ANALYSIS SYSTEM AND ANALYSIS METHOD USING SAME

An analysis system includes: an analyzer that performs an analysis using polymer filled in a polymer cartridge, acquires attribute information on the polymer cartridge, and transmits the attribute information to the outside; and a server that acquires the attribute information on the polymer cartridge transmitted from the analyzer, collates the attribute information with attribute information stored in a database, and transmits to the analyzer a determination result obtained by determining whether or not the polymer cartridge in which polymer corresponding to the collated attribute information has been filled already is proper as an object to be set on the analyzer.

TECHNICAL FIELD

The present invention relates to an analysis system represented by an electrophoresis device that separates and analyzes a nucleic acid, protein and the like, and an analysis method using the analysis system.

BACKGROUND ART

Recently, along with the development of Internet, the term “Internet of Things” (IoT) has been popularly used. IoT indicates a system where various equipment and devices that have not been connected to Internet have become connected to a server or a cloud service via a network, and these equipment and devices perform an exchange of information among them. In such a system, the equipment and devices that are connected via networks are, for example, sensor equipment, drive devices (actuators), houses and buildings, vehicles, home appliances, electronic equipment and the like.

It is expected that, by connecting these equipment and devices with Internet, processing, conversion, analysis and coordination of information that have been hidden up to now can be performed on a computer (a server) that performs the centralized management of the information.

In general, in the field of analytical chemistry, a role that a reagent plays is important. To acquire a proper analytical result, it is necessary to prepare both a device that is properly calibrated, and a reagent in a proper state. In general, devices are fixed assets. Reagents are consumable items. Accordingly, it is necessary for a client who is a client of consumable products to periodically purchase the consumable items from a reagent manufacturer. However, the order of consumable products is not automated even at present where Internet prevails. Accordingly, it is necessary for a client to perform a manual operation relating to the order of reagents and hence, there exists a task to reduce such an operation.

To overcome such a task, in Patent Literature 1, a radio frequency identifier (hereinafter referred to as RFID) is added to a reagent that is a consumable item and is also a product. RFID means an overall technique that transacts information from RF tags from near-distance wireless communication using an electromagnetic field or a wireless tag in which ID information is embedded. In this specification, RFID indicates the latter wireless tag. In Patent Literature 1, a technique is described where a reagent use situation of a client is monitored based on information from the RFID (wireless tag), and these information are transmitted to a server of a reagent supplier via a network. Using these information, a client can perform the warehouse replenishment, an inventory list, tracking and reorder. Accordingly, an order operation of a client can be completely automated, or manual inputting becomes almost unnecessary.

In the same manner, there has been also known a technique where unique labels are attached to containers for respective chemical substances. There has been known a technique where a shipping history and a use history of the chemical substances are stored via a network such as Internet with the use of these labels.

Recently, the importance of health care is called for so that a human lifespan is extended, and the era of 100-year lifespan has been sought. A rate of population over sixties with respect to the total population is steadily increased from now on, and all advanced countries are entering the ultra-aging society. Under such a circumstance, a genomic medicine has been attracting an attention. The genomic medicine is a medical discipline where genomic information on an individual patient is applied to a diagnosis, and a medical care that is suitable for the individual patient is applied to the patient. As a device for reading gene sequence information, a deoxyribonucleic acid (DNA) sequencer is used. That is, the DNA sequencer is one of typical analyzers.

A human genome project that aims at an analysis of complete base sequence of human genomes was completed in 2003. The technique relating to the decision of the base sequence (sequence) has made a great progress from the day of the completion the analysis of all base sequence of human genomes by today, and various techniques have been proposed. However, a classical DNA reading method referred to as the Sanger method that was adopted in the human genome project is an indispensable technique in genetic analysis because of its high accuracy in reading bases and its priority in terms of an analysis cost per one sample. A DNA sequencer that uses this Sanger method is referred to as a capillary sequencer.

In the capillary sequencer that uses the Sanger method, a capillary tube that is referred to as a capillary is filled with a polymer that is a separation medium. This polymer exhibits a molecular sieve effect, and plays a role of developing various DNA that are filled in a proximal end of the capillary and have different base lengths depending on molecular weights. Further, among reagents that are used in the capillary sequencer, polymer is most expensive and hence, a reagent manufacturer manages a manufacturing method of its own as a knowhow. Accordingly, the specific compositions and the specific manufacturing methods of the polymer are not disclosed.

At present, polymer is sold to a client in a mode where the polymer is preliminarily filled in a predetermined container. A label such as RFID is attached to the polymer container. Most of sequencer devices that are sold in markets now adopt a mode where an analysis is performed by directly mounting a polymer container on the sequencer device.

At present, Thermo Fisher Scientific Inc. has a large share in the field of a capillary sequencer. One of characteristics of capillary sequencers that the company sells is a part referred to as a polymer block. The polymer block is a part that becomes an interface between a polymer container and a sequencer device at the time of exchanging a polymer. An expiration date of a polymer mounted on the sequencer device is two weeks. Accordingly, a client has to mount a new polymer container on the sequencer device and to perform an analysis every two weeks. In this case, there arises a problem with respect to a consumption amount of polymer that occurs along with an exchange of a polymer container. That is, although such a problem is irrelevant to the analysis itself, a large amount of polymer becomes necessary for cleaning a flow passage in the polymer block and the removal of bubbles in the flow passage that are preparations to be performed before performing the analysis.

For example, in a case where the analysis is performed using a capillary having an inner diameter of 50 m and a total length of 47 cm, as expressed in an expression (1), approximately 500[μL] of polymer becomes necessary when 96 samples are prepared.

wherein, the first term indicates an inner diameter, the second term indicates a circle ratio, the third term is a total length, the fourth term is the number of samples, and the fifth term is a tolerance.

