Patent Description:
In recent years, in the medical field, an immunological test apparatus is widely used (for example, refer to <CIT>). The immunological test apparatus can easily and quickly perform a qualitative reaction test for testing positive and negative of an infectious disease, such as influenza. In the immunological test apparatus, a carrier holding a reagent (antibody) that is combined with a test substance (antigen) to be colored is used. A sample for determining whether or not a test substance is present, for example, a sample in which a body fluid such as pharyngeal swab or nasal swab is mixed with a predetermined solution, is dropped onto the carrier.

The immunological test apparatus receives the carrier having a sample dropped thereon, images a portion of the reagent with an imaging element, and measures the coloration state (density, chromaticity) of the reagent based on an imaging signal obtained by the imaging. Then, it is determined whether or not the test substance is present in the sample based on the measurement result, and the determination result is displayed for a user, such as a medical staff member.

On the other hand, creating a disease map by expressing the number of patients with infectious diseases for each area on a map based on the statistical information of patients with infectious diseases and displaying the created disease map have been performed. For example, <CIT> discloses an information processing system in which a measurement apparatus, an information processing apparatus (management server), and a client terminal are connected to each other through a network. The measurement apparatus is a thermometer, a sphygmomanometer, an imaging apparatus, a sample test apparatus, or the like, and transmits measured biological information to the information processing apparatus. The information processing apparatus calculates the number of patients with infectious diseases for each area, as statistical information, based on the biological information from the measurement apparatus and the installation location information of the measurement apparatus, and transmits the calculated number to a client terminal. The client terminal creates a disease map based on the number of patients with infectious diseases for each area from the server, and displays the disease map on a display unit.

<CIT> discloses an immunological test apparatus for identifying active cases of e. influenza disease through sampling in high risk locations, in accordance with the preamble of claim <NUM>. But this does not provide for means for discriminating middle stage diseases and early stage diseases. <CIT> discloses a diagnostic test reader system having a housing configured to mount a mobile phone and having an illumination source. A demagnifier is disposed in the housing so that the mobile phone can receive information from the test reader and process such information.

<CIT> discloses correction of a coloration degree on an immunochromatographic test strip based on an elapsed time from the change of absorbance at the first position to the change of absorbance at the second position.

Patients suffering from infectious diseases include patients with relatively mild symptoms at the early stage of infection (hereinafter, referred to as early stage patients) and patients with remarkable symptoms at the middle stage of infection (hereinafter, referred to as middle stage patients). The amount of test substance is relatively large in the case of middle stage patients but relatively small in the case of early stage patients. For this reason, in the immunological test apparatus, in the case of early stage patients, it takes a longer time to obtain a determination result indicating that a test substance is present in the sample than in the case of middle stage patients. Therefore, in the immunological test apparatus, it can be thought that the early stage patients and the middle stage patients can be distinguished from each other by referring to the elapsed time (hereinafter, referred to as required determination time) of a test taken until a determination result indicating that a test substance is present in the sample is obtained from the start of the test.

Once the early stage patients and the middle stage patients are distinguished from each other, the disease map can also be divided into a disease map relevant to the early stage patients and a disease map relevant to the middle stage patients. In particular, according to the disease map relevant to the former early stage patients, at the early stage of infection, it is possible to predict how the epidemic situation of the infectious disease changes from then on. Therefore, it can be thought that effective measures can be taken to prevent the spread of infection. However, <CIT> and <CIT> do not disclose that the required determination time is effectively used to prevent the spread of infection.

It is an object of the present invention to provide an immunological test apparatus and an operation method thereof, an information processing apparatus and an operation method and an operation program thereof, and an information processing system capable of effectively using a required determination time, which is the elapsed time of a test taken until a determination result indicating that a test substance is present in a sample is obtained from the start of the test, to prevent the spread of infection.

In order to solve the aforementioned problems, an immunological test apparatus of the present invention is an immunological test apparatus that receives a carrier holding a reagent, which is combined with a test substance as an antigen of an infectious disease to be colored, and having a sample dropped thereon, measures a state of the coloration, and determines whether or not the test substance is present in the sample based on a result of the measurement. The immunological test apparatus comprises: a timing unit that counts an elapsed time from start of a test; and an information output unit that outputs required determination time information regarding a required determination time, which is the elapsed time taken until a determination result indicating that the test substance is present in the sample is obtained, so as to be associated with information of the determination result.

It is preferable to further comprise: a chemical solution spreading unit that performs sensitization processing in which a chemical solution for sensitizing the coloration state is spread onto the carrier; and a driving controller that controls driving of the chemical solution spreading unit. It is preferable that, in a case where a determination result indicating that the test substance is present in the sample is not obtained during a period from the start of the test to a set time set in advance, the driving controller drives the chemical solution spreading unit to start the sensitization processing and that the information output unit outputs, as the required determination time information, at least information indicating that the elapsed time exceeds the set time.

It is preferable that the information output unit outputs the required determination time information only in a case where the elapsed time exceeds the set time and the sensitization processing is performed.

It is preferable that the information indicating that the elapsed time exceeds the set time is information indicating that the sensitization processing has been performed.

It is preferable that the information output unit transmits the required determination time information and the determination result information to an information processing apparatus connected through a network. It is preferable that the information output unit transmits the required determination time information and the determination result information for each test.

An operation method of an immunological test apparatus of the present invention is an operation method of an immunological test apparatus that receives a carrier holding a reagent, which is combined with a test substance as an antigen of an infectious disease to be colored, and having a sample dropped thereon, measures a state of the coloration, and determines whether or not the test substance is present in the sample based on a result of the measurement. The operation method comprises: a timing step of counting an elapsed time from start of a test; and an information output step of outputting required determination time information regarding a required determination time, which is the elapsed time taken until a determination result indicating that the test substance is present in the sample is obtained, so as to be associated with information of the determination result.

An information processing apparatus of the present invention is an information processing apparatus connected, through a network, to an immunological test apparatus that receives a carrier holding a reagent, which is combined with a test substance as an antigen of an infectious disease to be colored, and having a sample dropped thereon, measures a state of the coloration, and determines whether or not the test substance is present in the sample based on a result of the measurement. The information processing apparatus comprises: a reception unit that receives required determination time information regarding a required determination time, which is an elapsed time of a test taken until a determination result indicating that the test substance is present in the sample is obtained from start of the test, and information of the determination result from the immunological test apparatus through the network; and a statistical information creation unit that creates statistical information of early stage patients, who are patients at an early stage of infection of an infectious disease, based on the required determination time information, the determination result information, and installation location information regarding an installation location of the immunological test apparatus.

It is preferable to further comprise a map creation unit that creates a disease map by expressing the number of early stage patients of an infectious disease for each area on a map based on the statistical information. It is preferable that the statistical information creation unit also creates statistical information of middle stage patients who are patients at a middle stage of infection of an infectious disease and that the map creation unit also creates a disease map by expressing the number of middle stage patients of an infectious disease for each area on a map based on the statistical information of middle stage patients. It is preferable to further comprise an output controller that performs output control of the statistical information or the disease map.

An operation method of an information processing apparatus of the present invention is an operation method of an information processing apparatus connected, through a network, to an immunological test apparatus that receives a carrier holding a reagent, which is combined with a test substance as an antigen of an infectious disease to be colored, and having a sample dropped thereon, measures a state of the coloration, and determines whether or not the test substance is present in the sample based on a result of the measurement. The operation method comprises: a reception step of receiving required determination time information regarding a required determination time, which is an elapsed time of a test taken until a determination result indicating that the test substance is present in the sample is obtained from start of the test, and information of the determination result from the immunological test apparatus through the network; and a statistical information creation step of creating statistical information of early stage patients, who are patients at an early stage of infection of an infectious disease, based on the required determination time information, the determination result information, and installation location information regarding an installation location of the immunological test apparatus.

An operation program of an information processing apparatus of the present invention is an operation program of an information processing apparatus connected, through a network, to an immunological test apparatus that receives a carrier holding a reagent, which is combined with a test substance as an antigen of an infectious disease to be colored, and having a sample dropped thereon, measures a state of the coloration, and determines whether or not the test substance is present in the sample based on a result of the measurement. The operation program causes a computer to execute: a reception function of receiving required determination time information regarding a required determination time, which is an elapsed time of a test taken until a determination result indicating that the test substance is present in the sample is obtained from start of the test, and information of the determination result from the immunological test apparatus through the network; and a statistical information creation function of creating statistical information of early stage patients, who are patients at an early stage of infection of an infectious disease, based on the required determination time information, the determination result information, and installation location information regarding an installation location of the immunological test apparatus.

