JP2009175031A - Substrate type reagent, apparatus, method, and program for manufacturing inspection, apparatus, method, and program for analysis, server, method, and program for management, and recording medium - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To easily determine the presence or absence of defects of spent substrate type reagents. <P>SOLUTION: A card type reagent 100 is used for each analysis and provided with a reagent on a substrate. The card type reagent 100 is provided with an analytical region 120 and a two-dimensional bar code 130 on a card substrate 110. The analytical region 120 is a region provided with the reagent on the card substrate 110 for sample analysis. The two-dimensional bar code 130 records at least an image ID for identifying image information of the analytical region 120 photographed when manufactured and a card ID related to the image ID for identifying the card type reagent 100. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

  The present invention relates to a base-type reagent in which a reagent is provided on a base material used for each analysis. The present invention also relates to a manufacturing / inspection apparatus for the base-type reagent, an analyzer using the base-type reagent, and a management server for managing the base-type reagent. Furthermore, the present invention relates to a manufacturing inspection method, an analysis method, a management method, a manufacturing inspection program, an analysis program, a management program, and a recording medium.

  Conventionally, an image of a product is taken at a manufacturing stage as quality control for the product at a manufacturing site. For example, in a semiconductor manufacturing process, a technique has been proposed in which the presence or absence of a defect is determined by analyzing a photographed image (see, for example, Patent Document 1 below).

  On the other hand, conventionally, in clinical tests such as blood coagulation tests and urine tests, so-called monotests in which analysis is performed using a base material type reagent in which a reagent is provided on a base material are known. In such a mono test for a clinical test, a base reagent is used for each analysis. As an example of the base material type reagent, a card type reagent is used in the blood coagulation test. The card-type reagent is a reagent in which an analysis region filled with a reagent is provided on a card substrate, and a sample (blood) can be put into the analysis region and the sample can be analyzed.

  In addition, such a card type reagent is known in which a barcode on which information such as a calibration curve is recorded for each lot is provided on a card base material. By analyzing the calibration curve information recorded on the barcode before analysis, the analyzer can be used as a basis for quantitative determination or qualitative determination of the test sample. However, in such a card-type reagent or analyzer, for example, even if a data abnormality occurs in the analysis result, this abnormality is caused by a defect in the card-type reagent, or a human error of the measurer or There was a problem that it was not possible to immediately grasp whether it was due to a failure of the analyzer.

  Specifically, this card type reagent analyzes blood when the reagent reacts with blood, and once the card type reagent is subjected to analysis, the state before analysis becomes unclear. Therefore, it cannot be verified whether there is a defect in the card type reagent. That is, there is a problem that the situation at the inspection stage of the product cannot be immediately grasped. Therefore, when manufacturing such a card-type reagent, for example, it can be assumed that by applying the technique of Patent Document 1 described above, it is possible to verify the presence or absence of defects during manufacturing.

Japanese Patent Laid-Open No. 2001-155879

  However, when a card-type reagent is manufactured using the technique of Patent Document 1 described above, it is possible to determine the presence or absence of defects in the product at the time of manufacture, but to verify the presence or absence of defects in the product after shipment. There was a problem that could not.

  In the present invention, in order to solve the above-described problems caused by the prior art, when a failure occurs during the analysis, the cause is caused by the manufacturer of the base reagent, or the failure of the analyzer The purpose is to make it easy to verify whether a measurement error is caused by the measurement person.

  In order to solve the above-described problems and achieve the object, the substrate-type reagent according to the present invention is used for each analysis, and in the substrate-type reagent in which the reagent is provided on the substrate, A reagent is provided on the substrate, an analysis region for analyzing the sample, image identification information for identifying at least image information of the analysis region photographed at the time of manufacture on the substrate, and association with the image identification information And a recording area for recording reagent identification information for identifying the base material type reagent.

  According to the present invention, by providing the image identification information and the reagent identification information, it is possible to easily search for an image showing a state before use of the used base material type reagent.

  Further, the base material type reagent according to the present invention is the above-mentioned invention, wherein the base material is a card-like base material, and the analysis region is a region where a certain amount of reagent is provided on the card-like base material. The recording area is an area provided on the card-like base material. According to this invention, the substrate type reagent can be applied to a card-like reagent.

  Further, in the base material type reagent according to the present invention, in the above invention, in addition to the image identification information and the reagent identification information, the recording area includes analysis item information, manufacturing date information of the base material type reagent. And at least one of lot number information, analysis data of the same lot product, expiration date information, and calibration curve information. According to this invention, it is possible to record various information associated with the base reagent in the recording area.

  In the substrate type reagent according to the present invention, the recording area is composed of a barcode or an IC tag provided on the substrate. According to the present invention, the recording area can be easily formed.

  Further, the manufacturing inspection apparatus according to the present invention includes image identification information for identifying image information of an analysis region photographed at the time of manufacture of a base material type reagent used for each analysis, and the base material type reagent. Acquisition means for acquiring reagent identification information for identifying the information, association means for associating the information acquired by the acquisition means, and output means for outputting the information related by the association means It is characterized by.

  According to the present invention, the image identification information and the reagent identification information are output in association with each other, thereby allowing the substrate type reagent to record the image identification information and the reagent identification information, or storing the information in the external server. it can. Therefore, it is possible to easily search for an image showing a state before use of the used base material type reagent.

