JP5430452B2 - Sample analyzer and reagent management method - Google Patents

Description

  The present invention relates to a sample analyzer and a reagent management method for analyzing a predetermined measurement item using at least a first reagent and a second reagent in combination.

  Conventionally, a sample analyzer that analyzes a predetermined measurement item by combining a first reagent and a second reagent is known (see, for example, Patent Document 1).

  In the sample analyzer described in Patent Document 1, barcodes are attached to a first reagent container that contains a first reagent and a second reagent container that contains a second reagent. Based on the reagent information read by the bar code reader, a combination of the first reagent container and the second reagent container is registered in the reagent DB constructed on the hard disk of the control device.

JP 2008-275585 A

  In some cases, the first reagent container and the second reagent container are taken out of the sample analyzer and installed in another sample analyzer. In this case, since the pair information of the first reagent container and the second reagent container is registered only in the reagent DB of the original sample analyzer, in another sample analyzer, the first reagent container and the second reagent container May not be combined properly. At this time, if erroneous pair information is registered in the reagent DB of another sample analyzer, the remaining amount or expiration date of the reagent in the first reagent container, the remaining amount of the reagent in the other second reagent container, The expiration date does not match, and there is a possibility that a reagent that can be originally used cannot be used depending on the remaining amount of reagent in the reagent container and the expiration date.

  The present invention has been made in view of such problems, and an object thereof is to provide a sample analyzer and a reagent management method capable of appropriately combining reagents used in combination.

A first aspect of the present invention relates to a sample analyzer that analyzes a predetermined measurement item using at least a first reagent and a second reagent in combination. The sample analyzer according to this aspect includes a first reagent container that includes a first storage medium in which the first reagent is accommodated and information is read and written , and a second reagent in which the second reagent is accommodated and information is read and written . A reagent container holding unit capable of holding a second reagent container having a storage medium, a communication unit capable of communicating with the first and second storage media, and information in the first and second storage media via the communication unit A readable / writable control unit. Here, the control unit writes specific information for identifying the second reagent container paired with the first reagent container into the first storage medium of the first reagent container via the communication unit. Mu

  According to the sample analyzer of the first aspect, the specific information for specifying the second reagent container paired with the first reagent container is written in the first storage medium. Thereby, even when the first reagent container and the second reagent container are set in different sample analyzers, the second reagent container paired with the first reagent container can be clearly determined.

In the sample analyzer according to this aspect, the first storage medium stores first reagent management information for managing the first reagent, and the second storage medium manages the second reagent. Second controller management information is stored, and the control unit acquires the second reagent management information from the second storage medium via the communication unit and is included in the acquired second reagent management information. Information may be configured to be written as the specific information in the first storage medium via the communication unit .

In this case, the first and second reagent management information includes at least measurement item information and a lot number, and the control unit acquires the measurement item acquired from the first and second storage media via the communication unit. When the information is the same, the specific information may be written to the first storage medium via the communication unit .

Further, the first and second reagent management information includes a serial number assigned to a reagent, and the control unit uses the serial number stored in the second storage medium as the specific information as the communication unit. It may be configured to write in the first storage medium through.

Further, the sample analyzer of the present embodiment, the control unit has the the specific information acquired from the first storage medium via the communication unit, via the communication unit acquires from the second storage medium wherein Based on the second reagent management information, it may be configured to determine whether the first reagent container that has acquired the specific information and the second reagent container that has acquired the second reagent management information are paired.

Further, in the sample analyzer according to this aspect, the first storage medium stores first unique information uniquely given to the first storage medium, and the second storage medium is stored in the second storage medium. storing the second unique information attached to specific, the control unit, together with the second storage medium via the front Symbol communications unit obtains the second unique information, the acquired second unique information The specific information may be written to the first storage medium via the communication unit .

In this case, the control unit is configured and the particular information obtained from the first storage medium via the communication unit, and the second specific information acquired from the second storage medium via the communication unit matches In this case, the first reagent container that has acquired the specific information and the second reagent container that has acquired the second unique information may be determined to be paired.

Further, the sample analyzer of the present embodiment, the communication unit may be a wireless communication that can be configured via radio waves and said first and second storage medium. Here, the control unit, via the front Symbol communications unit, by wireless communications may be configured to read and write information to first and second storage medium.

  Further, in the sample analyzer according to this aspect, the first and second storage media may be configured to be RFID tags.

Moreover, in the sample analyzer according to this aspect, the control unit may be configured to write the specific information to the first storage medium via the communication unit as information that cannot be overwritten. In this way, there is no possibility that new pair information is overwritten on the RFID tag and a new pair is created.

According to a second aspect of the present invention, there is provided a first reagent container that includes a first storage medium that contains a first reagent and that reads and writes information via a communication unit, and a second reagent that is accommodated via the communication unit. The present invention relates to a reagent management method for combining with a second reagent container including a second storage medium from which information is read and written . In the reagent management method according to this aspect, information is acquired from the first storage medium and the second storage medium via the communication unit, and the second reagent container is connected to the first reagent container based on the acquired information. determined to become a pair, before Symbol first storage medium, the identification information for identifying the second reagent container becomes the first reagent container paired, write No write via the communication unit.

  According to the reagent management method according to the second aspect, the same effect as in the first aspect can be obtained.

  As described above, according to the present invention, it is possible to provide a sample analyzer and a reagent management method capable of appropriately combining reagents used in combination.

  The effects and significance of the present invention will become more apparent from the following description of embodiments. However, the embodiment described below is merely an example when the present invention is implemented, and the present invention is not limited to the following embodiment.

