Analysis system and analysis method using the same

Abstract

An analysis system (100) comprises: an analysis device (3) that performs analysis using a polymer (91) filled in a polymer cartridge (512), acquires attribute information of the polymer cartridge (512), and transmits the attribute information to the outside; and a server (6) that acquires the attribute information of the polymer cartridge (512) transmitted from the analysis device (3), compares the attribute information to attribute information stored in a database (61), and transmits to the analysis device (3) determination results indicating a determination as to whether the polymer cartridge (512) filled with the polymer corresponding to the compared attribute information is suitable as an object to be set to the analysis device (3).

Description

[Technical Field]

[0001] The present invention relates to an analysis system, typified by an electrophoresis apparatus, for separating and analyzing nucleic acids, proteins, etc., and an analysis method using the same. [Background technology]

[0002] In recent years, with the development of the Internet, the term IoT (Internet of Things) has come into frequent use. IoT refers to a system in which various devices and equipment that were previously not connected to the Internet are connected to servers and cloud services via a network, enabling them to exchange information with each other. Examples of network-connected devices and equipment include sensors, actuators, homes and buildings, cars, home appliances, and electronic devices. By connecting such devices and equipment to the Internet, it will become possible to process, convert, analyze, and link information that was previously buried on a centralized computer (server).

[0003] Generally, reagents play a major role in analytical chemistry. To obtain accurate analytical results, it is necessary to have properly calibrated equipment and reagents in the correct condition. Generally, equipment is a fixed asset, and reagents are consumables. For this reason, customers who use consumables must periodically order and purchase them from reagent manufacturers. However, even with the development of the Internet, ordering consumables has not been automated. Customers must manually order reagents, and there is a challenge in reducing this burden.

[0004] For this reason, Patent Document 1 affixes a radio frequency identifier (hereinafter referred to as RFID) to reagents, which are both consumables and products. RFID refers to a general technology for exchanging information from RF tags via short-range wireless communication using electromagnetic fields or radio waves, or to wireless tags with embedded ID information; here, the term refers to the latter type of wireless tag. Patent Document 1 describes how the customer's reagent usage status is monitored based on information from the RFID (wireless tag), and this information is then sent via a network to the reagent supplier's server. This information enables the customer to replenish product inventory, inventory, track, or reorder. This completely automates the customer's ordering process, or eliminates most manual input.

[0005] Similarly, there is also known a technique for attaching a unique label to each chemical container, and a technique for storing the shipping history and usage history of the chemical in a database via a network such as the Internet using the label.

[0006] In recent years, the importance of healthcare has been emphasized, and human lifespans have increased, leading to the promise of a 100-year lifespan. The proportion of the population aged 60 and over will increase in the future, and all developed countries will become super-aged societies. One area that has attracted attention in this context is genomic medicine. Genomic medicine applies the genetic information of individual patients to diagnosis and provides medical treatment appropriate to each individual patient. The device used to read this genetic sequence information is a DNA (deoxyribonucleic acid) sequencer. In other words, DNA sequencers can be said to be one of the most representative analytical devices.

[0007] The Human Genome Project, which aimed to analyze the entire base sequence of the human genome, was completed in 2003. Technology for determining base sequences (sequencing) has made great advances since then, and various methods have been proposed. However, the classic DNA reading method used in the Human Genome Project, the Sanger method, is an essential technology for genetic analysis due to its high base reading accuracy and advantageous analysis cost per sample. DNA sequencers that use this Sanger method are called capillary sequencers.

[0008] Capillary sequencers using the Sanger method fill a small tube called a capillary with a polymer, which acts as a separation medium. This polymer exerts a molecular sieve effect, and is responsible for separating the various DNA strands of different base lengths that are filled at the end of the capillary according to their molecular weight. Furthermore, polymers are the most expensive of the reagents used in capillary sequencers, and reagent manufacturers maintain their own proprietary methods for producing polymers as their own know-how. For this reason, the specific composition and manufacturing method of the polymer are not disclosed.

[0009] Currently, polymers are sold to customers in a pre-filled form in a specified container. The polymer container has a label such as RFID attached. Most sequencers currently on the market are used in a form in which the polymer container is directly attached and analyzed.

[0010] Thermo Fisher Science currently holds a large share of the capillary sequencer market. One of the features of the capillary sequencers sold by the company is a component called a polymer block. This is a component that acts as an interface between the polymer container and the instrument when replacing the polymer. The polymer installed in the instrument has a shelf life of two weeks. Therefore, customers must install a new polymer container in the instrument every two weeks to perform analysis. The problem here is the amount of polymer consumed when replacing the polymer container. A large amount of polymer is required for cleaning the flow paths inside the polymer block and removing air bubbles from the flow paths, which are pre-analysis preparations unrelated to the analysis itself.

[0011] For example, when analysis is performed using a capillary with an inner diameter of 50 μm and a total length of 47 cm, approximately 500 μL of polymer is required for 96 samples, as shown in formula (1).

number

[0012] On the other hand, the polymer volume of a polymer container is estimated to be approximately 5 mL. Therefore, the amount of polymer required for analysis can be estimated to be about 1 / 10 of the polymer actually purchased. In other words, 90% of the polymer not directly related to analysis is consumed for maintenance. This is due to the fact that Thermo Fisher Science sequencers use a component called a polymer block. Therefore, when using a Thermo Fisher Science sequencer, large amounts of polymer are inevitably consumed. [Prior art documents] [Patent documents]

[0013] [Patent Document 1] U.S. Patent Reissue No. 47599 Summary of the Invention [Problem to be solved by the invention]

[0014] Polymers, which are the migration media in conventional sequencing, are sold in pre-filled containers. However, polymers have the highest running costs among all capillary electrophoresis-based sequencing reagents. For this reason, customers of capillary electrophoresis-based sequencers strongly desire to reduce the consumption of electrophoresis polymers and thereby reduce running costs.

[0015] Therefore, it is conceivable to provide a capillary sequencer that does not have polymer blocks as components and uses them as consumables.

[0016] Thermo Fisher Science sells its separation media polymers not only as consumables that are directly attached to analytical instruments, but also in bottles. In addition to Thermo Fisher Science, other companies such as MCLAB (Molecular Cloning Laboratories), NimaGen BV, and Agilent Technologies also sell their own polymers.