  Moreover, the analyzer according to the present invention is an analyzer for analyzing a base-type reagent used for each analysis, a reading means for reading reagent identification information recorded on the base-type reagent, and a base material Analyzing means for analyzing the sample injected into the analysis region of the type reagent, discriminating means for discriminating whether or not the analysis result by the analyzing means is abnormal, and discriminating that the analysis result is abnormal by the discriminating means And an association means for associating the reagent identification information read by the reading means with the analysis result, and an output means for outputting the information associated by the association means. .

  According to the present invention, when there is an abnormality in the analysis result, the reagent identification information of the base material type reagent and the analysis result are associated with each other. Can be sent to the management server.

  In addition, the management server according to the present invention includes image information of an analysis region photographed at the time of manufacture of a base material type reagent used for each analysis, and reagent identification information for identifying the base material type reagent. Storage means for storing image identification information for identifying the image information in association with the reagent identification information, acquisition means for acquiring the reagent identification information, and the reagent identification information acquired by the acquisition means A search means for searching the image information stored in the storage means, an analysis means for image analysis of the analysis region of the base-type reagent using the image information searched by the search means, A discriminating unit for discriminating whether or not there is an abnormality in the analysis region based on an analysis result by the analyzing unit; and a presentation unit for presenting the discrimination result by the discriminating unit. That.

  According to this invention, based on the reagent identification information of the base reagent, the image showing the state before use of the base reagent is searched, and the image is analyzed to obtain the base reagent. Since it is determined whether or not there is an abnormality, it is possible to easily verify whether or not there is a defect in the base-type reagent before use.

  Further, the management server according to the present invention provides the substrate-type reagent using the storage unit that stores the determination result determined by the determination unit and the determination result stored in the storage unit. If the determination means for determining whether or not there is a predetermined number or more of the same lot number, and the determination means determines that there are the same lot number or more of the predetermined number, the substrate type reagent of the lot number is abnormal. And a warning means for giving a warning to a certain extent.

  According to this invention, when there are a predetermined number or more of abnormality in the analysis region for the base type reagent of the same lot number, it can be warned that the base type reagent of the lot number is abnormal. Measures such as discontinuation of use and recovery can be taken.

  Further, the substrate-type reagent production inspection method according to the present invention includes image identification information for identifying the image information of the analysis region photographed at the time of production of the substrate-type reagent used for each analysis, An acquisition step of acquiring reagent identification information for identifying the base material type reagent, an association step of associating the information acquired in the acquisition step, and the information associated in the association step are output. And an output step.

  According to the present invention, the image identification information and the reagent identification information are given to the base material type reagent, whereby an image showing a state before use can be easily searched for the used base material type reagent.

  Further, the analysis method of the analyzer according to the present invention reads the reagent identification information recorded in the base material type reagent in the analysis method of the analysis device that analyzes the base material type reagent used for each analysis. A reading step, an analysis step for analyzing the sample injected into the analysis region of the base reagent, a determination step for determining whether or not the analysis result is abnormal, and an abnormality in the analysis result in the determination step An association step for associating the reagent identification information read in the reading step with the analysis result, and an output step for outputting the information associated in the association step. It is characterized by including.

  According to the present invention, when there is an abnormality in the analysis result, the reagent identification information of the base material type reagent and the analysis result are associated with each other. Can be sent to the management server.

  Further, the management method of the substrate type reagent according to the present invention is for identifying the substrate type reagent and the image information of the analysis region taken at the time of manufacture of the substrate type reagent used for each analysis. A storage step for storing the reagent identification information and image identification information for identifying the image information associated with the reagent identification information, an acquisition step for acquiring the reagent identification information, and an acquisition step A search step for searching the image information stored in the storage step using the reagent identification information, and an analysis region of the base-type reagent using the image information searched in the search step An analysis process for image analysis, a determination process for determining whether or not there is an abnormality in the analysis region based on an analysis result of the analysis process, and a presentation process for presenting a determination result by the determination process It is characterized by .

  According to this invention, based on the reagent identification information of the base reagent, the image showing the state before use of the base reagent is searched, and the image is analyzed to obtain the base reagent. Since it is determined whether or not there is an abnormality, it is possible to easily verify whether or not there is a defect in the base-type reagent before use.

  A manufacturing inspection program according to the present invention causes a computer to execute the manufacturing inspection method.

  An analysis program according to the present invention causes a computer to execute the analysis method.

  A management program according to the present invention causes a computer to execute the management method.

  A recording medium according to the present invention is characterized in that the program described above is recorded in a computer-readable manner.

  According to the present invention, when a problem occurs during analysis based on image information on a used base material type reagent, the cause is caused by the base material reagent manufacturer side or a measurer. There is an effect that it is possible to easily verify whether it is caused by the measurer side such as human error or malfunction of the analyzer.

  Referring to the accompanying drawings below, a substrate type reagent, a manufacturing inspection device, an analysis device, a management server, a manufacturing inspection method, an analysis method, a management method, a manufacturing inspection program, an analysis program, a management program, and a recording according to the present invention A preferred embodiment of the medium will be described in detail.

(Embodiment)
(Configuration of card type reagent)
The structure of the base type reagent (hereinafter referred to as “card type reagent”) according to the embodiment of the present invention will be described. FIG. 1 is an explanatory diagram showing a configuration of a card type reagent 100 according to an embodiment of the present invention. The card-type reagent 100 according to the present embodiment is a card-shaped reagent used for blood coagulation tests and used for each analysis. In FIG. 1, a card type reagent 100 is configured to include a card base 110, an analysis region 120, and a two-dimensional barcode 130 as a recording region.

