measurement value is within the cell blank measurement value application range), computer 3 (multi-judgment unit 25) starts sampling of the sample (step SP9), and thereafter , Dispensing of the reagent (step SP10), measurement of water blank absorbance (step SP11), and reporting of the measurement result (step SP12) are sequentially executed. Subsequently, when there is another measurement sample (positive result in step SP13), the computer 3 (multi-judgment 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 measurement operation of the sample by the automatic analyzer 100 (step SP14).

  When a negative result is obtained in step SP4 (when not being used for the first time), the computer 3 (multi judgment unit 25) judges whether the measured value of water blank absorbance is smaller than the cell blank measured value application range 28 ( Step SP7). If a positive result is obtained in step SP7 (if it is within the applicable range), the computer 3 (multi-determination unit 25) determines that the difference between the latest measured value and the immediately preceding measured value is smaller than the previous tolerance 29 It is determined whether or not (step SP8). If a positive result is obtained in step SP8 (if the difference is within the previous tolerance), the computer 3 (multi judgment unit 25) judges that there is no problem in the reaction container 6 and the lamp 14, and Sampling is started (step SP9). Thereafter, the computer 3 (multi-determination unit 25) sequentially executes dispensing of the reagent (step SP10), measurement of absorbance (step SP11), and report of the measurement result (step SP12). Then, when there is still another measurement sample (step SP13), the computer 3 (multi-judgment unit 25) returns to step SP2.

  If a negative result is obtained in step SP8 (if the difference exceeds the previous tolerance), the computer 3 (multi-judgment unit 25) generates a random fluctuation in absorbance change (the lamp is deteriorated) And "deterioration of the lamp" is displayed on the alarm screen (step SP15). Furthermore, the computer 3 (multi-determination unit 25) stops sampling of the sample into the reaction container 6 (step SP16). Subsequently, the computer 3 (multi determination unit 25) determines whether or not the alarm caused by the deterioration of the lamp is continuously output for five different reaction containers 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 measurement operation of the sample 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-judgment unit 25) calculates the latest measurement value and the immediately preceding measurement value. It is determined whether or not the difference between the two is smaller than the previous tolerance 29 (step SP18). If a negative result is obtained in step SP18 (if the difference is larger than the previous tolerance), the computer 3 (multi-judgment unit 25) judges that the reaction container 6 is dirty and instructs to stop sampling of the sample ( Step SP19) After that, the individual cleaning of the reaction container 6 is instructed (step SP20).

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

  If an affirmative result is obtained in step SP18, the computer 3 (multi-judgment unit 25) judges that cleaning of the reaction container 6 is not effective (determines that the exchange of the reaction container 6 is necessary), and the reaction container The sampling of the sample (specimen) for step 6 is stopped (step SP22). After this, the computer 3 (multi-judgment unit 25) displays a warning of “requirement of replacement of reaction container” on the alarm screen (step SP23), and thereafter returns to step SP2 when “YES” via step SP13. .

(7) Effects Realized by the Embodiment According to the above-described automatic analyzer 100, the variation factor of the measured value of the water blank absorbance may be caused by the fouling of the reaction container 6, or the flaw of the surface of the reaction container 6 It is possible to automatically determine whether the cause is due to the end of the life of the lamp 14. For this reason, in the automatic analyzer 100, it is not necessary to clean the reaction container 6 as a part of the maintenance function as in the current device. That is, in the automatic analyzer 100, the individual cleaning may be performed only for the reaction container 6 that needs contamination, and it is not necessary to completely stop the measurement operation of the sample as in the current device.

  Further, in the automatic analyzer 100, since it is not necessary to clean all reaction containers including the reaction container in which the contamination has not progressed as in the current device, the cleaning time can be shortened. Furthermore, in the automatic analyzer 100, since unnecessary consumption of detergent is eliminated, a cost reduction effect is also expected. Moreover, the cleaning of the reaction vessel 6 in the automatic analyzer 100 can be performed in parallel with the measurement operation of the sample using the other reaction vessel 6 (within one cycle time). That is, since the reaction container 6 can be cleaned without stopping the measurement operation of the sample, continuous operation of the automatic analyzer 100 for 24 hours becomes possible.

  In addition, in the current device, a function to skip the measurement of the sample using the reaction container 6 when the measurement value of the water blank absorbance is disturbed before the measurement of the sample is installed. As in the case of the automatic analyzer 100 according to the present invention, the separate execution function of the cleaning operation is not installed, and it is not possible to determine the replacement of the reaction vessel 6 or the lamp 14. Thus, the automatic analysis device 100 can realize technical effects that can not be realized by the current device.

  Moreover, in the present apparatus, the confirmation of the reaction container 6 having abnormality is performed using only the latest measurement value of each reaction container, while in the automatic analyzer 100, the measurement value of the immediately preceding measurement is used. An approach is adopted that includes storing both latest measurements and comparing the difference between these two measurements. By adopting this method, the automatic analyzer 100 can distinguish 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 container 6 without stopping the operation of the device by the maintenance function (that is, while the measurement of the sample is continued). .

  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, the dedicated detergent held in one of the reagent containers installed in the reagent disc 12 is a reagent probe The solution is dispensed into the corresponding reaction vessel 6 using the above, and only the reaction vessel 6 is separately washed. In general, the accumulation of scratches and dirt adhering to the surface of the reaction container 6 and the deterioration of the reaction container 6 differ depending on the reagent used and the use condition of the user. In addition, the deterioration speed of the lamp 14 depends on the accumulated power on time of the automatic analyzer 100. For this reason, although the time of replacement of the reaction vessel 6 and the time of replacement of the lamp 14 are different for each user, the automatic analyzer 100 does not have a uniform cycle determined by the manufacturer but the replacement time according to usage conditions and circumstances. It is possible to accurately determine and communicate the necessity to the user.

