JP2010048788A - Automatic analysis apparatus - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an automatic analysis apparatus capable of obtaining highly precise analysis result reliably without overlooking positive analyte regardless of analysis items. <P>SOLUTION: The automatic analysis apparatus 1, dispensing a first reagent, analyte, and second regent to a reaction vessel 20 in order for analyzing the analyte by measuring the absorbance of the reaction liquid reacting in the reaction vessel 20, and keeping the absorbance of the un-reacted second regent larger than the absorbance of the first regent to the wavelength of 340 nm, includes: a light measurement part 18 for measurement the absorbance of the wavelength of 340 nm of reaction liquid; a dispensing determination part 34 for determining the occurrence of abnormal conditions in the dispense of the second regent when the absorbance just after the dispensing the previously set threshold or lower; and an analysis part 33 for determining whether the analyte is positive or negative based on the variation amount of the absorbance for wavelength 570 nm from just after dispensing the second regent to the predetermined laps of time, only when no abnormal conditions have happened to occur during dispensing the second regent. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

  The present invention relates to an automatic analyzer that analyzes a sample by reacting a reagent dispensed in a reaction container with the sample and measuring the absorbance of the reaction solution.

  Conventionally, an automatic analyzer that analyzes a sample by reacting a reagent dispensed in a reaction container with the sample and measuring the absorbance of the reaction solution is known. In this automatic analyzer, each reagent is selected for each analysis item, the reagent is reacted with the sample, and the sample is analyzed based on the absorbance of the analysis light transmitted through the reaction solution.

JP 2006-300814 A JP 2006-023214 A

  Incidentally, one of the analysis items is a CRP test for testing C-reactive protein (CRP). CRP is a kind of acute phase protein that increases in the blood and decreases with the recovery of the living body when the living body undergoes acute invasion due to infection, acute tissue damage, inflammation, and the like. For this reason, the CRP test is an extremely effective test for determining the severity or therapeutic effect in diseases of bacterial infection, myocardial infarction, and malignant tumor. In this CRP test, a first reagent, a sample, and a second reagent are dispensed into a reaction container in this order, the first reagent dilutes the sample, and the second reagent reacts with the sample. As this second reagent, a latex reagent is usually used.

  The latex reagent has CRP antibody-sensitized latex particles in the reagent, and the CRP antibody-sensitized latex particles scatter the analysis light, thereby preventing the analysis light from being transmitted. Furthermore, the CRP antibody-sensitized latex particles react with the CRP antigen of the specimen and aggregate, thereby further preventing the analysis light from being transmitted. For this reason, when the latex reagent is dispensed, the absorbance rapidly increases.If the sample is positive, the absorbance increases until the reaction between the sample and the latex reagent is completed. In the negative case, since the specimen and the latex reagent hardly react, the absorbance value rapidly increased when the latex reagent is dispensed is maintained almost constant. As a result, the CRP test analyzes the sample based on the amount of change in absorbance after a predetermined time has elapsed since the latex reagent was dispensed.

  However, if the amount of latex reagent dispensed is insufficient in the CRP test, the absorbance value at which the absorbance rapidly increases during latex reagent dispensing is low. As a result, the difference between the absorbance at the time of latex reagent dispensing when the sample is negative and the absorbance at the time of latex reagent dispensing when the latex reagent is not dispensed into the reaction container or when the amount in the dispensing is very small is small. An accurate CRP test result cannot be obtained. In addition, when the sample is negative, the absorbance after the latex reagent is dispensed is almost the same as when the latex reagent is not dispensed, so the sample is negative even when the absorbance changes after the latex reagent is dispensed. In some cases, it was impossible to determine whether the latex reagent was undispensed. In this case, even if the latex reagent was undispensed or dispensed in a very small amount and the sample was positive, the sample could be judged negative. If such a positive sample is missed, the reliability of the analysis result is greatly reduced, and the original purpose of analysis cannot be achieved.

  In addition, in the method of determining the dispensing abnormality of the dispensing device by providing a pressure sensor to the dispensing nozzle and measuring the pressure change at the time of aspirating and discharging the reagent or sample, only the state of the dispensing nozzle is monitored. Therefore, since it is not determined whether or not the reagent or sample to be sucked and discharged is actually dispensed into the reaction container, the reagent or sample may not be dispensed into the reaction container (Patent Literature). 1). Furthermore, even if the reagent and sample dispensed in the reaction container are reacted, the absorbance of this reaction solution is measured sequentially, and the measurement result is analyzed to determine dispensing abnormality, depending on the analysis item, It may not be possible to determine whether or not the second reagent has been dispensed into the reaction container from the measurement result (see Patent Document 2).

