JP4966879B2 - Automatic analyzer - Google Patents

Description

  The present invention relates to an automatic analyzer, and in particular, it is possible to analyze the concentration or activity value of a target component in a sample containing multiple components such as blood and urine using an independent reagent for each component. The present invention relates to an automatic biochemical analyzer in which a part or all of each part for carrying, stirring, and measuring a sample and a reaction solution during measurement is shared.

  Analysis of a specific component contained in a sample can be performed by using a reagent that specifically reacts with the target component. In the biochemical automatic analyzer, it is possible to measure a plurality of analysis items simultaneously or in parallel using these different reagents. However, in an automatic analyzer that shares a mechanism for separating samples and reagents, a container for reacting the sample and reagent, a mechanism for stirring the sample and reagent, etc. Since the injection machine, stirring mechanism, and reaction container are washed and used repeatedly, contamination that occurs between each sample, reaction solution, and reagent may cause an unintended reaction, resulting in errors in measurement results. .

In the sample dispensing mechanism, the carry-over of the sample attached to the inner and outer walls of the sample dispensing probe may affect the sample to be sampled next. For example, samples with different concentrations such as serum and urine were continuously measured. In some cases, when a low concentration sample is measured after a high concentration sample, an error may be given to the measured value.
In the reagent dispensing mechanism and the stirring mechanism, the carryover of the reagent components attached to the inner and outer walls of the reagent dispensing probe and the stirring bowl may affect the data of the item to be dispensed or stirred next. For example, if the reagent component of the analysis item A contains a substance (reaction suppression, promotion) involved in the reaction of the analysis item B, and the analysis item A and the analysis item B are continuously measured, When the reagent is contaminated with the reagent of the analysis item B, the reaction of the analysis item A may proceed simultaneously during the reaction of the analysis item B, which may cause an error in the measurement result.
In a reaction container, carry-over of reagent components and reaction liquid (reaction product) attached to the reaction container may affect the data of items to be dispensed into the reaction container next time. Depending on the reagent, dirt may remain in the reaction container and cause contamination, so there is currently a reaction container cleaning mechanism that prevents contamination by the cleaning mechanism automatically discharging detergent and then repeatedly washing with purified water. It has become mainstream in chemical automatic analyzers. For example, the detergent use method does not use the set detergent stock solution, but a large amount of the reaction container must be cleaned and space-saving is achieved. A method of discharging into a reaction vessel while automatically diluting within a concentration range is adopted.

Each time a user introduces a new device, adds a new measurement item, or changes a prescription, the user investigates whether there is an influence of contamination and uses a measurement method that does not cause contamination. Settings are being implemented. For example, in order to prevent the analysis item B from being measured immediately after the analysis item A, it is set to measure the analysis item C between the measurement of both items, or as a function of the biochemical automatic analyzer in advance. By registering a combination of analysis items that cause contamination, the user can change the analysis order to avoid it, or devise measures to prevent the occurrence of contamination (for example, a cleaning function using water or detergent) A method for avoiding the occurrence of contamination is employed.
In order to avoid such problems, it is important to clean the sample dispensing mechanism, reagent dispensing mechanism, stirring mechanism, and reaction vessel that are repeatedly washed and used. Since the carry-over amount varies greatly depending on the amount of cleaning water for cleaning the part, the concentration and position of the detergent, there may be an error in the measurement result due to contamination that does not occur in a normal state.
Therefore, Patent Document 1 discloses an apparatus that allows anyone to easily investigate the influence of contamination. In Patent Document 1, the result of the contamination influence investigation is stored, the newly measured investigation result is compared with the investigation result measured in the past, and the occurrence of contamination is suppressed when the investigation results are different. By notifying the user that a malfunction has occurred in the function, the apparatus state can be monitored.
JP 2002-181829 A

If the biochemical automatic analyzer is used for a long period of time, the function to suppress the occurrence of contamination cannot be fully achieved due to state changes such as accumulation of dirt or malfunction of the device. In some cases, the measurement result may cause an error due to contamination that does not occur.
At present, it is necessary to grasp the change in the state of the apparatus by checking the apparatus carried out by the user or finding a defect in the measurement data, and the reliability of the measurement result depends on the ability of the user. In particular, when the problem progresses gradually, there is a risk that the user does not notice the abnormality of the apparatus and an erroneous measurement result is adopted.
In addition, even if the user notices that there is an abnormality in the measurement result, the unit that is the source of contamination, such as the sample dispensing mechanism, reagent dispensing mechanism, stirring mechanism, or reaction vessel cleaning mechanism, is the cause. If the user cannot take countermeasures, the service will respond.However, before receiving a response from the user and taking countermeasures, preparation of the possible unit parts and investigation of the cause of the possible causes must be conducted. It was necessary to check the street, and it took time to take measures.
In the case of poor cleaning of the reaction container cleaning mechanism, it is necessary to determine whether the cleaning mechanism discharges the purified water or the detergent discharge poorly, and measure the concentration of the detergent discharged into the reaction container. If it is possible, it can be easily confirmed that the prescribed amount of detergent is discharged.