[0017] By injecting a polymer sold in a bottle into a consumable polymer cartridge and using it for analysis, customers can save the large amount of polymer that was previously wasted on polymer block maintenance. This allows customers to reduce the consumption of polymer for electrophoresis and significantly reduce the running costs of analysis.

[0018] A capillary sequencer that does not have a polymer block as a component but uses it as a consumable item has the advantage that it does not require the maintenance work of cleaning the flow path and removing air bubbles that accompanies polymer replacement.

[0019] However, for capillary sequencers that use polymer blocks as consumables, empty polymer containers may be provided through unauthorized channels. If these empty containers do not meet the analytical specifications, the expected accuracy of the analysis may not be achieved. It is also possible that customers may reuse empty containers. In this case, there is a concern about contamination with foreign DNA, which may also result in the containers not meeting the analytical specifications.

[0020] Therefore, an object of the present invention is to issue a warning when a mode does not satisfy the required specifications for analysis. [Means for solving the problem]

[0021] In order to solve the above-mentioned problems, the analytical system of the present invention provides attribute information including lot information of a reagent filling container into which a consumables user injects a reagent. and information on the start date and time of analysis of the reagent and acquiring the attribute information of the reagent filling container. and information on the start date and time of analysis of the reagent The external Server set up at an analytical device having a display and a transmission device configured to transmit information to a database storing attribute information including lot information of reagent filling containers shipped to the market; and a database storing the attribute information of the reagent filling containers transmitted from the transmission device. and information on the start date and time of the analysis of the reagent and acquiring the attribute information of the reagent filling container stored in the database. and expiration date information of the reagent, respectively. The container for filling reagents corresponding to the collated attribute information is checked to see if it has been shipped properly, is not an empty container reused by a consumables user, and is appropriate as an object to be set in the analyzer. and whether the reagent can withstand analysis. and a server configured to determine the value of the test sample and transmit the determination result to the analysis device, wherein the analysis device is configured to obtain the determination result from the server and display the determination result on the display.

[0022] The analytical method of the present invention is characterized in that a transmission device, which is a part of an analytical device having a display, transmits attribute information including lot information of a reagent filling container into which a consumables user pours a reagent. and information on the start date and time of analysis of the reagent and transmitting the attribute information of the reagent filling container transmitted from the transmission device to a server. and information on the start date and time of the analysis of the reagent and comparing the attribute information with attribute information stored in a database, including lot information of the reagent filling containers shipped to the market. The expiration date of the reagents and a step of checking whether the reagent filling container filled with the reagent corresponding to the checked attribute information is a properly shipped container, is not an empty container reused by a consumables user, and is appropriate as an object to be set in the analyzer; Whether the analysis start date of the reagent is before the expiration date and whether the reagent is suitable for analysis.and transmitting the determination result to the analysis device; and the analysis device acquiring the determination result from the server and displaying the determination result on the display. Other means will be described in the detailed description of the invention. [Effects of the Invention]

[0023] According to the present invention, it is possible to issue a warning when a mode does not satisfy the required specifications for analysis. [Brief explanation of the drawings]

[0024] [Figure 1] 1 is a configuration diagram of an analysis system according to an embodiment of the present invention. [Figure 2] FIG. 1 is a diagram illustrating the configuration and operation of an analysis system according to a first embodiment. [Figure 3A] 4 is a flowchart of an analysis preparation process according to the first embodiment. [Figure 3B] 4 is a flowchart of an analysis preparation process according to the first embodiment. [Figure 3C] 4 is a flowchart of an analysis preparation process according to the first embodiment. [Figure 4A] 10 is a flowchart of an analysis preparation process according to the second embodiment. [Figure 4B] 10 is a flowchart of an analysis preparation process according to the second embodiment. [Figure 4C] 10 is a flowchart of an analysis preparation process according to the second embodiment. [Figure 5] FIG. 10 is a diagram illustrating the configuration and operation of an analysis system according to a third embodiment. [Figure 6A] 10 is a flowchart of an analysis preparation process according to the third embodiment. [Figure 6B] 10 is a flowchart of an analysis preparation process according to the third embodiment. [Figure 6C] 10 is a flowchart of an analysis preparation process according to the third embodiment. [Figure 7]FIG. 10 is a diagram illustrating the configuration and operation of an analysis system according to a fourth embodiment. [Figure 8A] 10 is a flowchart of an analysis preparation process according to the fourth embodiment. [Figure 8B] 10 is a flowchart of an analysis preparation process according to the fourth embodiment. [Figure 8C] 10 is a flowchart of an analysis preparation process according to the fourth embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0025] Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings. FIG. 1 illustrates an analytical system 100 embodying the present invention. The analysis system 100 is configured by connecting a server 6 managed by a consumables supplier 2 and an analysis device 3 used by a consumables user 1 via a network 7 such as the Internet. The server 6 of the consumables supplier 2 and the analysis device 3 of the consumables user 1 transmit information to each other via the network 7.

[0026] The analytical device 3 is a capillary electrophoresis device configured to perform electrophoresis of a sample introduced into a capillary filled with a polymer as a separation medium using consumables 5 set in the analytical device 3.

[0027] The consumable 5 is supplied by the consumable supplier 2 to the consumable user 1 and is a component for assembling a polymer filling container that is configured to be filled by the consumable user 1 with a polymer supplied by a polymer supplier not shown.

[0028] Consumables 5 are consumables used during analysis by this analytical device 3. Based on the order information 4 of the consumables user 1, the consumables 5 are sent from the consumables supplier 2 to the consumables user 1 by physical means such as a courier. The consumables user 1 installs the consumables 5 provided by the consumables supplier 2 in the analytical device 3 and performs the analysis. Here, the analytical device 3 is not located near the consumables supplier 2. The analytical device 3 is owned by the consumables user 1 and is installed, for example, in the facility where the consumables user 1 performs the analysis.

[0029] The analytical information acquired by the analytical device 3 is transmitted from the analytical device 3 to the server 6 via an external network 7, and is thereby shared between the consumables supplier 2 and the consumables user 1. Similarly, information regarding the consumables 5 used by the consumables user 1 is also transmitted from the analytical device 3 to the server 6 via the external network 7, and is thereby shared between the consumables supplier 2 and the consumables user 1. This enables the consumables supplier 2 to grasp and manage the data on the consumables 5 used by the consumables user 1.

