JP5140491B2 - Automatic analyzer and dispensing accuracy confirmation method - Google Patents

Description

  The present invention relates to an automatic analyzer that automatically analyzes a sample such as blood or body fluid, and a dispensing accuracy confirmation method that confirms the dispensing accuracy of a dispensing mechanism provided in the automatic analyzer.

  Conventionally, an automatic analyzer is known as a device for biochemically or immunologically analyzing a specimen such as blood or body fluid. This automatic analyzer is provided with a water injection type dispensing mechanism realized by using components such as a probe and a syringe in order to dispense a sample and a reagent including a specimen.

  In such a dispensing mechanism, parts that are likely to deteriorate over time are periodically replaced. When parts are replaced, air is mixed into the dispensing mechanism. Therefore, after the parts are replaced, the work to remove the air mixed into the dispensing mechanism (air bleeding) is usually performed before the sample analysis is performed. . In the analysis after such work, if the air bleeding is incomplete, the analysis result may show an abnormality.Therefore, a dye stock solution with a known concentration is used as a method for confirming whether the air bleeding has been performed completely. There has been proposed a method of confirming the dispensing accuracy of an analyzer by dispensing with an analyzer and measuring the absorbance with a photometric device (see, for example, Patent Document 1).

  In addition, in order to maintain the dispensing performance of the dispensing device and prevent a decrease in analysis accuracy, a method for confirming the dispensing performance of the dispensing device has also been established (for example, see Non-Patent Document 1).

JP 2007-327779 A "Performance Confirmation Manual for General-purpose Automatic Analyzer", JCCLA, 2001, Vol.26

  However, in the case of the method as described above, it is necessary to test the amount, concentration, and dilution amount of the dye stock solution used for the measurement, and this test requires a lot of cost and time. Specifically, even when the same undiluted solution is used, the error when diluting varies depending on the work and each worker. For this reason, only the result including the dilution error can be obtained.

  The present invention has been made in view of the above, and evaluates the dispensing performance of a dispensing device by a simple method, thereby reducing the burden on an operator who confirms the dispensing performance of the dispensing device. An object of the present invention is to provide an automatic analyzer and a dispensing accuracy confirmation method capable of

  In order to solve the above-described problems and achieve the object, the automatic analyzer of the present invention includes a dispensing mechanism for dispensing a sample or a reagent, and automatically analyzes the components of the sample by reacting the sample and the reagent. An analyzer that measures the intensity of light transmitted through a set amount of a dye solution dispensed into a reaction container by the dispensing mechanism and obtains an evaluation absorbance of the dye solution for each set dispense amount A ratio of the evaluated absorbance to a preliminarily measured reference absorbance for each installed dispensed amount, a calculation means for calculating a difference from a difference between a maximum ratio and a minimum ratio and an average ratio, and the distribution based on the difference. Determination means for determining whether or not the dispensing accuracy of the dispensing mechanism is within an allowable range.

  The automatic analyzer of the present invention includes a dispensing mechanism for dispensing a sample or a reagent, and is an automatic analyzer for analyzing a component of the sample by reacting the sample and the reagent, and reacts by the dispensing mechanism. Measuring means for measuring the intensity of light transmitted through a set amount of the dye solution dispensed into the container, and obtaining the evaluation absorbance of the dye solution for each set dispensed amount, and the evaluated absorbance with respect to the reference absorbance measured in advance And calculating means for calculating the difference between each ratio determined for each set dispensing amount and the average ratio as a divergence, and the dispensing accuracy of the dispensing mechanism is based on the divergence. Determination means for determining whether or not it is within an allowable range.

  The automatic analyzer of the present invention includes a dispensing mechanism for dispensing a sample or a reagent, and is an automatic analyzer for analyzing a component of the sample by reacting the sample and the reagent, and reacts by the dispensing mechanism. Measuring means for measuring the intensity of light transmitted through a set amount of the dye solution dispensed into the container, and obtaining the evaluation absorbance of the dye solution for each set dispensed amount, and the evaluated absorbance with respect to the reference absorbance measured in advance For each set dispense volume, find the slope when connecting adjacent ratios with straight lines, and calculate the average of the absolute values of the slopes of the two straight lines that sandwich each ratio. It is characterized by comprising calculation means for calculating as a divergence, and determination means for determining whether or not the dispensing accuracy of the dispensing mechanism is within an allowable range based on the divergence.

  The automatic analyzer according to the present invention is characterized in that, in the above invention, the divergence is calculated based on a ratio obtained at a set dispensing amount selected from at least three or more points.