It is a perspective view which shows the whole structure of the sample analyzer which concerns on embodiment. It is a top view which shows the structure at the time of seeing the measurement mechanism part which concerns on embodiment from the upper side. It is a perspective view at the time of remove | excluding a cover part from the reagent installation part which concerns on embodiment. It is a perspective view in case the cover part is attached to the reagent installation part which concerns on embodiment. It is a perspective view which shows the structure of the R1 reagent container which concerns on embodiment, R2 reagent container, and R3 reagent container. It is a top view which shows typically the structure at the time of seeing the vicinity of the antenna which concerns on embodiment from the upper side. It is a conceptual diagram which shows the specific information and reagent management information which are memorize | stored in the RFID tag which concerns on embodiment. It is a figure which shows the circuit structure of the measurement mechanism part which concerns on embodiment. It is a figure which shows the circuit structure of the control apparatus which concerns on embodiment. It is an illustration figure of the screen which shows the arrangement | positioning state of the reagent displayed on the display part of the control apparatus which concerns on embodiment. It is a flowchart which shows the measurement preparation operation | movement of the inner side table and outer side table which concern on embodiment. It is a conceptual diagram which shows the example of a change of the specific information memorize | stored in the RFID tag which concerns on embodiment, and reagent management information.

  In the present embodiment, the present invention is applied to a sample analyzer for testing various items such as hepatitis B, hepatitis C, tumor marker, and thyroid hormone using a specimen such as blood.

In the sample analyzer according to the present embodiment, magnetic particles (R2 reagent) are bound to a capture antibody (R1 reagent) bound to an antigen contained in a sample such as blood to be measured, and then bound (Bound). An R1 reagent containing an unreacted (Free) capture antibody by attracting the antigen, capture antibody and magnetic particles to a magnet (not shown) of a primary BF (Bound Free) separation unit 11 (see FIGS. 1 and 2) Remove. Then, after binding the antigen to which the magnetic particles are bound and the labeled antibody (R3 reagent), the bound magnetic particles, the antigen and the labeled antibody are separated into the secondary BF separation unit 1.
The R3 reagent containing the unreacted (Free) labeled antibody is removed by pulling it to the second magnet (not shown). Furthermore, after adding a dispersion (R4 reagent) and a luminescent substrate (R5 reagent) that emits light during the reaction with the labeled antibody, the amount of luminescence generated by the reaction between the labeled antibody and the luminescent substrate is measured. Through such a process, the antigen contained in the specimen that binds to the labeled antibody is quantitatively measured.

  Hereinafter, the sample analyzer according to the present embodiment will be described with reference to the drawings.

  FIG. 1 is a perspective view showing the overall configuration of the sample analyzer 1.

  The sample analyzer 1 according to the present embodiment is electrically connected to the measurement mechanism unit 2, the sample transport unit (sampler) 3 disposed so as to be adjacent to the measurement mechanism unit 2, and the measurement mechanism unit 2. And a control device 4.

  The sample transport unit 3 is configured to be able to transport a rack on which a plurality of test tubes containing samples are placed. The control device 4 includes a main body 400 (see FIG. 9), an input unit 410, and a display unit 420. The control device 4 is connected to a handy type barcode reader 17 (see FIG. 9) having a function of reading a barcode.

  FIG. 2 is a plan view showing a configuration when the measurement mechanism unit 2 is viewed from above.

  The measurement mechanism unit 2 includes a sample dispensing arm 5, an R1 reagent dispensing arm 6, an R2 reagent dispensing arm 7, an R3 reagent dispensing arm 8, a reaction unit 9, a cuvette supply unit 10, and a primary. The BF separation unit 11, the secondary BF separation unit 12, the pipette tip supply unit 13, the detection unit 14, the R4 / R5 reagent supply unit 15, and the reagent installation unit 16 are configured.

  The cuvette supply unit 10 is configured to store a plurality of cuvettes, and sequentially supplies the cuvettes one by one to the sample discharge position 1b by the sample dispensing arm 5.

  As shown in the drawing, a pipette 6a for aspirating and discharging the R1 reagent is attached to the R1 reagent dispensing arm 6. The R1 reagent dispensing arm 6 uses the pipette 6a to aspirate the R1 reagent installed in the reagent installing unit 16, and dispense (discharge) the aspirated R1 reagent into the cuvette placed at the specimen discharge position 1b. .

  The pipette tip supply unit 13 conveys a plurality of input pipette tips (not shown) one by one to a tip mounting position (not shown) by the sample dispensing arm 5. Thereafter, the pipette tip is attached to the pipette tip of the sample dispensing arm 5 at the tip mounting position.

  After the pipette tip is mounted at the tip mounting position, the sample dispensing arm 5 sucks the sample in the test tube transported to the sample suction position 1a by the sample transport section 3, and the R1 reagent dispensing arm 6 dispenses the R1 reagent. The sample is dispensed (discharged) into the cuvette at the sample discharge position 1b. The cuvette is transferred to the reaction unit 9 by a catcher (not shown) of the R1 reagent dispensing arm 6.

  As shown in the drawing, a pipette 7a for aspirating and discharging the R2 reagent is attached to the R2 reagent dispensing arm 7. The R2 reagent dispensing arm 7 uses the pipette 7a to aspirate the R2 reagent installed in the reagent installing unit 16, and dispenses (discharges) the aspirated R2 reagent into a cuvette containing the R1 reagent and the sample.

  As shown in the figure, the reaction part 9 is formed in an annular shape so as to surround the circumference of the reagent installation part 16 having a circular shape. Moreover, the reaction part 9 has the some cuvette installation part 9a arrange | positioned at predetermined intervals along the external shape. The cuvette setting part 9a is formed in a circular and concave shape so that the cuvette can be inserted, and has a function of heating the cuvette set in the cuvette setting part 9a to about 42 ° C. Thereby, the sample stored in the cuvette is heated to about 42 ° C. in the reaction unit 9a, and the reaction between the specimen in the cuvette and various reagents is promoted. The reaction unit 9 is configured to be rotatable in the clockwise direction (the direction of the arrow A1), and the cuvette set in the cuvette setting unit 9a is subjected to various processes (such as reagent dispensing). Move to position.