The object of the present invention is to determine the presence / absence of contamination for each unit that is the source of contamination, with respect to the contamination threshold that does not occur under normal conditions set in advance and the detergent concentration threshold of the reaction vessel cleaning mechanism. If the concentration of the detergent in the reaction vessel cleaning mechanism is measured and it is determined that there is an abnormality, the unit status can be changed by notifying the user that the unit has a malfunction in the function to suppress the occurrence of contamination. To provide an automatic analyzer that can monitor and prevent occurrence of measurement errors and can identify the cause and reduce the investigation and countermeasure time.
In Patent Document 1, there is only a means for confirming the presence or absence of cross-contamination in a routine. In the present invention, the problem of the cleaning mechanism is confirmed by confirming the presence or absence of cross-contamination for each cleaning mechanism and the detergent concentration of the reaction container cleaning mechanism. The major difference is that it can be identified.

The present invention includes a sample dispensing mechanism that dispenses a sample into a reaction container, a reagent dispensing mechanism that dispenses a reagent into a reaction container into which the sample has been dispensed, and a reaction solution in the reaction container that is stirred by a stirring mechanism, In an automatic analyzer comprising an absorptiometer for measuring absorbance, and a cleaning unit for cleaning each unit of the sample dispensing mechanism, the reagent dispensing mechanism, the stirring mechanism, and the reaction vessel, 1 or by perform cleaning of the unit, and have a means for confirming unit cleaning results, when dispensed different samples divided from each other in the same sample injection mechanism, cross-contamination by carry-over between those samples Judgment of the presence or absence of cross-contamination that occurs when different reagents are dispensed by the same reagent injection mechanism. In addition, the presence or absence of cross-contamination due to carryover of the reaction solution is determined, and the detergent concentration of the cleaning mechanism used for the reaction vessel cleaning is measured. A cleaning condition determination function for the cleaning means for displaying to the user when the threshold value is equal to or greater than a preset threshold value is provided, and in the presence / absence determination of the cross contamination, a combination of items set for each unit of the cleaning means Each time, two data of the measurement result on the side affected by the affected item and the measurement result on the side not affected by the affected item are extracted, and the absolute value of the difference between the two data is extracted for the extracted data. If it is smaller than the predetermined threshold, it is determined that there is no contamination, and if it is greater than the predetermined threshold, contamination is determined. An automatic analyzer for alarm output to down there with the determined display screen.

Further, the present invention provides a cleaning unit that registers measurement intervals in advance, and automatically performs the determination of the presence or absence of each contamination or the determination of the appropriate concentration of detergent of the cleaning unit at the measurement intervals registered during normal sample measurement. an automatic analyzer Ru comprising a cleaning condition automatic determination function.

In the present invention, the reagent injection mechanism includes first and second reagent dispensing mechanisms, and first and second stirring mechanisms corresponding to the first and second reagent dispensing mechanisms, respectively, and the washing The condition determination function includes (1) the absolute value obtained by dispensing and stirring the reagent by the first and second reagent dispensing mechanisms and the first and second stirring mechanisms, and (2) the second 1. The second reagent dispensing mechanism and the first stirring mechanism perform reagent dispensing and stirring, and the second stirring mechanism does not perform stirring, and the absolute value obtained, (3) the first Reagent dispensing and agitation are performed by the reagent dispensing mechanism and the first stirring mechanism, system water is dispensed by the second reagent dispensing mechanism, and stirring is performed by the second stirring mechanism. (4) The reagent was dispensed by the first reagent dispensing mechanism. The system reagent is dispensed by the second reagent dispensing mechanism, the agitation is carried out by the first and second agitating mechanisms, and the obtained absolute values, the absolute values of the above (1) to (4), are obtained. all or part, the first, second reagent dispensing system, the first is an automatic analyzer to determine whether the cause cleaning failure in any mechanism of the second stirring mechanism.

  According to the present invention, in order to grasp the cleaning state of each unit of the sample dispensing mechanism, the reagent dispensing mechanism, the stirring mechanism, and the reaction container cleaning mechanism, which are repeatedly washed and used in the biochemical automatic analyzer, it is set in advance. The contamination threshold that does not occur under normal conditions is determined for each unit that is the source of contamination, and the detergent concentration of the cleaning mechanism is measured. By notifying the user that the function for suppressing the occurrence of contamination in any unit has been reported to the user, the device status can be monitored, and measurement errors can be prevented from occurring regardless of differences in the user's knowledge and technical capabilities. Realize an automated biochemical analyzer that can identify the cause and reduce investigation and countermeasure time. It can be.