An information processing system of the present invention is an formation processing system comprises: an immunological test apparatus that receives a carrier holding a reagent, which is combined with a test substance as an antigen of an infectious disease to be colored, and having a sample dropped thereon, measures a state of the coloration, and determines whether or not the test substance is present in the sample based on a result of the measurement; and an information processing apparatus connected to the immunological test apparatus through a network. The immunological test apparatus has: a timing unit that counts an elapsed time from start of a test; and an information output unit that transmits required determination time information regarding a required determination time, which is the elapsed time taken until a determination result indicating that the test substance is present in the sample is obtained, to the information processing apparatus through the network so as to be associated with information of the determination result. The information processing apparatus has: a reception unit that receives the required determination time information and the determination result information from the immunological test apparatus; and a statistical information creation unit that creates statistical information of early stage patients, who are patients at an early stage of infection of an infectious disease, based on the required determination time information, the determination result information, and installation location information regarding an installation location of the immunological test apparatus.

According to the present invention, since the required determination time information regarding the required determination time, which is the elapsed time of a test taken until the determination result indicating that a test substance is present in a sample is obtained from the start of the test, is output, it is possible to provide an immunological test apparatus and an operation method thereof, an information processing apparatus and an operation method and an operation program thereof, and an information processing system capable of effectively using the required determination time to prevent the spread of infection.

In <FIG>, an information processing system <NUM> comprises a plurality of immunological test apparatuses <NUM> and an information processing server <NUM> corresponding to an information processing apparatus. The immunological test apparatus <NUM> and the information processing server <NUM> are communicably connected to each other through a network <NUM>, such as the Internet or a wide area network (WAN) called a public communication network. In the network <NUM>, in consideration of information security, a virtual private network (VPN) is constructed, or a communication protocol with a high security level, such as hypertext transfer protocol security (HTTPS), is used.

The immunological test apparatus <NUM> is provided in a medical institution, such as a hospital, for example. The immunological test apparatus <NUM> performs an immunological test on a sample SSP (refer to <FIG>). More specifically, the immunological test apparatus <NUM> determines whether or not A type influenza virus or B type influenza virus, which is a test substance, is present in the sample SSP. That is, the immunological test apparatus <NUM> performs a qualitative reaction test for testing positive and negative of influenza as an infectious disease. The sample SSP is, for example, a solution obtained by mixing body fluid, such as pharyngeal swab or nasal swab collected from a patient, with a predetermined extract.

The immunological test apparatus <NUM> transmits a test record <NUM> (refer to <FIG>) to the information processing server <NUM> through the network <NUM>. The test record <NUM> includes determination result information <NUM>. In addition to the determination result information <NUM>, the test record <NUM> may include required determination time information <NUM> (refer to <FIG>). The required determination time information <NUM> is information regarding the required determination time that is the elapsed time of the test taken until a determination result indicating that influenza virus is present in the sample SSP is obtained from the start of the test. The determination result information <NUM> is information indicating that influenza virus is present in the sample SSP literally, that is, information of A type influenza positive and/or B type influenza positive.

A plurality of client terminals <NUM> are connected to the network <NUM>. Each of the client terminal <NUM> and the information processing server <NUM> is configured by installing a control program, such as an operating system, or various application programs (hereinafter, referred to as AP) on a computer as a base, such as a personal computer, a tablet computer, a server computer, or a workstation.

The information processing server <NUM> is managed by, for example, a sales company of the immunological test apparatus <NUM>. The information processing server <NUM> receives the test record <NUM> transmitted from the immunological test apparatus <NUM> through the network <NUM>. The sales company of the immunological test apparatus <NUM> has made a site for providing information based on the test record <NUM> on the Internet.

The client terminal <NUM> accesses the information providing site through the network <NUM> according to the operation instruction of the user, such as a medical staff member. The client terminal <NUM> transmits a request for distribution of a disease map <NUM> (refer to <FIG> and <FIG>), which is obtained by expressing the number of influenza patients for each area on a map, to the information processing server <NUM> through the information providing site. The information processing server <NUM> distributes the disease map <NUM> to the client terminal <NUM> of the distribution request source in response to the distribution request.

The information processing server <NUM> distributes the disease map <NUM> in the form of a screen (hereinafter, referred to as a disease map display screen <NUM>; refer to <FIG> and <FIG>) that can be viewed on the web browser of the client terminal <NUM>. Specifically, the information processing server <NUM> outputs the disease map display screen <NUM> in the form of screen data for web distribution that is created by a markup language, such as extensible markup language (XML), for example. Instead of the XML, other data description languages, such as JavaScript (registered trademark) Object Notation (JSON), may be used. In addition to the disease map display screen <NUM>, the information processing server <NUM> distributes various screens, such as an authentication screen for access to the information providing site, to the client terminal <NUM> in the form of screen data for web distribution.

In <FIG>, the immunological test apparatus <NUM> has an apparatus main body 10A. A rectangular opening <NUM> for receiving a dedicated cartridge <NUM> having the sample SSP dropped thereon, an openable lid <NUM> for covering the opening <NUM>, and a tray-shaped cartridge loading unit <NUM> onto which the cartridge <NUM> is loaded are provided in the front lower portion of the apparatus main body 10A. The cartridge loading unit <NUM> slides in the opening and closing direction of the lid <NUM> in conjunction with the opening and closing of the lid <NUM>. More specifically, the cartridge loading unit <NUM> slides between the exposed position shown in <FIG>, which is mostly exposed from the opening <NUM> in a case where the lid <NUM> is opened, and the housing position shown in <FIG>, which is housed in the apparatus main body 10A in a case where the lid <NUM> is closed.

The front upper portion of the apparatus main body 10A is an inclined surface portion, and a touch panel <NUM> is attached to the inclined surface portion. An operation instruction from the user is input to the touch panel <NUM>, and information regarding the immunological test is displayed. Examples of the operation instruction include a test start instruction, a test stop instruction, and an instruction to print out a determination result indicating that influenza virus is present in the sample SSP. The information regarding the immunological test includes patient identification (ID) for identifying a patient from whom the sample SSP is collected, an elapsed time from the start of the test, a determination result, and the like.

The cartridge <NUM> has a case 15A in which a carrier <NUM> (refer to <FIG>) is housed. On the upper surface of the case 15A, a reverse conical dropping port <NUM> through which the sample SSP is dropped is provided. In addition, a label <NUM> on which a patient ID and the like are written is attached to the upper surface of the case 15A.

As shown in the cutaway view of the cartridge <NUM> of <FIG> and <FIG>, a belt-shaped carrier <NUM> is housed in the case 15A along the longitudinal direction. The carrier <NUM> is, for example, a nitrocellulose film, and has a test region <NUM> formed by two test lines A and B and a control line C. On the test line A, a reagent that is combined with the A type influenza virus to be colored is fixed. On the test line B, a reagent that is combined with the B type influenza virus to be colored is fixed. The control line C is a line for determining whether or not the amount of sample SSP appropriate for measurement has normally flowed through the carrier <NUM>, and makes a color in a case where the amount of sample SSP appropriate for measurement has normally flowed through the carrier <NUM>.

The reagent of the test line A is anti-A type influenza virus antibody, anti-A type influenza virus antibody bonding gold colloid, anti-A type influenza virus antibody bonding colored latex, or the like. The reagent of the test line B is anti-B type influenza virus antibody, anti-B type influenza virus antibody bonding gold colloid, anti-B type influenza virus antibody bonding colored latex, or the like.

On the lower surface of the case 15A, an observation window <NUM> for observing the coloration state of the test lines A and B and the control line C is formed. A similar observation window <NUM> is also formed in the cartridge loading unit <NUM> at a position corresponding to the observation window <NUM> of the case 15A.