[0030] The server 6 belonging to the consumables supplier 2 compares at least one of the information related to the polymer and the attribute information of the consumables with the information stored in the database, and determines whether the polymer and the consumables corresponding to the transmitted information are appropriate as objects to be set in the analysis device 3. Furthermore, the consumables supplier 2 can grasp the status of the consumables 5 held by the consumables user 1, and manages inventory online in real time.

[0031] Furthermore, if the consumable user 1 runs out of consumables 5, the consumable user 1 can transmit ordering information to the consumables supplier 2 via the network 7. Because inventory management can be performed online, the server 6 of the consumables supplier 2 can estimate which consumables 5 are in short supply or are expected to be in short supply, even if the consumable user 1 does not pay attention to the inventory status of the consumables 5. The server 6 transmits the estimated information about the consumables 5 via the network 7 to the analysis device 3, and, for example, displays a warning on the GUI screen of the analysis device 3, prompting the consumable user 1 to order the consumables 5. The GUI screen of the analysis device 3 can transition to an ordering screen for the consumables 5. The consumable user 1 can perform the ordering process simply by operating the terminal of the analysis device 3, thereby reducing the various tasks associated with ordering. Alternatively, if the consumable user 1 desires automatic replenishment of consumables 5, the analysis device 3 can automatically perform the ordering process.

[0032] Consumables User 1 aims to reduce the cost of experiments. Polymer is a particularly expensive reagent among the analytical reagents used in capillary sequencers. Consumables User 1 wants to reduce the running costs of the polymer. To achieve this, Consumables User 1 assembles an empty container using parts of the reagent cartridge included in Consumables 5, and dispenses polymer purchased from a reagent manufacturer into this empty container.

[0033] On the other hand, the aim of the consumables supplier 2 is to secure profits by expanding sales of the consumables 5 and to guarantee the analytical accuracy of the analytical device 3. This is achieved by issuing a warning when the consumables 5 are used in a manner that does not meet the analytical specifications. To achieve this, the consumables supplier 2 must do the following:

[0034] (1) The consumables supplier 2 provides the consumables user 1 with attribute information specific to the consumables 5 in advance. (2) When performing an analysis, the consumables user 1 provides the consumables supplier 2 with attribute information of the consumables 5 and information on the polymer dispensed into the cartridge, which is the consumables 5. The server 6 of the consumables supplier 2 collates this information via the network 7.

[0035] (3) If the server 6 confirms the match, the consumables supplier 2 notifies the consumables user 1 of the match. For example, the server 6 confirms that the consumables 5 are genuine products manufactured by the consumables supplier 2, that the cartridges of the consumables 5 are not reused, that the polymer is guaranteed to work, and that the expiration date of the polymer has not passed. (4) If the consumable 5 is not genuine, if the cartridge of this consumable 5 is reused, if the polymer is not guaranteed to work, or if the expiration date of the polymer has passed, the consumable supplier 2 transmits warning information to the consumable user 1 via the server 6. This allows the consumable user 1 to know that the cartridge of this consumable 5 may not be suitable for analysis.

[0036] First Embodiment The analytical system of the first embodiment reads information about the empty polymer-filled container and the polymer provided to the customer, and transmits this information to the polymer-filled container's consumables supplier via the Internet when the device reads the information immediately before analysis. The consumables supplier then compares the information about the polymer-filled container with sales information and sends a determination of whether it is appropriate to the customer's analytical device. This allows the system to warn against reusing filled containers or using containers that are not guaranteed to work.

[0037] FIG. 2 is a diagram showing the configuration and operation of the analysis system 100 of the first embodiment. In the first embodiment, specifically, to perform an analysis using capillary electrophoresis, a consumables user 1 assembles parts 51 of a consumables 5 to form an empty container 511. Then, a polymer 91, which is an electrophoresis medium manufactured and sold by another reagent manufacturer, is injected into the empty container 511, and a label is attached to create a polymer cartridge 512. This polymer cartridge 512 is a container for filling with a reagent, which is already filled with the polymer 91. Furthermore, the consumables user 1 uses this polymer cartridge 512 to perform an analytical experiment, and shares the usage status of the consumables 5, the analytical conditions, and the results with the consumables supplier 2 via the network 7.

[0038] Polymer 91, an electrophoretic medium, is a medium for separating biopolymers, but it can be used for a variety of applications. Specifically, it can be used in DNA sequencing and DNA fragment analysis. These applications involve single-stranded DNA, which generally requires double-stranded DNA to be organized. Because these applications involve high concentrations of urea and other substances, polymers known as denaturing polymers are used for separation. Furthermore, if molecular weight measurement is desired in the double-stranded state without organizing the DNA into single strands, polymers known as non-denaturing polymers are generally used for separation. Furthermore, polymers for binding and dissociating proteins and nucleic acids are also commercially available.

[0039] DNA sizes vary widely, from short DNA molecules of about 100 bp (base pairs) to long DNA molecules of over 10 kbp, and a wide variety of polymers are commercially available.

[0040] 1, the analysis system 100 of the first embodiment includes a database 61, a barcode reader 81, and a printer 82. The analysis device 3 is connected to a barcode reader 31, and displays a GUI screen 32 on a touch panel display (not shown). The analysis device 3 performs analysis using a polymer 91 filled in a polymer cartridge 512, which is a container for filling a reagent, and also functions as a transmission device that acquires attribute information of the polymer cartridge 512 and transmits it to the server 6.

[0041] The server 6 is a computer that is connected to the analysis device 3 via a network 7 and that centrally manages information about the consumables 5 in a database 61. The server 6 compares the attribute information of the polymer cartridge 512 transmitted from the analysis device 3 with the attribute information stored in the database 61, and determines whether the polymer cartridge 512 corresponding to the compared attribute information is appropriate as an object to be set in the analysis device 3.