On the other hand, it is estimated that a capacity of polymer in the polymer container is approximately 5 [mL]. Accordingly, it can be estimated that polymer necessary for an analysis is approximately 1/10 of polymer that a client actually purchases. In other words, it is safe to say that polymer that is not directly relevant to the analysis is consumed by an amount of 90% for the maintenance. This attributes to a situation where the sequencer of Thermo Fisher Scientific Inc. adopts a part referred to as the polymer block. Accordingly, in a case where a client uses the sequencer manufactured by Thermo Fisher Scientific Inc., the consumption of a large amount of polymer is unavoidable.

CITATION LIST

Patent Literature

SUMMARY OF INVENTION

Technical Problem

Polymer that is an electrophoretic medium in a conventional sequence is sold in a mode where the polymer is preliminarily filled in a predetermined container. On the other hand, polymer requires a highest running cost among sequence reagents on an electrophoresis base. Accordingly, a client of the sequencer on a capillary electrophoresis base has a strong desire to reduce a running cost by reducing a consumption amount of the electrophoresis polymer.

In view of the above, it is considered to provide a capillary sequencer that does not include a polymer block as a part and is used as a consumable item.

Thermo Fisher Scientific inc. sells polymer that is a separate medium also in the form of a bottle shape without limiting polymer to the shape of a consumable item that is directly mounted on an analyzer. Further, besides Thermo Fisher Scientific inc., Molecular Cloning Laboratories (MCLAB), NimaGen B.V, Agilent Tchnologies Inc. and the like also sell their unique polymers.

By adopting a mode where polymer is used in an analysis by filling polymer that is sold in a bottle shape into a polymer cartridge that is a consumable item, a client can save a large amount of polymer that is wasted for maintenance of a polymer block. As a result, the client can largely reduce a running cost of an analysis by reducing a consumption amount of electrophoresis polymer.

With the use of the capillary sequencer that does not include the polymer block as a part and is used as a consumable item, the capillary sequencer also has an advantageous effect that flow passage cleaning and a bubble removing operation that are maintenance operations accompanying an exchanging operation of polymer become unnecessary.

However, in the capillary sequencer that uses the polymer block as a consumable item, it is considered that an empty container for polymer is offered through an informal route. In a case where the empty bottle does not satisfy the required specification of the analysis, there is a possibility that the accuracy that the analysis expects cannot be acquired. Further, there is also a possibility that a client reuses the empty container. In this case, there is a concern that mixing (contamination) of a foreign DNA occurs. In the same manner, there is a concern that the required specification for the analysis is not satisfied.

In view of the above-mentioned circumstances, it is an object of the present invention to issue a warning in a case where an analysis is in a mode that does not satisfy the required specification for the analysis.

Solution to Problem

To solve the above-described problem, an analysis system according to the present invention includes: an analyzer having: a transmission device that is configured to acquire attribute information that includes lot information of a reagent filling container and to transmit the attribute information of the reagent filling container to an outside, and a display; a database that stores attribute information that includes lot information of a reagent filling container shipped to a market; and a server that is configured to acquire the attribute information on the reagent filling container transmitted from the transmission device, to collate the attribute information on the reagent filling container transmitted from the transmission device with the attribute information on the reagent filling container stored in the database, to determine whether or not the reagent filling container that corresponds to the collated attribute information is proper as an object to be set on the analyzer, and to transmit a determination result to the analyzer. The analyzer is configured to acquire the determination result from the server, and to make the display display the determination result.

An analysis method according to the present invention includes the steps of: allowing a transmission device that is a part of an analyzer that includes a display to acquire attribute information including lot information of a reagent filling container and transmit the attribute information to a server; allowing the server to acquire the attribute information on the reagent filling container transmitted from the transmission device, and to collate the attribute information with attribute information that is stored in database and includes lot information on the reagent filling container shipped to a market; allowing the server to determine whether or not the reagent filling container in which a reagent has been already filled that corresponds to the collated attribute information is proper as an object to be set on the analyzer and to transmit a determination result to the analyzer; and allowing the analyzer to acquire the determination result from the server and to display the determination result on the display.

The other means will be described in Description of Embodiments.

Advantageous Effects of Invention

According to an aspect of the present invention, it is possible to issue a warning in a case where an analysis is in a mode that does not satisfy the required specification for the analysis.

DESCRIPTION OF EMBODIMENTS

Hereinafter, a mode for carrying out the present invention will be described with reference to the respective views.

An analysis system100that realizes the present invention is illustrated with reference toFIG.1.

The analysis system100is configured such that a server6managed by a consumable item supplier2and an analyzer3used by a consumable item user1uses are connected to each other via a network7such as Internet. The server6of the consumable item supplier2and the analyzer3of the consumable item user1transmit information between them via the network7.

The analyzer3is a capillary electrophoresis device having the configuration where, using a consumable item5set on the analyzer3, a sample performs electrophoresis, the sample being charged into a capillary filled with polymer that functions as a separation medium.

The consumable item5is a part that is supplied from the consumable item supplier2to the consumable item user1, and is a part for assembling a polymer filling container that is configured such that polymer received from a polymer supplier not illustrated in the drawing is filled in the polymer filling container by the consumable item user1.

The consumable item5is a consumable item that is used at the time of performing an analysis by the analyzer3. The consumable item5is transmitted from the consumable item supplier2to the consumable item user1by means of a physical means such as a courier service based on order information4from the consumable item user1. The consumable item user1mounts the consumable item5supplied from the consumable item supplier2in the analyzer3and performs an analysis. In this embodiment, the analyzer3is not installed in the vicinity of the consumable item supplier2. The consumable item user1possesses the analyzer3. For example, the analyzer3is installed in a facility where the consumable item user1performs the analysis.