  When the cuvette containing the sample, the R1 reagent, and the R2 reagent is transferred from the reaction unit 9 to the primary BF separation unit 11 by a catcher (not shown), the primary BF separation unit 11 removes the unreacted R1 from the sample in the cuvette. A reagent (unnecessary component) and magnetic particles are separated (B / F separation).

  As shown in the drawing, a pipette 8a for aspirating and discharging the R3 reagent is attached to the R3 reagent dispensing arm 8. The R3 reagent dispensing arm 8 aspirates the R3 reagent installed in the reagent installing unit 16 using the pipette 8a. Further, the R3 reagent dispensing arm 8 dispenses (discharges) the sucked R3 reagent into the cuvette transferred from the primary BF separation unit 11 to the reaction unit 9 by using the pipette 8a.

  When the cuvette containing the sample after the B / F separation by the primary BF separation unit 11 and the R3 reagent is transferred from the reaction unit 9 to the secondary BF separation unit 12 by a catcher (not shown), the secondary BF separation unit 12 Then, unreacted R3 reagent (unnecessary component) and magnetic particles are separated (B / F separation) from the sample in the cuvette.

  The R4 / R5 reagent supply unit 15 sequentially dispenses the R4 reagent and the R5 reagent into a cuvette containing the sample after the B / F separation by the secondary BF separation unit 12 through a tube (not shown).

The detection unit 14 acquires light generated in the reaction process between the labeled antibody that binds to the antigen of the sample that has been subjected to the predetermined processing and the luminescent substrate, by using a photomultiplier tube, and thereby acquires the sample. The amount of antigen contained is measured.

  A circular cover portion 161 is disposed on the upper surface of the reagent placement portion 16 so as to cover both the reagent placement portion 16 and the reaction portion 9. The cover 161 is provided with an opening at a predetermined location, and the cuvette is moved through the opening and a pipetting process is performed.

  FIG. 3 is a perspective view when the cover 161 is removed from the reagent installing unit 16. The reagent installing unit 16 includes an annular inner table 162 and an outer table 163 as viewed from above.

  The inner table 162 is formed with a plurality of holding portions that can hold the R1 reagent container 100 that stores the R1 reagent and a plurality of holding portions that can hold the R3 reagent container 120 that stores the R3 reagent. By this holding portion, the plurality of R1 reagent containers 100 on the inner table 162 are held in an annular shape so as to surround the outer side of the R3 reagent containers 120 arranged in a circle as shown in the figure. The plurality of R1 reagent containers 100 on the inner table 162 are held in a state adjacent to the R3 reagent container 120 in the radial direction, as will be described later.

  The inner table 162 is configured to be horizontally rotatable in the clockwise direction (arrow A1 direction) and the counterclockwise direction (arrow A2 direction). Specifically, the inner table 162 is configured to be rotated by a first stepping motor 162a (see FIG. 8). When the inner table 162 is rotated (turned), the R1 reagent container 100 and the R3 reagent container 120 are rotated (turned) at the same angle in the same direction.

  The outer table 163 is formed with a plurality of holding portions capable of holding the R2 reagent container 110 that stores the R2 reagent. By this holding portion, the R2 reagent container 110 on the outer table 163 is held in an annular shape so as to surround the outer side of the R1 reagent container 100 arranged in a circle as shown in the figure.

  The outer table 163 is configured to be horizontally rotatable in the clockwise direction (arrow A1 direction) and the counterclockwise direction (arrow A2 direction). Specifically, the outer table 163 is configured to be rotated by a second stepping motor 163a (see FIG. 8). The outer table 163 can rotate independently of the inner table 162. The outer table 163 has a function of rotating (turning) while stirring the R2 reagent accommodated in the R2 reagent container 110 to be held.

  In addition, antennas 162b and 163b (see FIG. 8) for reading and writing unique information and reagent management information stored in an RFID tag, which will be described later, are installed inside the inner table 162 and outside the outer table 163. Yes. The arrangement of the antennas 162b and 163b will be described later with reference to FIG.

  FIG. 4 is a perspective view when the cover 161 is attached to the reagent installing unit 16.

  As shown in the drawing, the cover 161 is formed with an inlet / outlet hole 161a so that the R1 to R3 reagent containers can be installed on the inner table 162 or the outer table 163 from the outside. In addition, mounting tables 162c and 163c that are movable in the vertical direction are installed in a region directly below the entrance / exit hole 161a. The mounting tables 162c and 163c are configured to be movable between the height of the cover portion 161 and the heights of the inner table 162 and the outer table 163.

  Thus, if the entrance / exit hole 161a and the mounting bases 162b and 163b are comprised, the user will be able to install or take out the R1 to R3 reagent containers from the upper outside of the cover portion 161. That is, the R1 reagent container 100 and the R3 reagent container 120 (R2 reagent 110) are placed on the placing table 162b (163b) positioned at the height of the cover portion 161 as shown in the drawing, and the placing table 162b (163b) is placed. When moved downward, these reagent containers are set on the inner table 162 (outer table 163). Further, the R1 reagent container 100 and the R3 reagent container 120 (R2 reagent 110) set on the inner table 162 (outer table 163) are moved to the cover table 161 when the mounting table 162b (163b) is moved upward. Moved to the outside of the upper surface of the. In this way, the R1 to R3 reagent containers can be installed or removed.