The best mode for carrying out the present invention will be described.
The outline of the present invention is configured as follows.
(1) A sample dispensing mechanism for dispensing a sample into a reaction vessel, a reagent dispensing mechanism for dispensing a reagent into a reaction vessel into which a sample has been dispensed, and a reaction solution in the reaction vessel after being stirred by a stirring mechanism, followed by absorbance In an automatic analyzer equipped with an absorptiometer that measures the amount of water and at least a sample dispensing mechanism, a reagent dispensing mechanism, a stirring mechanism, and a washing means for washing each reaction vessel, different samples are dispensed by the same sample dispensing mechanism (A) When cross-contamination due to carry-over between these samples is performed, (b) When different reagents are dispensed by the same reagent dispensing mechanism, (C) When different samples / reagents are dispensed in the same reaction vessel, cross contamination due to carryover of those reaction solutions (D) measure the detergent concentration of the cleaning mechanism used for washing the reaction vessel, and if the results of each of the results yield a result that exceeds a preset threshold value, It has a function to display to the user that a failure has occurred in the cleaning function for suppressing the occurrence of contamination in any unit.
(2) Preferably, in (1) above, whether or not there is cross-contamination between the sample dispensing mechanisms, between the reagent dispensing mechanism and the stirring mechanism, and between the reaction container cleaning mechanisms, and determination of the appropriate concentration of the detergent in the cleaning mechanism It has a function that can set and implement whether or not to implement each unit freely.
(3) Preferably, in the above (1) and (2), determination of presence / absence of cross-contamination and cleaning between the sample dispensing mechanisms, between the reagent dispensing mechanism and the stirring mechanism, and between the reaction container cleaning mechanisms. In order to determine the appropriate detergent concentration of the mechanism, it is provided with a function for inputting an item for determining the presence or absence of contamination of each unit, an item for determining the appropriate detergent concentration, and a threshold value as a determination criterion.
(4) Preferably, in the above (1), (2) or (3), if the measurement interval is registered in advance, it is automatically determined whether or not each unit is contaminated or the detergent has a proper concentration for the cleaning mechanism. A function for performing the determination is provided.
Embodiments of an automatic analyzer according to the present invention will be described below with reference to the drawings.

  A biochemical automatic analyzer according to a first embodiment of the present invention will be described with reference to FIG. First, the whole comprises an analysis unit 123 and a control unit 124. The analysis unit 123 holds a plurality of sample containers, holds a sample disk 115 as a sample moving device that moves the sample containers so as to be positioned at the sample suction position, and holds a plurality of reagent containers according to analysis items, respectively. Reagent disks 106 and 107 as reagent moving devices that move so as to position the reagent container at the reagent aspirating position, reaction container 101 for reacting the sample and the reagent, and a plurality of reaction containers 101 are arranged in a ring shape and function as a reaction line Reaction disk 125, sample dispensing mechanism 116 having sample probe 131 for collecting a predetermined amount of sample in reaction vessel 101, sample probe washing tank 126 for washing sample probe 131 after sample dispensing, and dispensing reagent in reaction vessel 101 Reagent dispensing mechanisms 104 and 105 having reagent probes 128 and 129 for collecting a predetermined amount in each, and reagents Reagent probe washing tanks 126 and 132 for washing the reagent probes 128 and 129 after the injection, the stirring mechanisms 103 and 111 for stirring and mixing the sample dispensed with the reagent, and the stirring mechanisms 103 and 111 after mixing the reaction liquid Stirring mechanism washing tanks 127 and 130 for performing the reaction, a multi-wavelength photometer 117 for measuring the absorbance of the reaction solution in the reaction vessel 101, and a reaction vessel washing mechanism provided along the reaction disk 125 for washing the reaction vessel 101 102. The control unit 119 performs operation control of each mechanical system and screen display control.

  The reaction disk 125 is controlled so as to repeat the operation of rotating and stopping the reaction container row by a predetermined number of reaction containers every cycle. The multi-wavelength photometer 117 has a plurality of detectors at the wavelength positions to be detected, and detects light transmitted through the reaction container contents when the reaction disk 125 is in a rotating state.

  Electrolyte measurement is performed using standard solution reagent container 112, diluent reagent container 113, comparative electrode solution reagent container 114, electrolyte dispensing mechanism 110 for dispensing an electrolyte measurement reagent, reaction container 101 from diluted sample, standard. It comprises a sipper mechanism 109 for sucking liquid and an electrolyte measuring unit 108 for performing electrolyte analysis.

  Next, an example of the sample analysis operation at the time of colorimetric analysis measurement in the automatic analyzer of the present embodiment will be described. When the start switch for starting the analysis operation in the interface 118 is pressed, the reaction vessel 101 starts washing the reaction vessel 101 and further measures the water blank. The measured value of the water blank serves as a reference for the absorbance measured thereafter in the reaction vessel 101. When the washed reaction container advances to the sample dispensing position 301 by repeating the operation of the reaction disk 125 for one cycle, that is, the operation of temporarily stopping by moving a certain distance, the sample container moves to the sample dispensing position 301. At the same time, the two reagent disks 106 and 107 move so that the reagent of the corresponding analysis item is positioned at the reagent suction position. Next, the sample dispensing mechanism 116 operates to suck the sample from the sample container, and then discharge a predetermined amount of the sample to the reaction container 101. Then, the sample probe 131 is washed in the sample probe washing tank 125, and the next Prepare for sample dispensing. On the other hand, the reagent dispensing mechanism 104 starts operation and sucks the reagent installed on the reagent disk 106.