Analysis information that is acquired from the analyzer3is transmitted from the analyzer3to the server6via an external network7. Accordingly, the analysis information is shared by the consumable item supplier2and the consumable item user1. In the same manner, information relating to the consumable item5used by the consumable item user1is also transmitted from the analyzer3to the server6via the external network7. Accordingly, the information relating to the consumable item5is also shared by the consumable item user1and the consumable item supplier2. As a result, the consumable item supplier2can grasp the data on the consumable item5used by the consumable item user1, and can manage the data.

The server6that belongs to the consumable item supplier2collates at least either one of information relating to polymer or attribute information on a consumable item with information stored in a database, and determines whether or not the polymer or the consumable item that corresponds to the transmitted information is proper as an object to be set on the analyzer3. Further, the consumable item supplier2can grasp the state of the consumable item5preserved by the consumable item user1and can perform the inventory management real time over online.

In a case where the consumable item user1faces a shortage of consumable items5, the consumable item user1can transmit delivery request information to the consumable item supplier2via the network7. The inventory management can be performed over online and hence, even when the consumable item user1does not pay attention to an inventory state of the consumable items5, the server6owned by the consumable item supplier2can estimate a shortage of the consumable items5or a possible shortage of the consumable items5. The server6transmits information on the shortage estimated consumable items5to the analyzer3via the network7. For example, the attraction of attention is displayed on a GUI screen of the analyzer3so as to prompt the consumable item user1to order the consumable items5. The GUI screen of the analyzer3is transferable to the order screen for the consumable items5. The consumable item user1can perform an order operation by only performing a manipulation on a terminal of the analyzer3and hence, the consumable item user1can reduce various operations accompanying an ordering operation.

Alternatively, in a case where the consumable item user1desires the automatic replenishment of the consumable items5, a mode is considered where the analyzer3automatically performs an ordering operation.

The purpose of the consumable item user1is the reduction of cost for performing an experiment. Polymer is a particularly expensive reagent among reagents for analysis used by a capillary sequencer. The consumable item user1is considering the reduction of a running cost of polymer. Accordingly, the consumable item user1assembles an empty container by using parts of reagent cartridges included in the consumable items5, and dispenses polymer purchased from a reagent manufacturer into the vacant container.

On the other hand, the purpose of the consumable item supplier2is the securing of a profit by expanding the sale of the consumable items5, and the guarantee of analysis accuracy by the analyzer3. This can be realized by issuing warning to the use of the consumable item5in a mode where the specification of the analysis is not satisfied. What the consumable item supplier2should perform to achieve such a purpose is the followings.

(1) The consumable item supplier2preliminarily provides the consumable item user1with the attribute information unique to the consumable item5.

(2) The consumable item user1provides the consumable item supplier2with the attribute information on the consumable item5and information on polymer that is dispensed to a cartridge that is the consumable item5at the time of performing an analysis. The server6of the consumable item supplier2collates this information via the network7.

(3) In a case where the consumable item supplier2has confirmed the collation via the server6, the consumable item supplier2notifies the consumable item user1of this confirmation of the collation. For example, the consumable item supplier2confirms, for example, that the consumable item5is a genuine product manufactured by the consumable item supplier2, that the cartridge of the consumable item5is not reused, that the polymer is an operation guaranteed product, that a usable period of the polymer is not expired, and the like.

(4) In a case where the consumable item5is not a genuine product, in a case where the cartridge of the consumable item5is reused, in a case where the polymer is not an operation guaranteed product, or in a case where an expiration date has passed, the consumable item supplier2transmits warning information to the consumable item user1via the server6. With such operations, the consumable item user1can know that there is a possibility that the cartridge of the consumable item5is not suitable for an analysis.

First Embodiment

An analysis system according to the first embodiment reads information on an empty polymer filling container and information on polymer that are supplied to a client, and transmits the information to the consumable item supplier of the polymer filling container via Internet at the time of performing device reading immediately before the analysis. The consumable item supplier collates the information on the polymer filling container with sale information, and transmits a result of determination whether or not the polymer filling container is proper to the analyzer of the client. Accordingly, it is possible to issue warning to the reuse of the filling container and the use of the filling container whose operation is not guaranteed.

FIG.2is a view illustrating the configuration of the manner of operation of the analysis system100according to the first embodiment.

In the first embodiment, to perform an analysis that specifically uses capillary electrophoresis, the consumable item user1assembles parts51of the consumable item5to form an empty container511. Then, the consumable item user1dispenses polymer91as an electrophoresis medium that is manufactured and is sold from other reagent manufacturer and adheres a label thus preparing a polymer cartridge512. This polymer cartridge512is a reagent filling container in which the polymer91is already filled. Then, the consumable item user1performs an analysis test using the polymer cartridge512, and shares a use state, an analysis condition and a result of the analysis of the consumable item5with the consumable item supplier2via the network7.

Although the polymer91that is an electrophoresis medium is a medium for separating a biopolymer, there are various applications in which the polymer91can be used. To be more specific, a DNA sequence analysis, and an application in which a DNA fragment analysis is performed are named. A single-stranded DNA is treated in these applications and hence, in general, it is necessary to arrange two-stranded DNA whereby the polymer91contains urea or the like at high concentration. Accordingly, the separation is performed using polymer referred to as modified polymer. Further, in a case where it is desirable to measure a molecule weight in a state of two-stranded DNA without arranging one-stranded DNA, in general, the separation is performed using polymer referred to as non-modified polymer in general. Further, polymer that performs bonding and dissociation between protein and a nucleic acid is commercially available.

