Patent Description:
At medical sites such as hospitals and examination centers, a large number of specimens are tested. Each specimen is measured using a plurality of measuring devices. For example, when a medical worker determines that there is a possibility of disease by measuring the specimen with a measuring device, a more detailed test is done to determine whether the specimen has a feature that appears in individual disease, using another measuring device with higher accuracy.

For example, it has been proposed to measure a blood specimen with a blood measuring device, prepare a smear preparation from the blood specimen based on a measurement result of the blood measuring device, and analyze an image of the smear specimen (see, for example, <CIT>). When inspecting for human T cell leukemia virus (HTLV) infection, sometimes, a blood specimen that has reacted with an anti-HTLV antibody and a labeled antibody is measured with a spectroscope, and further, the blood specimen is measured by a flow cytometer.

When the specimen is pretreated with a labeling reagent such as an antibody reagent to prepare a sample and the sample is analyzed by a flow cytometer, it is possible to examine the possibility of disease in more detail. A pretreatment device of the flow cytometer described in <CIT> reads a bar code recording a specimen ID, which is attached to a container containing a specimen to be pretreated, with a reader, and accesses an external management computer. The pretreatment device acquires measurement item information of the flow cytometer for the specimen from the management computer, mixes the specimen and the labeling reagent based on the measurement item information, and prepares a sample. In addition, the pretreatment device centrifuges the sample as necessary.

<CIT> Alrelates to an optical screening method and apparatus for identifying both the morphology and selected characteristics or properties expressed by cells, such as cancer cells. The cells are combined with one or more different sets of microspheres each set having a reactant bond thereto which will bind to a specific molecule which can exist on one or more types of cancer cells.

Among specimens measured by a primary measuring device, specimens that are pretreated with a labeling reagent and further measured by a flow cytometer in detail are a part of the whole. In the presence of a large number of specimens, it is complicated and difficult for a medical worker to manage and identify specimens for which more detailed measurements are required. In addition, when extracting a specimen for which more detailed measurement is required, there is a risk that a wrong specimen is extracted or the extracted specimen is transported to a wrong measuring device. Therefore, one of the objects of the present invention is to provide a specimen measurement system and a specimen measurement method capable of identifying a specimen that needs to be further measured in more detail by a flow cytometer, among the specimens measured by a primary measuring device.

The following paragraphs include embodiments, aspects and examples that may not be specifically claimed, but may be useful for understanding the invention.

The scope of the present invention is defined solely by the appended claims, and is not affected to any degree by the statements within this summary.

According to an aspect of the present disclosure, there is provided a specimen measurement system including a specimen measuring device <NUM> that measures a specimen, and a determination unit <NUM> that determines whether or not the specimen is to be measured by a flow cytometer, based on a measurement result of the specimen measuring device <NUM>. The determination unit <NUM> is included in a computer or the like.

According to the specimen measurement system, it is possible to identify the specimen that needs to be measured by a flow cytometer, among the specimens measured by the specimen measuring device <NUM>, based on the measurement result of the specimen measuring device <NUM>.

In the specimen measurement system, when the measurement result of the specimen matches a predetermined condition, the determination unit <NUM> may determine that the specimen is to be measured by the flow cytometer. The predetermined condition may be set in advance based on, for example, a criterion of disease possibility.

According to the specimen measurement system, it is possible to identify a specimen in which a subject that has provided the specimen may have a disease, as a specimen that needs to be measured by a flow cytometer.

In the specimen measurement system, the specimen measuring device <NUM> may include a flow cytometer that is separate from the above flow cytometer.

According to the specimen measurement system, it is possible to measure the specimen stepwise by a plurality of flow cytometers.

In the specimen measurement system, a specimen to be measured by the specimen measuring device <NUM> may not be treated with a labeling reagent containing an antibody.

According to the specimen measurement system, it is possible to suppress use of expensive labeling reagent.