[0042] The database 61 is used by the server 6 to manage the consumables 5 and polymers 91 that have been shipped to the market, and stores attribute information of the consumables 5 that have been shipped to the market, information on the polymers 91, and the like. Barcode reader 81 reads and decodes two-dimensional barcodes and is connected to printer 82. Barcode reader 81 is a first reader that reads information related to polymer 91, which is a reagent, and attribute information of polymer cartridge 512, which is a container for filling the reagent, independently of each other. The printer 82 is connected to the barcode reader 81 and prints predetermined information on a label, for example, a two-dimensional barcode as a label. This label is a data label that is output based on information read by the barcode reader 81, for example.

[0043] The barcode reader 31 reads and decodes two-dimensional barcodes and is connected to the analysis device 3. The barcode reader 31 is configured to read a data label on which information relating to the polymer 91 and attribute information of the polymer cartridge 512 are encoded.

[0044] However, the barcode reader 31 is not limited to this, and may be a second reader or transmission device configured to operate independently and read a data label on which integrated information that integrates information related to the polymer 91 and attribute information of the polymer cartridge 512 is encoded, and is communicably connected to the server 6. Furthermore, the first reader and the second reader may be the same reader. This same reader may be connectable to the analysis device 3, or may be a part of the analysis device 3.

[0045] To make this process easier to understand, the process will be explained below by dividing it into two steps: a step S10 of preparing a polymer cartridge 512 from an empty container 511, and an analysis step S11 using the analysis device 3.

[0046] <<Process S10 for Producing Polymer Cartridge 512>> First, a description will be given of step S10 of producing a polymer cartridge 512 from an empty container 511. The consumables 5 are stored in a packing bag 53 with a two-dimensional barcode label 52 attached. Ten sets of parts 51, such as syringes, seals, rubber stoppers, and caps, are stored in the packing bag 53. The two-dimensional barcode label 52 contains information such as the lot number of the parts 51 that make up the polymer cartridge 512, the date of manufacture, the expiration date, and the number of each component supplied.

[0047] The consumables user 1 assembles an empty container 511 of a polymer cartridge from these parts 51. The consumables user 1 injects a polymer 91, which is an electrophoresis medium sold by a reagent manufacturer, into this empty container 511 and seals it with a cap, thereby assembling a polymer cartridge 512.

[0048] Meanwhile, the attribute information of this polymer cartridge 512 and the information of the polymer 91, which is the reagent enclosed therein, are not yet linked in this polymer cartridge 512. The attribute information of the polymer cartridge 512 is information such as the lot number and the number of units provided related to the part 51, and is encoded in the two-dimensional barcode label 52. The information of the polymer 91, which is the reagent, is information such as the manufacturer, type, manufacturing date, expiration date, lot number, serial number, etc. of this reagent, and is encoded in the two-dimensional barcode label 92.

[0049] In order to link these pieces of information, the consumables user 1 creates a new two-dimensional barcode label 521 and attaches it to the polymer cartridge 512. The attribute information (component information) of the polymer cartridge 512 is recorded on the two-dimensional barcode label 52 attached to the packaging bag 53. On the other hand, information on the polymer 91, which is a reagent, is recorded on the two-dimensional barcode label 92. The barcode reader 81 reads the two-dimensional barcode label 52, decodes the attribute information, and adds identification number information for identifying the ten polymer cartridges 512 to the attribute information of the polymer cartridges 512. The barcode reader 81 then reads the two-dimensional barcode label 92, decodes the information on the polymer 91, and integrates it with the attribute information of the polymer cartridge 512. In this way, information is generated for each of the ten polymer cartridges 512 produced from the ten sets.

[0050] The printer 82 encodes the information generated by the barcode reader 81 and prints the encoded information as ten two-dimensional barcode labels 521. The print application in the printer 82 supports a wide variety of commercially available polymers and can integrate information corresponding to each polymer with attribute information (component information) of the polymer cartridge 512. In other words, by attaching these ten two-dimensional barcode labels 521 to the side of the polymer cartridge 512 filled with the polymer 91, the necessary information can be physically linked to the polymer cartridge 512. Although this depends on the experimental plan of the consumable user 1, the consumable user 1 usually stores the created polymer cartridge 512 in the refrigerator 83 at 4°C.

[0051] <<Analysis step S11 using the analysis device 3>> Next, the analysis step S11 in which analysis is performed using the polymer cartridge 512 filled with the polymer 91 will be described.

[0052] The consumables user 1 takes out the polymer cartridge 512, which has been stored at 4°C, from the refrigerator 83 and leaves it in the room for about an hour to return it to room temperature. After the temperature of the polymer inside the polymer cartridge 512 has sufficiently reached equilibrium with room temperature, the consumables user 1 reads the two-dimensional barcode label 521 attached to the polymer cartridge 512 with the barcode reader 31. Guidance for this series of operations is displayed on the GUI screen 32 displayed on the touch panel of the analyzer 3.

[0053] The information read by the barcode reader 31 is recorded in the analyzer 3 and then transmitted to the server 6 of the consumables supplier 2 via the network 7. The server 6 determines from the transmitted information whether the polymer cartridge 512 associated with this information is appropriate for the analysis and transmits the determination result to the analyzer 3 via the network 7. The analyzer 3 displays all or part of the integrated information, such as the type of polymer, lot number, serial number, expiration date, lot numbers of the components that make up the polymer cartridge 512, the expiration date, the number packed in the packaging bag 53, the number of those that have been consumed to date, and the identification information of each polymer cartridge 512, on the GUI screen 32, and also displays whether the polymer cartridge 512 is appropriate for the analysis. The consumables user 1 checks the GUI screen 32 and then performs the subsequent analysis.

[0054] Specific analyses can be sequence analysis using a capillary electrophoresis device, fragment analysis, or quality control (QC) of a next-generation sequencer library, or detection of cell-free DNA, cancer tumor DNA, protein-DNA interactions, aptamers, or protein-protein interactions.

[0055] In the first embodiment, a polymer has been used as an example in which the consumables user 1 dispenses a reagent into the empty container 511 by himself. However, the reagents that can be handled are not limited to polymers. Specifically, the target reagents may be, for example, an anode buffer or a cathode buffer in a capillary sequencer, and the consumables user 1 may dispense the corresponding buffer purchased separately from a reagent manufacturer into an empty container.

[0056] 3A to 3C are flowcharts of the analysis preparation process according to the first embodiment, and will be described with reference to FIG. 2 as needed. The specific tasks are carried out by two parties: a consumables user 1 and a consumables supplier 2. The process is roughly divided into two steps: one is a process S10 for producing a polymer cartridge 512, and the other is an analysis process S11 using the polymer cartridge 512.