  The card substrate 110 is made of a transparent synthetic resin. The analysis region 120 is provided on the card substrate 110 and includes a reagent filling unit 121, a sample loading unit 122, and an air hole 123. The reagent filling unit 121 is filled with a reagent and has a sealed surface. Further, the reagent filling unit 121 has one end communicating with the sample insertion unit 122 and the other end communicating with the air hole 123.

  From the sample input unit 122, blood as a sample (sample) is input. The charged specimen permeates into the reagent filling unit 121 when the air in the reagent filling unit 121 is discharged from the air hole 123.

  The two-dimensional barcode 130 is a display method code having information in the horizontal direction and the vertical direction. The two-dimensional barcode 130 includes an image ID (corresponding to image identification information) for identifying image information of the analysis region 120 photographed at the time of manufacture and a card ID (reagent identification) for identifying the card-type reagent 100. Corresponding to information). The details of recording the image ID and the card ID on the two-dimensional barcode 130 will be described later in the description of the manufacturing and inspection apparatus shown in FIGS. In addition to this, information recorded on the two-dimensional barcode 130 includes analysis item information, manufacturing date information, lot number information, analysis data of the same lot product, expiration date information, Calibration curve information is included.

  The analysis item information is, for example, analysis item information for a substance involved in the blood function (coagulation and fibrinolysis function) of the human body. The date of manufacture information is information indicating the date of manufacture of the card type reagent 100. The lot number information is information on a number assigned to each fixed manufacturing unit in order to manage the product at the time of manufacturing.

  The analysis data of the same lot product is data when various analyzes are performed on the card-type reagent 100 taken out at the time of manufacture. The expiration date information is information that defines the expiration date, for example, information on the year and month indicating 18 months from the time of manufacture. The calibration curve information is information relating to a calibration curve for reproducing the analysis result using the card type reagent 100. In the present embodiment, the two-dimensional barcode 130 is used as the recording area. However, the present invention is not limited to this, and an RFID (Radio Frequency Identification) tag or a one-dimensional barcode can also be used.

(Configuration of analyzer)
Next, the configuration of the analyzer 200 according to the present embodiment will be described with reference to FIGS. The analysis apparatus 200 according to the present embodiment is for analyzing blood introduced into the card type reagent 100 shown in FIG. FIG. 2A is a perspective view of the analyzer 200 according to the present embodiment. FIG. 2-2 is a top view of the analyzer 200 according to the present embodiment. FIG. 2-3 is a front view of the analyzer 200 according to the present embodiment.

  2A to 2C, the analyzer 200 includes a card insertion unit 201, an operation display unit 202, an operation panel 203, a liquid crystal display unit 204, a printer 205, a printer cover 206, and a scanner 207. And is configured.

  The card type reagent 100 is inserted into the card insertion part 201. The operation display unit 202 includes an LED (Light Emitting Diode), and emits red or green light appropriately according to, for example, analysis or standby. The operation panel 203 accepts an operation input from the measurer, for example, accepts selection of an analysis item, start of printing by the printer 205, and the like. The liquid crystal display unit 204 includes an LCD (Liquid Crystal Display), and displays the analysis result.

  The printer 205 prints the analysis result based on an operation from the measurer on the operation panel 203. The printer cover 206 is a cover that covers the printer 205. The scanner 207 is a barcode scanner that reads the two-dimensional barcode 130 of the card type reagent 100.

(Functional configuration of analyzer)
Next, a functional configuration of the analyzer 200 according to the present embodiment will be described with reference to FIG. FIG. 3 is a block diagram showing a functional configuration of the analyzer 200 according to the present embodiment. In FIG. 3, the analysis apparatus 200 includes an analysis unit 301, a reading unit 302, a determination unit 303, an association unit 304, and an output unit 305.

  The analysis unit 301 analyzes the sample input to the sample input unit 122 of the card type reagent 100. The reading unit 302 reads the two-dimensional barcode 130 provided on the card type reagent 100. The reading unit 302 is realized by the scanner 207 illustrated in FIGS. 2-1 to 2-3. The determination unit 303 determines whether there is an abnormality in the analysis result by the analysis unit 301.

  “Abnormal” here is a result that cannot be obtained by ordinary analysis. Specifically, for example, the analysis result is not valid by comparing the analysis result with reference data based on calibration curve information. Means the case. As a specific example, when an analysis result that can be obtained only as an analysis result for an adult is obtained as an analysis result for an infant, it is determined that the analysis result is not valid.

  The associating unit 304 causes the reading unit 302 to read the two-dimensional barcode 130 and associates the read information with the analysis result by the analyzing unit 301. Specifically, the associating unit 304 associates the card ID read by the scanner 207 with the analysis result.

  The output unit 305 outputs information associated with the association unit 304. The output unit 305 is realized by the liquid crystal display unit 204 and the printer 205 illustrated in FIGS. The output unit 305 can also transmit the information associated by the associating unit 304 to the management server when the analysis apparatus 200 is connected online with a management server (see FIG. 5) described later. .

  The analysis unit 301, the reading unit 302, the determination unit 303, the association unit 304, and the output unit 305 described above are programs and data recorded in a ROM, RAM, magnetic disk, or the like built in the analysis apparatus 200. The CPU executes a predetermined program and controls each unit in the analysis apparatus 200 to realize the function.

(An example of card-type reagent analysis processing performed by the analyzer)
Next, an example of the analysis process of the card type reagent 100 performed by the analyzer 200 according to the present embodiment will be described with reference to FIG. FIG. 4 is a flowchart showing an example of the analysis process of the card type reagent 100 performed by the analyzer 200 according to the present embodiment.