In addition to the carrier <NUM>, a solution feeding pad <NUM>, a solution absorbing pad <NUM> (not shown in <FIG>, refer to <FIG>), a reducing solution pot <NUM>, and a sensitizing solution pot <NUM> are housed in the case 15A. The solution feeding pad <NUM> and the solution absorbing pad <NUM> are disposed at positions interposing the carrier <NUM> from both sides in the test region <NUM> (refer to <FIG> and the like). The reducing solution pot <NUM> is disposed above the solution feeding pad <NUM>, and stores a reducing solution SR (refer to <FIG>) corresponding to a chemical solution for sensitizing the coloration state of the reagent. The sensitizing solution pot <NUM> is disposed above the end portion of the carrier <NUM> on the label <NUM> side, and stores a sensitizing solution SSE (refer to <FIG>) corresponding to a chemical solution.

The reducing solution SR is a solution of ammonium iron sulfate that is a divalent iron ion-containing compound. On the other hand, the sensitizing solution SSE is a solution of silver nitrate that is a silver ion-containing compound. As described above, there are two types of chemical solutions of a solution of a divalent iron ion-containing compound (reducing solution SR) and a solution of a silver ion-containing compound (sensitizing solution SSE). The silver ion-containing compound may be silver acetate, silver lactate, silver butyrate, silver thiosulfate, or the like.

In <FIG>, a guide rail <NUM>, a measurement unit <NUM>, and a chemical solution spreading unit <NUM> are provided in the apparatus main body 10A. The guide rail <NUM> guides a slide between the exposed position and the housing position of the cartridge loading unit <NUM>.

In a case where the cartridge <NUM> is located at the housing position, the measurement unit <NUM> is disposed at a position facing the observation window <NUM> of the case 15A and the observation window <NUM> of the cartridge loading unit <NUM>. The measurement unit <NUM> includes a pair of light sources <NUM> for emitting light to the test region <NUM>, which is formed by the test lines A and B and the control line C, through the observation windows <NUM> and <NUM> and an imaging element <NUM> for imaging the test region <NUM>.

The light source <NUM> is, for example, a module in which a light emitting diode (LED) is built, and emits white light. The light source <NUM> may emit monochromatic light as long as the chromaticity before and after sensitization processing, which will be described later, can be distinguished. The light source <NUM> can also be configured by a plurality of modules that emit monochromatic light components having different wavelengths. The imaging element <NUM> is, for example, a line sensor in which a plurality of photodiodes are linearly arranged or an area sensor in which a plurality of photodiodes are arranged in a matrix, and outputs an imaging signal corresponding to the amount of light received by the photodiodes.

The chemical solution spreading unit <NUM> performs sensitization processing for spreading the reducing solution SR and the sensitizing solution SSE, which are chemical solutions for sensitizing the coloration state of the reagent, on the carrier <NUM>. The chemical solution spreading unit <NUM> has a motor <NUM>, a first pressing unit <NUM>, and a second pressing unit <NUM>. The motor <NUM> is shared by the pressing units <NUM> and <NUM>.

In <FIG>, the first pressing unit <NUM> has a first arm <NUM> rotatable around a shaft 60A like a seesaw, a first pressing piece <NUM> fixed to a lower portion of the distal end of the first arm <NUM>, and a first cam <NUM> disposed on the lower side of the rear end of the first arm <NUM>. The first cam <NUM> is connected to a driving shaft 55A rotated by the motor <NUM> so as to be able to be connected and disconnected through an electromagnetic clutch or the like (not shown), for example. In a case where the first cam <NUM> rotates, the rear end of the first arm <NUM> is pushed up, and the first pressing piece <NUM> at the distal end is lowered. Similarly, the second pressing unit <NUM> has a second arm <NUM>, a second pressing piece <NUM>, and a second cam <NUM> (refer to <FIG>), and the second pressing piece <NUM> is lowered by the rotation of the second cam <NUM>.

The first pressing piece <NUM> is disposed immediately above the reducing solution pot <NUM> in a case where the cartridge <NUM> is located at the housing position. In a case where the first pressing piece <NUM> is lowered, the reducing solution pot <NUM> is crushed from the outside of the case 15A by the first pressing piece <NUM>, and the reducing solution SR is spread from the reducing solution pot <NUM>. On the other hand, the second pressing piece <NUM> is disposed immediately above the sensitizing solution pot <NUM> in a case where the cartridge <NUM> is located at the housing position. In a case where the second pressing piece <NUM> is lowered, the sensitizing solution pot <NUM> is crushed from the outside of the case 15A by the second pressing piece <NUM>, and the sensitizing solution SSE is spread from the sensitizing solution pot <NUM>.

Although not shown, an information reading unit for reading the information written on the label <NUM>, a printer for printing out the determination result on a predetermined sheet, and the like are provided in the apparatus main body 10A. Similarly to the measurement unit <NUM>, the information reading unit is configured to include a light source that emits light to the label <NUM> and an imaging element that images the label <NUM>. The information reading unit is disposed at a position facing the label <NUM> in a case where the cartridge <NUM> is located at the housing position.

In <FIG>, in the immunological test, first, the sample SSP is dropped onto the carrier <NUM> through the dropping port <NUM>. The sample SSP moves from the dropping port <NUM> onto the carrier <NUM> toward the test region <NUM>. The sample SSP reaches the test line A, then reaches the test line B, and finally reaches the control line C. Here, in a case where the A type influenza virus is present in the sample SSP, the reagent of the test line A is colored. In a case where the B type influenza virus is present in the sample SSP, the reagent of the test line B is colored.

The density of coloration of the reagent is correlated with the amount of influenza virus present in the sample SSP. That is, the density of coloration of the reagent is low in a case where only a small amount of influenza virus is present in the sample SSP, and the density of coloration of the reagent is high in a case where a large amount of influenza virus is present in the sample SSP. The amount of influenza virus in the early stage patient, who is a patient with relatively mild symptoms at the early stage of infection, is smaller than that in the middle stage patient, who is a patient with remarkable symptoms at the middle stage of infection. For this reason, the density of coloration of the reagent in the case of the early stage patient is lower than that in the case of the middle stage patient.

A region where a labeled substance is present is provided between the dropping port <NUM> of the carrier <NUM> and the test region <NUM>. In the sample SSP, the labeled substance is mixed during movement from the dropping port <NUM> to the test region <NUM>. The labeled substance is captured by the control line C, and accordingly the control line C is colored. Therefore, in a case where the sample SSP reaches the control line C after a predetermined time TE (for example, <NUM> minutes) has passed from dropping of the sample SSP, the control line C is colored regardless of the presence or absence of coloration of the reagent of the test lines A and B. In a case where the coloration of the control line C cannot be checked even after the time TE has passed, an error is determined.

In <FIG>, in a case where the first pressing unit <NUM> is driven and the reducing solution pot <NUM> is crushed by the first pressing piece <NUM>, the reducing solution SR is dropped from the reducing solution pot <NUM> onto the solution feeding pad <NUM>. The timing at which the reducing solution SR is dropped onto the solution feeding pad <NUM> is the timing of the start of the sensitization processing. The reducing solution SR is sent to the test region <NUM> along the short direction of the case 15A and absorbed by the solution absorbing pad <NUM>.

In <FIG>, in a case where the second pressing unit <NUM> is driven and the sensitizing solution pot <NUM> is crushed by the second pressing piece <NUM>, the sensitizing solution SSE is dropped from the sensitizing solution pot <NUM> onto the end portion of the carrier <NUM> on the label <NUM> side. The sensitizing solution SSE is sent to the test region <NUM> along the longitudinal direction of the case 15A.

In <FIG>, a main controller <NUM> performs overall control of the immunological test apparatus <NUM>. A measurement controller <NUM>, a determination unit <NUM>, a driving controller <NUM>, a display controller <NUM>, an instruction receiving unit <NUM>, and an information output unit <NUM> are connected to the main controller <NUM>.

The measurement controller <NUM> controls the driving of the measurement unit <NUM>. More specifically, the measurement controller <NUM> drives the light source <NUM> and the imaging element <NUM> of the measurement unit <NUM> at predetermined time intervals (for example, one minute intervals), so that the light source <NUM> emits light to the test region <NUM> and the imaging element <NUM> images the test region <NUM>.

The determination unit <NUM> receives an imaging signal from the imaging element <NUM> of the measurement unit <NUM> at predetermined intervals. The determination unit <NUM> determines whether or not A type influenza virus and/or B type influenza virus is present in the sample SSP from the coloration state (density, chromaticity) of the reagent derived based on the imaging signal. For example, in a case where the density and chromaticity of the coloration of the reagent exceed threshold values set in advance, the determination unit <NUM> determines that A type influenza virus and/or B type influenza virus is present in the sample SSP.