  Moreover, the automatic analyzer according to the present invention is characterized in that in the above-mentioned invention, the automatic analyzer further includes a storage unit for storing the reference absorbance.

  Further, the dispensing accuracy confirmation method of the present invention comprises a dispensing mechanism for dispensing a sample or a reagent, and in an automatic analyzer that analyzes the components of the sample by reacting the sample and the reagent, A method for confirming the dispensing accuracy of an automatic analyzer for confirming the dispensing accuracy, wherein the intensity of light transmitted through a dye solution dispensed in a predetermined amount into a plurality of reaction vessels is measured by the dispensing mechanism, and a set dispensing is performed. Measurement step for determining the evaluation absorbance of the dye solution for each amount, and the ratio of the evaluation absorbance to the pre-measured reference absorbance is determined for each set dispensing amount, and the difference is calculated from the difference between the maximum ratio and the minimum ratio and the average ratio And a determination step of determining whether or not the dispensing accuracy of the dispensing mechanism is within an allowable range based on the deviation.

  Further, the dispensing accuracy confirmation method of the present invention comprises a dispensing mechanism for dispensing a sample or a reagent, and in an automatic analyzer that analyzes the components of the sample by reacting the sample and the reagent, A method for confirming the dispensing accuracy of an automatic analyzer for confirming the dispensing accuracy, wherein the intensity of light transmitted through a dye solution dispensed in a predetermined amount into a plurality of reaction vessels is measured by the dispensing mechanism, and a set dispensing is performed. Measurement step for obtaining an evaluation absorbance of the dye solution for each amount, a ratio of the evaluation absorbance with respect to a reference absorbance measured in advance is obtained for each set dispensing amount, and each ratio obtained for each set dispensing amount and an average ratio A calculation step of calculating a difference or a slope when a ratio of adjacent dispensing amounts is connected by a straight line, and calculating an average of absolute values of inclinations of two straight lines sandwiching each ratio as a deviation in each set dispensing amount; Based on the divergence, Pipetting accuracy of serial dispensing mechanism, characterized in that it comprises a determination step of determining whether the allowable range, the.

  Moreover, the dispensing accuracy confirmation method of the present invention is characterized in that, in the above invention, the deviation is calculated based on a ratio obtained in a set dispensing amount selected at least three or more points.

  According to the present invention, in an automatic analyzer that includes a dispensing mechanism for dispensing a sample or a reagent and analyzes the components of the sample by reacting the sample and the reagent, the automatic dispensing apparatus can be started up or the dispensing mechanism. After the maintenance work, a process of measuring the intensity of light transmitted through the dye solution dispensed in a set amount into a plurality of reaction containers by the dispensing mechanism and obtaining an evaluation absorbance of the dye solution for each set dispense amount. A ratio of the evaluation absorbance with respect to the reference absorbance measured in advance is determined for each set dispensing amount, and the difference is calculated from the difference between the maximum ratio and the minimum ratio and the average ratio, and based on the deviation, the dispensing mechanism By determining whether or not the dispensing accuracy is within an allowable range, it is possible to reduce the burden on the operator who confirms the dispensing performance of the dispensing mechanism.

  Hereinafter, an automatic analyzer according to an embodiment of the present invention will be described with reference to the accompanying drawings. FIG. 1 is a plan view showing a configuration of a main part of the automatic analyzer according to the present invention. The automatic analyzer 1 shown in FIG. 1 analyzes the components of a sample including a specimen biochemically or immunologically, dispenses the sample and the reagent into a predetermined reaction container, and is generated in the reaction container. Analysis is performed by measuring the reaction optically. The automatic analyzer 1 dispenses a specimen and a reagent to be analyzed into a reaction vessel 131 and optically measures a reaction occurring in the dispensed reaction vessel 131 and an automatic including the measurement mechanism 2. A control mechanism 3 that controls the entire analysis apparatus 1 and analyzes a measurement result in the measurement mechanism 2 is provided. The automatic analyzer 1 automatically analyzes a plurality of specimens by the cooperation of these two mechanisms.

  The measurement mechanism 2 includes a sample transfer unit 11 that stores and sequentially transfers a plurality of racks 112 on which sample containers 111 that store samples such as blood and body fluid are mounted, and a sample container 121 that stores emergency samples and various samples. The sample table 12 to hold | maintain, the reaction table 13 to hold | maintain the reaction container 131 in which a sample and a reagent are dispensed, and the reagent table 14 to hold | maintain the reagent container 141 which accommodates various reagents are provided.