  Further, as shown in the figure, light emitting portions 164a and 165a of a transmission type sensor are installed on the back surface side of the cover portion 161, and the reagent setting portion 16 below the inner table 162 and the outer table 163 has a transmission property. Light receiving portions 164b and 165b of the type sensor are installed. The light emitted from the light emitting units 164a and 165a is configured to be received by the light receiving units 164b and 165b, respectively. Each holding portion of the inner table 162 and the outer table 163 is formed with an opening (not shown) penetrating in the vertical direction. As a result, when a holding part for holding the fitted R1 reagent container 100 and R3 reagent container 120, which will be described later, is positioned between the light emitting part 164a and the light receiving part 164b, the fitting part is fitted to the holding part. It can be seen that the R1 reagent container 100 and the R3 reagent container 120 are set. In addition, when a holding part for holding the R2 reagent container 110 is positioned between the light emitting part 165a and the light receiving part 165b, it can be seen that the R2 reagent container 110 is set in this holding part.

  5A, 5B, and 5C are perspective views showing configurations of the R1 reagent container 100, the R2 reagent container 110, and the R3 reagent container 120, respectively. In addition, in the same figure, illustration of the lid member is abbreviate | omitted from each reagent container for convenience.

  Referring to FIG. 2A, the container main body 101 of the R1 reagent container 100 has a cylindrical portion 102 formed in a substantially cylindrical shape on the upper side and a storage portion 103 for storing the reagent on the lower side. A circular opening 102 a is provided at the upper end of the cylindrical portion 102, and a pair of cutout grooves 102 b extending in the horizontal direction are formed symmetrically on the side surface of the cylindrical portion 102. A lid member (not shown) is attached to the cylindrical portion 102 of the container body 101 via a support member (not shown) engaged with the notch groove 102b.

Further, as shown in the drawing, a cutout portion 103a extending downward (in the direction of arrow Z2) from the upper surface of the storage portion 103 is formed on one side surface of the storage portion 103 on the side where the cutout groove 102b is provided. The notch 103a is configured to be capable of fitting a protruding portion 123a of the R3 reagent container 120 described later. By fitting the protrusion 123a of the R3 reagent container 120 into the notch 103a of the R1 reagent container 100, the R1 reagent container 100 and the R3 reagent container 120 can be easily arranged adjacent to each other with a predetermined interval. Is possible.

  In addition, an RFID (Radio Frequency IDentification) tag 104 and a barcode label 105 are attached to the side surface opposite to the side surface where the notch 103a is formed, as shown in the figure. Unique information and reagent management information are written in the RFID tag 104, and the unique information and reagent management information of the RFID tag 104 are read and written via radio waves by an antenna 162b described later. In addition, reagent management information is also written on the bar code label 105. The reagent management information of the barcode label 105 is read by the barcode reader 17. The unique information and reagent management information will be described later with reference to FIG.

  Referring to FIG. 2B, the container main body 111 of the R2 reagent container 110 has a configuration substantially similar to that of the R1 reagent container 100. That is, the RFID tag 114 having the same configuration as that of the R1 reagent container 100 and the barcode label 115 are attached to the storage unit 113. Unique information and reagent management information are written in the RFID tag 114, and the unique information and reagent management information of the RFID tag 105 are read and written via radio waves by an antenna 163b described later. In addition, reagent management information is also written on the bar code label 115. The reagent management information of the barcode label 115 is read by the barcode reader 17. The accommodating portion 113 is not formed with a notch corresponding to the notch 103a of the R1 reagent container 100. The cylindrical portion 112 is formed with an opening 112a and a pair of cutout grooves 112b.

  Referring to FIG. 3C, the container main body 121 of the R3 reagent container 120 has a configuration substantially similar to that of the R1 reagent container 100. The cylindrical portion 122 is formed with an opening 122a and a pair of cutout grooves 122b. As shown in the figure, a protruding portion 123a extending downward (in the direction of arrow Z2) from the upper surface of the accommodating portion 123 is formed on one side surface of the accommodating portion 123 on the side where the notch groove 122b is provided. The protruding portion 123a is configured to be fitted into the notch 103a of the R1 reagent container 100 described above.

  Here, the R1 reagent container 100 and the R3 reagent container 120 are set on the holding portion of the inner table 162 in a state where the R1 reagent container 100 and the R3 reagent container 120 are always fitted by the cutout portion 103a and the protruding portion 123a from the start of use. The R1 reagent container 100 and the R3 reagent container 120 are always used for the same measurement. Since it is not necessary to individually identify only the R3 reagent container 120 from such a use situation, the RFID tag and the barcode label are not attached to the R3 reagent container 120. In this case, the R1 reagent container 100 and the R3 reagent container 130 (hereinafter referred to as “R1 / R3 reagent container”) fitted according to the reagent management information read from the RFID tag and barcode label attached to the R1 reagent container 100. Are identified.

  FIG. 6 is a plan view schematically showing a configuration when the vicinity of the antennas 162b and 163b is viewed from above.

As shown in the figure, the antennas 162b and 163b are located inside the inner table 162 and outside the outer table 163, respectively, and are installed in the reagent installing unit 16. The antenna 162b reads / writes the reagent management information from / to the RFID tag 104 of the R1 / R3 reagent container positioned at the facing position (read / write position 162d) on the inner table 162 by wireless communication via radio waves. As described above, the RFID tag of the R1 / R3 reagent container is attached to the R1 reagent container 100. The antenna 163b is the RFID tag 1 of the R1 reagent container 100 that is positioned at a facing position (read / write position 163d) on the outer table 163.
For 04, the reagent management information is read and written by wireless communication via radio waves.