  In FIG. 4, the analyzer 200 reads the two-dimensional barcode 130 by the scanner 207 (step S402) when the card type reagent 100 loaded with the sample is inserted into the card insertion unit 201 (step S401). . Based on the read information, the expiration date is checked, the analysis item is grasped, and the calibration curve information is acquired. If the expiration date has expired, a message to that effect is displayed on the liquid crystal display unit 204.

  Thereafter, the sample is analyzed (step S403). Then, the validity of the analysis result is determined (step S404). When it is determined that the analysis result is valid (step S405: Yes), the analysis result is output from the liquid crystal display unit 204 or the printer 205 (step S406), and the series of processes is terminated. In addition, when connected to a management server described later online, in step S406, information that the analysis result is valid and information recorded in the two-dimensional barcode 130 can be transmitted to the management server. It is.

  On the other hand, if it is determined that the analysis result is not valid (step S405: No), it is determined whether or not the analysis is the first time (step S407). If it is determined in step S407 that the analysis is the first time (step S407: Yes), reanalysis is performed (step S408), and the process proceeds to step S401. In step S408, the liquid crystal display unit 204 may be displayed to urge reanalysis.

  On the other hand, if it is determined in step S407 that it is not the first analysis (step S407: No), that is, if it is the second or subsequent analysis, the analysis result is output and an abnormal comment is pasted (step S409). Then, a series of processing is completed. In step S409, the analysis result and information recorded in the two-dimensional barcode 130 such as a card ID are output in association with each other.

  In step S407, even if it is the first analysis (step S407: Yes), the analysis result may be output and an abnormal comment may be attached without performing reanalysis (step S409). In this case, in the determination of validity at the time of the first analysis, for example, an abnormal comment may be attached only when the reference value to be compared is greatly exceeded.

  In addition, when connected to a management server described later online, in step S409, information indicating that the analysis result is abnormal and information recorded in the two-dimensional barcode 130 may be transmitted to the management server. Is possible. Further, when the connection with the management server is not online, in the process of step S409, the card is used together with the information that the analysis result is abnormal, the information recorded in the two-dimensional barcode 130, the abnormal comment, and the like. It is also possible to notify the management center such as the manufacturer of the mold reagent 100 to urge communication.

  According to the above-described processing, when there is an abnormality in the analysis result, the card ID and the analysis result are associated with each other, so that information indicating that there is an abnormality in the card type reagent 100 and the two-dimensional barcode 130 are recorded. The information can be notified to the measurer or transmitted to the management server.

(Management server configuration)
A configuration of the management server 500 according to the embodiment of the present invention will be described. FIG. 5 is an explanatory diagram showing the configuration of the management server 500 according to the embodiment of the present invention. The management server 500 is arranged in a management center such as a manufacturer or a distributor, and stores image information photographed when the card type reagent 100 is manufactured. The management server 500 includes a PC 501 and receives various inputs from an operator who is engaged.

(Functional configuration of the management server)
Next, a functional configuration of the management server 500 according to the present embodiment will be described with reference to FIG. FIG. 6 is a block diagram showing a functional configuration of the management server 500 according to the present embodiment. 6, the management server 500 includes a storage unit 601, an acquisition unit 602, a search unit 603, an analysis unit 604, a determination unit 605, a presentation unit 606, a storage unit 607, a determination unit 608, a warning Part 609.

  The storage unit 601 identifies the image information of the analysis region 120 photographed at the time of manufacture of the card type reagent 100, the card ID for identifying the card type reagent 100, and the image information associated with the card ID. The image ID is stored. The image information is typically a still image, but may be a moving image. The storage unit 601 stores analysis item information, manufacturing date information, lot number information, analysis data of the same lot product, expiration date information, calibration curve recorded in the two-dimensional barcode 130 of the card type reagent 100. Information may be stored.

  The acquisition unit 602 acquires a card ID. The acquisition unit 602 may acquire a card ID based on an input from an operator via the PC 501, or when the management server 500 is connected online to the analysis device 200 described above, the analysis device 200. The card ID may be acquired based on the transmission from.

  The search unit 603 searches the image information stored in the storage unit 601 using the card ID acquired by the acquisition unit 602. Specifically, the search unit 603 searches for an image associated with the image ID by searching for an image ID associated with the card ID.

  The analysis unit 604 performs image analysis on the analysis region 120 of the card type reagent 100 using the image information searched by the search unit 603. Specifically, the analysis unit 604 performs image analysis of, for example, a reagent (such as bubbles in the reagent filling unit 121) in the analysis region 120 at the time of manufacture.

  The determination unit 605 determines whether there is an abnormality in the analysis region 120 based on the analysis result by the analysis unit 604. Specifically, the determination unit 605 determines the level of bubbles in the reagent filling unit 121 and the presence / absence of bubbles, and determines whether the analysis result is within a reference range as a product. The presentation unit 606 presents the determination result by the determination unit 605. The presentation unit 606 is realized by a display of the PC 501.

  In addition, the storage unit 607 stores the determination result (the presence or absence of abnormality of the card type reagent 100) determined by the determination unit 605. The determination unit 608 uses the determination result stored in the storage unit 607 to determine whether the card type reagent 100 has a predetermined number or more of the same lot number. Specifically, the determination unit 608 uses the lot number based on the card ID of the card type reagent 100 determined to be abnormal by the determination unit 605, and uses the card type having the same lot number as the card type reagent 100. It is determined whether or not the reagent 100 is equal to or greater than a predetermined threshold.