  The sample table 12, the reaction table 13, and the reagent table 14 are rotatable about a vertical line passing through the center of each table as a rotation axis by driving a stepping motor. An openable / closable cover is provided above each table, and a thermostatic bath is provided below each table (not shown). As a result, the container that comes inside the cover when the cover is closed can be kept at a constant temperature, and evaporation or denaturation of the sample or reagent contained in the container inside the cover can be suppressed.

  In addition to the above various tables, the measurement mechanism 2 irradiates the reaction vessel 131 with predetermined light by stirring the inside of the reaction vessel 131 to promote the reaction between the sample in the reaction vessel 131 and the reagent. The photometric unit 16 that receives the light that has passed through the reaction vessel 131 and measures the intensity of the light, and the cleaning unit 17 that cleans the reaction vessel 131 that has been measured by the photometric unit 16 are provided. Prepare. Among these, the photometry unit 16 includes a light source that generates light of a predetermined wavelength, and a light receiving unit that converts the intensity of light irradiated from the light source and transmitted through the liquid in the reaction vessel 131 into an electric signal (current value). And at least a part of measurement means for measuring the intensity of the received light to determine the absorbance of the liquid.

  Furthermore, the measurement mechanism 2 includes a sample dispensing mechanism 18 that dispenses the sample contained in the sample container 111 or the sample container 121 into the reaction container 131, and a reagent container as a dispensing mechanism that dispenses the sample or reagent into the reaction container 131. 141 includes a reagent dispensing mechanism 19 for dispensing the reagent accommodated in the reaction container 131.

  The control mechanism 3 includes a control unit 21, an input unit 22, an output unit 23, an analysis unit 24, a storage unit 25, a calculation unit 26, and a determination unit 27. The control unit 21 is connected to the sample transfer unit 11, the sample table 12, the reaction table 13, the reagent table 14, the stirring unit 15, the photometry unit 16, the washing unit 17, the sample dispensing mechanism 18, the reagent dispensing mechanism 19, and the like. Control the operation of each of the above parts. The input unit 22 is a part that performs an operation of inputting inspection items and the like to the control unit 21. For example, a keyboard and a mouse are used. The output unit 23 displays analysis contents, alarms, and the like, and a display panel or the like is used. Note that the input unit 22 and the output unit 23 may be realized by a touch panel.

  The analysis unit 24 is connected to the photometry unit 16 via the control unit 21, analyzes the component concentration of the sample from the absorbance of the liquid in the reaction container 131 based on the amount of light received by the light receiving unit, and analyzes the analysis results to the control unit 21. Output to. The storage unit 25 is configured using a hard disk that stores information magnetically and a memory that loads various programs related to the process from the hard disk and electrically stores them when the measurement mechanism 2 executes the process. Various information including the analysis result of the sample is stored. Further, when the accuracy of sample dispensing is ensured in the storage unit 25, for example, the standard of the dye solution for each set dispensing amount measured in advance by the photometry unit 16 before shipping the automatic analyzer. The absorbance may be stored in advance together with the analysis parameter.

  The calculating part 26 and the determination part 27 play the role for implementing the dispensing precision confirmation method of this invention with the control part 21 and the memory | storage part 25. FIG. The calculation unit 26 obtains the ratio of the evaluation absorbance of the dye solution obtained by the photometry unit 16 and the analysis unit 24 with respect to the reference absorbance of the dye solution measured in advance for each set dispensing amount, and the maximum ratio and the minimum ratio of the obtained ratio. The deviation is calculated from the ratio difference and the average ratio. As the reference absorbance, those stored in the storage unit 25 can be used. The determination unit 27 determines whether the deviation calculated by the calculation unit 26 is within a predetermined allowable range, displays the determination result on the display device, or notifies the operator by generating an alarm sound. You may let them.

  FIG. 2 is an explanatory diagram schematically showing a schematic configuration of the sample dispensing mechanism 18. In the sample dispensing mechanism 18 shown in the figure, a hollow probe 181 that sucks and discharges a sample is attached to an arm 182. The arm 182 operates by driving the drive unit 183. More specifically, the arm 182 is vertically moved through the connecting unit 184 that connects the arm 182 and the driving unit 183 and passes through the connecting unit 184. It can freely rotate around the axis O.

  A distal end portion 181a of the probe 181 is tapered, and a tubular tube 31 serving as a cleaning liquid flow path, which will be described later, is connected to the upper end of the probe 181. The other end of the tube 31 is connected to a syringe 185 that is a pressure generating means for suction or discharge. The syringe 185 includes a cylinder 185a and a piston 185b, and the piston 185b is moved by driving the piston driving unit 186.