Sizing of DNA covers a wide range, wherein a short DNA molecule is approximately 100 bp (Base Pair), and a long DNA molecule has a length of 10 kbp or more. Accordingly, various polymers are commercially available under the current situation.

The analysis system100according to the first embodiment includes, in addition to the server6and the analyzer3illustrated inFIG.1, a database61, a barcode reader81, and a printer82. A barcode reader31is connected to the analyzer3, and a GUI screen32is displayed on a touch panel display not illustrated in the drawing. The analyzer3performs an analysis using the polymer91filled in a polymer cartridge512that is a reagent filling container. The analyzer3also functions as a transmission device that acquires attribute information on the polymer cartridge512, and transmits the attribute information to the server6.

The server6is a computer that performs a centralized management of the information on consumable item5on the database61by being connected with the analyzer3via the network7. The server6collates the attribute information on the polymer cartridge512transmitted from the analyzer3with the attribute information stored in the database61, and determines whether or not the polymer cartridge512that corresponds to the collated attribute information is proper as an object to be set on the analyzer3.

The database61is provided for allowing the server6to manage the consumable item5, the polymer91, and the like shipped to a market. The database61stores the attribute information on the consumable item5shipped to the market, information on the polymer91, and the like.

The barcode reader81reads a two-dimensional barcode and decodes the read two-dimensional barcode, and is connected to a printer82. The barcode reader81is a first reader that reads the information relating to the polymer91that is a reagent and the attribute information on the polymer cartridge512that is a reagent filling container in a mutually independent manner.

The printer82is connected to the barcode reader81, and prints predetermined information on a label. For example, the printer82prints a two-dimensional barcode as the label. The label is a data label that is outputted based on information read by the barcode reader81, for example.

The barcode reader31reads a two-dimensional barcode, and decodes the read two-dimensional barcode, and is connected to the analyzer3. The barcode reader31is configured to read a data label in which information where information relating to the polymer91and the attribute information on the polymer cartridge512are integrated with each other is encoded.

The barcode reader31is not limited to such a configuration. That is, the barcode reader31may be a second reader or a transmission device that is operated as a single unit, and is configured to read a data label in which information where information relating to the polymer91and the attribute information on the polymer cartridge512are integrated with each other is encoded, and is communicably connected with the server6.

That is, the configuration of the barcode reader31is not limited. Further, the first reader and the second reader may be the same reader. This same reader may be connected to the analyzer3, or may form a part of the analyzer3.

To facilitate the understanding of this step, this step is described hereinafter by dividing the step into a preparation step S10of preparing the polymer cartridge512from the empty container511, and an analysis step S11that uses the analyzer3.

First, the preparation step S10of the polymer cartridge512from the empty container511is described. A package bag53to which the two-dimensional barcode label52adheres is stored in the consumable item5. Ten sets of parts51each consisting of a syringe, a seal, a rubber plug, a cap, and the like are stored in the package bag53. Information on a lot number, a manufacturing year/month/date, an expiration date, the number of supplied respective constitutional parts, and the like of the parts51that form the polymer cartridge512are described on the two-dimensional barcode label52.

The consumable item user1assembles the empty container511of the polymer cartridge from these parts51. The consumable item user1fills the polymer91that is an electrophoresis medium and is sold from a reagent manufacturer into the empty container511, and seals the empty container511with a cap thus assembling the polymer cartridge512.

On the other hand, in such a state, with respect to the polymer cartridge512, the attribute information on the polymer cartridge512and the information on the polymer91that is a reagent sealed in the polymer cartridge512are not linked with each other. The attribute information on the polymer cartridge512is information such as a lot number, supplied number relating to the parts51, and is encoded in the two-dimensional barcode label52. The information on the polymer91that is a reagent is information on a manufacturer, a kind, a manufacturing year/month/data, an expiration date, a lot number, a serial number, and the like, and is encoded in the two-dimensional barcode label92.

To link these information with each other, the consumable item user1prepares a new two-dimensional barcode label521, and adheres the new two-dimensional barcode label521to the polymer cartridge512. The attribute information (constitutional part information) of the polymer cartridge512is recorded in the two-dimensional barcode label52adhering to the package bag53. On the other hand, the information on the polymer91that is a reagent is recorded in the two-dimensional barcode label92.

The barcode reader81reads the two-dimensional barcode label52and decodes the attribute information, and adds identification number information that identifies ten polymer cartridges512from each other in the attribute information on the polymer cartridge512. Then, the barcode reader81reads the two-dimensional barcode label92and decodes information on the polymer91, and integrates the decoded data with the attribute information on the polymer cartridge512. With such steps, information corresponding to ten polymer cartridges512that are prepared from ten sets of parts is generated.

The printer82encodes information that the barcode reader81generates, and prints the encoded information as ten pieces of two-dimensional barcode labels521. Print applications installed in the printer82correspond to various commercially available polymers and hence, information corresponding to the respective polymers and the attribute information (information on constitutional parts) of the polymer cartridge512can be integrated with each other. That is, by adhering these ten pieces of two-dimensional barcode labels521to a side surfaces of the polymer cartridge512in which the polymer91is filled, it is possible to link information physically necessary for the polymer cartridge512with each other. Although it depends on a plan of an experiment performed by the consumable item user1, usually, the consumable item user1preserves the prepared polymer cartridge512in a refrigerator83at a temperature of 4[° C.].

Next, the analysis step S11where the analysis is performed using the polymer cartridge512filled with the polymer91is described.