In the specimen measurement system, the specimen is a blood specimen, the specimen measuring device <NUM> includes a blood cell measuring apparatus that measures blood cells contained in the blood specimen, and the determination unit <NUM> may determine whether or not the specimen is to be measured by a flow cytometer, based on a measurement result of the blood cell measuring apparatus. The blood cells may be at least one of leukocytes including blasts, lymphocytes and the like, erythrocytes and platelets. In at least any of the cases where blasts are present, the number of lymphocytes meets a predetermined criterion, the number of erythrocytes meets a predetermined criterion, and the number of platelets meets a predetermined criterion, the determination unit <NUM> may determine that the specimen is to be measured by the flow cytometer.

According to the specimen measurement system, it is possible to identify a blood specimen that needs to be measured by the flow cytometer, based on the state of blood cells contained in the blood specimen.

The specimen measurement system further includes an image analysis apparatus <NUM> that analyzes an image of a preparation smeared with a blood specimen in addition to the specimen measuring device <NUM>, and the determination unit <NUM> may determine whether or not the specimen is to be measured by the flow cytometer, further based on an analysis result of the image analysis apparatus <NUM>. Alternatively, in the specimen measurement system, the specimen is a blood specimen, and the specimen measuring device <NUM> includes an image analysis apparatus that analyzes an image of a preparation smeared with the blood specimen, and the determination unit <NUM> may determine whether or not the specimen is to be measured by the flow cytometer, based on an analysis result of the image analysis apparatus. The image analysis apparatus <NUM> may analyze whether the image of the preparation includes leukemia cells, and when the image of the preparation includes leukemia cells, the determination unit <NUM> may determine that the specimen is to be measured by the flow cytometer. The specimen measurement system may further include a smear preparing apparatus <NUM> that prepares a preparation smeared with a blood specimen.

According to the specimen measurement system, it is possible to identify a blood specimen that needs to be measured by the flow cytometer, based on the smear preparation of the blood specimen.

In the specimen measurement system, blood specimens may be derived from the same subject at different times. The determination unit <NUM> may determine whether or not the specimen is to be measured by the flow cytometer, based on a change in the number of blood cells contained in a blood specimen derived from the same subject at different times.

According to the specimen measurement system, it is possible to identify a blood specimen that needs to be measured by the flow cytometer, based on the smear preparation of the blood specimen derived from the same subject.

The specimen measurement system may further include a measurement order generating unit <NUM> that generates a measurement order for the flow cytometer, based on the measurement result of the specimen measuring device <NUM>.

Alternatively, the specimen measurement system may further include a measurement order generating unit <NUM> that generates a measurement order for the flow cytometer, based on the measurement result of the specimen measuring device <NUM> and the analysis result of the image analysis apparatus <NUM>.

According to the specimen measurement system, it is possible to automatically generate the measurement order for the flow cytometer, based on the measurement result of the specimen measuring device <NUM> or the measurement result of the specimen measuring device <NUM> and the analysis result of the image analysis apparatus <NUM>.

In the specimen measurement system, in the measurement order, a labeling reagent for preparing a sample from the specimen is designated. The specimen measurement system may further include a sample preparation device <NUM> that prepares a sample to be measured by the flow cytometer, at least from a labeling reagent and the specimen, and the sample preparation device <NUM> may prepare the sample based on the measurement order.

According to the specimen measurement system, it is possible to automatically designate a labeling reagent for preparing a sample from the specimen, and the sample preparation device <NUM> can automatically prepare a sample.

When the specimen measurement system may further include a specimen transport device <NUM> that transports the specimen to the sample preparation device <NUM> when the determination unit <NUM> determines that the specimen is to be measured by the flow cytometer. In the specimen measurement system, the specimen transport device <NUM> may transport a specimen container containing the specimen.

According to the specimen measurement system, it is possible to automatically transport the specimen determined by the determination unit <NUM> to be measured by the flow cytometer to the sample preparation device <NUM>.