  The syringe 185 is also connected to a tubular tube 32 different from the tube 31. An injection valve 187 and a pump 188 are sequentially interposed in the tube 32. The end of the tube 32 that is different from the one connected to the syringe 185 is made of an incompressible fluid such as ion exchange water and reaches the cleaning liquid tank 189 that stores the cleaning liquid that also functions as an extrusion liquid. The cleaning liquid stored in the cleaning liquid tank 189 flows out to the tube 32 by the suction operation of the pump 188, and flows into the syringe 185 when the injection valve 187 is open. The drive unit 183, the piston drive unit 186, the injection valve 187, and the pump 188 are electrically connected to the control unit 21.

  Before the sample dispensing mechanism 18 sucks or discharges the sample, the injection valve 187 is opened, the cleaning liquid is sucked by the pump 188, and the probe 181, the syringe 185, the tubes 31 and 32 are filled with the cleaning liquid, and then the injection is performed. The valve 187 is closed to end the operation of the pump 188. Thereafter, when aspirating or discharging the sample, the piston driving unit 186 is driven to move the piston 185b of the syringe 185, so that an appropriate suction pressure or discharge pressure is applied to the tip 181a of the probe 181 via the cleaning liquid. Apply. At the tip 181a of the probe 181, since an air layer is interposed between the cleaning liquid and the sample, the sample is not mixed with the cleaning liquid when the sample is sucked.

  The reagent dispensing mechanism 19 has the same configuration as that of the sample dispensing mechanism 18, and the probe 191 and the arm 192 operate under the control of the control unit 21, and the syringe has an appropriate suction pressure at the tip of the probe 191. Alternatively, the reagent is aspirated or discharged by applying a discharge pressure.

  In the sample dispensing mechanism 18 and the reagent dispensing mechanism 19 described above, a liquid level detection function for detecting the liquid level is provided at the lower ends of the probes 181 and 191, and the height of the liquid level changes. In addition, only a predetermined length of each probe tip is set to enter from the liquid surface.

  Next, the dispensing accuracy confirmation method of the sample dispensing mechanism 18 of the automatic analyzer according to the embodiment of the present invention will be described using the flowchart of FIG.

  First, a sample container 121 that contains a dye solution for confirming the dispensing accuracy of the sample dispensing mechanism 18 is set on the sample table 12 (step S100). The same dye solution as that set as an analysis parameter is used when measuring a preliminarily measured reference absorbance. In the present embodiment, orange G is used, but it is sufficient if it has absorption that can be used for analysis at the wavelength of analysis light (340 to 800 nm). The concentration of the dye solution used in this embodiment does not need to be verified, and the concentration of the dye solution to be measured is determined by the photometry unit 16 in consideration of the set dispensing amount and the diluted solution amount of the sample dispensing mechanism 18. What is necessary is just to be in the photometric range (usually 0 to 3.0 Abs). In the present embodiment, orange G having a concentration of about 20 Abs is used. Next, the reagent container 141 that stores the diluent is set on the reagent table 14 (step S101). The diluted solution is used for diluting the dye solution to the photometric range of the photometric unit 16. Usually, ion-exchanged water is used. The amount of the diluted solution is a meterable range (usually 0 to 3.0 Abs) of the photometry unit 16 when orange G (about 20 Abs) of a set dispensing amount (for example 1 to 25 μl) is diluted with ion-exchanged water (for example 150 μl). ) To enter. After setting the dye solution and the diluting solution, the sample table 12 transfers the sample container 121 containing the dye solution to the sample suction position B, and after obtaining the amount of the dye solution dispensed (step S102), the sample dispensing mechanism 18 The dye solution in the sample container 121 is sucked by the probe 181 and the sucked set amount of the dye solution is discharged to the reaction container 131 at the sample dispensing position C on the reaction table 13 (step S103). The dispensing amount of the dye solution may be obtained from the storage unit 25 when the reference absorbance measured in advance in the storage unit 25 is stored for each set dispensing amount.