  Next, the reagent dispensing mechanism 104 moves to the corresponding reaction vessel 101 on the reaction disk 125 and discharges a predetermined amount of the reagent that has been sucked and held, and then the reagent probe 129 is washed in the reagent probe washing tank 126. To prepare for the next reagent dispensing. After the reagent dispensing by the reagent dispensing mechanism 104, the measurement by the multiwavelength photometer 117 is started. Photometry is performed when the reaction vessel 101 crosses the light beam while the reaction disk 125 is rotating. After the reagent is added, the reaction vessel 101 moves to the stirring position 303, and the stirring mechanism 103 operates to stir the sample and the reagent. After the stirring, the stirring mechanism 103 is cleaned in the stirring mechanism cleaning tank 130 to prepare for the next stirring. Next, a reagent is added to the reaction vessel 101 by the reagent pipetting mechanism 105, and the reagent probe 128 is washed in the reagent probe washing tank 132 to prepare for the next reagent dispensing. Thereafter, the mixed solution is stirred by the stirring mechanism 111. After completion of the stirring, the stirring mechanism 111 is cleaned in the stirring mechanism cleaning tank 127 to prepare for the next stirring. As the reaction disk 125 rotates, the reaction vessel 101 crosses the light beam one after another, and the absorbance of each reaction solution is measured each time. After completion of the measurement, the reaction vessel 101 is washed by the reaction vessel washing mechanism 102 to prepare for the next sample measurement. The concentration or enzyme activity value is converted from the measured absorbance, and the analysis result is displayed on the display unit 122.

  Next, an example of the sample analysis operation at the time of electrolyte measurement in the automatic analyzer of the present embodiment will be described. As in the case of the colorimetric measurement, after the sample is discharged into the reaction vessel 101, the diluent is sucked from the diluent reagent container 113 by the electrolyte pipetting mechanism 110, and at the diluent discharge position 302 of the reaction vessel 101. Dispense the diluent into the reaction vessel into which the sample has been dispensed. Subsequently, the mixture is agitated and mixed by the agitation mechanism 103 when it moves to the agitation position 303. Thereafter, the reaction container moves to the diluted sample suction position 304, and the sipper mechanism 109 faces the reaction container, sucks the diluted sample to the electrolyte measurement unit 108, and measures the potential level.

  The control system includes a control unit 119, an input unit 120 for inputting information, an information storage unit 121 for storing the information, and a display unit 122 for displaying measurement data, and a colorimetric analysis unit and an electrolyte via an interface 118. Controls the analysis unit.

  FIG. 2 is a diagram illustrating an example of a processing flow for investigating the presence or absence of contamination in the cleaning mechanism condition automatic determination function in the biochemical analyzer of the present embodiment. In FIG. 2, first, an item for determining the presence / absence of contamination (step 202) and a threshold value as a determination criterion (step 203) for each cleaning mechanism (step 201) for which the cleaning condition is to be confirmed from the input / output unit of the biochemical analyzer. ). Next, the unit of the cleaning mechanism whose condition is to be confirmed is selected (step 204), and the measurement is executed (step 205). The measurement sequence varies depending on the cleaning mechanism to be confirmed. The cleaning condition confirmation of the sample dispensing mechanism is confirmed by, for example, the sequence shown in FIG. 14, and the cleaning condition of the reagent dispensing mechanism / stirring mechanism is, for example, the sequence shown in FIG. The cleaning condition of the reaction vessel cleaning mechanism is measured according to the sequence shown in FIG. 5, for example. The operation sequence for confirming each cleaning mechanism is measured sequentially for each selected unit. The obtained measurement result (step 206) is checked for the presence or absence of contamination (step 207). If it is determined that there is contamination, an alarm is displayed (step 208) to notify the user.

In the presence / absence determination of contamination (step 207), two data are extracted for each item combination set for each unit of the cleaning mechanism.
Data 1: Measurement results on the affected side of the affected item Data 2: Measurement results on the unaffected side of the affected item Determine whether the following formula is satisfied for the extracted data | (Data 1 )-(Data 2) | <threshold value ... judgment formula (1)

  If the determination formula (1) is satisfied, it is determined that there is no contamination, and if it is not satisfied, it is determined that there is contamination and an alarm is displayed.

  Even when the cleaning condition is not investigated, if a measurement interval is set in advance for each cleaning mechanism of each mechanism, the measurement is automatically performed. For example, in the case of an apparatus that can always mount a contamination determination sample, the measurement interval is registered in advance on the parameter setting screen of FIG. 9 to measure at the interval registered during normal sample measurement. In the case of a device that cannot always be installed, a dedicated sample installation rack or the like is used, and measurement is performed at an arbitrary interval during normal sample measurement.