The consumable item user1takes out the polymer cartridge512preserved at a temperature of 4[° C.] from the refrigerator83and leaves the polymer cartridge512in a room for approximately one hour for returning the temperature of the polymer cartridge512to a room temperature. After the temperature of the polymer in the polymer cartridge512sufficiently reaches an equilibrium state with a room temperature, the consumable item user1reads the two-dimensional barcode label521adhering to the polymer cartridge512using the barcode reader31. A guidance for a series of these manipulations is displayed on the GUI screen32displayed on the touch panel of the analyzer3.

The information read by the barcode reader31is recorded in the analyzer3and, thereafter, is transmitted to the server6of the consumable item supplier2via the network7. The server6determines whether or not the polymer cartridge512relating to this information is proper for an analysis based on the transmitted information, and gives a result of determination to the analyzer3via the network7. The analyzer3displays the following information as the GUI screen32. That is, the analyzer3displays the entirety or a portion of the information where the kind of the read polymer, the lot number, the serial number, and the expiration date, the lot number of the parts constituting the polymer cartridge512, the expiration date, the number of parts packaged in the package bag53, the number of parts consumed by now, the identification information on the respective polymer cartridges512, and the like are integrated with each other. At the same time, the analyzer3displays whether or not the polymer cartridge512is proper for an analysis on the GUI screen32. The consumable item user1performs the analysis described hereinafter after the consumable item user1checks the GUI screen32.

The specific analysis may be a sequence analysis using a capillary electrophoresis device, a fragment analysis, or a quality control (QC) of a library of a next generation sequencer. Alternatively, the specific analysis may be the detection of cell free DNA, the detection of cancer tumor DNA, the detection of interaction between protein and DNA, the detection of aptamer, or a detection method of an interaction between protein and protein.

In the first embodiment, as an example where the consumable item user1dispenses a reagent into the empty container511by himself/herself, a case where polymer is used has been described. However, a reagent that can be used in the first embodiment is not limited to polymer. To be more specific, as a reagent that can be used in the first embodiment, for example, in a capillary sequencer, also with respect to an anode buffer, a cathode buffer or the like, the consumable item user1can dispense such a buffer purchased from a different reagent manufacturer into the empty container.

FIG.3AtoFIG.3Cillustrate a flowchart of analysis preparation processing according to the first embodiment, and the analysis preparation processing is described also with reference toFIG.2when necessary.

The specific operations are performed by two operators, that is, the consumable item user1and the consumable item supplier2. Further, the step is roughly divided into two steps. One step is a preparation step S10of preparing the polymer cartridge512, and an analysis step S11of performing an analysis using the polymer cartridge512.

First, a pre step of the preparation step S10of the polymer cartridge512is described. In purchasing of the consumable item5by the consumable item user1, the consumable item supplier2transmits the consumable item5to the consumable item user1, and the server6records the barcode information on the cartridge transmitted to the consumable item user1in the database61(step S20). Accordingly, it is possible to collate lot information on the consumable item5that is a polymer filling container with lot information on the polymer filling container transmitted from the analyzer3owned by the consumable item user1. When the processing in step S20is finished, the processing advances to the preparation step S10of the polymer cartridge512.

In the preparation step S10of the polymer cartridge512, the consumable item user1receives the consumable item5from the consumable item supplier2(step S21). The consumable item user1assembles the empty container511using the parts51of the polymer cartridge512packaged in the package bag53(step S22). Then, the consumable item user1fills the polymer91in the empty container511(step S23). Next, the consumable item user1attaches a cap to the empty container511and fastens the cap thus sealing the polymer91(step S24).

In parallel with the operations performed from step S22to step S24, the consumable item user1reads the two-dimensional barcode label52attached to the package bag53of the parts51of the polymer cartridge512using the barcode reader81(step S25). Then, the consumable item user1reads the two-dimensional barcode label92attached to the container of the polymer91using the barcode reader81(step S26). Then, the consumable item user1prints the two-dimensional barcode label521that is formed by integrating the information (attribute information) of the parts51of the polymer cartridge512and the reagent information on the polymer91using the printer82(step S27).

The consumable item user1adheres this printed two-dimensional barcode label521to the polymer cartridge512(step S29). With such an operation, the attribute information such as lot numbers and the number of supplied parts relating to the parts51that constitute the polymer cartridge512, and information such as a manufacturer, a kind, a manufactured year/month/day, an expiration date, a lot number, a serial number of the polymer91that is a reagent sealed in the polymer cartridge512are integrated with each other and are brought into a linked state. To be more specific, a situation is brought about where the reagent is disposed on the device immediately before an analysis, when the consumable item user1reads the two-dimensional barcode label521adhered to the polymer cartridge512to be used in the analysis, it is possible to prevent misunderstanding between a thing and information on the thing. These processing from step S21to step S28are included in the preparation step S10.

In general, once the polymer cartridge512is prepared, the polymer cartridge512is preserved in the refrigerator83at a temperature of 4° C. (step S29). However, it is not always the case that this low temperature preservation is indispensable, and the processing may advance to the analysis step S11directly without being subjected to the preservation.

Next, the analysis step S11that is performed using the polymer cartridge512is described. The consumable item user1takes out the polymer cartridge512from the refrigerator83, and returns the temperature of the polymer cartridge512to a room temperature (step S30). Then, the consumable item user1reads the two-dimensional barcode label521of the polymer cartridge512by the barcode reader31connected to the analyzer3(step S31). This information is transmitted from the analyzer3to the server6via the network7. That is, the server6acquires the barcode information on the polymer cartridge512that the consumable item user1is going to use (step S32). This information also includes analysis start date information.