  Thereafter, the reaction container 131 from which the dye solution has been discharged is transferred to the reagent dispensing position E on the reaction table 13, the reagent container 141 containing the diluent is transferred to the reagent suction position D by the reagent table 14, and then the reagent dispensing is performed. The mechanism 19 sucks a predetermined amount of the diluent in the reagent container 141, and discharges the sucked diluent to the reaction container 131 transferred to the reagent dispensing position E on the reaction table 13 (step S104). Thereafter, the reaction container 131 is transferred to the stirring position F on the reaction table 13, and after the liquid in the reaction container 131 is stirred by the stirring unit 15 (step S <b> 105), the reaction container 131 is moved to the photometric position G on the reaction table 13. Transport. The photometry unit 16 irradiates the diluted dye solution in the reaction vessel 131 with predetermined light from a light source, receives light that has passed through the dye solution at a light receiving unit, and measures the intensity of the received light ( Step S106).

  The above-described analysis process of the dye solution is repeated by a predetermined number of times (a specified number) by changing the amount of the dye solution dispensed by the sample dispensing mechanism 18. The amount of the dye solution dispensed in each analysis process is input every time it is dispensed, or is acquired from the storage unit 25 if it is stored in the storage unit 25 (step S102). If the number of analysis processes (number of analyzes) has not reached the prescribed number (step S107, No), the processes in steps S102 to S106 are repeated for each dispensed amount. When the number of analyzes reaches the specified number (step S107, Yes), the calculation unit 26 obtains the ratio of the evaluation absorbance with respect to the reference absorbance measured in advance for each set dispensing amount, and the difference between the maximum ratio and the minimum ratio and the average The deviation is calculated from the ratio (step S108). When the deviation is within the allowable range (step S109, Yes), it is determined that the dispensing accuracy of the sample dispensing mechanism 18 is normal, and the analysis of the sample (main analysis) is started (step S110). If it is not within the allowable range (No at Step S109), it is determined that the dispensing accuracy of the sample dispensing mechanism 18 is abnormal, and the analysis operation is stopped (Step S111). In this case, a warning may be displayed or an audio warning may be output from the output unit 23 of the automatic analyzer 1 realized by a display, a printer, a microphone, or the like.

  Next, the deviation As1 obtained from the difference between the maximum ratio and the minimum ratio and the average ratio will be described using an actual analysis example. The deviation As1 is obtained from the difference between the maximum ratio and the minimum ratio of each ratio obtained and the average ratio of each ratio, by obtaining the ratio of the evaluation absorbance to the reference absorbance for each set dispensing amount. The deviation As1 represents the dispensing accuracy of the entire dispensing process in the method of this embodiment performed to confirm the dispensing accuracy, and the calculated deviation As1 is the dispensing process of the sample dispensing mechanism 18. This is an index for determining whether or not the entire dispensing accuracy is possible.

  As shown in Table 1, the standard absorbance of the dye solution is measured in advance for each set dispensing amount. The set dispensing amount is set corresponding to the dispensing amount that is actually dispensed in the main analysis of the sample dispensing mechanism 18. When the dispensing accuracy of the sample dispensing mechanism 18 is ensured, the reference absorbance is measured in advance by the photometry unit 16 of the apparatus before shipping the automatic analyzer, for example, as shown in Table 2. It can be stored in the storage unit 25 together with the analysis parameters shown, or may be individually stored as data.

  In the example of Table 1, the dye solution set dispensing amounts are 1, 2, 3, 5, 10, 15, and 25 μl, and the standard absorbance is measured for each dispensing amount. The absorbance (20 Abs), actual dispensing volume, and dilution volume (150 μl) of the dye solution used (orange G) do not need to be assayed, and the standard absorbance can be easily obtained.

  The analysis operator measures the evaluation absorbance at the dye solution set dispensing amount shown in Table 1, and confirms the dispensing accuracy of the sample dispensing mechanism 18. In order to confirm the dispensing accuracy more accurately, it is preferable to measure the evaluation absorbance at a larger set dispensing amount. However, at least three or more points are selected from the above set dispensing amounts. The evaluation absorbance is measured, the ratio with respect to the reference absorbance is determined for each set dispensing amount, and the dispensing accuracy is confirmed by calculating the deviation from the difference between the maximum ratio and the minimum ratio and the average ratio. Table 3 shows that in the automatic analyzer after continuous operation, a set amount of the dye solution is dispensed into the reaction vessel 131 by the sample dispensing device 18, and 150 μl of the diluted solution is dispensed by the reagent dispensing device 19 in the same reaction vessel. After dispensing into 131, the photometric unit 16 measures the evaluation absorbance of the dye solution. Table 3 shows the measurement results.