  The present invention has been made in view of the above, and an object thereof is to provide an automatic analyzer capable of obtaining a highly reliable analysis result without missing a positive sample regardless of the analysis item. To do.

  In order to solve the above-described problems and achieve the object, an automatic analyzer according to the present invention dispenses a first reagent, a sample, and a second reagent into a reaction container in this order, and reacts in the reaction container. In the automatic analyzer that analyzes the specimen by measuring the absorbance of the reaction solution, at least the measuring means for measuring the absorbance in the predetermined wavelength region of the reaction solution, and the absorbance in the predetermined wavelength region measured by the measuring means, When the absorbance immediately after dispensing the second reagent is equal to or less than a preset threshold value, dispensing determination means for determining that an abnormality has occurred in dispensing of the second reagent, and the dispensing determination means include the second reagent If it is not determined that an abnormality has occurred in dispensing, the absorbance in the analysis wavelength region measured by the measurement means and necessary for the sample analysis, and the amount of change in absorbance from the second reagent dispensing until a predetermined time has elapsed The specimen on the basis is characterized by comprising a determining analysis means whether negative or positive, the.

  The automatic analyzer according to the present invention is characterized in that, in the above-mentioned invention, the unreacted second reagent has a greater absorbance in the predetermined wavelength region than the absorbance of the first reagent. To do.

  In the automatic analyzer according to the present invention as set forth in the invention described above, the predetermined wavelength region is a shorter wavelength region than the analysis wavelength region.

  In the automatic analyzer according to the present invention, in the above invention, when the dispensing determination unit does not determine that an abnormality has occurred in the dispensing of the second reagent, the second reagent measured by the measurement unit The concentration of the reaction solution is calculated based on the absorbance when a predetermined time has elapsed after dispensing, and when the calculated concentration is within the predetermined concentration range, it is determined that the dispensing amount of the second reagent is normal. The analysis means determines whether the sample is positive or negative when the dispensing determination means determines that the dispensing amount of the second reagent is normal. .

  In the automatic analyzer according to the present invention as set forth in the invention described above, the predetermined concentration range is a concentration range when the dispensing amount of the second reagent is 90% or more.

  In the automatic analyzer according to the present invention as set forth in the invention described above, the predetermined wavelength region is 300 nm to 400 nm.

  In the automatic analyzer according to the present invention as set forth in the invention described above, the second reagent is a latex reagent.

  According to the present invention, since the absorbance of the unreacted second reagent is larger than the absorbance of the first reagent for a predetermined wavelength region, the absorbance measured immediately after dispensing the second reagent If it is less than the set threshold value, it is determined that an abnormality has occurred in the dispensing of the second reagent, and if it is not determined that an abnormality has occurred in the dispensing of the second reagent, the absorbance at the time when a predetermined time has elapsed after the dispensing of the second reagent. Since it is determined whether the sample is positive or negative based on the amount of change, it is possible to reliably determine whether the second reagent is undispensed or dispensed in small quantities, regardless of the analysis item. There is an effect that a highly reliable analysis result can be obtained without missing a positive sample.

  DESCRIPTION OF EXEMPLARY EMBODIMENTS Hereinafter, preferred embodiments of an automatic analyzer according to the invention will be described with reference to the drawings. Note that the present invention is not limited to the embodiments. In the description of the drawings, the same parts are denoted by the same reference numerals.

(Embodiment 1)
FIG. 1 is a schematic diagram illustrating a schematic configuration of the automatic analyzer according to the first embodiment of the present invention. As shown in FIG. 1, the automatic analyzer 1 dispenses the first reagent, the sample, and the second reagent, which are analysis targets, into the reaction container 20 and measures the absorbance of the reaction that occurs in the dispensed reaction container 20. And a control mechanism 3 that controls the entire automatic analyzer 1 including the measurement mechanism 2 and analyzes the measurement result in the measurement mechanism 2. 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, a sample dispensing mechanism 12, a reaction table 13, a reagent storage 14, a reagent dispensing mechanism 16, a stirring unit 17, a photometric unit 18, and a washing unit 19.