  When the reagent management information of the RFID tags 104 and 114 cannot be read, the barcode labels 105 and 115 are used. That is, when the RFID tags 104 and 114 cannot be read by the antennas 162b and 163b due to breakage or the like, the user takes out the reagent container from the reagent installing unit 16 and uses the handy type barcode reader 17 connected to the control unit 4. , Read barcode information. Thereby, even when the RFID tag cannot be read, the reagent container can be identified.

  FIG. 7 is a conceptual diagram showing unique information and reagent management information stored in the RFID tags 104 and 114.

  As shown in the figure, the RFID tags 104 and 114 are configured to store 128-byte information. Of the storage capacity of 128 bytes, 16 bytes are allocated to the unique ID area indicating the unique information, and 112 bytes are allocated to the user data area indicating the reagent management information. The unique ID area is an area in which a unique ID that can individually identify the RFID tag is stored, and can only be read. The user data area is an area where the user can freely write information. In the user data area, an area where only reading is performed and writing is not performed (read-only area) and an area where both reading and writing are performed (writeable area) are set.

  In the read-only area, measurement items, lot numbers, serial numbers, reagent types, storage deadlines, and filling amounts are stored. In the writable area, the remaining amount, the expiration date, and pair information are written. In addition, no information is written in the writable area of the RFID tag attached to the reagent container installed on the inner table 162 and the outer table 163 for the first time. The bar code labels 105 and 115 store the same information as the read-only areas stored in the RFID tags 104 and 114, respectively.

  The measurement item indicates a measurement item performed by a reagent stored in a reagent container to which the RFID tag is attached. The R1 / R3 reagent container and the R2 reagent container 110 are uniquely identified by the measurement item, lot number, and serial number (hereinafter referred to as “specific information”). The serial number is a number that allows the reagent container to be uniquely identified within the range of the same lot number and the same measurement item. The R1 / R3 reagent container and the R2 reagent container 110 are the same as the same measurement item. Those having the same lot number are bundled and provided to the user. In addition, the R1 / R3 reagent container and the R2 reagent container 110 are used as a pair having the same measurement item and lot number due to the nature of use.

  The reagent type indicates whether the reagent container to which the RFID tag is attached is an R1 / R3 reagent container or an R2 reagent container 110. The storage period indicates the period for which this reagent can be stored. The filling amount indicates the number of measurements that can be performed with this reagent. The remaining amount indicates the number of remaining measurements that can be performed with this reagent. The expiration date indicates the expiration date when this reagent can be used. The expiration date is set when the reagent starts to be used.

  In the pair information item, specific information of the reagent container paired with this reagent container is written. That is, the specific information of the RFID tag 114 of the R2 reagent container 110 used as a pair is written in the pair information of the RFID tag 104 of the R1 / R3 reagent container that is installed on the inner table 162 for the first time. In addition, the identification information of the RFID tag 104 of the R1 / R3 reagent container used as a pair is written in the pair information of the RFID tag 114 of the R2 reagent container installed on the outer table 163 for the first time.

  FIG. 8 is a diagram illustrating a circuit configuration of the measurement mechanism unit 2.

  The measurement mechanism unit 2 includes a control unit 200, a first stepping motor 162a, a second stepping motor 163a, antennas 162b and 163b, a light emitting sensor unit 211, a light receiving sensor unit 212, and a mechanism unit 213. . The control unit 200 includes a CPU 201, a ROM 202, a RAM 203, a communication interface 204, and an I / O interface 205.

  The CPU 201 executes a computer program stored in the ROM 202 and a computer program loaded in the RAM 203. The RAM 203 is used for reading a computer program recorded in the ROM 202. The RAM 203 is also used as a work area for the CPU 201 when executing these computer programs.

  The communication interface 204 is connected to the sample transport unit 3 and the control device 4. The CPU 201 transmits optical information of the sample (data on the amount of luminescence generated by the reaction between the labeled antibody and the luminescent substrate) to the control device 4 and receives a signal from the control device 4 via the communication interface 204. . Further, the CPU 201 transmits a signal for driving instruction to the sample transport unit 3 via the communication interface 204.

  In addition, the CPU 201 connects to the first stepping motor 162a, the second stepping motor 163a, the antennas 162b and 163b, the light emission sensor unit 211, the light reception sensor unit 212, and the mechanism unit 213 via the I / O interface 205. It is connected.

  The first stepping motor 162 a and the second stepping motor 163 a are driven independently under the control of the CPU 201. The antennas 162b and 163b read the reagent management information of the RFID tags 104 and 114, respectively, under the control of the CPU 201. The reagent management information read by the antennas 162b and 163b is output to the CPU 201 via the I / O interface 205 and stored in the RAM 203. The light emission sensor unit 211 includes light emission units 164a and 165a, and emits light under the control of the CPU 201. The light receiving sensor unit 212 includes light receiving units 164 b and 165 b, and a detection signal of the light receiving sensor unit 211 is output to the CPU 201 via the I / O interface 205. The mechanism unit 213 includes other mechanisms of the measurement mechanism unit 2 and is driven by the control of the CPU 201.

  FIG. 9 is a diagram illustrating a circuit configuration of the control device 4.

  The control device 4 includes a personal computer, and includes a main body 400, an input unit 410, and a display unit 420. The main body 400 includes a CPU 401, a ROM 402, a RAM 403, a hard disk 404, a reading device 405, an input / output interface 406, an image output interface 407, and a communication interface 408.

  The CPU 401 executes computer programs stored in the ROM 402 and computer programs loaded in the RAM 403. The RAM 403 is used for reading computer programs recorded in the ROM 402 and the hard disk 404. The RAM 403 is also used as a work area for the CPU 401 when executing these computer programs.