  When measurement is performed, the presence / absence of contamination is determined in the same manner as described above. If it is determined that there is contamination, an alarm is output on the alarm display screen shown in FIG. 13 that a problem has occurred in the corresponding cleaning mechanism. Therefore, the user does not need to monitor the device under measurement, and can prevent the occurrence of measurement error due to the user's check omission.

Next, in the biochemical automatic analyzer described above, an operation / operation example of the cleaning mechanism condition automatic determination function will be described.
The display unit 122 switches to a screen for conducting a check investigation of each cleaning mechanism condition. FIG. 6 is a view showing an example of a cleaning mechanism condition confirmation / execution screen. This screen allows you to select which cleaning function condition to check. If you want to check all cleaning mechanisms, enable all check marks, and select each cleaning mechanism you want to execute from the selection screen and combine them freely. You can also. For example, when it is desired to check the cleaning condition of the reaction container cleaning mechanism and the detergent concentration of the reaction container cleaning mechanism, the check marks of two items of the reaction container mechanism cleaning confirmation and the detergent concentration confirmation are validated. In order to confirm the measurement result, when the measurement result key corresponding to each cleaning mechanism is selected, FIG. 7 or FIG. 8 is displayed as an example of the result screen. By selecting the parameter setting key, the screen transitions to FIG. 9, which is an example of a condition input screen for each cleaning mechanism. The measurement is performed, for example, by selecting and executing a cleaning mechanism condition confirmation key from the maintenance screen of FIG. Alternatively, it may be possible to measure as a maintenance operation in combination with other maintenance items as one of the maintenance items.

  FIG. 9 is a diagram showing an example of a condition input screen for each cleaning mechanism. This input screen displays input information necessary for investigating the influence of cleaning conditions. The user selects an affected item and an affected item for detecting contamination suitable for each cleaning mechanism, and inputs a sample installation position at the time of measurement. Next, a threshold value for determining the presence or absence of contamination is input. When automatically confirming the cleaning condition, an interval time or the number of interval measurement items is input as a measurement interval, and measurement is performed when the interval time and the number of measurement items have elapsed since the previous measurement. In addition, regarding the detergent concentration confirmation of the washing mechanism for washing the reaction vessel, the lower limit and upper limit values of the concentration and the detergent concentration of the washing mechanism are used to confirm whether the concentration is a measurement item and an appropriate concentration. To automatically confirm the confirmation, the interval time or the number of interval measurement items is input as the measurement interval.

  First, the confirmation sequence of the sample cleaning mechanism condition will be described. FIG. 14 shows an example of a confirmation sequence of the sample cleaning mechanism condition. Sequence No. For example, a sample affecting the sample disk position 1 (hereinafter referred to as a Pos sample) is set as 1. The sample to be affected next (hereinafter referred to as Neg sample) may show an abnormal value due to the diffusion of the sample adhering to the outer wall of the sample probe. Therefore, in order to avoid measurement error, A sample cup containing a Neg sample is set in the apparatus. Here, for example, the sequence No. Samples affected by sample disk positions 2 to 4 are set in 2 to 4.

  The sample dispensing sequence is dispensed in the order of Pos → Neg1 → Neg2 → Neg3. For example, LDH highly active serum is used as the Pos sample, physiological saline is used as the Neg sample, and the measurement item is measured using the LDH item. By doing this, if the sample dispensing mechanism after dispensing LDH highly active serum cannot be washed normally as a Pos sample, LDH highly active serum is mixed in the physiological saline of the Neg sample to be dispensed next. A result appears that physiological saline that should not react as LDH reacts as a positive error. Alternatively, a dye may be substituted for the purpose of reducing the cost as a sample. For example, pooled serum containing Orange G equivalent to 3000 Abs as a Pos sample, physiological saline as a Neg sample, and measurement items may be substituted by preparing and confirming items containing a diluent such as physiological saline as a reagent. . Here, the presence or absence of contamination is determined according to the above-described determination formula (1), sample data 1-1 immediately after Pos sample dispensing (data 1 of determination formula 1) and unaffected sample data 2-1 (determination) The cleaning condition of the sample mechanism can be confirmed by comparing the difference of the data 2) of Formula 1 with a threshold value at a level where no contamination occurs in a normal state set in advance.

  If there is any abnormality in the sample cleaning mechanism, the difference becomes larger than the threshold value, and an alarm is generated on the alarm screen shown in FIG. 13 to notify the user. At this time, the alarm makes it possible to immediately know the name of the cleaning mechanism such as an abnormality in the sample dispensing cleaning mechanism.