  The sample transfer unit 11 includes a plurality of sample racks 11b that hold a plurality of sample containers 11a containing liquid samples such as blood and urine, and sequentially transfer them in the direction of the arrows in the figure. The sample in the sample container 11a transferred to the sample suction position P1 on the sample transfer unit 11 is dispensed by the sample dispensing mechanism 12 to the reaction container 20 that is transported to the sample dispensing position P11 on the reaction table 13. The

  The sample dispensing mechanism 12 includes an arm 12a that freely moves up and down in the vertical direction and rotates around a vertical line passing through its base end as a central axis. A probe for aspirating and discharging the specimen is attached to the tip of the arm 12a. The sample dispensing mechanism 12 includes an intake / exhaust mechanism using an unillustrated intake / exhaust syringe. The sample dispensing mechanism 12 sucks the sample from the sample container 11a transferred to the sample suction position P1 on the sample transfer unit 11 with the probe, rotates the arm 12a clockwise in FIG. Dispensing is performed by discharging the sample into the reaction container 20 transported to the sample dispensing position P11.

  The reaction table 13 transports the reaction container 20 to a predetermined position in order to dispense a sample or reagent into the reaction container 20, to stir, wash or measure the reaction container 20. The reaction table 13 is rotatable about a vertical line passing through the center of the reaction table 13 as a rotation axis by driving a drive mechanism (not shown) under the control of the control unit 31. An openable and closable lid and a thermostat (not shown) are provided above and below the reaction table 13, respectively.

  The reaction container 20 is a very small container having a capacity of several nL to several mL, a liquid holding part that holds a liquid is formed by the side wall and the bottom wall, and has an opening at the top of the liquid holding part. The reaction vessel 20 is made of a transparent material that transmits 80% or more of the light contained in the analysis light emitted from the light source of the photometry unit 18, for example, glass including heat-resistant glass, synthetic resin such as cyclic olefin and polystyrene. .

  The reagent storage 14 can store a plurality of reagent containers 15 in which reagents to be dispensed in the reaction container 20 are stored. In the reagent storage 14, a plurality of storage chambers are arranged at equal intervals, and a reagent container 15 is detachably stored in each storage chamber. The reagent storage 14 can be rotated clockwise or counterclockwise about a vertical line passing through the center of the reagent storage 14 as a rotation axis by driving a drive mechanism (not shown) under the control of the control unit 31. The desired reagent container 15 is transferred to the reagent suction position P2. An openable / closable lid (not shown) is provided on the upper part of the reagent storage 14. In addition, a thermostat (not shown) is provided at the lower part of the reagent storage 14. As a result, when the reagent container 15 is stored in the reagent container 14 and the lid is closed, the reagent stored in the reagent container 15 is kept at a constant temperature, and the reagent stored in the reagent container 15 is evaporated. Denaturation can be suppressed.

  Similar to the sample dispensing mechanism 12, the reagent dispensing mechanism 16 includes an arm 16a to which a probe for aspirating and discharging the sample is attached to the tip. The arm 16a freely moves up and down in the vertical direction and rotates around a vertical line passing through its base end as a central axis. The reagent dispensing mechanism 16 sucks the reagent in the reagent container 15 moved to the reagent suction position P2 on the reagent storage 14 with the probe, and rotates the arm 16a in the clockwise direction in FIG. Dispense into the reaction container 20 conveyed to the pouring position P21.

  The agitation unit 17 agitates the first reagent, the sample, and the second reagent dispensed in the reaction container 20 conveyed to the agitation position P31 on the reaction table 13 to promote the reaction.

  The photometry unit 18 irradiates the reaction container 20 conveyed to the photometry position P41 on the reaction table 13 with light, spectroscopically analyzes the light that has passed through the liquid in the reaction container 20, and measures the absorbance at a wavelength specific to the reaction liquid. To do. The measurement result obtained by the photometry unit 18 is output to the control unit 31 and analyzed by the analysis unit 33.