In a case where it is determined that A type influenza virus is present in the sample SSP, the determination unit <NUM> outputs a first determination result indicating that A type influenza virus is present in the sample SSP to the main controller <NUM>. In a case where it is determined that B type influenza virus is present in the sample SSP, the determination unit <NUM> outputs a second determination result indicating that B type influenza virus is present in the sample SSP to the main controller <NUM>. In addition, the determination unit <NUM> determines whether or not the measurement has ended correctly from the coloration state of the control line C, and outputs the determination result to the main controller <NUM>.

The first determination result indicates that the patient, from whom the sample SSP has been collected, is infected with A type influenza virus (A type influenza positive). The second determination result indicates that the patient, from whom the sample SSP has been collected, is infected with B type influenza virus (B type influenza positive).

Assuming that the intensity of light emitted from the light source <NUM> to the test region <NUM> is I and the intensity of reflected light from the test region <NUM> imaged by the imaging element <NUM> is IR, the density OC of the coloration of the reagent is defined by the following Equation (<NUM>).

The chromaticity is a quantitative expression of the hue and the saturation of the color of the reagent, and is calculated from the imaging signal using a known calculation equation. As a color system of chromaticity, a general commission internationale de I'eclairage (CIE) color system can be used.

The driving controller <NUM> controls the driving of the chemical solution spreading unit <NUM>. In practice, the driving controller <NUM> is a driver of the motor <NUM> of the chemical solution spreading unit <NUM>. The driving controller <NUM> drives the chemical solution spreading unit <NUM> to start sensitization processing.

The main controller <NUM> corresponds to a timing unit, and counts an elapsed time TP from the start of the test. The main controller <NUM> outputs a driving command to the driving controller <NUM> in a case where at least one of the first determination result or the second determination result is not received from the determination unit <NUM> even though the elapsed time TP exceeds a set time TS (for example, <NUM> minutes) set in advance (TP > TS). The driving controller <NUM> drives the chemical solution spreading unit <NUM> in response to the driving command. That is, in a case where neither the first determination result nor the second determination result is obtained or either the first determination result or the second determination result is not obtained during a period from the start of the test to the set time TS (<NUM> < TP ≤ TS), the sensitization processing is started. Conversely, in a case where both the first determination result and the second determination result are obtained during the period from the start of the test to the set time TS, the sensitization processing is not performed.

In a case where the elapsed time TP becomes the time TE taken for the sample SSP to reach the control line C (TP = TE) and a determination result indicating that the measurement has ended correctly is received from the determination unit <NUM>, the main controller <NUM> ends the test. In a case where neither the first determination result nor the second determination result is obtained at the end of the test, it is understood that the patient from whom the sample SSP has been collected is not infected with both A type influenza virus and B type influenza virus (A type influenza virus negative and B type influenza virus negative). In a case where the test has ended, the user can take out the cartridge <NUM> from the immunological test apparatus <NUM>.

The display controller <NUM> controls the display of various display screens on the touch panel <NUM>. The instruction receiving unit <NUM> receives the above-described various operation instructions input by the user through the touch panel <NUM>.

In a case where a test start instruction is received by the instruction receiving unit <NUM>, the main controller <NUM> starts counting the elapsed time TP, and the measurement controller <NUM> causes the measurement unit <NUM> to start measurement. In a case where a test stop instruction is received by the instruction receiving unit <NUM>, the main controller <NUM> stops the test. Therefore, the user can take out the cartridge <NUM> from the immunological test apparatus <NUM> as in the case where the test ends. In a case where an instruction to print out the determination result is received by the instruction receiving unit <NUM>, the printer prints out the determination result on a predetermined sheet.

The test stop instruction can be input in a case where a determination result indicating that at least one of A type influenza virus or B type influenza virus is present in the sample SSP is obtained. Therefore, for this reason, in a case where the first determination result indicating that A type influenza virus is present in the sample SSP is obtained, the test can be stopped immediately without waiting for the second determination result indicating that B type influenza virus is present in the sample SSP.

In the qualitative reaction test of influenza, it does not matter so much whether the patient is infected with either A type influenza virus or B type influenza virus. This is because, regardless of A type influenza virus or B type influenza virus, treatment methods such as the type, dose, and usage of the drug to be administered are generally common. For this reason, in a case where the infection with either A type influenza virus or B type influenza virus is found, the minimum purpose of the qualitative reaction test of influenza can be achieved.

Therefore, in a case where a determination result indicating that at least one of A type influenza virus or B type influenza virus is present in the sample SSP is obtained, a test stop instruction is received, and accordingly the stopping of the test does not cause any problem. For this reason, in this example, in a case where a determination result indicating that at least one of A type influenza virus or B type influenza virus is present in the sample SSP is obtained, it is possible to stop the test.

The information output unit <NUM> outputs required determination time information regarding the required determination time, which is the elapsed time taken until the determination result indicating that influenza virus is present in the sample SSP is obtained, so as to be associated with information of the determination result. More specifically, the information output unit <NUM> transmits the required determination time information and the information of the determination result to the information processing server <NUM>, which is connected through the network <NUM>, for each test.

Here, the sensitization processing is performed only in a case where the density of coloration of the reagent is low as it is and confirmation that influenza virus is present in the sample SSP cannot be obtained, and is not performed in a case where the density of coloration of the reagent is sufficiently high. For this reason, it is considered that the sensitization processing is performed in the case of an early stage patient having only a small amount of influenza virus in the sample SSP and is not performed in the case of a middle stage patient having a large amount of influenza virus in the sample SSP.

Before the sensitization processing is performed, at least a time from the start of the test to the set time TS is required. Therefore, in order to distinguish whether the patient from whom the sample SSP has been collected is an early stage patient or a middle stage patient based on the required determination time information, the required determination time information may be at least information indicating that the elapsed time TP exceeds the set time TS and further may be information indicating that the sensitization processing has been performed. In a case where information indicating that the sensitization processing has been performed is output as the required determination time information, a distinction between the early stage patient and the middle stage patient is made according to the presence and absence of the information. Therefore, in a case where the sensitization processing is not performed, it is not necessary to output the required determination time information.

Therefore, the information output unit <NUM> outputs a first test record 90A shown in <FIG> in a case where the sensitization processing is not performed, and outputs a second test record 90B shown in <FIG> in a case where the sensitization processing is performed. The first test record 90A shown in <FIG> that is output in a case where the sensitization processing is not performed is obtained by attaching an apparatus ID for identifying the immunological test apparatus <NUM> to the determination result information <NUM>. On the other hand, the second test record 90B shown in <FIG> that is output in a case where the sensitization processing is performed has the required determination time information <NUM> in addition to the determination result information <NUM>, and is obtained by adding an apparatus ID to these.

In <FIG>, "A type influenza positive" indicating the first determination result is exemplified as the determination result information <NUM>. In <FIG>, "B type influenza positive" indicating the second determination result is exemplified as the determination result information <NUM>. The required determination time information <NUM> is "perform sensitization processing", and is information indicating that the sensitization processing has been performed.

Thus, the information output unit <NUM> outputs, as the required determination time information <NUM>, information indicating that at least the elapsed time TP exceeds the set time TS, that is, information indicating that the sensitization processing has been performed. In addition, the information output unit <NUM> outputs the required determination time information <NUM> only in a case where the sensitization processing is performed.

In <FIG>, the basic configurations of computers that form the information processing server <NUM> and the client terminal <NUM> are the same, and each computer comprises a storage device <NUM>, a memory <NUM>, a central processing unit (CPU) <NUM>, a communication unit <NUM>, and an input and output device <NUM>. These are connected to each other through a data bus <NUM>.

The storage device <NUM> is a hard disk drive, which is built into a computer that forms the information processing server <NUM> or the like or which is connected to the computer through a cable or a network, or a disk array formed by connecting a plurality of hard disk drives. A control program such as an operating system, various application programs, various kinds of data associated with these programs, and the like are stored in the storage device <NUM>.