(8) Other Embodiments The present invention is not limited to the embodiments described above, but includes various modifications. For example, the embodiment described above is described in detail in order to explain the present invention in an easy-to-understand manner, and it is not necessary to necessarily include all the configurations described. For example, part of the configuration of another embodiment may be added, deleted or replaced.

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

  In the embodiment described above, the process shown in FIG. 4 has been described as being repeatedly executed for each of the 12 wavelengths, but the measurement of the water blank absorbance corresponding to each of the 12 wavelengths is performed in step SP2 Step SP5, SP7, SP8, SP18 perform determination using the immediately preceding measurement value and the latest measurement value corresponding to each wavelength, and the condition for the water blank absorbance corresponding to at least one wavelength If the conditions are not satisfied, it may be determined that the conditions of steps SP5, SP7, SP8 and SP18 are not satisfied.

  Further, each configuration, function, processing unit, processing means, etc. described above may be realized by hardware, for example, by designing part or all of them with an integrated circuit. Further, each configuration, function, and the like described above may be realized by the processor interpreting and executing a program that realizes each function (that is, software). Information such as a program, a table, and a file that implements each function can be stored in a memory, a hard disk, a storage device such as a solid state drive (SSD), or a storage medium such as an IC card, an SD card, or a DVD. Further, the control lines and the information lines indicate what is considered to be necessary for the description, and do not represent all the control lines and the information lines necessary for the product. In practice, it can be considered that almost all configurations are mutually connected.

1 ... sample disc 1A ... sample cup (reaction vessel)
2 ... sample bar code reader 3 ... computer 4 ... interface 5 ... sampling mechanism 6 ... reaction vessel 7 ... sample pump 8 ... motor 9 ... reaction disc 10 ... reagent probe 11 ... reagent pump 12 ... reagent disc 13 ... stirring mechanism 14 ... lamp 15 ... photometric unit 16 ... keyboard 17 ... printer 18 ... CRT screen 19 ... reagent bar code reader 20 ... reaction container washing tank system 21 ... multiplexer 22 ... FD drive 23 ... HD drive 25 ... multi judgment unit 26 ... water blank absorbance Storage unit 27 ... Analysis parameter input unit 28 ... Cell blank measurement value application range 29 ... Previous tolerance

Claims (11)

A sample probe for dispensing a sample into a reaction container;
A reagent probe for dispensing a reagent into the reaction container;
A sample disc for establishing a container for holding the sample;
A reaction disk for setting up the reaction container;
A reagent disc for establishing a container for holding the reagent;
A photometry unit having a lamp and a light receiving unit and measuring the water blank absorbance of the reaction container;
A first storage unit that stores, for each of the reaction containers, a combination of immediately preceding measurement value and latest measurement value of water blank absorbance measured using the same reaction container;
A second storage unit that stores a first threshold value for the latest measurement value and a second threshold value for the difference between the previous measurement value and the latest measurement value;
A multi determination unit that determines the state of the reaction container and the state of the lamp based on the immediately preceding measurement value and the latest measurement value stored for the same reaction container;
The multi judgment unit
When the latest measurement value is smaller than the first threshold and the difference is smaller than the second threshold, both the reaction container and the lamp are determined to be normal.
When the latest measured value is smaller than the first threshold and the difference is larger than the second threshold, it is determined that the lamp is deteriorated.
When the latest measurement value is larger than the first threshold and the difference is larger than the second threshold, it is determined that the reaction container should be cleaned.
It is determined that the reaction container should be replaced when the latest measurement value is larger than the first threshold and the difference is smaller than the second threshold. In the automatic analyzer according to claim 1,
The multi judgment unit
An automatic analyzer characterized in that the reaction container determined to require cleaning is excluded as a sample dispensing target and designated as a cleaning target. In the automatic analyzer according to claim 2,
The multi judgment unit
Aspirating the detergent from one of the containers mounted on the reagent disc using the reagent probe, and then dispensing the aspirated detergent to the reaction container determined to require cleaning. Automatic analyzer featuring. In the automatic analyzer according to claim 1,
The multi judgment unit
An automatic analyzer characterized in that the reaction container determined to be replaced is excluded from sample dispensing targets and designated as a replacement target. In the automatic analyzer according to claim 1,
The multi judgment unit
An automatic analyzer characterized by automatically stopping an operation of measuring a sample in progress when it is determined that the same reaction container needs to be washed a predetermined number of times continuously. In the automatic analyzer according to claim 1,
The multi judgment unit
An automatic analyzer characterized by automatically stopping an operation of measuring a sample being executed when the number of times of determination that cleaning of the same reaction container is required reaches a predetermined number of times. In the automatic analyzer according to claim 1,
The multi judgment unit
An automatic analyzer characterized by automatically stopping an operation of measuring a sample in progress when it is determined that washing is required a predetermined number of times continuously for different reaction containers. In the automatic analyzer according to claim 1,
The multi judgment unit
An automatic analyzer characterized by automatically stopping an operation of measuring a sample in progress when it is determined that the lamp needs to be replaced a predetermined number of times in succession. In the automatic analyzer according to claim 1,
In the second storage unit, one set of the first threshold and the second threshold are stored for each of a plurality of wavelengths of measurement light used for measuring the water blank absorbance. Automatic analyzer featuring. In the automatic analyzer according to claim 1,
An automatic analyzer characterized by further comprising an analysis parameter input unit for individually inputting the first threshold and the second threshold. In the automatic analyzer according to claim 1,
The multi judgment unit
If it is determined that the reaction container needs to be cleaned, if it is determined that the reaction container needs to be replaced, or if it is determined that the lamp needs to be replaced, that effect is displayed on the operation screen. An automatic analyzer characterized by displaying.

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