  The cleaning unit 19 cleans the reaction container 20 transported to the cleaning position P51 on the reaction table 13. The cleaning unit 19 sucks and discharges the mixed solution into the reaction vessel 20 that has been measured by the photometric unit 18 by a nozzle (not shown), and performs cleaning by injecting and sucking a cleaning solution such as detergent or cleaning water. . The washed reaction vessel 20 is reused or discarded after one measurement is completed depending on the contents of inspection.

  Next, the control mechanism 3 will be described. The control mechanism 3 includes a control unit 31, an input unit 32, an analysis unit 33, a dispensing determination unit 34, a storage unit 35, an output unit 36, and a transmission / reception unit 37. These units included in the measurement mechanism 2 and the control mechanism 3 are connected to the control unit 31.

  The control unit 31 is realized using a CPU or the like, and controls processing and operation of each unit of the automatic analyzer 1. The control unit 31 performs predetermined input / output control on information input / output to / from each of these components, and performs predetermined information processing on this information.

  The input unit 32 is realized using a keyboard, a mouse, a touch panel that also functions as an input / output function, and the like, and acquires various information necessary for analyzing the sample, instruction information for the analysis operation, and the like from the outside. The input unit 32 acquires and transmits instruction information to the control unit 31 via a communication network (not shown).

  The analysis unit 33 performs component analysis of the sample based on the measurement result of the absorbance acquired from the photometry unit 18. In addition, when the dispensing determination unit 34 determines that there is no abnormality in the dispensing of the second reagent, the analysis unit 33 changes the absorbance when a predetermined time has elapsed after dispensing the second reagent measured by the photometric unit 18. Whether the specimen is positive or negative is determined based on the amount.

  The dispensing determination unit 34 determines that an abnormality has occurred in the dispensing of the second reagent when the absorbance after dispensing the second reagent measured by the photometry unit 18 is equal to or less than a preset threshold value. If the dispensing determination unit 34 determines that there is no abnormality in the dispensing of the second reagent, the dispensing determination unit 34 further reacts based on the absorbance at the elapse of a predetermined time after the second reagent dispensing measured by the photometry unit 18. The concentration of the liquid is calculated, and when the calculated concentration is within a predetermined concentration range, it is determined that the dispensing amount of the second reagent is normal.

  The storage unit 35 stores at least information on absorbance measured by the photometry unit 18 in the reaction solution in a predetermined wavelength region. The storage unit 35 stores the determination result of the dispensing determination unit 34.

  If at least the dispensing determination unit 34 determines that an abnormality has occurred in the dispensing of the second reagent, the output unit 36 notifies and outputs that an abnormality has occurred in the dispensing of the second reagent.

  The transmission / reception unit 37 has a function as an interface for transmitting / receiving information to / from the outside according to a predetermined format via a communication network (not shown).

  In the automatic analyzer 1 configured as described above, the sample dispensing mechanism 12 dispenses the sample in the sample container 11a to the plurality of reaction containers 20 that are sequentially transported in a row, and reagent dispensing. After the mechanism 16 dispenses the reagent in the reagent container 15, the photometry unit 18 measures the absorbance of the reaction solution, and the analysis unit 33 analyzes the measurement result, so that the component analysis of the specimen is automatically performed. Is called. Further, the cleaning unit 19 cleans the reaction container 20 that is transported after the measurement by the photometry unit 18 is completed, so that a series of analysis operations are continuously repeated.

(Outline of processing)
Here, when performing CRP inspection which is one of the analysis items, the automatic analyzer 1 uses a latex reagent as the second reagent. First, the automatic analyzer 1 refers to the wavelength-dependent characteristics of the absorbance with respect to the dispensing rate of the latex reagent, and determines whether or not the latex reagent is dispensed into the reaction container 20. Thereafter, the automatic analyzer 1 determines whether the sample is positive or negative based on the amount of change in absorbance only for the latex reagent dispensed.