The memory <NUM> is a work memory for the CPU <NUM> to execute processing. The CPU <NUM> performs overall control of each unit of the computer by loading a program stored in the storage device <NUM> to the memory <NUM> and executing the processing according to the program. The communication unit <NUM> is a network interface to perform transmission control of various kinds of information through the network <NUM>. The input and output device <NUM> is a display unit, such as a display, and an operation unit, such as a keyboard or a mouse, or a touch panel (serving as both a display unit and an operation unit).

In the following description, for the sake of distinction, a suffix "S" is attached to the reference numeral of each unit of the computer that forms the information processing server <NUM>, and a suffix "L" is attached to the reference numeral of each unit of the computer that forms the client terminal <NUM>.

In <FIG>, in a case where the web browser is started, the CPU <NUM> of the client terminal <NUM> cooperates with the memory <NUM> or the like to function as a browser controller <NUM>. The browser controller <NUM> controls the operation of the web browser. The browser controller <NUM> receives screen data of various screens from the information processing server <NUM>. The browser controller <NUM> reproduces various screens to be displayed on the web browser based on the screen data, and displays the various screens on the display unit of the input and output device <NUM>.

The browser controller <NUM> receives various operation instructions input by the user through various screens. Examples of the operation instruction include an instruction for access to the information providing site, an instruction to distribute the disease map <NUM>, and the like. The browser controller <NUM> issues various requests according to the operation instructions to the information processing server <NUM>.

The access instruction includes user ID and password input by the user on the access authentication screen. In a case where there is an access instruction, the browser controller <NUM> issues an access request, which includes an address for identifying each client terminal <NUM> and a user ID and a password, to the information processing server <NUM>. In a case where there is an instruction to distribute the disease map <NUM>, the browser controller <NUM> issues a request for distribution of the disease map <NUM> including the address of the client terminal <NUM> to the information processing server <NUM>.

In <FIG>, an operation program <NUM> as an AP is stored in the storage device <NUM> of the information processing server <NUM>. The operation program <NUM> is an AP for making the computer that forms the information processing server <NUM> function as an information processing apparatus. In addition to the operation program <NUM>, a test record table <NUM> and an installation location information <NUM> are stored in the storage device <NUM>.

In a case where the operation program <NUM> is started, the CPU <NUM> of the information processing server <NUM> cooperates with the memory <NUM> or the like to function as a reception unit <NUM>, an information management unit <NUM>, a request receiving unit <NUM>, a statistical information creation unit <NUM>, a map creation unit <NUM>, and a screen output controller <NUM>.

The reception unit <NUM> has a reception function for receiving the test record <NUM> transmitted from the immunological test apparatus <NUM> through the network <NUM>. In the case of the first test record 90A, the reception unit <NUM> receives only the determination result information <NUM>. In the case of the second test record 90B, the reception unit <NUM> receives the required determination time information <NUM> in addition to the determination result information <NUM>. The reception unit <NUM> outputs the received test record <NUM> to the information management unit <NUM>.

The information management unit <NUM> manages storage of various kinds of information in the storage device <NUM> and reading of various kinds of information from the storage device <NUM>. Specifically, the information management unit <NUM> stores the test record <NUM> from the reception unit <NUM> in the test record table <NUM>. The information management unit <NUM> transmits the test record <NUM> stored in the test record table <NUM> and the installation location information <NUM> to the statistical information creation unit <NUM>. The test record <NUM> stored in the test record table <NUM> for more than a predetermined period (for example, one year) may be deleted from the test record table <NUM>.

The request receiving unit <NUM> receives various requests from the client terminal <NUM> including the request for distribution of the disease map <NUM>. The request receiving unit <NUM> outputs the request for distribution of the disease map <NUM> to the statistical information creation unit <NUM>.

The statistical information creation unit <NUM> has a statistical information creation function for receiving a request for distribution of the disease map <NUM> from the request receiving unit <NUM> and creating statistical information <NUM> (refer to <FIG> and <FIG>) based on the installation location information <NUM> and the test record <NUM> from the information management unit <NUM>. The statistical information creation unit <NUM> outputs the created statistical information <NUM> to the map creation unit <NUM>.

The map creation unit <NUM> creates the disease map <NUM> by expressing the number of influenza patients for each area on a map based on the statistical information <NUM> from the statistical information creation unit <NUM>. The map creation unit <NUM> outputs the created disease map <NUM> to the screen output controller <NUM>.

The screen output controller <NUM> corresponds to an output controller that performs output control of the disease map <NUM>. The screen output controller <NUM> controls distribution of various screens including the disease map display screen <NUM> to the client terminal <NUM>. More specifically, the screen output controller <NUM> generates screen data of various screens for web distribution, and distributes the screen data to the client terminal <NUM> of the distribution request source.

The test record table <NUM> has two types of tables, a first test record table 116A shown in <FIG> in which the first test record 90A is stored and a second test record table 116B shown in <FIG> in which the second test record 90B is stored. The first test record 90A and the second test record 90B are stored in the tables 116A and 116B, respectively, together with the date and time received by the reception unit <NUM>.

The first test record table 116A is a collection of first test records 90A that are output in a case where the sensitization processing is not performed. Therefore, since there is no need for sensitization processing, this can be said to be accumulated information of a middle stage patient having influenza virus in the sample SSP. On the other hand, the second test record table 116B is a collection of second test records 90B that are output in a case where the sensitization processing is performed. Therefore, since there is only a very small amount of influenza virus in the sample SSP, this can be said to be accumulated information of an early stage patient for whom the sensitization processing is required.

In <FIG>, in the installation location information <NUM>, the address (prefecture, municipality, aza, and the like) of the medical institution where the immunological test apparatus <NUM> is installed is registered as the installation location for each apparatus ID of the immunological test apparatus <NUM>. According to the installation location information <NUM>, the area where each immunological test apparatus <NUM> is installed, and therefore, the area of the transmission source of the test record <NUM>, becomes clear on a prefectural basis, a municipality basis, or an aza basis. The address is input by the administrator of the information processing server <NUM> through the input and output device <NUM> in a case where the immunological test apparatus <NUM> is delivered to the medical institution, for example. Alternatively, the user may be made to input the address at the information providing site in the form of online user registration at the time of purchase of the immunological test apparatus <NUM>.

In a case where a request for distribution of the disease map <NUM> is received from the request receiving unit <NUM>, the statistical information creation unit <NUM> outputs an extraction command to the information management unit <NUM>. In response to the extraction command, the information management unit <NUM> extracts the test record <NUM> whose reception date and time is within a predetermined period (for example, one week before the date on which the request for distribution of the disease map <NUM> is received) from the test record table <NUM>. The information management unit <NUM> outputs the extracted test record <NUM> to the statistical information creation unit <NUM>.

The statistical information creation unit <NUM> determines from which area each test record <NUM> from the information management unit <NUM> has been transmitted by comparing the apparatus ID of the test record <NUM> with the apparatus ID of the installation location information <NUM>. For example, in the case of the first test record 90A having an apparatus ID "IMM001" in <FIG>, since the address of the apparatus ID "IMM001" is "Kitadaika, Toshima-ku, Tokyo ···" according to the installation location information <NUM>, it is determined that the area of the transmission source is "Kitadaika, Toshima-ku, Tokyo ···". In addition, for example, in the case of the second test record 90B having an apparatus ID "IMM100" in <FIG>, since the address of the apparatus ID "IMM100" is "Kawagoe City, Saitama Prefecture ···" according to the installation location information <NUM>, it is determined that the area of the transmission source is "Kawagoe City, Saitama Prefecture •••". The statistical information creation unit <NUM> summarizes the determination result of the area of the transmission source of each test record <NUM>, which is obtained as described above, as the statistical information <NUM>.

The statistical information 130A shown in <FIG> is the result of counting the number of first test records 90A for each prefecture of the transmission source of the first test record 90A that is determined by comparing the apparatus ID of the first test record 90A with the apparatus ID of the installation location information <NUM>. The number of first test records 90A for each prefecture indicates the number of middle stage influenza patients for each prefecture.

The statistical information 130B shown in <FIG> is the result of counting the number of second test records 90B for each prefecture of the transmission source of the second test record 90B that is determined by comparing the apparatus ID of the second test record 90B with the apparatus ID of the installation location information <NUM>. The number of second test records 90B for each prefecture indicates the number of early stage influenza patients for each prefecture whereas the number of first test records 90A for each procedure in the statistical information 130A in <FIG> indicates the number of middle stage influenza patients for each prefecture.