The server6of the consumable item supplier2performs a collation operation between the attribute information relating to parts51of the polymer cartridge512and the barcode information on the consumable item5shipped to a market and the like based on the barcode information from the analyzer3(step S33). In this collation operation, the server6collates whether or not the polymer cartridge512that corresponds to the barcode information is a product genuinely shipped, and also collates whether or not the polymer cartridge512is reused based on the identification information included in the barcode information. In a case where the polymer cartridge512is a product genuinely shipped and also is not reused, the server6determines that the collation result is correct.

In the step S33, the server6further determines whether or not an allowable condition that the polymer91can withstand the analysis based on information such as a manufacturer that manufactured the polymer91filled in the polymer cartridge512, the lot number, the serial number, and the expiration date. To be more specific, the server6determines whether the polymer91can withstand the analysis by collating the analysis start date and the expiration date of the polymer with each other.

The analyzer3acquires the collation result and the determination result of the analysis allowable condition from the server6via the network7(step S34). Then, the analyzer3determines whether or not this collation result is correct, and also whether or not the polymer91satisfies the analysis allowable condition (step S35).

In the step S35, in a case where the collation result of the barcode information is correct and the polymer91satisfies the analysis allowable condition (Yes), the analyzer3displays a dialogue “The barcode information on the polymer cartridge is confirmed.” on the GUI screen32(step S36).

In the step S35, in a case where either the collation result of the barcode information is not correct or the polymer91does not satisfy the analysis allowable condition (No), the analyzer3displays a dialogue “The analysis performance cannot be guaranteed.” on the GUI screen32(step S37).

The consumable item user1mounts the polymer cartridge512that is a consumable item and a sample on the analyzer3, and pushes an analysis start button for starting an analysis (step S38). The analysis takes approximately 30 minutes in case of a shortest analysis and takes approximately one week in case of a longest analysis. During such a time, the analyzer3performs an analysis. (step S39). When the analysis finishes (step S40), the analyzer3automatically transmits analysis information such as an analysis result and the number of times of injection to the consumable item supplier2via the network7. The server6acquires these analysis information via the network7(step S41).

In the database61of the server6, information is stored, the information relating to all consumable items that is supplied to the consumable item user1by the consumable item supplier2. The server6can estimate an amount of consumable item5that the consumable item user1currently preserves by subtracting an amount of consumable item5that was used in the latest analysis that is notified newly by the analyzer3from consumable item information supplied to the consumable item user1.

The server6transmits the remaining number information on the consumable items5to the analyzer3via the network7(step S42). Then, the analyzer3acquires information on the remaining number of the consumable items5from the server6via the network7(step S43).

In a case where an amount of the consumable items5is insufficient or it is anticipated that a shortage of the consumable items5will occur in near future, the analyzer3displays a message that prompts the consumable item user1to purchase the consumable items5that are expected to be in short on the GUI screen32(step S44). Upon receiving such a message, the consumable item user1purchases the consumable items5that are expected to be in short (step S45). The consumable item user1can order the consumable items5on the GUI screen32of the analyzer3. With such an operation, the order information4is transmitted from the analyzer3to the server6.

When the server6acquires the order information4of consumable items5(step S46), the processing returns to the step S20inFIG.3A.

Because of the message in step S44, the consumable item user1notices a shortage of the consumable items5. Then, the analyzer3, thereafter, immediately displays the screen on the GUI screen32where the consumable item user1orders the consumable items5. As a result, the consumable item user1can smoothly order and acquire the consumable items5. Then, the consumable item supplier2can smoothly supply the consumable items5.

In the first embodiment, the preparation of an analysis is performed in such a manner that the consumable item user1himself/herself fills the polymer91that is a separation medium used in electrophoresis into the polymer cartridge512. Whether the polymer cartridge512and the polymer91are proper is determined on the consumable item supplier2side by way of the network7, and the consumable item supplier2notifies the determination result to the consumable item user1. Accordingly, the cost performance of the consumable item user1relating to the polymer91can be enhanced and hence, it is possible to promote a consumable item supply activity.

Second Embodiment

FIG.4AtoFIG.4Cillustrate a flowchart of analysis preparation processing according to the second embodiment. The flowchart of the second embodiment differs from the flowchart of the first embodiment with respect to a pint that, with respect to the transmitting of information via the Internet, the device confirms, each time, the consumable item user1whether or not the disclosure of information to the consumable item supplier2is favorable or not.

Processing from step S50to step S60in the second embodiment is substantially the same as step S20to step S30in the first embodiment.

In step S31of the flowchart of the first embodiment, the consumable item user1reads the two-dimensional barcode label521of the polymer cartridge512by the barcode reader31connected to the analyzer3. When this operation is completed, the analyzer3transmits the barcode information to the server6. The server6acquires the barcode information on the polymer cartridge512that the consumable item user1is going to use, by the analyzer3via the network7(step S32).

To the contrary, in the flowchart of the second embodiment, in step S61, even if an operation of reading the two-dimensional barcode label521of the polymer cartridge512using the barcode reader31connected to the analyzer3is completed, the analyzer3does not transmit the barcode information to the server6. The analyzer3pops up a dialogue that asks the consumable item user1whether or not the barcode information is to be transmitted to the consumable item supplier2(step S62), and determines whether or not a transmission button is pushed (step S63). Accordingly, the consumable item user1can decide whether or not the barcode information is to be disclosed to the consumable item supplier2by his/her own will.

When a transmission button on the screen of the analyzer3is pushed in step S63(Yes), the analyzer3transmits barcode information to the server6. The server6acquires barcode information from the analyzer3via the network7(step S64). When a cancel button or the like on the screen of the analyzer3is pushed in the step S63(No), the processing advances to step S70inFIG.4C.

The processing from step S64to S72in the second embodiment is substantially equal to the processing from step S32to step S39in the first embodiment.