  Next, the confirmation sequence of the cleaning condition of the reagent mechanism and the stirring mechanism will be described. FIG. 4 shows an example of a cleaning condition confirmation sequence of the reagent mechanism and the stirring mechanism. When the normal mode is selected in the reagent mechanism / stirring mechanism cleaning confirmation on the parameter setting screen of FIG. 9, only the normal range of FIG. 4 is measured. Set the sample at one position of the sample disk set on the parameter setting screen. If the affected item is the Pos item and the affected item is the Neg item, the reagent is dispensed by the reagent dispensing mechanism in the order of Pos item → Neg item 1 → Neg item 2 → Neg item 3 and immediately after that. The reaction solution is stirred by the stirring mechanism. For example, physiological saline is used as a sample, and a phosphate buffer (PHOSE) item containing high-concentration phosphorus is selected as a two-agent reagent as a Pos item. An inorganic phosphorus (IP) item is selected as a two-reagent reagent as the Neg item. PHOSE item 1st reagent and 2nd reagent contain high-concentration phosphate buffer of the same concentration. Effect and washing of reagent dispensing mechanism between PHOSE item → IP item dispensing during first reagent dispensing Each effect of mechanism washing will be confirmed in a stacked state, and the effects of washing the reagent dispensing mechanism between the PHOSE item and IP item dispensing during the second reagent dispensing and the stirring mechanism washing were further accumulated. Since it is confirmed by the state, it can be confirmed in a state where the influence of the contamination for a total of four times is repeated, so that the cleaning condition of the reagent mechanism and the stirring mechanism under severe conditions can be confirmed. The item to be used may be replaced with a dye for the purpose of reducing the cost. For example, the sample may be replaced by using physiological saline, using physiological saline containing orange G equivalent to 3000 Abs as the Pos item, and using physiological saline as the Neg item. Here, the presence or absence of contamination is determined according to the above-described determination formula (1), reagent data 1-1 immediately after Pos dispensing (data 1 of determination formula 1) and unaffected reagent data 2-1 (determination) The cleaning condition of the reagent mechanism / stirring mechanism can be confirmed by comparing the difference of the data 2) of Formula 1 with a threshold value at a level where no contamination occurs in a normal state set in advance.

  The confirmation of the cleaning condition is performed based on the determination flowchart in the normal mode shown in FIG. If there is any abnormality in the cleaning mechanism, the difference becomes larger than the threshold (step 1001), and an alarm is generated on the alarm screen shown in FIG. 13 to notify the user (step 1002). At this time, the alarm makes it easy to identify the name of the cleaning mechanism such as an abnormality in cleaning the reagent dispensing mechanism / stirring mechanism.

  However, it is not clear which abnormality occurred in the washing mechanism during the first reagent dispensing / stirring or during the second reagent dispensing / stirring. Therefore, if the detailed mode is selected in the reagent mechanism / stirring mechanism cleaning confirmation on the parameter setting screen of FIG. 9, the entire operation sequence of FIG. 4 is measured. The measurement consumes more time and reagents than in the normal mode, but the cause can be determined and determined. Sequence No. At the time of dispensing the PHOSE item 1, the first reagent dispensing / stirring and the second reagent dispensing / stirring are performed as usual. Sequence No. When dispensing the PHOSE item reagent No. 5, the first reagent is dispensed and stirred as usual, and when the second reagent is dispensed, the reagent is dispensed normally but not stirred. Sequence No. At the time of dispensing the PHOSE item 9 of the reagent, the first reagent is dispensed and stirred as usual, and at the time of dispensing the second reagent, the reagent does not dispense the reagent, but instead the system water in the reagent probe channel. Dispense the same amount and do not stir. Sequence No. At the time of dispensing the 13 PHOSE item reagent, the reagent is normally dispensed when the first reagent is dispensed, but stirring is not performed. At the time of dispensing the second reagent, the reagent is not dispensed. Instead, the same amount of the apparatus system water in the reagent probe flow path is dispensed and stirring is not performed.