The specimen measurement system may further include a storage unit <NUM> for storing a specimen container. The storage unit <NUM> may be disposed between the specimen measuring device <NUM> and the sample preparation device <NUM>. The storage unit <NUM> may store the specimen container until the sample preparation device <NUM> can prepare a sample from the specimen.

According to the specimen measurement system, it is possible to stand by keeping the specimen in the container until the sample preparation device <NUM> can prepare a sample from the specimen.

In the specimen measurement system, the specimen transport device <NUM> may transport the specimen using a specimen rack capable of holding a plurality of specimen containers.

According to the specimen measurement system, the specimen transport device <NUM> can automatically transport a plurality of specimens that need to be measured by the flow cytometer to the sample preparation device <NUM>, among the specimens measured by the specimen measuring device <NUM>, based on the measurement result of the specimen measuring device <NUM>.

The specimen measurement system may further include a specimen transfer device <NUM> that transfers the specimen container held in the specimen rack to another specimen rack, according to the destination of the specimen.

According to the specimen measurement system, it is possible to transfer the specimen container held in the specimen rack to another specimen rack according to the destination of the specimen.

The specimen measurement system may further include a placement unit <NUM> on which the specimen is placed, and the specimen transport device <NUM> may transport the specimen from the placement unit <NUM> to the specimen measuring device <NUM>. The specimen transport device <NUM> may return the specimen not transported to the sample preparation device <NUM> to the placement unit <NUM>.

According to the specimen measurement system, it is possible to prevent retention of the specimen which does not need to be transported to the sample preparation device <NUM>.

The specimen measurement system may further include a sample transport device that transports the sample prepared by the sample preparation device to the sample measuring device. The sample transport device may transport a sample container containing a sample from the sample preparation device <NUM> to the flow cytometer.

According to the specimen measurement system, the sample transport device can automatically transport a specimen that needs to be measured by the flow cytometer, to the flow cytometer among the specimens measured by the specimen measuring device <NUM>, based on the measurement result of the specimen measuring device <NUM>.

Further, according to an aspect of the present disclosure, there is provided a specimen measurement method, in which a specimen measuring device <NUM> measures a specimen, and a determination unit <NUM> determines whether or not the specimen is to be measured by a flow cytometer, based on a measurement result of the specimen measuring device <NUM>.

According to the specimen measurement method, it is possible to identify the specimen that needs to be measured by the flow cytometer, among the specimens measured by the specimen measuring device <NUM>, based on the measurement result of the specimen measuring device <NUM>.

In the specimen measurement method, in the determination, when the measurement result of the specimen matches a predetermined condition, the determination unit <NUM> may determine that the specimen is to be measured by the flow cytometer.

The predetermined condition may be set in advance based on, for example, a criterion of disease possibility.

According to the specimen measurement method, it is possible to identify a specimen in which a subject that has provided the specimen may have a disease, as a specimen that needs to be measured by the flow cytometer.

In the specimen measurement method, in the measurement, the specimen may be measured by the flow cytometer separate from the flow cytometer.

According to the specimen measurement method, it is possible to measure the specimen stepwise by a plurality of flow cytometers.

In the specimen measurement method, the specimen to be measured by the specimen measuring device <NUM> may not be treated with a labeling reagent containing an antibody.

According to the specimen measurement method, it is possible to suppress use of expensive labeling reagent.

In the specimen measurement method, the specimen is a blood specimen, in the measurement, a blood cell measuring apparatus included in the specimen measuring device <NUM> measures blood cells contained in the blood specimen, and in the determination, the determination unit <NUM> determines whether or not the specimen is to be measured by the flow cytometer, based on a measurement result of the blood cell measuring apparatus. The blood cells are at least one of leukocytes including blasts and lymphocytes, erythrocytes and platelets, and in any of the cases where blasts are present, the number of lymphocytes meets a predetermined criterion, the number of erythrocytes meets a predetermined criterion, and the number of platelets meets a predetermined criterion, and in the determination, the determination unit <NUM> determines that the specimen is to be measured by the flow cytometer.