When the analysis is finished, in the step S40of the flowchart in the first embodiment, the analyzer3transmits the analysis information such as the analysis result and the number of times of injection to the consumable item supplier2via the network7. The server6acquires these analysis information via the network7(step S41).

On the other hand, even when the analysis is finished in the step S72in the second embodiment, the analyzer3does not transmit the analysis information such as the analysis result and the number of times of injection to the consumable item supplier2via the network7. The analyzer3pops up a dialog that asks the consumable item supplier2whether or not the analysis information is to be transmitted to the server6on the screen (step S73), and determines whether or not the transmission button is pushed (step S74). Accordingly, the consumable item user1can decide whether or not the analysis information is to be disclosed to the consumable item supplier2based on his/her own will.

When the transmission button on the screen of the analyzer3is pushed in step S74(Yes), the analyzer3transmits the analysis information to the server6. The server6acquires the analysis information from the analyzer3via the network7(step S75). When the cancel button on the screen of the analyzer3is pushed in step S74(No), the processing advances ordering (purchasing) of the consumable items5in step S79. At this stage of processing, as a matter of fact, the consumable item user1can perform the selection of not performing ordering.

Hereinafter, processing from the step S76to the step S78in the second embodiment is substantially equal to the processing from the step S42to the step S44in the first embodiment.

Further, in the second embodiment, the barcode reader31is connected to the analyzer3. However, the barcode reader31may be built in the analyzer3.

Third Embodiment

FIG.5is a view illustrating the configuration and the manner of operation of an analysis system100A according to the third embodiment.

InFIG.5, the third embodiment differs from the second embodiment described with reference toFIG.2with respect to a point that the barcode label that is formed by integrating information relating to the polymer91that is a reagent and the attribute information relating to the parts51of the polymer cartridge512is not prepared. That is, the analysis system100A includes neither the barcode reader81nor the printer82compared to the analysis system100according to the second embodiment.

Further, in the preparation step S12of the polymer cartridge512and the analysis step S13performed using the analyzer3, unlike the preparation step S10and the analysis step S11in the first embodiment, the two-dimensional barcode label521is not adhered to the polymer cartridge512.

The two-dimensional barcode label92of the polymer91and the two-dimensional barcode label52attached to the package bag53that holds the parts51of the polymer cartridge512are read by the barcode reader31connected to the analyzer3, and are directly recorded in the analyzer3. In this processing, it is not always necessary that the barcode reader31is connected to the analyzer3by wiring, and it is sufficient that information can be transmitted to the analyzer3by any wireless communication method such as Wi-Fi (registered trademark). An advantageous effect of the analysis system100A according to the third embodiment is that a printer that the consumable item user1uses for printing barcodes and a barcode reader that is operated by being connected with the printer become unnecessary.

FIG.6AtoFIG.6Cillustrate a flowchart of analysis preparation processing according to the third embodiment.

The processing from the step S90to the step S96in the third embodiment are substantially equal to the processing from the step S20to the step S26in the first embodiment. The processing in the step S91to the step S94, the step S97and the step S98is included in the preparation step S12. The processing in the step S96and the processing from the step S99to S114are included in the analysis step S13.

In parallel with the operations from the step S92to the step S96, the consumable item user1performs the operations from the step S97to the step S101. The consumable item user1preserves the two-dimensional barcode label52attached to the package bag53for the parts51of the polymer cartridge512(step S97) and, further, preserves the two-dimensional barcode label92attached to the polymer container (step S98).

Then, in parallel with the use operation of the polymer cartridge512in the step S96, the consumable item user1reads the preserved two-dimensional barcode labels52,92by the barcode reader81connected to the analyzer3. This information is transmitted to the server6from the analyzer3via the network7. That is, the server6acquires the barcode information of the polymer cartridge512that that consumable item user1is going to use via the network7(step S100). The analysis start date information is also included in the information.

The server6of the consumable item supplier2performs a collation operation between the attribute information relating to the parts51of the polymer cartridge512and the barcode information of consumable items5shipped to a market using the barcode information from the analyzer3(step S101). In the collation operation in the step S101, the server6collates whether or not the polymer cartridge512that corresponds to the barcode information is shipped as a genuine product. In a case where the polymer cartridge512is a product that is shipped as the genuine product, the server6determines that the collation result is correct.

In the step S101, the server6further determines whether or not the polymer cartridge512satisfies an allowable condition that can withstand an analysis based on information such as a manufacturer who manufactured the polymer91filled in the polymer cartridge512, the rod number, the serial number, and the expiration date. To be more specific, the server6determines whether or not the polymer cartridge512can withstand the analysis by collating the analysis start date and the use expiration date information of the polymer91.

Hereinafter, the processing from the step S102to the step S114in the third embodiment are substantially equal to the processing from the step S34to the step S46in the first embodiment.

Fourth Embodiment

FIG.7is a view illustrating the configuration and the manner of operation of an analysis system100B according to the fourth embodiment.

The analysis system100B according to the fourth embodiment differs from the analysis system100according to the second embodiment described with reference toFIG.2with respect to a point that a barcode is not printed, and the information of the polymer91is not read by the analyzer3. Due to such a difference, although the database61stores the attribute information of the consumable item5shipped to a market, the database61does not store the information on the polymer91.

In the analysis system100B according to the fourth embodiment, the consumable item supplier2transmits the attribute information of the parts51of the polymer cartridge512to the server6of the consumable item user1. In this case, in using the consumable items5that the consumable item supplier2transmits, it is necessary for the consumable item user1to perform only inputting of the attribute information that the consumable item supplier2discloses into the analyzer3.