  The above analysis is performed using the analysis parameters at the time of measuring the standard absorbance shown in Table 2. Orange G is the same as that at the time of measuring the standard absorbance, and ion-exchanged water is used as the dilution water. The concentration of Orange G used for the evaluation absorbance measurement can be used as long as it is the same as that at the time of the standard absorbance measurement (19 Abs), and there is no need for an assay. The amount of the diluted solution may be a concentration that falls within the photometric range (usually 0 to 3.0 Abs) of the photometric unit 16 of the automatic analyzer 1 when the dye solution having the concentration is diluted with the diluted solution. 149 μl) need not be assayed. In this method, the concentration of the dye solution required for the analysis does not need to be exact, and it is not necessary to test the concentration and amount. This reduces the burden on the analytical worker and eliminates the calibration process. And mechanical errors can be prevented.

Based on the evaluation absorbance (Table 3) obtained by the above analysis, the ratio of the evaluation absorbance with respect to the reference absorbance (Table 1) measured in advance is calculated for each set dispensing amount, and the maximum ratio and the minimum ratio of the obtained ratio are calculated. The deviation As1 is obtained from the difference and the average ratio. As described above, the deviation As1 represents a deviation from the set dispensing amount of the entire dispensing process of the sample dispensing apparatus 18, and is represented by the following equation (1).
As1 (%) = (maximum ratio-minimum ratio) / average ratio × 100 (1)

  The determination unit 27 determines whether or not the deviation As1 obtained by the equation (1) is within the allowable range of the dispensing accuracy of the sample dispensing mechanism 18. The allowable range can be determined individually according to the analysis sample, but the sample dispensing accuracy standard of the automatic analyzer 1 is ± 1.5%, and this may be used as the allowable range. When the deviation As1 exceeds 3% (± 1.5%) of the sample dispensing accuracy standard, it is determined that the sample dispensing accuracy is abnormal.

The deviation As1 is determined from the reference absorbance and the evaluated absorbance in Tables 1 and 3. Since the maximum ratio is 1.0266, the minimum ratio is 0.9480, and the average ratio is 0.9669, the deviation As1 is
8.13 (%) = (1.0266-0.9480) ÷ 0.9669 × 100
It becomes. Since the deviation As1 calculated from the evaluation absorbance in Table 3 exceeds 3.0% of the sample dispensing accuracy standard, the dispensing accuracy of the sample dispensing mechanism 18 used for the dispensing is determined to be outside the allowable range, and the sample Dispensing abnormality warning will be issued by display panel or voice.

  The method for confirming the dispensing performance according to this embodiment can reduce the burden on the operator who confirms the dispensing accuracy of the dispensing mechanism, and the dispensing accuracy of the sample dispensing mechanism 18 can be increased by using the method. Since it can be confirmed easily, it is possible to frequently check the dispensing accuracy, and thus it is possible to prevent a decrease in analysis accuracy.

  In addition, as a modification of the above-described embodiment, using the deviation As2 that is a divergence obtained for each set dispensing amount and that is a difference between each ratio and the average ratio obtained for each set dispensing amount, The method of confirming is illustrated. In this method, for example, in the main analysis of the automatic analyzer 1, when the dispensing probe is properly used according to the dispensing volume, an abnormal dispensing volume can be clearly indicated and a warning can be given. It is possible to identify a certain dispensing probe, and the subsequent treatment is easy.

  As for the deviation As2, the ratio of the evaluation absorbance with respect to the reference absorbance is obtained for each set dispensing amount, and the average of the obtained ratios is calculated in the same manner as the deviation As1. Deviation from the average ratio of the ratios determined for each set dispensing volume (average ratio−ratio at each set dispensing volume) is the deviation As2, and it is divided depending on whether the deviation As2 is within the allowable range of the setting. Whether or not the ordering accuracy is possible is determined. As in the case of the deviation As1, the allowable range may be ± 1.5% of the sample dispensing accuracy standard, or the allowable range may be set for each dispensing probe or each dispensing amount.

  Further, as a modification of the above-described embodiment, the deviation is obtained for each set dispensing amount, and the ratio of the evaluation absorbance to the reference absorbance is obtained for each setting dispensing amount, and the ratio of adjacent dispensing amounts is connected by a straight line. An example is a method in which the slope at the time is obtained, the average of the absolute values of the slopes of two straight lines sandwiching each ratio is calculated as the deviation As3 in each set dispensing amount, and the dispensing performance is confirmed based on the deviation. As with the deviation As1, first, the ratio of the evaluation absorbance to the reference absorbance is obtained for each set dispensing amount, and a line graph (set dispensing amount-ratio characteristic diagram) showing the relationship between the dye solution setting dispensing amount and the ratio is created. . FIG. 4 shows a line graph showing the relationship between the set dispensing amount of the dye solution and the ratio. The deviation As3 is obtained from the average of the absolute values of the slopes of the two straight lines sandwiching the ratio of each dispensing amount, and the dispensing accuracy is determined based on whether or not the deviation As3 is within the set allowable range. Dispensing volume (1 and 25 μl) that does not have two or more adjacent points may be calculated by calculating the slope As3 as a straight line drawn between 1 and 25 μl. Other dispensing that is not adjacent The deviation As3 may be calculated from the quantity. Also in this modification, the deviation is calculated for each set dispensing volume, so if the dispensing probe is used differently according to the dispensing volume, a warning is given clearly indicating the dispensing volume with an abnormality. It has the advantage of being able to.