According to the specimen measurement method, it is possible to identify a blood specimen that needs to be measured by the flow cytometer, based on the state of blood cells contained in the blood specimen.

In addition to that the specimen measurement method in which the blood cell measuring apparatus included in the specimen measuring device <NUM> measures blood cells contained in the blood specimen, in that the image analysis apparatus <NUM> analyzes an image of a preparation smeared with the blood specimen, and in the determination, the determination unit <NUM> may determine whether or not the specimen is to be measured by the flow cytometer, further based on an analysis result of the image of the preparation. Alternatively, in the specimen measurement method, the specimen is a blood specimen, in the measurement, the image analysis apparatus included in the specimen measuring device <NUM> analyzes an image of a preparation smeared with the blood specimen, and in the determination, the determination unit <NUM> may determine whether or not the specimen is to be measured by the flow cytometer, based on an analysis result of the image analysis apparatus. In analyzing the image of the preparation, it is analyzed whether the image of the preparation includes leukemia cells, and when the image of the preparation includes leukemia cells, in the determination, the determination unit <NUM> may determine that the specimen is to be measured by the flow cytometer. In the specimen measurement method, the smear preparing apparatus <NUM> may prepare a preparation smeared with the blood specimen.

According to the specimen measurement method, it is possible to identify a blood specimen that needs to be measured by the flow cytometer, based on a smear preparation of the blood specimen.

In the specimen measurement method, the determination unit <NUM> may determine whether or not the specimen is to be measured by the flow cytometer, based on a change in the number of blood cells contained in a blood specimen derived from the same subject at different times.

According to the specimen measurement method, it is possible to identify a blood specimen that needs to be measured by the flow cytometer, based on the smear preparation of the blood specimen derived from the same subject.

In the specimen measurement method, the measurement order generating unit <NUM> may generate a measurement order for the flow cytometer, based on the measurement result of the specimen measuring device <NUM>. Alternatively, in the specimen measurement method, the measurement order generating unit <NUM> may generate a measurement order for the flow cytometer, based on the measurement result of the specimen measuring device <NUM> and the analysis result of the image of the preparation.

According to the specimen measurement method, it is possible to automatically generate the measurement order of a sample to be prepared from the specimen, based on the measurement result of the specimen measuring device <NUM> or the measurement result of the specimen measuring device <NUM> and the analysis result of the image analysis apparatus <NUM>.

In the specimen measurement method, in the measurement order, a labeling reagent for preparing a sample to be measured by the flow cytometer from the specimen is designated. In the preparation, the sample preparation device <NUM> prepares a sample to be measured by the flow cytometer based on the measurement order.

According to the specimen measurement method, it is possible to designate a labeling reagent for preparing a sample to be measured by the flow cytometer from the specimen, and the sample preparation device <NUM> can prepare a sample.

According to the present invention, it is possible to provide a specimen measurement system and a specimen measurement method capable of identifying a specimen that needs to be further examined by a flow cytometer, among specimens examined by a primary test device.

In the following description of the drawings, the same or similar parts are denoted by the same or similar symbols. However, the drawings are schematic. Therefore, specific dimensions and the like should be determined in light of the following description. It is a matter of course that parts having different dimensional relationships and ratios are included also among the drawings.

The embodiments shown below are examples in which the present disclosure is applied to hematopoietic tumor test. The specimen measurement system according to the embodiment includes, as shown in <FIG>, a specimen measuring device <NUM> that measures a specimen, and a host computer <NUM> including a determination unit that determines whether or not the specimen is to be measured by a flow cytometer, based on a measurement result of the specimen measuring device <NUM>. The specimen measurement system according to the embodiment may include a plurality of specimen measuring devices <NUM>. In <FIG>, a flow cytometer is included in the sample measuring device <NUM>.