In the statistical information 130A and the statistical information 130B, since the test records <NUM> (patients) to be counted are different, the numbers are not necessarily the same even in the same prefecture. There is a prefecture (such as Saitama Prefecture) in which the number of first test records 90A (the number of middle stage patients) is larger than the number of second test records 90B (the number of early stage patients), and conversely, there is a prefecture (such as Chiba Prefecture) in which the number of second test records 90B (the number of early stage patients) is larger than the number of first test records 90A (the number of middle stage patients). In addition, there is a prefecture (such as Kanagawa Prefecture) in which the number of first test records 90A (the number of middle stage patients) and the number of second test records 90B (the number of early stage patients) are approximately the same.

In addition to the statistical information 130A indicating the number of middle stage influenza patients for each prefecture shown in <FIG> and the statistical information 130B indicating the number of early stage influenza patients for each prefecture shown in <FIG>, the statistical information creation unit <NUM> can also create, as statistical information, the total number of influenza patients (the number of middle stage patients + the number of early stage patients) for each prefecture, the number of middle stage patients or the number of early stage patients for each of A type influenza and B type influenza for each prefecture, and the number of middle stage patients, the number of early stage patients, and the total number of patients for each municipality instead of each prefecture.

In <FIG> and <FIG>, the disease map <NUM> and a legend <NUM> created by the map creation unit <NUM> based on the statistical information <NUM> from the statistical information creation unit <NUM> are displayed on the disease map display screen <NUM>. The disease map <NUM> shown in <FIG> and <FIG> is based on a Japanese map in which all prefectures are separated from each other. In the disease map <NUM>, sections of the respective prefectures are filled with colors and/or patterns shown in the legend <NUM> according to the number of patients in the statistical information <NUM>.

<FIG> exemplifies the disease map 136A of middle stage patients created based on the statistical information 130A shown in <FIG> and the legend 137A. On the other hand, <FIG> exemplifies the disease map 136B of early stage patients created based on the statistical information 130B shown in <FIG> and the legend 137B.

Display switching between the disease map 136A shown in <FIG> and the disease map 136B shown in <FIG> is performed using a menu <NUM> shown in <FIG>, for example. The menu <NUM> is displayed on the disease map display screen <NUM> by right-clicking the mouse of the client terminal <NUM>, for example. "Display switching" options of the menu <NUM> include "all patients" in which the disease map <NUM> (not shown) of all patients is displayed and "side-by-side display" in which the disease map 136A and the disease map 136B are displayed side by side (not shown) in addition to "middle stage patients" in which the disease map 136A of middle stage patients is displayed and "early stage patients" in which the disease map 136B of early stage patients is displayed. In a case where "setting" of the menu <NUM> is selected, setting of the legend <NUM>, setting of the type of influenza targeted in the statistical information <NUM>, and the like can be performed.

In addition to the map of the whole Japan shown in <FIG> and <FIG>, a map of each prefecture in which municipalities are divided is also prepared as a base map of the disease map <NUM>. In a case where one of the prefectures is selected in the display state shown in <FIG> and <FIG>, the disease map <NUM> (not shown) based on a map in which the municipalities of the selected prefecture are divided is displayed instead of the disease map <NUM> based on the map of the whole Japan shown in <FIG> and <FIG>. In this case, the sections of the respective municipalities are filled based on the legend and the statistical information indicating the number of middle stage patients, the number of early stage patients, and the total number of patients for each municipality.

Hereinafter, the operation based on the above configuration will be described with reference to the flowchart shown in <FIG>. First, the user applies the sample SSP, which is collected from a patient to be subjected to an immunological test, onto the dropping port <NUM> of the cartridge <NUM>, opens the lid <NUM> to load the cartridge <NUM> into the cartridge loading unit <NUM>, and closes the lid <NUM>. Then, the user operates the touch panel <NUM> to input a test start instruction. Then, the test start instruction is received by the instruction receiving unit <NUM>.

In a case where the test start instruction is received by the instruction receiving unit <NUM>, counting of the elapsed time TP is started by the main controller <NUM> (step ST100 in <FIG>, timing step). Then, measurement is started by the measurement unit <NUM> (step ST110). Then, an imaging signal is output from the imaging element <NUM> of the measurement unit <NUM> to the determination unit <NUM>. Then, the determination unit <NUM> derives the coloration state (density, chromaticity) of the reagent based on the imaging signal, and determines whether or not influenza virus is present in the sample SSP from the coloration state (density, chromaticity) of the reagent (step ST120).

In a case where both the first determination result indicating that A type influenza virus is present in the sample SSP and the second determination result indicating that B type influenza virus is present in the sample SSP are obtained in the determination of step ST120 (YES in step ST130), the first test record 90A is transmitted from the information output unit <NUM> to the information processing server <NUM> (step ST140). In this case, the main controller <NUM> ends the test without waiting for the elapsed time TP to become the time TE. The user can take out the cartridge <NUM> from the immunological test apparatus <NUM>.

In a case where either the first determination result or the second determination result is obtained in the determination of step ST120 (NO in step ST130 and YES in step ST150), it is possible to input a test stop instruction through the touch panel <NUM>. Here, in a case where the test stop instruction is input (YES in step ST160), as in the case where the first and second determination results are obtained in the determination of step ST120 (YES in step ST130), the first test record 90A is transmitted from the information output unit <NUM> to the information processing server <NUM> (step ST140). Then, the test is stopped by the main controller <NUM>.

On the other hand, in a case where the test stop instruction is not input (NO in step ST160) and the elapsed time TP does not exceed the set time TS (<NUM> < TP ≤ TS, NO in step ST170), the process returns to step ST100 to continue the test. Also in a case where neither the first determination result nor the second determination result is obtained in the determination of step ST120 (NO in both steps ST130 and ST150) and the elapsed time TP does not exceed the set time TS (<NUM> < TP ≤ TS, NO in step ST170), the process returns to step ST100 to continue the test.

In a case where either the first determination result or the second determination result is obtained and the test stop instruction is not input (NO in step ST130, YES in step ST150, and NO in step ST160) and a case where neither the first determination result nor the second determination result is obtained (NO in both steps ST130 and ST150), in a case where the elapsed time TP exceeds the set time TS (TP > TS, YES in step ST170), sensitization processing is performed as shown in step ST300 in <FIG>.

Specifically, a driving command is output from the main controller <NUM> to the driving controller <NUM>, and the chemical solution spreading unit <NUM> (motor <NUM>) is driven by the driving controller <NUM> that has received the driving command. By the driving of the chemical solution spreading unit <NUM>, the reducing solution pot <NUM> is crushed by the first pressing piece <NUM> of the first pressing unit <NUM>, and the reducing solution SR is spread to the test region <NUM>. Then, the sensitizing solution pot <NUM> is crushed by the second pressing piece <NUM> of the second pressing unit <NUM>, and the sensitizing solution SSE is spread to the test region <NUM>. This increases the density of coloration of the reagent.

Thereafter, as in steps ST100 to ST120 in <FIG>, counting of the elapsed time TP (step ST310, timing step), measurement (step ST320), and determination (step ST330) are performed.

In a case where both the first determination result and the second determination result are obtained in the determination of step ST330 (YES in step ST340), the second test record 90B is transmitted from the information output unit <NUM> to the information processing server <NUM> (step ST350, information output step). In this case, the main controller <NUM> ends the test without waiting for the elapsed time TP to become the time TE. The user can take out the cartridge <NUM> from the immunological test apparatus <NUM>.

In a case where either the first determination result or the second determination result is obtained in the determination of step ST330 (NO in step ST340 and YES in step ST360), it is possible to input the test stop instruction through the touch panel <NUM> in the same manner as before the sensitization processing is performed. Here, in a case where the test stop instruction is input (YES in step ST370), as in the case where the first and second determination results are obtained in the determination of step ST330 (YES in step ST340), the second test record 90B is transmitted from the information output unit <NUM> to the information processing server <NUM> (step ST350, information output step). Also in this case, the main controller <NUM> ends the test without waiting for the elapsed time TP to become the time TE.