  Based on the determination result in the detailed mode shown in FIG. 11, the presence or absence of contamination is confirmed while separating the cleaning failure of the reagent dispensing mechanism and the stirring mechanism based on the measurement result of the above sequence. First, the sequence No. In the Neg item after the reagent is dispensed and stirred under the condition No. 5, since the second reagent of the Pos item is not stirred, the poor cleaning of the stirring mechanism on the second reagent side can be ignored. Therefore, the reagent determination data 1 obtained by the contamination determination formula (1) based on the measured values of (reagent data 1-2) and (reagent data 2-2) at this time is determined to be contaminated. In this case, the cause of the cleaning failure is that the cleaning failure has occurred in any of the remaining first reagent dispensing mechanism, first reagent stirring mechanism, or second reagent dispensing mechanism (step 1101). If it is determined that there is no contamination, it is understood that the cause of the cleaning failure is the stirring mechanism on the second reagent side, so an alarm is output on the alarm screen of FIG. 13 (step 1102). Next, the sequence No. In the Neg item after the reagent is dispensed and stirred under the condition of No. 9, since the R2 reagent of the Pos item dispenses system water and is not agitated, the influence on the second reagent side can be ignored. Therefore, the reagent determination data 3 obtained by the contamination determination formula (1) based on the measured values of (reagent data 1-3) and (reagent data 2-3) at this time is determined to be contaminated. In this case, the cause of the cleaning failure is that the cleaning failure has occurred in either the remaining first reagent dispensing mechanism or the first reagent stirring mechanism (step 1103). If it is determined that there is no contamination, it is understood that the cause of the cleaning failure is the second reagent dispensing mechanism, so an alarm is output on the alarm screen of FIG. 13 (step 1104). The next sequence No. The Neg item after the reagent is dispensed and stirred under the conditions of 13 does not carry out stirring at the time of dispensing the first reagent, and the second reagent dispenses system water and does not carry out stirring. Therefore, the agitation on the first reagent side and the influence on the second reagent side can be ignored. Therefore, if the result obtained by the contamination determination formula (1) based on the measured values of (reagent data 1-4) and (reagent data 2-4) at this time is determined to be contaminated, cleaning is performed. The cause of the failure is that the first reagent dispensing mechanism has caused a cleaning failure, so an alarm is output on the alarm screen of FIG. 13 (step 1105). If it is determined that there is no contamination, it is understood that the cause of the cleaning failure is the stirring mechanism on the first reagent side, so an alarm is output on the alarm screen of FIG. 13 (step 1106). As described above, by checking the presence / absence of contamination while separating the reagent dispensing mechanism and the washing mechanism of the stirring mechanism based on the detailed mode determination flowchart shown in FIG. It is possible to easily find the location where the cleaning failure occurs.

  Next, the confirmation sequence of the cleaning condition of the reaction container cleaning mechanism will be described. FIG. 5 shows an example of a cleaning condition confirmation sequence of the reaction container cleaning mechanism. In the first round, reaction vessel no. The Pos item affecting No. 1 was dispensed, and reaction vessel no. The Neg item affected by No. 2 is dispensed. In the second round, reaction vessel no. Neg items affected by No. 1 are dispensed. Neg items affected by No. 2 are also dispensed. Therefore, the reaction container No. 2 in the second round. The first measured value (container data 1-1) and the reaction container No. 2 in the second round. If the container determination data 1 obtained by the contamination determination formula (1) based on the second measurement value (container data 1-2) is determined to be contaminated, the reaction container cleaning mechanism determines that the cleaning is defective. It is happening. Here again, a phosphate buffer may be used as the Pos item, a phosphorus item may be used as the Neg item, and a dye may be used as the Pos item.

  Here, a method for confirming the detergent concentration of the reaction container cleaning mechanism will be described. For example, if an alkaline detergent mainly composed of sodium hydroxide is used as a detergent, the detergent concentration is confirmed by measuring the sodium concentration using the electrolyte measuring unit 108 in the biochemical automatic analyzer. Can do. In the confirmation sequence, the diluted detergent discharged into the reaction container by the reaction container cleaning mechanism is collected as a sample by the sample dispensing mechanism, and dispensed to the electrolyte measurement unit 108 for measurement. If the measurement result is compared with a preset threshold value and is outside the range, it can be seen that the specified concentration detergent has not been discharged, so an alarm is output on the alarm screen of FIG. Here, the sodium concentration was measured using the electrolyte measurement unit. However, in a biochemical automatic analyzer without an electrolyte measurement unit, a sodium item for the colorimetric part may be used instead.

  The user can always check the measurement result in the cleaning condition confirmation of each of the series of mechanisms shown above on the result confirmation screen shown in FIGS.

  As described above, according to the present embodiment, the cleaning condition of each mechanism can be confirmed regardless of the technical ability of the user, the defective part of the cleaning condition can be specified, and the occurrence of a measurement error due to the apparatus failure Can be prevented.

It is a block diagram of the automatic analyzer of an Example. It is explanatory drawing of an example of the processing flow of the presence or absence investigation of contamination in the washing | cleaning mechanism condition automatic determination function of the automatic analyzer of an Example. It is explanatory drawing of an example of the dispensing operation | movement figure of the automatic analyzer of an Example. It is explanatory drawing of an example of the washing | cleaning condition confirmation sequence of the reagent dispensing mechanism and stirring mechanism of the automatic analyzer of an Example. It is explanatory drawing of an example of the washing | cleaning condition confirmation sequence of the reaction container washing | cleaning mechanism of the automatic analyzer of an Example. It is explanatory drawing of an example of each washing | cleaning mechanism execution presence / absence selection screen of the washing | cleaning mechanism condition automatic determination function of the automatic analyzer of an Example. It is explanatory drawing of an example of each cleaning mechanism measurement result confirmation screen of the cleaning mechanism condition automatic determination function of the automatic analyzer of an Example. It is explanatory drawing of an example of the detergent density | concentration measurement result confirmation screen of the washing | cleaning mechanism condition automatic determination function of the automatic analyzer of an Example. It is explanatory drawing of an example of the parameter setting screen of the washing | cleaning mechanism condition automatic determination function of the automatic analyzer of an Example. It is explanatory drawing of an example of the normal mode determination processing flow at the time of confirming the washing condition of the reagent dispensing mechanism and stirring mechanism of the automatic analyzer of an Example. It is explanatory drawing of an example of the detailed mode determination processing flow at the time of confirming the washing condition of the reagent dispensing mechanism and stirring mechanism of the automatic analyzer of an Example. It is explanatory drawing of an example of the maintenance screen of the automatic analyzer of an Example. It is explanatory drawing of an example of the alarm screen of the automatic analyzer of an Example. It is explanatory drawing of an example of the washing | cleaning condition confirmation sequence of the sample dispensing mechanism of the automatic analyzer of an Example.