(Dispensing judgment)
As shown in FIG. 2, the time change in absorbance during the CRP examination greatly changes immediately after the time point t3 when the latex reagent as the second reagent is dispensed. In FIG. 2, curve L1 shows the time change of absorbance when the dispensed amount of latex reagent is 100% and the sample is positive, and curve L2 shows the dispensed amount of latex reagent at 100%. It shows the time change of absorbance when the sample is dispensed and the sample is negative. Curve L3 shows the time change in absorbance when the amount of latex reagent dispensed is 50% and the sample is positive, and curve L4 shows the amount of latex reagent dispensed at 50%. The time change of the absorbance when the sample is negative is shown. Curve L5 shows the temporal change in absorbance when the amount of latex reagent dispensed is 10% and the sample is positive, and curve L6 shows the amount of latex reagent dispensed at 10%. The time change of the absorbance when the sample is negative is shown. Furthermore, the curve L7 shows the time change of the absorbance when the latex reagent is not dispensed. In the CRP test, in order to correctly determine positive or negative, the latex reagent dispensing rate needs 90% or more, and the absorbance value when the dispensing rate is 90% is the absorbance threshold LT.

  That is, when the latex reagent is not dispensed at time t3, the absorbance does not change after time t3 as shown by curve L7, and maintains the same constant value as before time t3. On the other hand, when the latex reagent is dispensed at time t3, immediately after time t3, the absorbance rapidly increases corresponding to the increase in the dispensing rate (dispensing rate 10% → point P3, dispensing rate 50). % → point P2, dispensing rate 100% → point P1). Thereafter, when the sample is negative, the absorbance value that suddenly increased is maintained (curves L2, L4, and L6), and when the sample is positive, the absorbance value that suddenly increased gradually increases with time. Absorbance change is shown (curves L1, L3, L5). Therefore, when the dispensing rate of the latex reagent is as low as 10%, the absorbance change when undispensed (curve L7) and the absorbance change when the sample is negative (curve L6) are both absorbance values with no time change. Is constant and the absorbance values are close to each other, it was impossible to reliably discriminate between the case where the latex reagent was not dispensed and the case where the latex reagent was dispensed in a small amount and the sample was negative.

  Therefore, in this embodiment, the dispensing determination unit 34 dispenses the latex reagent when the absorbance immediately after the time point t3 exceeds the absorbance corresponding to 90% of the latex reagent dispensed. Judgment is made as Here, as the analysis light, dispensing determination is performed with analysis light of 570 nm used for specimen determination.

(Sample determination)
Thereafter, the analysis unit 33 causes the absorbance value to be indicated by a curve L1 from immediately after time t3 to time t4 with respect to the reaction solution that has been determined to be normally dispensed by the dispensing determination unit 34. It is determined that the sample is positive when the absorbance value P4 is greater than the absorbance value P1 immediately after the time point t3, and the absorbance value does not change as shown by the curve L2, and is almost the same as the absorbance value P1 immediately after the time point t3. When the absorbance values are the same P5, it is determined that the sample is negative.

(Dispensing judgment 2)
Here, FIG. 3 shows the relationship between the dispensing rate of the latex reagent in which the specimen is determined to be negative and the concentration value of the reaction solution. Here, the concentration is proportional to an absorbance difference obtained by subtracting the absorbance after dispensing the second reagent from the absorbance after a predetermined time when the sample is positive. Specifically, when the dispensing rate of the latex reagent is 50%, it is proportional to the absorbance value obtained by subtracting the absorbance at time t3 from the absorbance at time t4 in the curve L3 shown in FIG. As shown in FIG. 3, the curve L11 in which the specimen is determined to be negative increases in concentration value as the dispensing rate decreases, and is difficult to determine when the dispensing rate is 10% or less. Therefore, the specimen determination is preferably performed when the dispensing rate of the latex reagent exceeds 10%. That is, in this dispensing determination 2, the dispensing determination unit 34 replaces the absorbance when the latex reagent dispensing rate is 90% in the above-described dispensing determination with a threshold value, and dispenses the latex reagent. Whether or not the latex reagent is normally dispensed may be determined using the absorbance corresponding to the rate of 10% as a threshold value.

  Therefore, in this dispensing determination 2, the absorbance threshold LT in the dispensing determination described above is set as the absorbance value when the latex reagent dispensing rate is 10%. However, as described above, this absorbance value is close to the undispensed absorbance value, and thus it is difficult to distinguish it. For this reason, as shown in FIG. 4, not the absorbance at the wavelength of 570 nm, but the absorbance at the wavelength of 340 nm is determined to perform dispensing determination. Of course, it is preferable to use the absorbance at a wavelength of 340 nm not only in the dispensing determination 2 but also in the dispensing determination described above.