  If the determination unit 608 determines that there is a predetermined number or more of the same lot number, the warning unit 609 issues a warning that there is an abnormality in the card type reagent 100 of the lot number. The information indicating that there is an abnormality is, for example, information indicating that use of the card type reagent 100 with the lot number is prohibited or information indicating that the inspection system of the card type reagent 100 with the lot number is to be reviewed. . The warning that there is an abnormality is made by the presentation unit 606 by voice or display.

(Example of management processing for card-type reagents performed by the management server)
Next, an example of a management process for the card type reagent 100 performed by the management server 500 according to the present embodiment will be described with reference to FIG. FIG. 7 is a flowchart showing an example of management processing for the card-type reagent 100 performed by the management server 500 according to this embodiment.

  In FIG. 7, the management server 500 acquires the card ID of the card type reagent 100 by the acquiring unit 602 (step S701). Note that the card type reagent 100 having the card ID to be acquired is a reagent in which an abnormality has occurred during analysis by the analyzer 200. Further, as described above, the acquisition format of the card ID by the acquisition unit 602 may be based on an input from the operator via the PC 501, or when connected to the analyzer 200 online, the analyzer It may be based on transmission from 200.

  Then, the search unit 603 searches for image information stored in the storage unit 601 using the card ID (step S702). Then, using the retrieved image information, the analysis unit 604 performs image analysis on the analysis region 120 of the card type reagent 100 (step S703). Thereafter, the determination unit 605 determines whether or not the analysis result is within the reference range (step S704). If it is determined in step S704 that the analysis result is within the reference range (step S704: Yes), an abnormality that does not exist in the current standard is newly verified (step S705). In addition, verification in step S705 is performed by an operator's visual observation.

  If there is a new abnormality (step S706: Yes), a new inspection standard is established (step S707), and the series of processes is terminated. On the other hand, when there is no new abnormality (step S706: No), it is determined that there is no abnormality in the card type reagent 100 and the current inspection standard, and a series of processes is ended. The new abnormality is an abnormality that has not occurred in the past, for example, which occurs in the shape of bubbles or the seal state of the reagent filling unit 121.

  If it is determined in step S704 that the analysis result is not within the reference range (step S704: No), the storage unit 607 stores the determination result of “abnormal” (step S708). This discrimination result is recorded and stored for each lot number. Then, the determination unit 608 determines whether or not there are a predetermined number or more of the card type reagents 100 with the same lot number (step S709).

  If it is determined in step S709 that there are a predetermined number or more of the card type reagents 100 having the same lot number (step S709: Yes), the card type reagent 100 having the same lot number is reconfirmed and the inspection system is reviewed (step S710). ), A series of processing ends. In step S710, the warning unit 609 issues warnings such as reconfirmation of the card type reagent 100 and review of the inspection system.

  If it is determined in step S709 that there are not more than a predetermined number of card type reagents 100 with the same lot number (step S709: No), the series of processes is terminated. In this case, the number of times indicating an abnormality with respect to the lot number is counted, and the storage unit 607 stores the number of times.

  According to the processing described above, based on the card ID, an image showing a state before use of the card type reagent 100 is searched, and the card type reagent 100 is analyzed to analyze whether or not there is an abnormality. Therefore, it is possible to easily verify whether or not the card-type reagent 100 before use has a defect.

  Further, when a predetermined number or more of the card type reagents 100 having the same lot number are present in the analysis region 120, there is a warning that the card type reagent 100 of the lot number is abnormal. It is possible to take measures such as reviewing the inspection system and stopping and collecting the use. Further, when there is a new abnormality, a new inspection standard can be established, so that it is possible to improve the accuracy of the product at the time of manufacture.

(Functional configuration of manufacturing inspection equipment)
Next, the functional configuration of the manufacturing inspection apparatus 800 according to the present embodiment will be described with reference to FIG. FIG. 8 is a block diagram showing a functional configuration of the manufacturing / inspection apparatus 800 according to the present embodiment. The production inspection apparatus 800 is an apparatus provided after the freeze-drying of the card-type reagent 100, that is, after the card-type reagent product is completed.

  In FIG. 8, the manufacturing inspection apparatus 800 includes an acquisition unit 801, an association unit 802, an output unit 803, and an imaging unit (not shown). The acquisition unit 801 acquires an image ID for identifying image information of the analysis region 120 of the card type reagent 100 photographed by the photographing unit, and a card ID for identifying the card type reagent 100. The acquisition format by the acquisition unit 801 is based on, for example, reading of a card ID recorded in advance on the two-dimensional barcode 130 of the card type reagent 100 and input of a card ID given at the time of photographing the analysis area 120.

  The associating unit 802 associates the image ID acquired by the acquiring unit 801 with the card ID. Specifically, the associating unit 802 associates the image ID with the card ID recorded in advance on the two-dimensional barcode 130 of the card type reagent 100. The output unit 803 outputs the information associated by the associating unit 802. The information output by the output unit 803 is recorded in the two-dimensional barcode 130 and is stored in the storage unit 601 (see FIG. 6) of the management server 500 by being transmitted to the management server 500 described above.

(Example of information recording process performed by manufacturing inspection equipment)
Next, an example of information recording processing performed by the manufacturing inspection apparatus 800 according to the present embodiment will be described with reference to FIG. FIG. 9 is a flowchart showing an example of information recording processing performed by the manufacturing inspection apparatus 800 according to the present embodiment.