Explanation of symbols

101 Reaction vessel 102 Cleaning mechanism 103 Stirring mechanism 104 Reagent dispensing mechanism 105 Reagent dispensing mechanism 106 Reagent disk 107 Reagent disk 108 Electrolyte measuring unit 109 Shipper mechanism 110 Pipetting mechanism for electrolyte 111 Stirring mechanism 112 Reagent container 113 for standard solution Diluent Reagent container 114 Comparative electrode solution reagent container 115 Sample disk 116 Sample pipetting mechanism 117 Multi-wavelength photometer 118 Interface 119 Control unit 120 Input unit 121 Information storage unit 122 Display unit 123 Analysis unit 124 Control unit 125 Reaction disk 126 Reagent probe Cleaning tank 127 Stirring mechanism cleaning tank 128 Reagent probe 129 Reagent probe 130 Stirring mechanism cleaning tank 131 Sample probe 132 Reagent probe cleaning tank 201-208 Flow step 301 Sample dispensing position 302 Dilution liquid discharge position 303 Stirring position 304 Diluted sample suction position 305 Standard liquid suction position 306 Standard liquid supply positions 1001 to 1002 Flow steps 1101 to 1107 Flow steps

Claims (3)

A sample dispensing mechanism for dispensing a sample into a reaction vessel, a reagent dispensing mechanism for dispensing a reagent into a reaction vessel into which a sample has been dispensed, and stirring the reaction liquid in the reaction vessel with a stirring mechanism, and then measuring the absorbance In an automatic analyzer equipped with an absorptiometer and a washing means for washing each unit of the sample dispensing mechanism, the reagent dispensing mechanism, the stirring mechanism, and the reaction container,
It was washed of the unit according to one or more of said cleaning means, and have a means for confirming unit cleaning results,
When different samples are dispensed using the same sample injection mechanism, whether cross contamination is detected due to carry-over between these samples, and when different reagents are dispensed using the same reagent injection mechanism In addition, the presence / absence of cross-contamination generated between these reagents is determined, the presence / absence of cross-contamination is determined by carryover of the reaction solution, and the cleaning mechanism used for cleaning the reaction vessel is used. The detergent concentration is measured, and when the determination result or the measurement result carried out is equal to or higher than a preset threshold value, the cleaning unit has a cleaning condition determination function for displaying the fact to the user.
In the presence / absence determination of the cross contamination, for each item combination set for each unit of the cleaning means, there are two measurement results: a measurement result on the side that is affected by the affected item and a measurement result on the side that is not affected by the affected item. Data is extracted. If the absolute value of the difference between the two data is smaller than a predetermined threshold, it is determined that there is no contamination, and if it is greater than a predetermined threshold, it is determined that there is contamination. An automatic analyzer that outputs an alarm on the display screen . The automatic analyzer according to claim 1, wherein
The cleaning condition automatic determination function of the cleaning means that registers the measurement intervals in advance and automatically determines the presence or absence of each contamination or the appropriate concentration of detergent for the cleaning means at the measurement intervals registered during normal sample measurement. automatic analyzer according to claim Rukoto equipped with. The automatic analyzer according to claim 1, wherein
The reagent injection mechanism includes first and second reagent dispensing mechanisms, and first and second stirring mechanisms corresponding to the first and second reagent dispensing mechanisms,
The washing condition determination function is
(1) Using the first and second reagent dispensing mechanisms and the first and second stirring mechanisms, the reagent is dispensed and stirred, and the absolute values obtained are as follows:
(2) The first and second reagent dispensing mechanisms and the first stirring mechanism perform reagent dispensing and stirring, the second stirring mechanism does not perform stirring, and the absolute value obtained,
(3) The reagent is dispensed and stirred by the first reagent dispensing mechanism and the first stirring mechanism, the system water is dispensed by the second reagent dispensing mechanism, and the second stirring is performed. The mechanism does not carry out stirring, the absolute value obtained,
(4) Reagent dispensing is performed by the first reagent dispensing mechanism, system water is dispensed by the second reagent dispensing mechanism, and stirring is performed by the first and second stirring mechanisms. The absolute value obtained and determined,
Whether the first or second reagent dispensing mechanism or the first or second stirring mechanism causes a cleaning failure from all or part of the absolute values of (1) to (4) above. An automatic analyzer characterized by determining .

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