  That is, as shown in FIG. 4, the curve L21 showing the wavelength dependence of the absorbance when the latex reagent dispensing rate is 100% and the wavelength dependence of the absorbance when the latex reagent dispensing rate is 0% are shown. The curve L22 shown indicates that the absorbance value increases as the wavelength becomes shorter, but the difference in absorbance also increases. Therefore, for dispensing determination, the wavelength is 340 nm, which is shorter than the wavelength of 570 nm used for specimen determination. The absorbance value at the time of reagent dispensing is measured.

  Specifically, the difference between the value P11 of the curve L21 at the wavelength of 340 nm and the value P12 of the curve L22 as compared to the difference between the value P21 of the curve L21 at the wavelength of 570 nm and the value P22 of the curve L22. Is bigger. Then, considering the curve L23 when the dispensing rate of the latex reagent is 10%, the curve at the wavelength of 340 nm is compared with the difference between the value P23 of the curve L23 at the wavelength of 570 nm and the value P22 of the curve L22. Is the difference between the value P13 of the L23 and the value P12 of the curve L22 larger, and is the measurement with the wavelength 340 nm surely the latex reagent dispensing rate is 10% or less than the measurement with the wavelength 570 nm? % Can be judged. Curve LT1 shows the wavelength dependency of absorbance when the dispensing rate of the latex reagent is 90%, and the value LT at a wavelength of 570 nm corresponds to the absorbance threshold LT shown in FIG. Even when determining whether or not the dispensing rate is 90%, as described above, it is possible to make a more reliable determination by determining at a wavelength of 340 nm. The wavelength 340 nm is only required to be shorter than the wavelength 570 nm. For example, the wavelength 340 nm may be measured in the wavelength region A1 of 300 nm to 400 nm.

  That is, in this dispensing determination 2, the latex reagent has a greater absorbance for the wavelength region A1 than the absorbance of the first reagent (absorbance when the latex reagent is not dispensed), and the reaction immediately after the latex reagent is dispensed. When the absorbance in the wavelength region A1 of the liquid is measured and the measured absorbance is a predetermined threshold (an absorbance value corresponding to a dispensing rate of 10%), for example, the value P13 or less, the latex reagent is dispensed normally. Judge as not done. Subsequent specimen determination is as described above.

  FIG. 4 shows the wavelength dependence of absorbance with the latex reagent dispensing rate as a parameter, but FIG. 5 shows the relationship between the absorbance and latex reagent dispensing rate. In FIG. 5, curve L31 shows the relationship between the absorbance measured at a wavelength of 340 nm and the dispensing rate of the latex reagent, and curve L32 shows the relationship between the absorbance measured at a wavelength of 570 nm and the dispensing rate. As can be seen from FIG. 5, even when the dispensing rate of the latex reagent is 10%, the absorbance value P13 at the wavelength of 340 nm is larger than the absorbance value P23 at the wavelength of 570 nm, and the absorbance value P23 By using the absorbance value P13 for threshold determination instead, the threshold determination can be performed easily and reliably.

(Negative judgment)
When the sample is negative, as shown in FIG. 3, it is difficult to determine the negative curve L11 when the concentration rate increases with a decrease in the dispensing rate and the dispensing rate is 10% or less. It has become a thing. In this case, the concentration value of the reaction solution for reliably determining whether or not the sample is negative is in the region D shown in FIG. 3 showing the analysis system range when including dispensing accuracy and the like. The dispensing rate is 90% or more. Therefore, in the dispensing determination described above, it is preferable to use the absorbance value when the dispensing rate is 90% as a threshold value.

  That is, in the case of a negative sample, when the dispensing rate is 90% or more, the determination reliability is high. Even if the dispensing rate is more than 10% and less than 90%, there is a possibility that it will be correctly determined as positive. However, if the negative determination in this region D is actually positive, a positive specimen is selected. I will miss it. Therefore, a dispensing rate with a high degree of reliability of 90% or more, in other words, a sample with only a negative determination within the concentration range D is determined as negative, and the other samples are subject to retest including a positive determination. It is preferable.

  In this embodiment, using the relationship between the characteristic curve L11 and the region D shown in FIG. 3, based on the absorbance value of the reaction solution at the time point t4 (measurement wavelength may be either 570 nm or 340 nm), The concentration value of the reaction solution is obtained, and the dispensing amount of the latex reagent is obtained based on this concentration value. By determining the dispensed amount, it is possible to reconfirm whether the dispensed amount of the latex reagent is a dispensed amount that can finally ensure reliability, and a positive sample may be included as a negative sample. I try to lose sex. In other words, only the latex reagent dispensed amount determined to be negative when it is 90% or more is determined and output as a negative sample.