On the other hand, in a case where the test stop instruction is not input (NO in step ST370) and the elapsed time TP is not the time TE (TP ≠ TE, NO in step ST380), the process returns to step ST310 to continue the test. Also in a case where neither the first determination result nor the second determination result is obtained or either the first determination result or the second determination result is not obtained in the determination of step ST330 (NO in both steps ST340 and ST360) and the elapsed time TP is not time TE (TP ≠ TE, NO in step ST390), the process returns to step ST310 to continue the test.

In a case where the test stop instruction is not input (NO in step ST380) and the elapsed time TP becomes the time TE and a determination result indicating that the measurement has ended correctly is output from the determination unit <NUM> (YES in step ST380), the second test record 90B is transmitted from the information output unit <NUM> to the information processing server <NUM> (step ST350, information output step).

On the other hand, in a case where neither the first determination result nor the second determination result is obtained or either the first determination result or the second determination result is not obtained in the determination of step ST330 (NO in both steps ST340 and ST360) and the elapsed time TP becomes the time TE (TP = TE) and a determination result indicating that the measurement has ended correctly is output from the determination unit <NUM> (YES in step ST390), the main controller <NUM> ends the test. In this case, the test record <NUM> is not transmitted from the information output unit <NUM> to the information processing server <NUM>.

As shown in <FIG>, in the information processing server <NUM>, the test record <NUM> transmitted from the information output unit <NUM> of the immunological test apparatus <NUM> through the network <NUM> is received by the reception unit <NUM> (step ST500, reception step). The test record <NUM> is output from the reception unit <NUM> to the information management unit <NUM>, and is stored in the test record table <NUM> by the information management unit <NUM> (step ST510).

The user operates the client terminal <NUM> to access the information providing site, and transmits a request for distribution of the disease map <NUM> to the information processing server <NUM> through the client terminal <NUM>. As shown in <FIG>, in the information processing server <NUM>, the request for distribution of the disease map <NUM> transmitted from the client terminal <NUM> through the network <NUM> is received by the request receiving unit <NUM> (step ST600). The request for distribution of the disease map <NUM> is output from the request receiving unit <NUM> to the statistical information creation unit <NUM>.

In a case where the request for distribution of the disease map <NUM> is received, an extraction command is output from the statistical information creation unit <NUM> to the information management unit <NUM>. As a result, the test record <NUM> whose reception date and time is within a predetermined period is extracted from the test record table <NUM> (step ST610). The extracted test record <NUM> and the installation location information <NUM> are output from the information management unit <NUM> to the statistical information creation unit <NUM>.

In the statistical information creation unit <NUM>, the statistical information <NUM> is created based on the test record <NUM> and the installation location information <NUM> (step ST620, statistical information creation step). The statistical information <NUM> is output from the statistical information creation unit <NUM> to the map creation unit <NUM>.

The map creation unit <NUM> creates the disease map <NUM> based on the statistical information <NUM> (step ST630). The disease map <NUM> is output from the map creation unit <NUM> to the screen output controller <NUM>.

The screen output controller <NUM> generates the disease map display screen <NUM> based on the disease map <NUM>. The disease map display screen <NUM> is distributed from the screen output controller <NUM> to the client terminal <NUM> of the distribution request source (step ST640). In the client terminal <NUM>, under the control of the browser controller <NUM>, the disease map display screen <NUM> is displayed on the web browser of the display unit of the input and output device <NUM>.

As described above, since the immunological test apparatus <NUM> outputs the required determination time information <NUM> regarding the required determination time, which is taken until the determination result indicating that influenza virus is present in the sample SSP is obtained, so as to be associated with the determination result information <NUM>, it is possible to make effective use of the required determination time to prevent the spread of influenza infection.

The immunological test apparatus <NUM> starts the sensitization processing in a case where at least one of the first determination result indicating that A type influenza virus is present in the sample SSP or the second determination result indicating that B type influenza virus is present in the sample SSP is not obtained during a period from the start of the test to the set time TS. Accordingly, in a case where there is only a very small amount of influenza virus in the sample SSP and the density of coloration of the reagent is very low, that is, only in a case where it is certainly necessary to increase the density of coloration of the reagent, the sensitization processing can be performed.

Since the information output unit <NUM> outputs, as the required determination time information <NUM>, at least information indicating that the elapsed time TP exceeds the set time TS, and further, information indicating that the sensitization processing has been performed, distinction as to whether the patient, from who the sample SSP is collected, is an early stage patient or a middle stage patient can be made reliably based on the required determination time information <NUM>. Therefore, it is possible to improve the reliability of the statistical information <NUM> created according to the distinction, and therefore, the disease map <NUM>.

Since the information output unit <NUM> outputs the required determination time information <NUM> only in a case where the sensitization processing is performed, it is not necessary to perform excessive processing in a case where the sensitization processing is not performed. In addition, as there is no required determination time information <NUM>, the data capacity of the first test record 90A can be smaller than that of the second test record 90B.

Since the information output unit <NUM> transmits the test record <NUM> to the information processing server <NUM> through the network <NUM>, transmission of the test record <NUM> does not require much time and effort. The test records <NUM> from the plurality of immunological test apparatuses <NUM> can be easily accumulated in the information processing server <NUM>.

Since the information output unit <NUM> transmits the test record <NUM> to the information processing server <NUM> for each test, the latest test record <NUM> is always accumulated in the information processing server <NUM>. Therefore, since it is possible to ensure the immediacy of the statistical information <NUM>, and therefore, the disease map <NUM>, it is possible to notify the user of the epidemic situation of the ongoing influenza.

The output form of the test record <NUM> is not limited to the form of transmission through the network <NUM> described above. For example, the test record <NUM> may be written into a removable medium, such as a universal serial bus (USB) memory. Alternatively, instead of transmitting the test record <NUM> for each test, the test record <NUM> for a predetermined period, for example, one day, may be stored in the immunological test apparatus <NUM>, and the entire test record <NUM> of the day may be transmitted at the end of the test of one day.

The information processing server <NUM> creates the statistical information <NUM> of influenza patients based on the required determination time information <NUM>, the determination result information <NUM>, and the installation location information <NUM>, creates the disease map <NUM> by expressing the number of influenza patients for each area on a map, and outputs this as the disease map display screen <NUM>. Therefore, particularly in the case of the disease map 136B of early stage patients, the user can predict how the epidemic situation of influenza will change from the disease map display screen <NUM> at the early stage of influenza infection. As a result, it is possible to take effective measures to prevent the spread of infection.

Since the information processing server <NUM> creates and outputs the disease map 136A of middle stage patients in addition to the disease map 136B of early stage patients, it is possible to obtain information, which cannot be known with a single disease map, by comparing the disease maps 136A and 136B with each other. For example, in a prefecture where the number of first test records 90A (the number of middle stage patients) is larger than the number of second test records 90B (the number of early stage patients), it can be predicted that the epidemic of influenza has peaked and is going down. Conversely, in a prefecture where the number of second test records 90B (the number of early stage patients) is larger than the number of first test records 90A (the number of middle stage patients), it can be predicted that there is a sign that influenza will spread from now on. In a prefecture where the number of first test records 90A (the number of middle stage patients) is approximately the same as the number of second test records 90B (the number of early stage patients), it can be predicted that the epidemic of influenza is heading to a peak.

The statistical information creation unit <NUM> may create at least the statistical information 130B of early stage patients of influenza, and the map creation unit <NUM> may create at least the disease map 136B by expressing the number of early stage patients of influenza for each area on a map.

As in a test record <NUM> shown in <FIG>, the required determination time itself may be used as required determination time information <NUM>. In this case, the set time TS may be grasped on the information processing server <NUM> side, and whether to perform the sensitization processing may be determined according to whether or not the required determination time exceeds the set time TS.

In <FIG>, the required determination time is "<NUM> minutes", which exceeds <NUM> minutes that is the set time TS in this example. Therefore, it can be seen that the test record <NUM> has been subjected to the sensitization processing and the patient from which the sample SSP has been collected is an early stage patient.

In the above embodiment, the immunological test apparatus <NUM> has been described as having a function of performing sensitization processing. However, the present invention is not limited thereto. The present invention can also be applied to an immunological test apparatus that does not have the function of performing sensitization processing.

In the case of the immunological test apparatus having no function of performing sensitization processing, a required determination time is output as exemplified in <FIG> as the required determination time information. Then, a threshold value of the required determination time is set in advance on the information processing server <NUM> side, and determination as a middle stage patient is made in a case where the required determination time of the required determination time information is equal to or less than the threshold value, and determination as an early stage patient is made in a case where the required determination time of the required determination time information is larger than the threshold value.