The specimen is a blood specimen such as peripheral blood. The specimen may be a body fluid including bone marrow fluid, lymph node suspension, pleural effusion, ascites fluid, or the like. Hereinafter, an example in which the specimen is a blood specimen will be described. As shown in <FIG>, the specimen is contained in a specimen container T such as a test tube. An opening of the specimen container is sealed with a stopper CP made of rubber or the like. As shown in <FIG>, one or more specimen containers T may be held by a specimen rack L. Each of the specimen container T and the specimen rack L is provided with identifiers BL1 and BL2 such as barcodes.

The specimen measurement system according to the embodiment includes, as shown in <FIG>, a placement unit <NUM> on which a specimen rack holding a plurality of specimen containers is placed. The placement unit <NUM> includes a reader that reads an identifier. The reader included in the placement unit <NUM> reads the identifier of the specimen container and the identifier of the specimen rack. The reader sends the read identifier to a transport controller <NUM>.

The transport controller <NUM> queries the host computer <NUM> via a communication network whether the received identifier corresponds to a specimen to be examined by any of the plurality of specimen measuring devices <NUM>. When the received identifier corresponds to the specimen to be examined by any of the plurality of specimen measuring devices <NUM>, the transport controller <NUM> controls the placement unit <NUM>, and the placement unit <NUM> sends out the specimen rack containing the specimen container to the specimen transport device <NUM>. Further, the transport controller <NUM> controls the specimen transport device <NUM>, and the specimen transport device <NUM> transports the specimen rack holding the specimen container from the placement unit <NUM> to the specimen measuring device <NUM> designated by the transport controller <NUM>. The specimen transport device <NUM> includes a conveyor.

Each of the plurality of specimen measuring devices <NUM> includes a reader that reads an identifier. The reader included in each of the plurality of specimen measuring devices <NUM> reads the identifier of the specimen container and the identifier of the specimen rack. The reader sends the read identifier to an information processing unit <NUM>. The information processing unit <NUM> queries the host computer <NUM> via the communication network for a measurement order prepared in advance for the identifier. The information processing unit <NUM> sends the measurement order received from the host computer <NUM> to each of the plurality of specimen measuring devices <NUM>. However, a medical worker may carry the specimen to each of the plurality of specimen measuring devices <NUM>.

For example, each of the plurality of specimen measuring devices <NUM> pierces a stopper of the specimen container with a suction tube, aspirates a required amount of specimen from the specimen container, and measures the specimen according to the measurement order transmitted from the host computer <NUM>. Each of the plurality of specimen measuring devices <NUM> includes a blood cell measuring apparatus that measures blood cells contained in a blood specimen. Examples of blood cells include leukocytes including blasts, lymphocytes and the like, erythrocytes and platelets and the like. In general, blasts are sometimes referred to as leukemia cells because there are no blasts in the peripheral blood of healthy individuals and are blasts in the peripheral blood of acute leukemia patients. The blood cell measuring apparatus may measure hemoglobin concentration.

A flow cytometer can be used as the blood cell measuring apparatus. However, the flow cytometer included in the specimen measuring device <NUM> is a device separate from the flow cytometer included in the sample measuring device <NUM>. When measuring the specimen with a flow cytometer included in the specimen measuring device <NUM>, pretreatment of the specimen with a labeling reagent such as an antibody reagent is not necessarily required. For example, when measuring the specimen with a flow cytometer included in the specimen measuring device <NUM>, the specimen is not treated with a labeling reagent used when preparing a sample by the sample preparation device <NUM>. The labeling reagent used when preparing a sample by the sample preparation device <NUM> includes, for example, an antibody such as a monoclonal antibody.

As shown in <FIG>, a flow cytometer <NUM> included in the specimen measuring device <NUM> includes a flow cell <NUM>. The flow cytometer <NUM> sends the specimen to the flow cell <NUM>. The specimen supplied to the flow cell <NUM> is irradiated with light from a light source <NUM>, and a light detection unit <NUM> detects forward scattered light, side scattered light, and fluorescence emitted from the specimen. An analysis unit <NUM> is connected to the light detection unit <NUM>. The analysis unit <NUM> analyzes the forward scattered light, the side scattered light, and the fluorescence detected by the light detection unit <NUM> to classify the types of blood cells contained in the specimen and measure the blood cells. The analysis unit <NUM> is included in the information processing unit <NUM> illustrated in <FIG>.