[0057] First, the steps preceding the manufacturing step S10 of the polymer cartridge 512 will be described. When the consumables user 1 purchases the consumables 5, the consumables supplier 2 ships the consumables 5 to the consumables user 1, and the server 6 records the barcode information of the cartridge shipped to the consumables user 1 in the database 61 (step S20). This makes it possible to compare the lot information of the consumables 5, which is a polymer-filled container, with the lot information of the polymer-filled container sent from the analysis device 3 owned by the consumables user 1. Once the processing of step S20 is completed, the process proceeds to the manufacturing step S10 of the polymer cartridge 512.

[0058] The manufacturing process S10 of the polymer cartridge 512 is a process in which the consumables user 1 assembles the parts 51 of the polymer cartridge 512 supplied by the consumables supplier 2 and fills them with a polymer 91 that is circulated in the multi-product market to manufacture the polymer cartridge 512.

[0059] In the process S10 for producing the polymer cartridge 512, the consumables user 1 receives the consumables 5 from the consumables supplier 2 (step S21). The consumables user 1 assembles an empty container 511 using the parts 51 of the polymer cartridge 512 contained in the packaging bag 53 (step S22). The consumables user 1 then injects the polymer 91 into the empty container 511 (step S23). Next, the consumables user 1 places a cap on the empty container 511 and tightens the cap to seal the polymer 91 (step S24).

[0060] In parallel with the operations of steps S22 to S24, the consumables user 1 reads the two-dimensional barcode label 52 attached to the packaging bag 53 of the part 51 of the polymer cartridge 512 with the barcode reader 81 (step S25). The consumables user 1 further reads the two-dimensional barcode label 92 attached to the container of the polymer 91 with the barcode reader 81 (step S26). Then, the consumables user 1 prints, with the printer 82, a two-dimensional barcode label 521 that integrates information (attribute information) of the part 51 of the polymer cartridge 512 and reagent information of the polymer 91 (step S27).

[0061] The consumables user 1 attaches this printed two-dimensional barcode label 521 to the polymer cartridge 512 (step S29). As a result, attribute information such as the lot number and number provided for the parts 51 that make up the polymer cartridge 512 is integrated with information such as the manufacturer, type, manufacturing date, expiration date, lot number, and serial number of the polymer 91 that is the reagent sealed in the polymer cartridge 512, and they become linked. Specifically, when the reagent is placed in the device immediately before analysis, reading the two-dimensional barcode label 521 attached to the polymer cartridge 512 to be used for analysis prevents the product from being confused with the corresponding information. The processes from steps S21 to S28 are included in the manufacturing process S10.

[0062] Generally, once the polymer cartridge 512 is produced, it is stored at 4° C. in the refrigerator 83 (step S29). However, this low-temperature storage is not essential, and the polymer cartridge 512 may proceed immediately to the analysis step S11 without being stored.

[0063] Next, the analysis step S11 using the polymer cartridge 512 will be described. The consumables user 1 removes the polymer cartridge 512 from the refrigerator 83 and returns it to room temperature (step S30). After this, the consumables user 1 reads the two-dimensional barcode label 521 of the polymer cartridge 512 with the barcode reader 31 connected to the analysis device 3 (step S31). This information is transmitted from the analysis device 3 to the server 6 via the network 7. That is, the server 6 acquires barcode information of the polymer cartridge 512 that the consumables user 1 is about to use via the network 7 (step S32). This information also includes information on the date and time when the analysis will start.

[0064] The server 6 of the consumables supplier 2 compares the attribute information on the parts 51 of the polymer cartridge 512 with the barcode information of the consumables 5 shipped to the market using the barcode information from the analyzer 3 (step S33). In this comparison, the server 6 checks whether the polymer cartridge 512 corresponding to the barcode information has been shipped properly, and checks whether the polymer cartridge 512 has been reused using the identification information included in the barcode information. If the polymer cartridge 512 has been shipped properly and has not been reused, the server 6 determines that the comparison result is correct.

[0065] In step S33, the server 6 further determines whether the polymer 91 injected into the polymer cartridge 512 satisfies the allowable conditions for withstanding analysis based on information such as the manufacturer, lot number, serial number, expiration date, etc. Specifically, the server 6 compares the analysis start date and time with the expiration date information of the polymer to determine whether the polymer is suitable for analysis.

[0066] The analysis device 3 receives the collation result and the determination result of the analysis acceptable conditions from the server 6 via the network 7 (step S34). Then, the analysis device 3 determines whether the collation result is correct and whether the analysis acceptable conditions are met (step S35).

[0067] If the barcode information matching result is correct and satisfies the analysis acceptance conditions (Yes) in step S35, the analyzer 3 displays a dialog on the GUI screen 32 stating "The barcode information of the polymer cartridge has been confirmed" (step S36).

[0068] If the result of the barcode information matching is invalid or does not satisfy the analysis acceptance conditions (No) in step S35, the analyzer 3 displays a dialog on the GUI screen 32 stating "Analysis performance cannot be guaranteed" (step S37).

[0069] The consumables user 1 places the consumable polymer cartridge 512 and the sample in the analyzer 3 and presses the analysis start button to begin the analysis (step S38). The analysis time can range from as little as 30 minutes to as long as about a week. During this time, the analyzer 3 performs the analysis (step S39). When the analysis is complete (step S40), the analyzer 3 automatically sends the analysis results, the number of injections, and other analysis information to the consumables supplier 2 via the network 7. The server 6 acquires this analysis information via the network 7 (step S41).

[0070] The database 61 of the server 6 stores information about all consumables that the consumable supplier 2 has provided to the consumable user 1 up to now. The server 6 can estimate the amount of consumables 5 currently held by the consumable user 1 by subtracting the amount of consumables 5 used in the current analysis, which has been newly notified by the analysis device 3, from the consumable information provided to the consumable user 1.

[0071] The server 6 transmits the remaining quantity information of the consumables 5 to the analysis device 3 via the network 7 (step S42). Then, the analysis device 3 acquires the remaining quantity information of the consumables 5 from the server 6 via the network 7 (step S43).