The hard disk 404 is installed with various computer programs to be executed by the CPU 401 such as an operating system and application programs, and data used for executing the computer programs. That is, the hard disk 404 is installed with a program for displaying on the display unit 420 based on reagent management information read from the RFID tags 104 and 114, a program for writing pair information to the RFID tags 104 and 114, and the like.

  The reading device 405 is configured by a CD drive, a DVD drive, or the like, and can read a computer program and data recorded on a recording medium. An input unit 410 such as a mouse or a keyboard is connected to the input / output interface 406, and data is input to the control device 4 when the operator uses the input unit 410. The image output interface 407 is connected to a display unit 420 configured with a display or the like, and outputs a video signal corresponding to the image data to the display unit 420. The display unit 420 displays an image based on the input video signal. Further, the communication interface 408 enables data transmission / reception to / from the measurement mechanism unit 2 and the barcode reader 17.

  FIG. 10 is an exemplary view of a screen showing a reagent arrangement state displayed on the display unit 420 of the control device 4. The screen showing the reagent arrangement state includes a reagent arrangement display area 510 and an operation determination display area 520.

  Inside the reagent arrangement display area 510 (hereinafter referred to as “inner area”), 28 R1 / R3 reagent marks 511 are displayed in an annular shape, and outside the reagent arrangement display area 510 (hereinafter referred to as “outer area”). ), 28 R2 reagent marks 512 are displayed in an annular shape. The R1 / R3 reagent mark 511 and the R2 reagent mark 512 are respectively an R1 / R3 reagent container held in each holding part of the inner table 162 and an R2 reagent container held in each holding part of the outer table 163. 120.

  The R1 / R3 reagent mark 511 includes a position display unit 511a that displays the position of the holding unit, and a content display unit that displays the measurement items and the remaining amount of the RFID tag 104 of the R1 reagent container 100 held in the holding unit. 511b is included. Similarly, the R2 reagent mark 512 includes a position display unit 512a that displays the position of the holding unit, and a content display that displays the measurement items and the remaining amount of the RFID tag 114 of the R2 reagent container 110 held in the holding unit. Part 512b.

  If it is determined that the measurement can be performed without any problem based on the reading results of the RFID tags 104 and 114, the R1 / R3 reagent mark 511 and the R2 reagent mark 512 corresponding to the holding part of the reagent container are, for example, Displayed as shown in the holding position (2) of the inner area and the holding position (17) of the outer area. If it is determined that there is no reagent container to be used as a pair based on the reading results of the RFID tags 104 and 114, as shown in the holding position (15) in the inner area and the holding position (1) in the outer area, R1 / R3 reagent mark 511 and R2 reagent mark 512 corresponding to the holding part of the container are surrounded by a thick line.

  In addition, if it is determined that the reagent container is not set based on the light emitting sensor unit 211 and the light receiving sensor unit 212, the content display unit corresponding to this holding unit becomes blank. If it is determined that the remaining amount of the reagent container is low based on the reading results of the RFID tags 104 and 114, as shown in the holding position (18) of the inner area and the holding position (5) of the outer area, The content display part corresponding to the part is displayed with slanted lines at narrow intervals. When it is determined that the remaining amount of the reagent container is 0 or the expiration date has expired, the contents corresponding to this holding portion are shown in the holding position (22) of the inner area and the holding position (9) of the outer area. The display section is displayed with wide-interval diagonal lines. When the RFID tags 104 and 114 cannot be used due to a reading error, as shown in the holding position (26) of the inner area and the holding position (13) of the outer area, the content display section corresponding to the holding section is displayed in a grid, “Error” is displayed in the content display area.

  The operation determination display area 520 includes a measurement start button 521 and a measurement interruption button 522. When the measurement start button 521 is pressed, the measurement is started, and when the measurement interruption button 522 is pressed, the measurement is interrupted.

  FIG. 11 is a flowchart showing the measurement preparation operation of the inner table 162 and the outer table 163. The measurement preparation operations for the inner table 162 and the outer table 163 are executed in parallel when the measurement start button 521 in FIG. 10 is pressed. Hereinafter, only the measurement preparation operation of the inner table 162 will be described, but the measurement preparation operation of the outer table 163 is performed in the same manner.

  When the CPU 201 of the measurement mechanism unit 2 receives the measurement preparation operation instruction from the control device 4 when the measurement start button 521 is pressed, the CPU 201 drives the first stepping motor 162a to rotate the inner table 162 to the initial position. (S11). Thereby, the rotation position of the inner table 162 is adjusted to the origin, and the subsequent rotation positions are adjusted appropriately. Subsequently, the CPU 201 rotates the inner table 162 to check whether the R1 / R3 reagent container is held in each holding unit (S12). At the time of such a check, as described above, the light emitting unit 164a and the light receiving unit 164b are used.

  Next, the CPU 201 rotates the inner table 162 to move the R1 / R3 reagent container to the read / write position 162d (S13). Subsequently, the CPU 201 reads the reagent management information from the RFID tag 104 attached to the R1 reagent container 100 by the antenna 162b (S14), associates the read reagent management information with the holding unit, and stores it in the RAM 203 of the measurement mechanism unit 2. Store (S15).

  Subsequently, the CPU 201 determines whether or not the reading of the reagent management information has been completed for all the R1 / R3 reagent containers on the inner table 162 (S16). When the reading of all the reagent management information is completed (S16: YES), the process proceeds to S17. When the reading of all the reagent management information is not completed (S16: NO), the process returns to S13 and is next. The same processing is performed for the R1 / R3 reagent container held in the holding portion.

  Subsequently, the CPU 201 causes the process to wait until reading of the reagent management information is completed for all the R2 reagent containers 110 on the outer table 163 (S17). When reading of the reagent management information for all the R2 reagent containers 110 on the outer table 163 is completed, the reagent management information for all the R2 reagent containers 110 on the outer table 163 is stored in the RAM 203 of the measurement mechanism unit 2. become.