As shown in <FIG>, the determination unit <NUM> included in the host computer <NUM> receives a measurement result of the specimen from the information processing unit <NUM> connected to the specimen measuring device <NUM> shown in <FIG>.

The measurement result of the specimen is a flag indicating the possibility of the presence of blasts, counting results of leukocytes including lymphocytes, erythrocytes and platelets and the like, and hemoglobin concentration. The determination unit <NUM> determines whether or not the specimen is to be measured by the flow cytometer included in the sample measuring device <NUM>, based on the measurement result of the specimen by the specimen measuring device <NUM>. For example, the determination unit <NUM> determines whether the specimen meets a predetermined condition. The determination unit <NUM> may determine whether the specimen meets the predetermined condition, based on a change in the number of blood cells contained in a blood specimen derived from the same subject at different times. The predetermined condition is set in advance based on, for example, a criterion of disease possibility.

The specimen measurement system according to the embodiment further includes a smear preparing apparatus <NUM> that prepares a preparation smeared with a blood specimen. When the specimen meets the predetermined condition, the determination unit <NUM> determines that the specimen is to be measured by the flow cytometer included in the sample measuring device <NUM>. For example, in this case, the determination unit <NUM> determines that the specimen is to be transported to the smear preparing apparatus <NUM> or the sample preparation device <NUM> by the specimen transport device <NUM>. The determination unit <NUM> may determine that the specimen is to be transported to the sample preparation device <NUM> without interposing the smear preparing apparatus <NUM>, based on the measurement result of the specimen by the specimen measuring device <NUM>. When the specimen does not meet the predetermined condition in the measurement result of the specimen, the determination unit <NUM> determines that the specimen is not to be measured by the flow cytometer included in the sample measuring device <NUM>. For example, in this case, the determination unit <NUM> determines that the specimen is not to be transported to the smear preparing apparatus <NUM> and the sample preparation device <NUM> by the specimen transport device <NUM>.

For example, the determination unit <NUM> determines whether predetermined criteria such as whether the number of leukocytes is high, whether leukocyte count classification is abnormal, or whether a flag indicating the presence of blasts is set are met. The leukocyte count classification is, for example, the number or abundance of neutrophils, lymphocytes, monocytes, eosinophils and basophils in leukocytes. When the predetermined criteria are met, the subject who provided the specimen may have a hematopoietic tumor. When the predetermined criteria are not met, the possibility that the subject has a hematopoietic tumor is low.

When the subject may have a hematopoietic tumor, the determination unit <NUM> determines that the specimen is to be measured by the flow cytometer included in the sample measuring device <NUM>. For example, in this case, the determination unit <NUM> determines that the specimen is to be transported to the smear preparing apparatus <NUM> or the sample preparation device <NUM> by the specimen transport device <NUM>. When the possibility that the subject has a hematopoietic tumor is low, the determination unit <NUM> determines that the specimen is not to be measured by the flow cytometer included in the sample measuring device <NUM>. For example, in this case, the determination unit <NUM> determines that the specimen is not to be transported to the smear preparing apparatus <NUM> and the sample preparation device <NUM> by the specimen transport device <NUM>.

For example, an output device <NUM> that outputs a determination result of the determination unit <NUM> is connected to the host computer <NUM> including the determination unit <NUM>. As the output device <NUM>, a display such as a liquid crystal display and an organic EL display can be used. When the determination unit <NUM> determines that the specimen is to be measured by the flow cytometer, a medical worker may carry the specimen to the flow cytometer.