  Although the method for confirming the dispensing accuracy of the sample dispensing mechanism 18 has been described above, the dispensing accuracy of the reagent dispensing mechanism 19 can also be confirmed by this method. In such a case, as shown in the flowchart of FIG. 5, the reagent container 141 that stores the dye solution is set on the reagent table 14 (step S200), and the sample container 121 that stores the diluent is set on the sample table 12 (step S201). ) After obtaining the amount of the dye solution to be dispensed by the reagent dispensing mechanism 19 (step S202), the dispensing accuracy of the reagent dispensing mechanism 19 is confirmed by performing the same process (steps S203 to S211). For the reagent dispensing mechanism 19 as well, the reference absorbance in the range to be dispensed is measured in advance for each set dispensed amount, the evaluated absorbance is measured for each set dispensed amount by the photometric unit 16, and the ratio of the evaluated absorbance to the reference absorbance is measured. Can be calculated for each set dispensing amount, and any of the above deviations can be calculated based on the obtained ratio, and the dispensing accuracy of the reagent dispensing mechanism 19 can be confirmed based on the deviation.

  Furthermore, even in an automatic analyzer having two reagent dispensing mechanisms, the dispensing accuracy can be confirmed by selecting the dispensing mechanism for dispensing the dye solution and the diluent and carrying out the method of this embodiment. .

  According to the embodiment of the present invention described above, it is possible to improve the reliability of analysis by analyzing the sample after confirming the dispensing accuracy in the dispensing mechanism. In addition, erroneous measurement of data due to air intrusion after replacement of parts of the dispensing mechanism can be avoided, and the burden on the operator who performs parts replacement and maintenance work after maintenance work can be reduced.

  The present invention is not limited to the embodiment described above, and may include various embodiments not described here. That is, the present invention can be subjected to various design changes and the like without departing from the technical idea specified by the claims.

It is a top view which shows the structure of the automatic analyzer principal part which concerns on one embodiment of this invention. It is explanatory drawing which shows schematic structure of the sample dispensing mechanism of the automatic analyzer which concerns on one embodiment of this invention. It is a flowchart which shows the flow of a process of the dispensing accuracy confirmation method of the automatic analyzer which concerns on one embodiment of this invention. It is a graph showing about the setting dispensing amount of a sample, and its ratio in the dispensing accuracy confirmation method of the automatic analyzer which concerns on one embodiment of this invention. It is a flowchart which shows the flow of a process of the dispensing accuracy confirmation method of the automatic analyzer which concerns on the modification of one embodiment of this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Automatic analyzer 2 Measurement mechanism 3 Control mechanism 11 Specimen transfer part 12 Sample table 13 Reaction table 14 Reagent table 15 Stirring part 16 Photometric part 17 Washing part 18 Sample dispensing mechanism 19 Reagent dispensing mechanism 21 Control part 22 Input part 23 Output Section 24 Analyzing section 25 Storage section 26 Calculation section 27 Determination section 31, 32 Tube 111 Sample container 112 Rack 121 Sample container 131 Reaction container 141 Reagent container 181, 191 Probe 181a Tip section 182, 192 Arm 183 Drive section 184 Connection section 185 Syringe 185a Cylinder 185b Piston 186 Piston drive part 187 Injection valve 188 Pump 189 Cleaning liquid tank

Claims (8)