  In FIG. 9, when the product is completed (step S901), the manufacturing inspection apparatus 800 images the analysis region 120 of the card type reagent 100 by the imaging unit (step S902). Then, an ID (image ID) is assigned to the photographed image (step S903). Thereafter, the image ID is associated with the card ID recorded on the two-dimensional barcode 130, and the image ID is recorded on the two-dimensional barcode 130 (step S904). Further, the captured image is stored in the storage unit 601 as the management server 500 (step S905).

  Thereafter, the image is enlarged and a visual check is performed by a plurality of people (step S906). If the shipping standard is satisfied by visual check (step S907: Yes), the product is sent to the packaging machine (step S908), and the series of processes is terminated. On the other hand, when the shipping standard is not satisfied by the visual check (step S907: No), the image is saved and the company control data is acquired (step S909). Then, by analyzing the image of the analysis region 120, it is determined whether or not the state of the analysis region 120 is within the reference range of the company control data (step S910).

  In step S910, when it is determined that the state of the analysis area 120 is within the reference range (step S910: Yes), the shipping standard in the visual check is reviewed (step S911), and the series of processes is terminated. If it is determined that the analysis region 120 is out of the reference range (step S910: No), the card-type reagent 100 is discarded (step S912), and the series of processing ends.

  Even if it is determined in step S907 that the shipping standard is satisfied (step S907: Yes), the company control data is acquired (step S909), and it is determined whether or not the state of the analysis region 120 is within the reference range. May be performed (step S910), and when it is determined that it is within the reference range (step S910: Yes), it may be sent to the packaging machine (step S908). In this case, if it is determined in step S910 that it is not within the reference range (step S910: No), that is, if the shipping standard is satisfied by visual check but is outside the reference range by image analysis, the checker is checked. The inspection system should be reviewed to encourage strengthening.

  According to the processing described above, the card type reagent 100 is manufactured by associating the image ID of the photographed image with the card ID. Therefore, the image showing the state before use of the used card type reagent 100. Can be easily searched. In addition to the visual check, since the image is analyzed using the company's control data, oversight due to the visual check can be prevented. Furthermore, the product can be manufactured with high accuracy by updating the control data as needed based on the new abnormality of the card type reagent 100 obtained by the management server 500.

  In the description using FIGS. 2-1 to 9 described above, the card-type reagent 100 is used as the base-type reagent. However, the card-type reagent 100 is not limited to the card-type reagent 100. It is also possible to use a card. In the following, in addition to the card type reagent 100, another base type reagent capable of realizing the present invention will be described.

(Composition of urine test paper)
FIG. 10 is an explanatory diagram showing the configuration of the urine test paper 1000. As shown in FIG. In FIG. 10, a urine test paper 1000 includes a paper base 1001, a reagent filling unit 1002 as an analysis region, and a two-dimensional barcode 1003 as a recording region. The urine test paper 1000 is a base-type reagent in which the reagent filling unit 1002 reacts to a predetermined color tone by components contained in urine after 10 to 30 seconds when the reagent filling unit 1002 is immersed in urine for 1 second. Then, the density or ratio of the target item is determined by comparing the color tone with which the tester responded and the sample.

  The two-dimensional barcode 1003 includes an image ID (corresponding to image identification information) for identifying image information of the reagent filling unit 1002 photographed at the time of manufacture, and a paper base ID (reagent for identifying the urine test paper 1000). Corresponding to the identification information). In addition, the information recorded in the two-dimensional barcode 1003 includes analysis item information, production date information, lot number information, analysis data of the same lot product, expiration date information, Calibration curve information is included. In addition to the two-dimensional barcode 1003, an RFID tag can be used as the recording area.

  Even when such a urine test paper 1000 is used, if there is an abnormality in the determination result, the used urine test can be performed using information recorded in the two-dimensional barcode 1003 of the urine test paper 1000. For the paper 1000, an image showing a state before use can be easily searched. Therefore, it can be verified whether the abnormality of the determination result is caused by the urine test paper 1000 or not.

(Composition of confirmation judgment reagent for influenza virus)
FIG. 11 is an explanatory diagram showing the configuration of an influenza virus confirmation determination reagent (hereinafter referred to as “flu reagent”) 1100. In FIG. 11, the influenza reagent 1100 includes a test plate 1110, an analysis region 1120, and a two-dimensional barcode 1130.

  The analysis region 1120 includes a sample dropping unit 1121, a determination unit 1122, and a confirmation window 1123. When this influenza reagent 1100 drops a sample on the sample dropping unit 1121 and is left for 15 minutes, a red-purple line is detected in the portion “A” or “B” of the determination unit 1122, and the confirmation window 1123 A positive determination is made when color development is detected.

  The two-dimensional barcode 1130 includes an image ID (corresponding to image identification information) for identifying image information of the analysis region 1120 photographed at the time of manufacture, and a test plate ID (reagent identification information) for identifying the influenza reagent 1100. Equivalent). In addition to the two-dimensional barcode 1130, an RFID tag can be used as the recording area.

  Even when such an influenza reagent 1100 is used, if there is an abnormality in the determination result, the information recorded on the two-dimensional barcode 1130 of the influenza reagent 1100 is used to use the influenza reagent that has been used. For the reagent 1100, an image showing a state before use can be easily searched. Therefore, it can be verified whether or not the abnormality of the determination result is caused by the influenza reagent 1100.

(Composition of pregnancy test drug)
FIG. 12 is an explanatory diagram showing a configuration of the pregnancy test medicine 1200. In FIG. 12, the pregnancy test medicine 1200 includes a base material 1210, an analysis region 1220, and a two-dimensional barcode 1230. The analysis region 1220 includes a sample dropping unit 1221 and a determination unit 1222. When this pregnancy test medicine 1200 dropped urine on the sample dropping unit 1221 and left for 5 to 10 minutes, a red-purple line was detected in both the “T” portion and the “C” portion of the determination unit 1222. In this case, a positive determination is made, and a negative determination is made when a magenta line is detected only on the “C” side.