When the determination unit <NUM> determines that the specimen is to be transported to the smear preparing apparatus <NUM> or the sample preparation device <NUM> by the specimen transport device <NUM>, the transport controller <NUM> controls the specimen transport device <NUM>, and the specimen transport device <NUM> transports the specimen rack holding the specimen container from the specimen measuring device <NUM> to the smear preparing apparatus <NUM> or the sample preparation device <NUM>. When the determination unit <NUM> determines that the specimen is not to be transported to the smear preparing apparatus <NUM> and the sample preparation device <NUM> by the specimen transport device <NUM>, the transport controller <NUM> controls the specimen transport device <NUM>, and the specimen transport device <NUM> returns the specimen rack holding the specimen container from the specimen measuring device <NUM> to the placement unit <NUM>.

When the determination unit <NUM> determines that the specimen is to be transported to the smear preparing apparatus <NUM> by the specimen transport device <NUM>, the transport controller <NUM> controls the specimen transport device <NUM>, and the specimen transport device <NUM> transports the specimen rack holding the specimen container from the specimen measuring device <NUM> to the smear preparing apparatus <NUM>. The reader included in the smear preparing apparatus <NUM> reads the identifier of the specimen container and the identifier of the specimen rack. The reader sends the read identifier to an information processing unit <NUM>. The information processing unit <NUM> queries the host computer <NUM> via the communication network for whether the specimen provided with the identifier is a target of smear preparation. When the specimen provided with the identifier is the target of smear preparation, for example, the smear preparing apparatus <NUM> pierces a stopper of the specimen container with a suction tube to aspirate a required amount of specimen from the specimen container. The smear preparing apparatus <NUM> smears the specimen on a transparent substrate such as a slide glass. The smear preparing apparatus <NUM> stains the specimen with a staining solution to prepare a smear preparation.

The specimen measurement system according to the embodiment further includes an imaging device <NUM> that images a smear preparation. A precipitation transport device <NUM> is disposed between the smear preparing apparatus <NUM> and the imaging device <NUM>.

The precipitation transport device <NUM> transports a cassette containing the smear preparation prepared by the smear preparing apparatus <NUM> from the smear preparing apparatus <NUM> to the imaging device <NUM>. The imaging device <NUM> captures an image of a smear preparation using a microscope unit.

The specimen measurement system according to the embodiment further includes an image analysis apparatus <NUM> that analyzes the image of the smear preparation captured by the imaging device <NUM>. The image analysis apparatus <NUM> counts blood cells contained in the image of the smear preparation by type. The image analysis apparatus <NUM> analyzes, for example, whether blasts are included in the image of the smear preparation. When blasts are included in the image of the smear preparation, the image analysis apparatus <NUM> extracts blasts from the image of the smear preparation and calculates the number or concentration of blasts.

The determination unit <NUM> of the host computer <NUM> is connected to the image analysis apparatus <NUM> via the communication network. The determination unit <NUM> receives an analysis result of the image of the smear preparation from the image analysis apparatus <NUM>. The analysis result of the image of the smear preparation is the concentration of blasts. The determination unit <NUM> determines whether the specimen meets a predetermined condition, based on the measurement result of the specimen by the specimen measuring device <NUM> and the analysis result of the image of the smear preparation by the image analysis apparatus <NUM>. The predetermined criteria indicates that, for example, the measurement result of the specimen by the specimen measuring device <NUM> indicates that the number of leukocytes is high, the leukocyte count classification is abnormal, and blasts are present, and also refers that the analysis result of the image of the smear preparation indicates that the number or concentration of blasts is equal to or more than a predetermined value. Alternatively, the predetermined criteria indicates that, for example, the measurement result of the specimen by the specimen measuring device <NUM> indicates abnormal leukocyte scattergram, and also refers that the analysis result of the image of the smear preparation indicates that the number or concentration of blasts is equal to or more than a predetermined value. When the specimen meets the predetermined condition, the determination unit <NUM> determines that the specimen is to be measured by the flow cytometer included in the sample measuring device <NUM>. For example, in this case, the determination unit <NUM> determines that the specimen is to be transported to the sample preparation device <NUM> by the specimen transport device <NUM>. When the specimen does not meet the predetermined condition in the measurement result of the specimen, the determination unit <NUM> determines that the specimen is not to be measured by the flow cytometer included in the sample measuring device <NUM>. For example, in this case, the determination unit <NUM> determines the specimen is not to be transported to the sample preparation device <NUM> by the specimen transport device <NUM>.