  Next, the CPU 201 rotates the inner table 162 to move the R1 / R3 reagent container to the read / write position 162d (S18). The CPU 201 determines whether the R1 / R3 reagent container positioned at the read / write position 162d is a reagent container installed for the first time (S19). That is, the CPU 201 determines whether there is specific information in the pair information item of the R1 / R3 reagent container based on the reagent management information stored in the RAM 203. If there is no specific information in the pair information item, it is determined that this R1 / R3 reagent container is the first reagent container installed. If there is specific information in the pair information item, this R1 / R3 reagent container is installed for the first time. It is determined that the reagent container has not been used.

If this R1 / R3 reagent container is the first reagent container installed (S19: YES), the CPU 201 determines whether the R2 reagent container 110 that can be paired with this R1 / R3 reagent container is on the outer table 163. (S20). That is, the CPU 201 has the same measurement item as the measurement item of the R1 / R3 reagent container based on the reagent management information stored in the RAM 203, and is installed for the first time (no specific information as pair information). Reagent container 11
It is determined whether 0 is on the outer table 163.

  When the R2 reagent container 110 that can be paired is on the outer table 163 (S20: YES), the CPU 201 writes the specific information of the R2 reagent container 110 that can be paired in the pair information of the R1 / R3 reagent container (S21). . On the other hand, if there is no R2 reagent container 110 that can be paired on the outer table 163 (S20: NO), the CPU 201 stores in RAM 203 that there is no pair in this R1 / R3 reagent container (S23).

  On the other hand, if this R1 / R3 reagent container is not the first reagent container installed (S19: NO), the CPU 201 determines whether the R2 reagent container 110 paired with this R1 / R3 reagent container is on the outer table 163. (S22). That is, based on the reagent management information stored in the RAM 203, the CPU 201 determines whether or not the R2 reagent container 110 that matches the specific information written in the pair information of the R1 / R3 reagent container is on the outer table 163. judge.

  If the paired R2 reagent container 110 is on the outer table 163 (S22: YES), the process proceeds to S24, and if the paired R2 reagent container 110 is not on the outer table 163 (S22: NO), the CPU 201 Stores in RAM 203 that there is no pair in the R1 / R3 reagent container (S23).

  Next, in S24, the CPU 201 determines whether or not the processing of S18 to S23 is completed for all the R1 / R3 reagent containers held in the inner table 162. CPU201 performs the process of S18-S23 until the process of S18-S23 is completed about all the R1 / R3 reagent containers. When the processing of S18 to S23 is completed for all the R1 / R3 reagent containers (S24: YES), the measurement preparation operation of the inner table 162 ends.

  When the measurement preparation operation of the inner table 162 is completed, the CPU 201 controls the reagent management information stored in the RAM 203 and the information stored when the process of S23 is executed via the communication interface 204. Transmit to device 4. Based on the received information, the CPU 401 of the control device 4 displays a screen showing the reagent arrangement state as shown in FIG. In this case, the reagent mark of the reagent container in which the process of S23 has been executed is surrounded by a thick line as described above. Further, in the remaining amount of the reagent displayed in the content display sections 511 and 512, when the reagent container is the first reagent container installed, the filling amount of the reagent management information is displayed, and this reagent container is installed for the first time. If it is not a reagent container, the remaining amount of reagent management information is displayed.

  As described above, according to the present embodiment, when the R1 / R3 reagent container is first installed on the inner table 162, if the R2 reagent container 110 that can be paired exists on the outer table 163, the RFID of the R2 reagent container 110 is provided. The specific information of the tag 114 is written in the pair information of the RFID tag 104 of the R1 / R3 reagent container. Further, when the R2 reagent container 110 is first installed on the outer table 163, if there is an R1 / R3 reagent container that can be paired on the inner table 162, the specific information of the RFID tag 104 of this R1 / R3 reagent container is: It is written in the pair information of the RFID tag 114 of the R2 reagent container 110. In this way, because the paired reagent container specific information is written in the RFID tags of these reagent containers, even when the R1 / R3 reagent container and the R2 reagent container 110 are set in different sample analyzers, Paired reagent containers can be clearly determined.

In addition, in this way, since the reagent containers to be paired are determined based on the information from the RFID tag, it is possible to prevent the unpaired reagents from being erroneously used for a predetermined measurement item. it can. That is, if the reagent in one of the paired reagent containers is used by mistake, even if the reagent in the proper pair of reagent containers is used thereafter, the reagent that was used incorrectly will disappear first. . For this reason, the remaining reagent must be discarded. According to the present embodiment, as described above, reagents that are not a pair are not erroneously used, so that it is possible to avoid that one of the reagents that make a pair disappears first. For this reason, it is possible to avoid a situation in which the remaining reagent is discarded wastefully, and it is possible to prevent waste of resources.

  As mentioned above, although embodiment of this invention was described, embodiment of this invention is not limited to these.

  For example, in the above embodiment, blood is exemplified as a measurement target, but urine may also be a measurement target. That is, the present invention can be applied to a sample analyzer that uses urine as a test, and further, the present invention can be applied to a clinical sample test apparatus that tests other clinical samples.

  In the above embodiment, in S20, the R2 reagent container 110 having the same measurement item as the measurement item of the R1 / R3 reagent container and installed for the first time (there is no specific information as pair information) is the outer table. 163 is determined. However, not limited to this, the R2 reagent container 110 having the same measurement item and lot number as the measurement item and lot number of the R1 / R3 reagent container and installed for the first time (no specific information as pair information) It may be determined whether it is on the outer table 163.