  The two-dimensional barcode 1230 includes an image ID (corresponding to image identification information) for identifying image information of the analysis region 1220 photographed at the time of manufacture and a base material ID (reagent identification information) for identifying the pregnancy test medicine 1200. Equivalent). In addition to the two-dimensional barcode 1230, an RFID tag can be used as the recording area.

  Even when such a pregnancy test medicine 1200 is used, if there is an abnormality in the determination result, the information used in the two-dimensional barcode 1230 of the pregnancy test medicine 1200 is used, and the used pregnancy test is used. The medicine 1200 can be easily searched for an image showing a state before use. Therefore, it can be verified whether or not the abnormality in the determination result is caused by the pregnancy test medicine 1200.

(Configuration of card-type reagent for allergy testing)
FIG. 13 is an explanatory diagram showing the configuration of an allergy test card type reagent (hereinafter referred to as “allergy test card”) 1300. In FIG. 13, the allergy test card 1300 includes a base material 1310, an analysis region 1320, and a two-dimensional barcode 1330. The analysis region 1320 includes a sample inlet 1321, a developing solution inlet window 1322, and a determination window 1323.

  Here, a usage example of the allergy test card 1300 will be described. First, a processed sample in which blood and a sample processing solution are mixed is dropped into the sample inlet 1321, and after the processed sample penetrates into the determination window 1323, the developing solution is input into the developing solution input window 1322. After that, it is left for 20 minutes, and after a blue color line is detected at the site corresponding to the “control” of the judgment window 1323, the “cedar”, “cat”, and “mite” corresponding to the judgment window 1323 correspond. If a color development line is observed at the site, the corresponding item is determined as a positive reaction.

  The two-dimensional barcode 1330 includes an image ID (corresponding to image identification information) for identifying the image information of the analysis region 1320 photographed at the time of manufacture and a base material ID (reagent identification information for identifying the allergy test card 1300). Equivalent). In addition to the two-dimensional barcode 1330, an RFID tag can be used as the recording area.

  Even when such an allergy test card 1300 is used, if there is an abnormality in the determination result, the used allergy test can be performed using information recorded in the two-dimensional barcode 1330 of the allergy test card 1300. For the card 1300, an image showing a state before use can be easily searched. Therefore, it is possible to verify whether the abnormality of the determination result is caused by the allergy test card 1300.

  As described above, according to the base material type reagent according to the present invention, an image showing the state before use can be easily obtained for the used base material type reagent by adding the image identification information and the reagent identification information. Can be searched. Therefore, if a problem occurs during analysis, the cause is caused by the manufacturer of the substrate type reagent, or by the measurer such as a problem with the analyzer or human error of the measurer. Can be easily verified.

  In addition, the management server according to the present invention searches for an image showing a state of the base material type reagent before use based on the reagent identification information of the base material type reagent, analyzes the image, It is determined whether or not there is an abnormality in the base material type reagent. Therefore, if a problem occurs during analysis, the cause is caused by the manufacturer of the substrate type reagent, or by the measurer such as a problem with the analyzer or human error of the measurer. Can be easily verified. In addition, by accumulating image information of substrate-type reagents in which abnormalities have occurred, new abnormalities can be discovered even in products that were previously determined to be normal. It can be connected to

  Further, according to the analyzer of the present invention, when there is an abnormality in the analysis result, the reagent identification information of the base material type reagent and the analysis result are output in association with each other. It is possible to notify the measurer of the fact that there is information together with the information recorded in the recording area, or to transmit it to the management server.

  Further, according to the production inspection apparatus according to the present invention, the image showing the state before use of the used base material type reagent by adding the image identification information and the reagent identification information to the base material type reagent at the time of manufacture. Can be easily searched. Moreover, the quality at the time of manufacture can be more stabilized by accumulating the image information at the time of abnormality accumulated by the management server.

  Note that the management server management method, analysis device analysis method, and manufacturing inspection device manufacturing inspection method described in the present embodiment execute a prepared program on a computer such as a personal computer or a workstation. Can be realized. This program is recorded on a computer-readable recording medium such as a hard disk, a flexible disk, a CD-ROM, an MO, and a DVD, and is executed by being read from the recording medium by the computer. The program may be a transmission medium that can be distributed via a network such as the Internet.

  The present invention is useful for a base-type reagent in which a reagent is provided on a base material that is used for each analysis.

It is explanatory drawing which shows the structure of the card type reagent concerning embodiment of this invention. It is a perspective view of the analyzer concerning this embodiment. It is a top view of the analyzer concerning this embodiment. It is a front view of the analyzer concerning this embodiment. It is a block diagram which shows the functional structure of the analyzer concerning this Embodiment. It is a flowchart which shows an example of the analysis process of the card-type reagent which the analyzer concerning this Embodiment performs. It is explanatory drawing which shows the structure of the management server concerning embodiment of this invention. It is a block diagram which shows the functional structure of the management server concerning this Embodiment. It is a flowchart which shows an example of the management process with respect to the card type reagent which the management server concerning this Embodiment performs. It is a block diagram which shows the functional structure of the manufacturing inspection apparatus concerning this Embodiment. It is a flowchart which shows an example of the information recording process which the manufacturing inspection apparatus concerning this Embodiment performs. It is explanatory drawing which shows the structure of a urine test paper. It is explanatory drawing which shows the structure of the confirmation determination reagent for influenza viruses. It is explanatory drawing which shows the structure of a pregnancy test | inspection medicine. It is explanatory drawing which shows the structure of the card type reagent for an allergy test.