(Dispensing judgment process)
Here, with reference to the flowchart shown in FIG. 6, the dispensing determination process procedure by the dispensing determination part 34 is demonstrated. In FIG. 6, first, the dispensing determination unit 34 determines whether or not the dispensing operation of the second reagent, which is a latex reagent, has been performed on the reaction container 20 (step S101). When the dispensing operation of the second reagent is not performed in the reaction container 20 (step S101: No), the process proceeds to step S113. On the other hand, when the second reagent dispensing operation is performed (step S101: Yes), the absorbance of the reaction solution measured at 340 nm in the wavelength region A1 immediately after the second reagent dispensing is acquired (step S102).

  Thereafter, the dispensing determination unit 34 determines whether or not the acquired absorbance is equal to or less than a predetermined threshold value (for example, the absorbance value when the dispensing rate of the second reagent is 90%) (step S103). ). If the acquired absorbance is not less than or equal to the threshold value (step S103: No), it is determined that the second reagent is dispensed normally (step S104), and the process proceeds to step S107. On the other hand, when the acquired absorbance is equal to or less than the threshold (step S103: Yes), it is determined that the dispensing of the second reagent is abnormal (step S105), and the dispensing determination unit 34, via the control unit 31, An output indicating that an abnormality has occurred in the dispensing of the second reagent is output to the output unit 36 (step S106), and the process proceeds to step S113.

  Thereafter, the dispensing determination unit 34 acquires the absorbance of the reaction solution measured at 340 nm within the wavelength region A1 after a predetermined time has elapsed (time t4) (step S107), and the concentration of the reaction solution based on the acquired absorbance. Is calculated (step S108). Thereafter, the dispensing determination unit 34 determines whether or not the calculated concentration of the reaction solution satisfies a predetermined concentration range (region D) (the dispensing rate of the second reagent is 90% or more) (step S109). When the calculated concentration of the reaction solution satisfies the predetermined concentration range (step S109: Yes), it is determined that the dispensing amount of the second reagent is normal (90% or more) (step S110), and the process proceeds to step S113. . On the other hand, when the calculated concentration of the reaction solution does not satisfy the predetermined concentration range (step S109: No), it is determined that the dispensing amount of the second reagent is abnormal (less than 90%) (step S111), and dispensing is performed. The determination unit 34 outputs, through the control unit 31, an indication that an abnormality has occurred in the dispensing amount of the second reagent on the output unit 36 (step S112), and proceeds to step S113.

  Thereafter, the dispensing determination unit 34 determines whether or not an analysis end instruction has been received from the control unit 31 (step S113). If no analysis end instruction has been received (step S113: No), the process proceeds to step S101. Then, the above process is repeated. On the other hand, when an instruction to end the analysis is received (step S113: Yes), this process ends.

  As described above, the threshold value in step S103 may be an absorbance value when the dispensing rate of the second reagent is 10%. Further, as described above, the absorbance in steps S102 and S107 is preferably the wavelength region A1, but may be a wavelength region having a wavelength longer than this and including a wavelength of 570 nm used for specimen determination. Moreover, the dispensing determination process except the dispensing amount determination by the concentration determination shown in steps S104 to S112 may be performed.

(Sample determination processing)
Next, a sample determination processing procedure by the analysis unit 33 will be described with reference to the flowchart shown in FIG. In FIG. 7, first, the analysis unit 33 determines whether or not the dispensing determination unit 34 has determined that the dispensing of the second reagent is normal (step S <b> 201). If dispensing of the second reagent is not determined to be normal (step S201: No), the process proceeds to step S207. On the other hand, when it is determined that the second reagent is dispensed normally (step S201: Yes), immediately after the second reagent is dispensed, the absorbance of the reaction solution at a wavelength of 570 nm is acquired (step S202).