An automatic analyzer having a dispensing mechanism for dispensing a sample or a reagent, and analyzing the components of the sample by reacting the sample and the reagent,
A measuring means for measuring the intensity of light transmitted through a predetermined amount of the dye solution dispensed into the reaction container by the dispensing mechanism, and obtaining an evaluation absorbance of the dye solution for each set dispensing amount;
A calculation means for calculating a deviation from the difference between the maximum ratio and the minimum ratio and the average ratio, by determining the ratio of the evaluation absorbance to the preliminarily measured reference absorbance of the dye solution for each set dispensing amount;
A determination means for determining whether or not the dispensing accuracy of the dispensing mechanism is within an allowable range based on the deviation;
And the concentration of the dye solution used for the measurement of the reference absorbance and the evaluation absorbance is not calibrated . An automatic analyzer having a dispensing mechanism for dispensing a sample or a reagent, and analyzing the components of the sample by reacting the sample and the reagent,
A measuring means for measuring the intensity of light transmitted through a predetermined amount of the dye solution dispensed into the reaction container by the dispensing mechanism, and obtaining an evaluation absorbance of the dye solution for each set dispensing amount;
The ratio of the evaluation absorbance to the preliminarily measured reference absorbance of the dye solution is determined for each set dispensing amount, and the difference between each ratio and the average ratio determined for each setting dispensing amount is defined as the difference in each setting dispensing amount. Computing means for computing;
A determination means for determining whether or not the dispensing accuracy of the dispensing mechanism is within an allowable range based on the deviation;
And the concentration of the dye solution used for the measurement of the reference absorbance and the evaluation absorbance is not calibrated . An automatic analyzer having a dispensing mechanism for dispensing a sample or a reagent, and analyzing the components of the sample by reacting the sample and the reagent,
A measuring means for measuring the intensity of light transmitted through a predetermined amount of the dye solution dispensed into the reaction container by the dispensing mechanism, and obtaining an evaluation absorbance of the dye solution for each set dispensing amount;
The ratio of the evaluation absorbance to the preliminarily measured reference absorbance of the dye solution is determined for each set dispensing amount, the slope when the dispensing amounts are adjacent to each other is obtained by a straight line, and two straight lines sandwiching each ratio are obtained. A computing means for computing the average of the absolute values of the slopes as the deviation in each set dispensing volume;
A determination means for determining whether or not the dispensing accuracy of the dispensing mechanism is within an allowable range based on the deviation;
And the concentration of the dye solution used for the measurement of the reference absorbance and the evaluation absorbance is not calibrated .   The automatic analyzer according to any one of claims 1 to 3, wherein the divergence is calculated based on a ratio obtained at a set dispensing amount selected at least three or more points.   The automatic analyzer according to claim 1, further comprising a storage unit that stores the reference absorbance. Dispensing accuracy of an automatic analyzer that is equipped with a dispensing mechanism for dispensing a sample or reagent and that analyzes the components of the sample by reacting the sample with the reagent and that confirms the dispensing accuracy of the dispensing mechanism Check method,
A measurement step of measuring the intensity of light transmitted through the dye solution dispensed in a predetermined amount into the reaction container by the dispensing mechanism, and obtaining an evaluation absorbance of the dye solution for each set dispensing amount;
A ratio of the evaluation absorbance to a pre-measured reference absorbance of the dye solution is determined for each set dispensing amount, and a calculation step of calculating a difference from the difference between the maximum ratio and the minimum ratio and the average ratio;
A determination step of determining whether or not the dispensing accuracy of the dispensing mechanism is within an allowable range based on the deviation; and
Unrealized, dispensing accuracy check how the concentration of the dye solution used in the measurement of the reference absorbance and the evaluation absorbance is characterized by not being assayed. Dispensing accuracy of an automatic analyzer that is equipped with a dispensing mechanism for dispensing a sample or reagent and that analyzes the components of the sample by reacting the sample with the reagent and that confirms the dispensing accuracy of the dispensing mechanism Check method,
A measurement step of measuring the intensity of light transmitted through the dye solution dispensed in a predetermined amount into the reaction container by the dispensing mechanism, and obtaining an evaluation absorbance of the dye solution for each set dispensing amount;
The ratio of the evaluation absorbance to the preliminarily measured reference absorbance of the dye solution is determined for each set dispensing amount, the difference between each ratio determined for each setting dispensing amount and the average ratio, or the ratio where the dispensing amount is adjacent Calculating an average of the absolute values of the inclinations of the two straight lines sandwiching each ratio as a deviation in each set dispensing amount;
A determination step of determining whether or not the dispensing accuracy of the dispensing mechanism is within an allowable range based on the deviation; and
Unrealized, dispensing accuracy check how the concentration of the dye solution used in the measurement of the reference absorbance and the evaluation absorbance is characterized by not being assayed.   The dispensing accuracy confirmation method according to claim 6 or 7, wherein the deviation is calculated based on a ratio obtained in a set dispensing amount selected at least three or more points.

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