The immunological test apparatus <NUM> having a function performing sensitization processing exemplified in the above embodiment and an immunological test apparatus having no function of performing sensitization processing may be mixed.

The management entity of the information processing server <NUM> is not limited to the sales company of the immunological test apparatus <NUM>. A public organization such as the Ministry of Health, Labor and Welfare may manage the information processing server <NUM>. The disease map <NUM> may be widely open to general users as well as users having the access authority of the information providing site.

The screen output controller <NUM> may output a statistical information display screen <NUM> shown in <FIG> or <FIG> in addition to or instead of the disease map display screen <NUM>. The statistical information display screen <NUM> shown in <FIG> displays the statistical information <NUM> obtained by integrating the statistical information 130A and 130B shown in <FIG> and <FIG>. A scroll bar <NUM> for scrolling a non-displayed portion is provided in the statistical information <NUM>. The statistical information display screen <NUM> shown in <FIG> displays the degree of magnitude of the number of middle stage patients and the number of early stage patients in a city, a prefecture to which the city belongs, an area to which the prefecture belongs, and the whole country. Thus, the epidemic situation of influenza can be predicted based on the statistical information <NUM> not based on the disease map <NUM>. The epidemic situation of influenza can also be predicted by displaying the degree of magnitude of the number of patients instead of specific numbers as in the statistical information <NUM> shown in <FIG>.

In the above embodiment, an example has been described in which measurement and determination are repeated until the elapsed time TP reaches the time TE after the sensitization processing. However, measurement and determination after the sensitization processing may be performed only once.

The hardware configuration of a computer, which forms the information processing apparatus of the present invention, can be modified in various ways. For example, in order to improve the processing capacity or reliability, the information processing apparatus can also be formed by a plurality of computers that are separated from each other as hardware. Specifically, the functions of the reception unit <NUM> and the information management unit <NUM> and the functions of the request receiving unit <NUM>, the statistical information creation unit <NUM>, the map creation unit <NUM>, and the screen output controller <NUM> in the above embodiment can be distributed on two computers. In this case, the two computers form the information processing apparatus.

In the above embodiment, an example has been described in which the map creation unit <NUM> and the screen output controller <NUM> are provided in the information processing server <NUM> that is an information processing apparatus. However, the screen output controller <NUM> or the map creation unit <NUM> and the screen output controller <NUM> may be provided in the client terminal <NUM>. In a case where the screen output controller <NUM> is provided in the client terminal <NUM>, the information processing server <NUM> transmits the disease map <NUM> created by the map creation unit <NUM> to the client terminal <NUM>. In a case where the map creation unit <NUM> and the screen output controller <NUM> are provided in the client terminal <NUM>, the information processing server <NUM> transmits the statistical information <NUM> created by the statistical information creation unit <NUM> to the client terminal <NUM>.

The immunological test apparatus <NUM> may be operated as an information processing apparatus. In this case, for example, each unit such as the reception unit <NUM> or the statistical information creation unit <NUM> constructed in the CPU <NUM> of the information processing server <NUM> of the embodiment described above is constructed in the main controller <NUM> of one of the plurality of immunological test apparatuses <NUM>. In this case, the immunological test apparatus <NUM> operating as an information processing apparatus receives the test record <NUM> transmitted from the other immunological test apparatuses <NUM> and the test record <NUM> output from its own information output unit <NUM> by the reception unit <NUM>.

In addition to or instead of the client terminal <NUM>, the disease map display screen <NUM> may be transmitted to the immunological test apparatus <NUM>. In this case, the request for distribution of the disease map <NUM> is input through the touch panel <NUM>, and the disease map display screen <NUM> is displayed on the touch panel <NUM>.

Thus, the hardware configuration of a computer can be appropriately changed according to the required performance, such as processing capacity, safety, or reliability. Needless to say, in order to ensure the safety or reliability, an AP, such as the operation program <NUM>, may be duplicated or may be stored in a plurality of storage devices in a distributed manner, without being limited to hardware.

In the embodiment described above, a form is exemplified in which each screen, such as the disease map display screen <NUM>, is distributed from the screen output controller <NUM> to the client terminal <NUM> in the form of screen data for web distribution. However, an AP for displaying each screen may be installed on the client terminal <NUM>, and an instruction to cause the AP to display each screen may be output from the screen output controller <NUM>.

The output form of the statistical information <NUM> or the disease map <NUM> is not limited to the disease map display screen <NUM> or the statistical information display screen <NUM> exemplified in the embodiment described above, and print output of the statistical information <NUM> or the disease map <NUM> to a paper medium or file output using e-mail and the like are included.

In each of the embodiments described above, the hardware structures of processing units for executing various kinds of processing, such as the main controller <NUM> corresponding to the timing unit, the driving controller <NUM>, the information output unit <NUM>, the reception unit <NUM>, the information management unit <NUM>, the request receiving unit <NUM>, the statistical information creation unit <NUM>, the map creation unit <NUM>, and the screen output controller <NUM>, are various processors shown below. The various processors include a central processing unit (CPU) that is a general-purpose processor that executes software (program) to function as various processing units, a programmable logic device (PLD) that is a processor whose circuit configuration can be changed after manufacture, such as a field programmable gate array (FPGA), and a dedicated electric circuit that is a processor having a circuit configuration that is designed for exclusive use in order to execute specific processing, such as an application specific integrated circuit (ASIC).

One processing unit may be configured by one of various processors, or may be a combination of two or more processors of the same type or different types (for example, a combination of a plurality of FPGAs or a combination of a CPU and an FPGA). Alternatively, a plurality of processing units may be configured by one processor. As an example of configuring a plurality of processing units using one processor, first, there is a form in which one processor is configured by a combination of one or more CPUs and software and this processor functions as a plurality of processing units. Second, as represented by a system on chip (SoC) or the like, there is a form of using a processor for realizing the function of the entire system including a plurality of processing units with one integrated circuit (IC) chip. Thus, various processing units are configured by using one or more of the above-described various processors as a hardware structure.

In addition, the hardware structure of these various processors is an electrical circuit (circuitry) in the form of a combination of circuit elements, such as semiconductor elements.

From the above description, it is possible to grasp the invention shown in the following supplementary items.

An immunological test apparatus that receives a carrier holding a reagent, which is combined with a test substance as an antigen of an infectious disease to be colored, and having a sample dropped thereon, measures a state of the coloration, and determines whether or not the test substance is present in the sample based on a result of the measurement, the apparatus comprising: a timing processor that counts an elapsed time from start of a test; and an information output processor that outputs required determination time information regarding a required determination time, which is the elapsed time taken until a determination result indicating that the test substance is present in the sample is obtained, so as to be associated with information of the determination result.

An information processing apparatus connected, through a network, to an immunological test apparatus that receives a carrier holding a reagent, which is combined with a test substance as an antigen of an infectious disease to be colored, and having a sample dropped thereon, measures a state of the coloration, and determines whether or not the test substance is present in the sample based on a result of the measurement, the information processing apparatus comprising: a reception processor that receives required determination time information regarding a required determination time, which is an elapsed time of a test taken until a determination result indicating that the test substance is present in the sample is obtained from start of the test, and information of the determination result from the immunological test apparatus through the network; and a statistical information creation processor that creates statistical information of early stage patients, who are patients at an early stage of infection of an infectious disease, based on the required determination time information, the determination result information, and installation location information regarding an installation location of the immunological test apparatus.

Claim 1:
An immunological test apparatus (<NUM>) adapted to receive a carrier (<NUM>) holding a reagent, which is combined with a test substance as an antigen of an infectious disease to be colored, and having a sample dropped thereon, to measure coloration, and to determine whether or not the test substance is present in the sample based on a result of the measurement, wherein the apparatus (<NUM>) comprises a timing unit (<NUM>) adapted to count an elapsed time; and an information output unit (<NUM>),
characterized in that the timing unit (<NUM>) is adapted to count an elapsed time (TP) from start of a test; and
an information output unit (<NUM>) adapted to output required determination time information regarding a required determination time, which is the elapsed time (TP) taken until a determination result indicating that the test substance is present in the sample is obtained, so as to be associated with information of the determination result.