  Thereafter, after the second reagent dispensing (time point t3), the analysis unit 33 acquires the absorbance of the reaction solution at a wavelength of 570 nm when a predetermined time has elapsed (time point t4) (step S203). Thereafter, it is determined whether or not the absorbance difference acquired in steps S202 and S203 exceeds a predetermined value that is substantially close to 0 (step S204). If the absorbance difference does not exceed the predetermined value (step S204: No), the sample is determined to be negative and output (step S206). On the other hand, if the absorbance difference exceeds a predetermined value (step S204: Yes), the sample is determined to be positive and output (step S205).

  Thereafter, the analysis unit 33 determines whether or not an analysis end instruction has been received from the control unit 31 (step S207). If the analysis end instruction has not been received (step S207: No), the process proceeds to step S201. The above processing is repeated. On the other hand, when an instruction to end the analysis is received (step S207: Yes), this process ends.

  In this embodiment, the example in which dispensing abnormality is determined when a latex reagent is used as the second reagent has been described. However, the present invention is not limited to this, and the unreacted second reagent in the wavelength region of dispensing determination What is necessary is just to determine whether dispensing of a 2nd reagent is abnormal by giving a big value compared with the light absorbency of a 1st reagent.

It is a schematic diagram which shows schematic structure of the automatic analyzer concerning embodiment of this invention. It is a figure which shows the time change of a light absorbency in a CRP test | inspection. It is a figure which shows the relationship between the dispensing rate of the latex reagent and the density | concentration value of a reaction liquid which a test substance determines to be negative. It is a figure which shows the wavelength dependence of the light absorbency which used the dispensing rate of the latex reagent as a parameter. It is a figure which shows the relationship between the dispensing rate and the light absorbency of the latex reagent which used the wavelength as a parameter. It is a flowchart which shows the dispensing determination processing procedure by a dispensing determination part. It is a flowchart which shows the sample determination processing procedure by an analysis part.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Automatic analyzer 2 Measuring mechanism 3 Control mechanism 11 Specimen transfer part 11a Specimen container 11b Specimen rack 12 Specimen dispensing mechanism 12a, 16a Arm 13 Reaction table 14 Reagent storage 15 Reagent container 16 Reagent dispensing mechanism 17 Stirring part 18 Photometric part 19 Cleaning unit 20 Reaction vessel 31 Control unit 32 Input unit 33 Analysis unit 34 Dispensing determination unit 35 Storage unit 36 Output unit 37 Transmission / reception unit

Claims (7)

In an automatic analyzer that dispenses a first reagent, a sample, and a second reagent in this order into a reaction vessel and analyzes the sample by measuring the absorbance of a reaction solution that reacts in the reaction vessel,
Measuring means for measuring at least the absorbance of the reaction solution in a predetermined wavelength region;
A portion for determining that an abnormality has occurred in the dispensing of the second reagent when the absorbance in the predetermined wavelength region measured by the measuring means is equal to or less than a preset threshold value immediately after the second reagent dispensing. Note judging means,
If the dispensing determination means does not determine that an abnormality has occurred in the dispensing of the second reagent, the absorbance in the analysis wavelength region required for the sample analysis measured by the measuring means, after the second reagent dispensing Analysis means for determining whether the sample is positive or negative based on the amount of change in absorbance from the time until a predetermined time has elapsed,
An automatic analyzer characterized by comprising:   2. The automatic analyzer according to claim 1, wherein the unreacted second reagent has a greater absorbance in the predetermined wavelength region than the absorbance of the first reagent.   The automatic analyzer according to claim 1, wherein the predetermined wavelength region is a shorter wavelength region than the analysis wavelength region. If the dispensing determination means does not determine that an abnormality has occurred in the dispensing of the second reagent, the reaction solution is based on the absorbance at the elapse of a predetermined time after the second reagent dispensing measured by the measuring means. When the calculated concentration is within a predetermined concentration range, it is determined that the dispensing amount of the second reagent is normal,
The analysis unit determines whether the sample is positive or negative when the dispensing determination unit determines that the dispensing amount of the second reagent is normal. Item 4. The automatic analyzer according to any one of Items 1 to 3.   5. The automatic analyzer according to claim 4, wherein the predetermined concentration range is a concentration range when the dispensing amount of the second reagent is 90% or more.   The automatic analyzer according to claim 1, wherein the predetermined wavelength region is 300 nm to 400 nm.   The automatic analyzer according to any one of claims 1 to 6, wherein the second reagent is a latex reagent.

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