[0072] If the amount of this consumable item 5 is insufficient or is predicted to run short in the near future, the analysis device 3 displays a message on the GUI screen 32 urging the user 1 to purchase the consumable item 5 predicted to run short (step S44). In response to this, the consumable item user 1 purchases the consumable item 5 predicted to run short (step S45). On the GUI screen 32 of the analysis device 3, the consumable item user 1 can order the consumable item 5. As a result, order information 4 is transmitted from the analysis device 3 to the server 6. When the server 6 acquires the order information 4 for the consumables 5 (step S46), the process returns to step S20 in FIG. 3A.

[0073] The message in step S44 makes the consumables user 1 aware of the shortage of the consumables 5. The analyzer 3 then immediately displays a screen on the GUI screen 32 for placing an order for the consumables 5. This enables the consumables user 1 to smoothly order and obtain the consumables 5. This enables the consumables supplier 2 to smoothly provide the consumables 5.

[0074] In the first embodiment, a consumables user 1 himself / herself fills a polymer cartridge 512 with polymer 91, which is a separation medium used in electrophoresis, to prepare for analysis. A consumables supplier 2 determines via a network 7 whether the polymer cartridge 512 and polymer 91 are appropriate, and notifies the consumables user 1 of the determination result. This improves the cost performance of the consumables user 1 regarding the polymer 91, thereby promoting consumables supply activities.

[0075] Second Embodiment 4A to 4C are flowcharts of the analysis preparation process according to the second embodiment. The difference from the flowchart of the first embodiment is that, when sending information via the Internet, the device asks the consumables user 1 whether or not to disclose the information to the consumables supplier 2 each time.

[0076] The processing from steps S50 to S60 in the second embodiment is similar to the processing from steps S20 to S30 in the first embodiment.

[0077] In step S31 of the flowchart of the first embodiment, the consumables user 1 reads the two-dimensional barcode label 521 of the polymer cartridge 512 with the barcode reader 31 connected to the analysis device 3. When this operation is completed, the analysis device 3 transmits this barcode information to the server 6. The server 6 acquires the barcode information of the polymer cartridge 512 that the consumables user 1 is about to use from the analysis device 3 via the network 7 (step S32).

[0078] In contrast to this, in the flowchart of the second embodiment, even if the operation of reading the two-dimensional barcode label 521 of the polymer cartridge 512 by the barcode reader 31 connected to the analyzer 3 is completed in step S61, the analyzer 3 does not transfer this barcode information to the server 6. The analyzer 3 pops up a dialog on the screen asking whether to send the barcode information to the consumables supplier 2 (step S62), and determines whether the send button has been pressed (step S63). This allows the consumables user 1 to decide whether or not to disclose the barcode information to the consumables supplier 2 of his or her own volition.

[0079] If the send button on the screen of the analyzer 3 is pressed in step S63 (Yes), the analyzer 3 transmits the barcode information to the server 6. The server 6 acquires the barcode information from the analyzer 3 via the network 7 (step S64). If the cancel button or the like on the screen of the analyzer 3 is pressed in step S63 (No), proceed to step S70 in FIG. 4C.

[0080] The processing from steps S64 to S72 in the second embodiment is similar to the processing from steps S32 to S39 in the first embodiment. When the analysis is completed in step S40 of the flowchart of the first embodiment, the analysis device 3 transmits analysis information such as the analysis results and the number of injections to the consumables supplier 2 via the network 7. The server 6 acquires this analysis information via the network 7 (step S41).

[0081] In contrast to this, even if the analysis is completed in step S72 of the second embodiment, the analysis device 3 does not transmit analysis information such as the analysis results and the number of injections to the consumables supplier 2 via the network 7. The analysis device 3 pops up a dialog box on the screen asking whether to send the analysis information to the server 6 (step S73), and determines whether the send button has been pressed (step S74). This allows the consumables user 1 to decide whether or not to disclose the analysis information to the consumables supplier 2 of his or her own volition.

[0082] If the send button on the screen of the analysis device 3 is pressed in step S74 (Yes), the analysis device 3 transmits the analysis information to the server 6. The server 6 acquires the analysis information from the analysis device 3 via the network 7 (step S75). If the cancel button or the like on the screen of the analysis device 3 is pressed in step S74 (No), the process proceeds to step S79, where the consumables 5 are ordered (purchased). Naturally, the consumables user 1 can also choose not to place an order here.

[0083] Thereafter, the processing from steps S76 to S78 in the second embodiment is the same as the processing from steps S42 to S44 in the first embodiment.

[0084] Furthermore, in the second embodiment, the barcode reader 31 is connected to the analysis device 3, but it may also be built into the analysis device 3.

[0085] Third Embodiment FIG. 5 is a diagram showing the configuration and operation of an analysis system 100A of the third embodiment. 5 differs from the second embodiment described in FIG. 2 in that a barcode label is not created that integrates information about the polymer 91, which is a reagent, and attribute information about the part 51 of the polymer cartridge 512. In other words, the analysis system 100A does not include the barcode reader 81 and printer 82 that the analysis system 100 of the second embodiment has. Furthermore, in the manufacturing step S12 of the polymer cartridge 512 and the analysis step S13 using the analyzer 3, unlike the manufacturing step S10 and the analysis step S11 of the first embodiment, the two-dimensional barcode label 521 is not attached to the polymer cartridge 512.

[0086] The two-dimensional barcode label 92 on the polymer 91 and the two-dimensional barcode label 52 attached to the packaging bag 53 holding the parts 51 of the polymer cartridge 512 are read by a barcode reader 31 connected to the analysis device 3 and are recorded as is in the analysis device 3. Here, the barcode reader 31 does not necessarily need to be connected to the analysis device 3 by a wire, as long as it can transmit information to the analysis device 3 by some wireless communication method such as Wi-Fi (registered trademark). An advantage of the analysis system 100A of the third embodiment is that the consumable user 1 does not need a printer for printing barcodes or a barcode reader that operates by connecting to this printer.

[0087] 6A to 6C are flowcharts of the analysis preparation process according to the third embodiment. The processes from steps S90 to S96 in the third embodiment are the same as the processes from steps S20 to S26 in the first embodiment. Note that the processes from steps S91 to S94 and steps S97 and S98 are included in the fabrication process S12. The process from step S96 and steps S99 to S114 are included in the analysis process S13.