Then, the server6acquires the attribute information of the polymer cartridge512transmitted from the analyzer3, collates the acquired attribute information with the attribute information stored in the database61, and determines whether or not the polymer cartridge512in which the polymer corresponding to the collated attribute information is already filled is proper as an object to be set on the analyzer3.

Further, the preparation step S14of the polymer cartridge512and the analysis step S15performed using the analyzer3differ from the preparation step S10and the analysis step S11according to the first embodiment.

In this case, the information inputted to the analyzer3is not limited to the barcode information, and may be information that the consumable item supplier2offers to the consumable item user1in advance, to be more specific, the information may be information such as a password unique to the package bag53that that consumable item supplier2provides.

In the manual of the analyzer3, there is a description that “must use a genuine consumable item (including polymer cartridge parrs for assembling the empty container of the polymer cartridge) that the consumable item supplier provides”. In a case where the consumable item user1uses a consumable item that a third vender supplies, there is a possibility that a drawback arises. The analysis system100B according to the fourth embodiment warns the possibility of the occurrence of such a drawback, and attracts an attention of the consumable item user1.

Further, in the same manner, also with respect to the polymer used in the analysis, a kind of polymer to be used in the analysis is explicitly described in the manual. Accordingly, even in a case where any drawback arises as a result of the use of other polymer by the consumable item user1in the analysis, it is unnecessary for the consumable item supplier2to owe the responsibility.

FIG.8AtoFIG.8Cillustrate a flowchart of analysis preparation processing according to the fourth embodiment.

The processing from the step S120to the step S126according to the fourth embodiment are substantially equal to processing step S20to the step S26according to the first embodiment. Processing from the step S121to the step S124and the processing in the step S127are included in the preparation step S14. The processing in the step S126and the processing from the step S128to the step S143are included in the analysis step S15.

In parallel to the operations from the step S122to the step S126, the consumable item user1preforms the operations from the step S27to the step S130. The consumable item user1preserves unique information54packaged in the package bag53of the parts51of the polymer cartridge512(step S127). This unique information54is constituted of various information respectively relating to ten polymer cartridges512of the parts51such as parts numbers of the parts51of the polymer cartridge512.

Then, in parallel with the use operation of the polymer cartridge512in the step S126, the consumable item user1inputs the preserved unique information54to the analyzer3(step S128). This information is transmitted from the analyzer3to the server6via the network7. That is, the server6acquires the unique information54of the polymer cartridge512that the consumable item user1is going to use via the network7(step S129). The analysis start date information is also included in the information.

The server6of the consumable item supplier2performs a collation operation between the attribute information relating to the parts51of the polymer cartridge512and the unique information54of the consumable items5shipped to a market by the consumable item supplier2based on the unique information54from the analyzer3(step S130). In this collation operation, the server6collates whether or not the polymer cartridge512corresponding to the unique information54is genuinely shipped product, and such a polymer cartridge512is not reused. In a case where the polymer cartridge512is a genuinely shipped product and is not reused, the server6determines that the collation result is correct.

The analyzer3acquires the collation result from the server6via the network7(step S131). Then, the analyzer3determines whether or not the collation result of the unique information54is correct (step S132).

In the step S132, in a case where the collation result of the unique information54is correct (Yes), the analyzer3displays a dialog “the information of the polymer cartridge is confirmed” on the GUI screen32(step S133).

In the step S132, in a case where the collation result of the unique information54is incorrect (No), the analyzer3displays a dialog “the analysis performance cannot be guaranteed” on the GUI screen32(step S134).

The consumable item user1mounts the polymer cartridge512that is a consumable item and the sample on the analyzer3, and pushes the analysis start button for starting the analysis (step S135).

Hereinafter, the processing from the step S135to the step S143are substantially equal to the step S38to the step S46in the first embodiment. Accordingly, the consumable item user1can perform smooth ordering and acquisition of the consumable items5. Then, the consumable item supplier2can smoothly provide the consumable items5.

It should be noted that the present invention is not limited to the embodiments described above, and includes various modification examples. For example, the embodiments described above have been described in detail to simply describe the present invention, and are not necessarily required to include all the described configurations. In addition, part of the configuration of one embodiment can be replaced with the configurations of other embodiments, and in addition, the configuration of the one embodiment can also be added with the configurations of other embodiments. In addition, part of the configuration of each of the embodiments can be subjected to addition, deletion, and replacement with respect to other configurations.

The respective configurations, the respective functions, the respective processing units, the respective processing means and the like described above may be partially or wholly realized by a hardware such as an integrated circuit, for example. The respective configurations, the respective functions and the like described above may be realized by software by allowing a processor to interpret and execute programs for realizing the respective functions. The information on programs, tables, files and the like for realizing the respective functions may be stored in a recording device such as a memory, a hard disk, a solid state drive (SSD), or a recording medium such as a flash memory card and digital versatile disk (DVD).

In the respective embodiments, with respect to control lines and information lines, those lines that are considered necessary for the description of the present invention are indicated. It is not always the case that all control lines and information lines that are necessary in terms of the product are described. In an actual system, it is safe to say that almost all configurations are mutually connected to each other.

As modifications of the present inventions, for example, the following modifications (a) to (d) are considered.

(a) The present invention is not limited to the case where the polymer is used as a reagent, and any arbitrary reagent may be used.

(b) The barcode reader31according to present invention is not limited to a barcode reader that is connected to the analyzer3, and may be a transmission device that independently transmits information to the server6via the network7, for example.

(c) The barcode reader81and the barcode reader31according to the first embodiment may be the same barcode reader.

(d) A wireless tag may be attached to the package bag53of consumable items5in place of the two-dimensional barcode label. Further, the analysis system100may include a wireless tag reader in place of the barcode reader, and may include a wireless tag writer in place of the printer.

REFERENCE SIGNS LIST