Explanation of symbols

DESCRIPTION OF SYMBOLS 100 Card type reagent 110 Card base material 120 Analysis area | region 130 Two-dimensional barcode 200 Analyzer 201 Card insertion part 207 Scanner 301 Analysis part 302 Reading part 303 Discriminating part 304 Association part 305 Output part 500 Management server 601 Storage part 602 Acquisition part 603 Search unit 604 Analysis unit 605 Discrimination unit 606 Presentation unit 607 Storage unit 608 Judgment unit 609 Warning unit 800 Manufacturing test device 801 Acquisition unit 802 Association unit 803 Output unit 1000 Urine test paper 1100 Reagent for influenza 1200 Pregnancy test drug 1300 Allergy test card

Claims (15)

In the base-type reagent in which the reagent is provided on the base material used for each analysis,
An analysis region for analyzing a sample by providing a reagent on the substrate;
Image identification information for identifying at least image information of the analysis region photographed at the time of manufacture on the substrate, and reagent identification information for identifying the substrate type reagent associated with the image identification information And a recording area for recording
A substrate-type reagent comprising: The base material is a card-like base material,
The analysis region is a region in which a certain amount of reagent is provided on the card-like base material,
The base material type reagent according to claim 1, wherein the recording region is a region provided on the card-like base material.   The recording area, in addition to the image identification information and the reagent identification information, analysis item information, production date information, lot number information, analysis data of the same lot product, expiration date information, 3. The base reagent according to claim 1, wherein at least one of the calibration curve information is recorded.   The substrate-type reagent according to any one of claims 1 to 3, wherein the recording region comprises a barcode or an IC tag provided on the substrate. Acquires image identification information for identifying the image information of the analysis region photographed at the time of manufacture of the base material type reagent used for each analysis and reagent identification information for identifying the base material type reagent. Acquisition means to
Associating means for associating the information acquired by the acquiring means;
Output means for outputting the information associated by the association means;
A substrate-type reagent manufacturing and inspection apparatus comprising: In an analyzer for analyzing a base-type reagent used for each analysis,
Reading means for reading reagent identification information recorded in the base-type reagent;
An analysis means for analyzing the sample injected into the analysis region of the substrate type reagent;
Discriminating means for discriminating whether or not there is an abnormality in the analysis result by the analyzing means;
An association means for associating the reagent identification information read by the reading means with the analysis result when the determination means determines that the analysis result is abnormal;
Output means for outputting the information associated by the association means;
An analysis apparatus comprising: The image information of the analysis region photographed at the time of manufacture of the base material type reagent used for each analysis, the reagent identification information for identifying the base material type reagent, and the reagent identification information are associated with the reagent identification information. Storage means for storing image identification information for identifying image information;
Obtaining means for obtaining the reagent identification information;
Search means for searching the image information stored in the storage means, using the reagent identification information acquired by the acquisition means;
Using the image information searched by the search means, an analysis means for image analysis of the analysis region of the base material reagent;
Based on the analysis result by the analysis means, a determination means for determining whether or not there is an abnormality in the analysis region,
Presenting means for presenting a discrimination result by the discrimination means;
A management server comprising: Storage means for storing the determination result determined by the determination means;
Using the determination result stored in the storage means, determination means for determining whether or not the base-type reagent has a predetermined number or more of the same lot number;
When it is determined by the determination means that the predetermined lot or more of the same lot number is present, warning means for giving a warning that there is an abnormality in the base material type reagent of the lot number;
The management server according to claim 7, further comprising: Acquires image identification information for identifying the image information of the analysis region photographed at the time of manufacture of the base material type reagent used for each analysis and reagent identification information for identifying the base material type reagent. An acquisition process to
An associating step for associating the information acquired in the acquiring step;
An output step of outputting the information associated in the association step;
A method for producing and inspecting a base material type reagent, comprising: In the analysis method of the analyzer for analyzing the base-type reagent used for each analysis,
A reading step of reading the reagent identification information recorded in the base-type reagent;
An analysis process for analyzing the sample injected into the analysis region of the base reagent;
A determination step of determining whether or not there is an abnormality in the analysis result;
An association step of associating the reagent identification information read in the reading step with the analysis result when it is determined that the analysis result is abnormal in the determination step;
An output step of outputting the information associated in the association step;
The analysis method characterized by including. The image information of the analysis region photographed at the time of manufacture of the base material type reagent used for each analysis, the reagent identification information for identifying the base material type reagent, and the reagent identification information are associated with the reagent identification information. A storage step of storing image identification information for identifying image information;
An acquisition step of acquiring the reagent identification information;
A search step for searching the image information stored in the storage step using the reagent identification information acquired in the acquisition step,
Using the image information searched in the search step, an analysis step for image analysis of the analysis region of the base material type reagent,
A determination step for determining whether or not there is an abnormality in the analysis region based on the analysis result of the analysis step;
A presenting step for presenting a discrimination result by the discrimination step;
A method for managing a substrate-type reagent, comprising:   A manufacturing inspection program that causes a computer to execute the manufacturing inspection method according to claim 9.   An analysis program for causing a computer to execute the analysis method according to claim 10.   A management program for causing a computer to execute the management method according to claim 11.   15. A computer-readable recording medium on which the program according to any one of claims 12 to 14 is recorded.

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