[0088] In parallel with the operations from steps S92 to S96, the consumables user 1 performs the operations from steps S97 to S101. The consumables user 1 saves the two-dimensional barcode label 52 affixed to the packaging bag 53 of the part 51 of the polymer cartridge 512 (step S97), and further saves the two-dimensional barcode label 92 affixed to the polymer container (step S98).

[0089] Then, in parallel with the operation of using the polymer cartridge 512 in step S96, the consumables user 1 reads the stored two-dimensional barcode label 52, 92 with the barcode reader 81 connected to the analyzer 3. This information is transmitted from the analyzer 3 to the server 6 via the network 7. That is, the server 6 acquires, via the network 7, the barcode information of the polymer cartridge 512 that the consumables user 1 is about to use (step S100). This information also includes information on the date and time when the analysis is to start.

[0090] The server 6 of the consumables supplier 2 compares the attribute information on the parts 51 of the polymer cartridge 512 with the barcode information of the consumables 5 shipped to the market using the barcode information from the analyzer 3 (step S101). In the comparison in step S101, the server 6 checks whether the polymer cartridge 512 corresponding to the barcode information has been shipped properly. If the polymer cartridge 512 has been shipped properly, the server 6 determines that the comparison result is correct.

[0091] Furthermore, in step S101, the server 6 determines whether the polymer 91 injected into the polymer cartridge 512 satisfies the allowable conditions for withstanding analysis based on information such as the manufacturer, lot number, serial number, expiration date, etc. Specifically, the server 6 compares the analysis start date and time with the expiration date information of the polymer 91 to determine whether the polymer 91 is suitable for analysis.

[0092] Thereafter, the processes from steps S102 to S114 in the third embodiment are the same as the processes from steps S34 to S46 in the first embodiment.

[0093] Fourth Embodiment FIG. 7 is a diagram showing the configuration and operation of an analysis system 100B according to the fourth embodiment. The analysis system 100B of the fourth embodiment differs from the analysis system 100 of the second embodiment described in Fig. 2 in that barcodes are not printed and information about the polymer 91 is not read into the analysis device 3. Accordingly, the database 61 stores attribute information about the consumables 5 shipped to the market, but does not store information about the polymer 91.

[0094] In the analysis system 100B of the fourth embodiment, the consumables supplier 2 transmits attribute information of the part 51 of the polymer cartridge 512 to the server 6 of the consumables user 1. In this case, when using the consumables 5 sent by the consumables supplier 2, the consumables user 1 only needs to input the attribute information disclosed by the consumables supplier 2 into the analysis device 3.

[0095] The server 6 then acquires the attribute information of the polymer cartridge 512 transmitted from the analysis device 3, compares it with the attribute information stored in the database 61, and determines whether the polymer cartridge 512 filled with polymer corresponding to the compared attribute information is appropriate as an object to be set in the analysis device 3.

[0096] Furthermore, a manufacturing step S14 of the polymer cartridge 512 and an analysis step S15 using the analysis device 3 are different from the manufacturing step S10 and the analysis step S11 of the first embodiment.

[0097] In this case, the information to be input into the analysis device 3 is not limited to barcode information, but may be information previously provided to the consumables user 1 by the consumables supplier 2, specifically, information such as a password specific to the provided packaging bag 53.

[0098] The instruction manual for the analyzer 3 states that "genuine consumables (including polymer cartridge parts for assembling empty containers for polymer cartridges) provided by the consumables supplier should be used." If consumables supplied by a third-party vendor are used, there is a risk of malfunction. The analysis system 100B of the fourth embodiment warns of the possibility of such malfunctions and calls the attention of the consumables user 1.

[0099] Similarly, the type of polymer to be used for analysis is clearly stated in the instruction manual, so even if a defect occurs as a result of consumables user 1 using a different polymer for analysis, consumables supplier 2 does not have to bear responsibility.

[0100] 8A to 8C are flowcharts of the analysis preparation process according to the fourth embodiment. The processes from steps S120 to S126 in the fourth embodiment are the same as the processes from steps S20 to S26 in the first embodiment. Note that the processes from steps S121 to S124 and step S127 are included in the fabrication process S14. The process from step S126 and steps S128 to S143 are included in the analysis process S15.

[0101] In parallel with the operations from steps S122 to S126, the consumables user 1 performs the operations from steps S27 to S130. The consumables user 1 saves the unique information 54 enclosed in the packaging bag 53 of the parts 51 of the polymer cartridge 512 (step S127). The unique information 54 includes various information related to each of the ten polymer cartridges 512 of the parts 51, such as the part number of the parts 51 of the polymer cartridge 512.

[0102] Then, in parallel with the operation of using the polymer cartridge 512 in step S126, the consumable product user 1 inputs the saved unique information 54 into the analyzer 3 (step S128). This information is transmitted from the analyzer 3 to the server 6 via the network 7. That is, the server 6 acquires the unique information 54 of the polymer cartridge 512 that the consumable product user 1 is about to use via the network 7 (step S129). This information also includes information on the analysis start date and time.

[0103] The server 6 of the consumables supplier 2 compares the attribute information on the parts 51 of the polymer cartridge 512 with the unique information 54 of the consumables 5 shipped to the market by the consumables supplier 2 using the unique information 54 from the analysis device 3 (step S130). In this comparison, the server 6 checks whether the polymer cartridge 512 corresponding to the unique information 54 has been shipped properly and is not a reused one. If the polymer cartridge 512 has been shipped properly and is not a reused one, the server 6 determines that the comparison result is correct.

[0104] The analysis device 3 acquires the collation result from the server 6 via the network 7 (step S131). Then, the analysis device 3 determines whether the collation result of the unique information 54 is correct (step S132).

[0105] In step S132, if the collation result of the unique information 54 is correct (Yes), the analyzer 3 displays a dialogue "Polymer cartridge information confirmed" on the GUI screen 32 (step S133).

[0106] If the collation result of the unique information 54 is invalid (No) in step S132, the analysis device 3 displays a dialogue on the GUI screen 32 saying "Analysis performance cannot be guaranteed" (step S134).

[0107] The consumables user 1 places the polymer cartridge 512, which is a consumable, and a sample in the analyzer 3, and presses the analysis start button to start the analysis (step S135).