  Moreover, in the said embodiment, reagent management information is memorize | stored in a non-contact-type IC tag (RFID tag), and the information is read and written by radio | wireless communication via an electromagnetic wave. However, the present invention is not limited to this, and reagent management information may be stored in the contact IC tag, and the information may be read and written by wired communication via a reader / writer terminal.

  In the above embodiment, the pair item is written with the measurement item, lot number, and serial number of the reagent container as a pair, but not limited thereto, as shown in FIG. Only the serial number of the paired reagent container may be used. That is, as described above, the serial number is a number capable of uniquely identifying the reagent container within the range of the measurement item and the lot number, and the measurement item and the lot number are the same for the paired reagent container. For this reason, if the serial number is written as specific information in the pair information of the reagent container, from the measurement item and lot number obtained from the read-only area of this reagent container, and the serial number of the pair information written in the writable area, A pair of reagent containers can be uniquely identified as in the above embodiment.

  Further, the unique information held in the unique ID area of the RFID tag of the reagent container as a pair may be written in the pair information as shown in FIG. As described above, the unique ID is an ID that enables individual identification of the RFID tag. For this reason, if the unique ID is written as the identification information in the pair information of the reagent container, it becomes possible to uniquely identify the reagent container to be paired as in the above embodiment.

  Further, the pair information may be stored in the writable area as overwriting prohibition information. By doing so, there is no possibility that new pair information is overwritten on the RFID tag and a new pair is created.

  In addition, the embodiment of the present invention can be variously modified as appropriate within the scope of the technical idea shown in the claims.

DESCRIPTION OF SYMBOLS 1 ... Sample analyzer 100 ... R1 reagent container (1st reagent container)
104 ... RFID tag (first storage medium)
110 ... R2 reagent container (second reagent container)
114 ... RFID tag (second storage medium)
120 ... R3 reagent container (first reagent container)
162 ... Inner table (reagent container holding part)
162b ... Antenna (wireless communication unit)
163 ... Outer table (reagent container holding part)
163b ... Antenna (wireless communication unit)
201: CPU (control unit)

Claims (11)

A sample analyzer for analyzing a predetermined measurement item using a combination of at least a first reagent and a second reagent,
Wherein the first reagent is housed, a first reagent container with a first storage medium in which information is read or written, and, the second reagent is accommodated, the second reagent container with a second storage medium on which information is read or written A reagent container holding unit capable of holding;
A communication unit capable of communicating with the first and second storage media;
A control unit capable of reading and writing information to and from the first and second storage media via the communication unit ,
Wherein the control unit, the specific information for identifying the first reagent container and the second reagent container to be paired, via the communication unit, write No write on the first storage medium of the first reagent container,
A sample analyzer characterized by that. The sample analyzer according to claim 1,
The first storage medium stores first reagent management information for managing the first reagent,
The second storage medium stores second reagent management information for managing the second reagent,
The control unit acquires the second reagent management information from the second storage medium via the communication unit, and uses the information included in the acquired second reagent management information as the specific information as the communication unit. Write to the first storage medium via
A sample analyzer characterized by that. The sample analyzer according to claim 2,
The first and second reagent management information includes at least measurement item information and a lot number,
Wherein, when said measurement item information acquired from the first and second storage medium via the communication unit is the same, via the communication unit, writes the specific information into said first storage medium ,
A sample analyzer characterized by that. The sample analyzer according to claim 3,
The first and second reagent management information includes a serial number assigned to the reagent,
The control unit writes the serial number stored in the second storage medium as the specific information to the first storage medium via the communication unit .
A sample analyzer characterized by that. In the sample analyzer according to any one of claims 2 to 4,
Wherein the control unit is configured and the particular information obtained from the first storage medium via the communication unit, based on the obtained second reagent management information from the second storage medium via the communication unit, wherein Determining whether the first reagent container that acquired the specific information and the second reagent container that acquired the second reagent management information are paired;
A sample analyzer characterized by that. The sample analyzer according to claim 1,
The first storage medium stores first unique information uniquely assigned to the first storage medium,
The second storage medium stores second unique information uniquely given to the second storage medium,
Wherein the control unit, together with the through pre Symbol communications unit obtains the second unique information from the second storage medium, the obtained second unique information, as the specific information, said via said communication unit Write to the first storage medium,
A sample analyzer characterized by that. The sample analyzer according to claim 6,
Wherein, when the the specific information acquired from the first storage medium via the communication unit, and via the communication unit acquired from the second storage medium said second unique information match, Determining that the first reagent container from which the specific information has been acquired and the second reagent container from which the second specific information has been acquired are paired;
A sample analyzer characterized by that. In the sample analyzer according to any one of claims 1 to 7,
The communication unit is capable of wireless communication via radio waves and said first and second storage medium,
Wherein the control unit, via the front Symbol communications unit, by wireless communication, reads and writes information to the first and second storage medium,
A sample analyzer characterized by that. In the sample analyzer according to any one of claims 1 to 8,
The first and second storage media are RFID tags;
A sample analyzer characterized by that. In the sample analyzer according to any one of claims 1 to 9,
The control unit writes the specific information as information that cannot be overwritten to the first storage medium via the communication unit .
A sample analyzer characterized by that. A first reagent container that contains a first storage medium that contains a first reagent and that reads and writes information via a communication unit, and a second memory that contains a second reagent and that reads and writes information via the communication unit A reagent management method for combining with a second reagent container comprising a medium ,
Obtaining information from the first storage medium and the second storage medium via the communication unit;
Determining that the second reagent container is paired with the first reagent container based on the acquired information;
Before SL in the first storage medium, the specific information for specifying the second reagent container comprising a first reagent container paired, write No write via the communication unit,
And a reagent management method.

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