[0108] The subsequent processes from step S135 to step S143 are the same as the processes from step S38 to step S46 in the first embodiment. This allows the consumables user 1 to smoothly order and obtain the consumables 5. This also allows the consumables supplier 2 to smoothly provide the consumables 5.

[0109] (Variation) The present invention is not limited to the above-described embodiments and includes various modifications. For example, the above-described embodiments have been described in detail to clearly explain the present invention, and are not necessarily limited to those including all of the described configurations. It is possible to replace part of the configuration of one embodiment with the configuration of another embodiment, and it is also possible to add the configuration of another embodiment to the configuration of one embodiment. Furthermore, it is also possible to add, delete, or replace part of the configuration of each embodiment with other configurations.

[0110] The above-described configurations, functions, processing units, processing means, etc. may be realized in part or in whole by hardware such as an integrated circuit. The above-described configurations, functions, etc. may be realized by software by a processor interpreting and executing a program that realizes each function. Information such as the programs, tables, and files that realize each function can be stored in a storage device such as a memory, a hard disk, or an SSD (Solid State Drive), or on a storage medium such as a flash memory card or a DVD (Digital Versatile Disk).

[0111] In each embodiment, the control lines and information lines shown are those that are considered necessary for the explanation, and not all control lines and information lines in the product are necessarily shown. In reality, it can be considered that almost all components are interconnected. As modified examples of the present invention, for example, the following (a) to (d) are available.

[0112] (a) The present invention is not limited to the use of polymers as reagents, but may use any reagent. (b) The barcode reader 31 of the present invention is not limited to one connected to the analysis device 3, but may be, for example, an independent transmission device that transmits information to the server 6 via the network 7. (c) The barcode reader 81 and the barcode reader 31 in the first embodiment may be the same. (d) A wireless tag may be attached to the packing bag 53 of the consumables 5 instead of the two-dimensional barcode label. Furthermore, the analysis system 100 may be provided with a wireless tag reader instead of the barcode reader, and a wireless tag writer instead of the printer. [Explanation of symbols]

[0113] 100 Analysis Systems 1 Consumables user 2 Consumables Supplier 3 Analyzer 31 Barcode reader 32 GUI screen 4. Ordering Information 5 Consumables 51 parts 511 Empty container 512 Polymer Cartridge (Reagent Filling Container) 52 2D barcode labels 521 2D barcode label 53 Packing Bag 54 Unique Information 6 Server 61 databases 7 Network 81 Barcode reader 82 Printer 83 Refrigerator 91 Polymer (reagent) 92 2D barcode labels

Claims

1. an analyzer including a transmission device and a display configured to acquire attribute information including lot information of a reagent filling container into which a consumables user pours a reagent and information on an analysis start date and time of the reagent, and to transmit the attribute information of the reagent filling container and the information on the analysis start date and time of the reagent to an external server; a database for storing attribute information including lot information of reagent filling containers shipped to the market; a server configured to acquire the attribute information of the reagent filling container and the information on the analysis start date and time of the reagent transmitted from the transmission device, compare the attribute information of the reagent filling container and the expiration date information of the reagent stored in the database, respectively, determine whether the reagent filling container corresponding to the compared attribute information has been officially shipped and is not an empty container reused by a consumables user, and is appropriate as an object to be set in the analysis device, and whether the reagent can withstand analysis, and transmit the determination result to the analysis device; Equipped with The analysis system is characterized in that the analysis device is configured to obtain the determination result from the server and display the determination result on the display.

2. 2. The analysis system according to claim 1, wherein the analysis device performs analysis using a reagent injected into the reagent-filling container.

3. The server transmits remaining quantity information of consumables to the analysis device. The analysis system according to claim 1 .

4. the transmitting device acquires information related to the reagent in addition to the attribute information of the reagent filling container and transmits the information to an external server; the database stores information on the reagents shipped to the market in addition to the attribute information including lot information of the reagent-filling containers shipped to the market; The server acquires the information related to the reagent in addition to the attribute information of the reagent filling container transmitted from the transmission device, compares the information related to the reagent and the attribute information of the reagent filling container with the information and attribute information stored in the database, determines whether the reagent filling container filled with reagent corresponding to the compared information and attribute information has been shipped officially, is not an empty container reused by a consumables user, and is appropriate as an object to be set in the analyzer, and transmits the determination result to the analyzer. The analysis system according to claim 1 .

5. a first reader that reads information related to the reagent and attribute information of the reagent filling container; a second reader configured to read a data label on which integrated information is encoded, the integrated information being the information related to the reagent read by the first reader and the attribute information of the reagent filling container, and communicably connected to the server; the server acquires the information relating to the reagent and the attribute information of the reagent filling container transmitted from the second reader, compares the information and the attribute information with the information and attribute information stored in the database, determines whether the reagent filling container filled with the reagent corresponding to the compared information and attribute information has been shipped officially, is not an empty container reused by a consumables user, and is appropriate as an object to be set in the analyzer, and transmits the determination result to the analyzer.

5. The analysis system according to claim 4.

6. the first reader and the second reader are the same reader; 6. The analysis system according to claim 5.

7. The same reader is connectable to the analytical device.

7. The analysis system according to claim 6.

8. The same reader is part of the analytical device.

7. The analysis system according to claim 6.

9. the reagent is a polymer; 5. The analysis system according to claim 4.

10. a transmission device that is a part of an analyzer equipped with a display, acquiring attribute information including lot information of a reagent filling container into which a consumables user pours a reagent and information on the analysis start date and time of the reagent, and transmitting the acquired attribute information to a server; the server acquires the attribute information of the reagent filling container and the information on the analysis start date and time of the reagent transmitted from the transmission device, and compares the attribute information with attribute information stored in a database, including lot information of the reagent filling container shipped to the market, and information on the expiration date of the reagent; the server determines whether the reagent filling container filled with the reagent corresponding to the collated attribute information is a properly shipped container, is not an empty container reused by a consumables user, and is appropriate as an object to be set in the analyzer, and whether the analysis start date and time of the reagent is before the expiration date and is suitable for analysis, and transmits the determination result to the analyzer; a step in which the analysis device acquires the determination result from the server and displays the determination result on the display; An analytical method characterized by carrying out the steps of:

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