When the determination unit <NUM> determines that the specimen is to be transported to the sample preparation device <NUM> by the specimen transport device <NUM>, the transport controller <NUM> controls the specimen transport device <NUM>, and the specimen transport device <NUM> transports the specimen rack holding the specimen container from the smear preparing apparatus <NUM> to the sample preparation device <NUM>. When the determination unit <NUM> determines that the specimen is not to be transported to the sample preparation device <NUM> by the specimen transport device <NUM>, the transport controller <NUM> controls the specimen transport device <NUM>, and the specimen transport device <NUM> returns the specimen rack holding the specimen container from the smear preparing apparatus <NUM> to the placement unit <NUM>.

The specimen measurement system according to the embodiment further includes a measurement order generating unit <NUM> shown in <FIG> that generates a measurement order of the flow cytometer included in the sample measuring device <NUM>, based on at least one of the measurement result by the specimen measuring device <NUM> and the analysis result of the image of the smear preparation by the image analysis apparatus <NUM>. The measurement order generating unit <NUM> is included in the host computer <NUM>.

The measurement result of the specimen by the specimen measuring device <NUM> indicates that the number of leukocytes is high, the leukocyte count classification is abnormal, and blasts are present, and when the analysis result of the image of the smear preparation indicates that the number or concentration of blasts is equal to or more than a predetermined value, the subject may have acute myeloid leukemia (AML). When the predetermined criteria are met, the measurement order generating unit <NUM> generates a measurement order that labels the specimen with an antibody panel used for determination of acute myeloid leukemia (AML). Antigens targeted by the antibody panel used for the determination of acute myeloid leukemia (AML) are, for example, CD7, CD11b, CD13, CD14, CD15, CD16, CD33, CD34, CD45, CD56, CD117 and HLA-DR. In this case, since the antibody panel used for determination of acute lymphocytic leukemia (ALL) is not necessary, it is possible to reduce the cost of the labeling reagent used in the measurement by the flow cytometer included in the sample measuring device <NUM>.

When the measurement result of the specimen by the specimen measuring device <NUM> indicates abnormal leukocyte scattergram, and the analysis result of the image of the smear preparation indicates that the number or concentration of blasts is equal to or more than a predetermined value, the subject may have acute lymphocytic leukemia (ALL). When the predetermined criteria are met, the measurement order generating unit <NUM> generates a measurement order that labels the specimen with an antibody panel used for the determination of acute lymphocytic leukemia (ALL). Antigens targeted by the antibody panel used for the determination of acute lymphocytic leukemia (ALL) are, for example, CD5, CD10, CD19, CD20, CD45, Igκ, Igλ, CD2, CD3, CD4, CD7, CD8 and CD56. In this case, since the antibody panel used for determination of acute myeloid leukemia (AML) is not necessary, it is possible to reduce the cost of the labeling reagent used in the measurement by the flow cytometer included in the sample measuring device <NUM>.

The measurement order generating unit <NUM> generates wavelength of excitation light used in the flow cytometer included in the sample measuring device <NUM>, wavelength of fluorescence to be measured, and flow velocity of a fluid flowing through a flow cell, according to a fluorescent reagent contained in the labeling reagent.

The output device <NUM> may output the generated measurement order. In addition, as shown in <FIG>, the output device <NUM> may display for querying a medical worker whether the sample may be prepared based on measurement items of the generated measurement order.

The measurement order generating unit <NUM> illustrated in <FIG> may receive a change in the generated measurement order. The measurement order generating unit <NUM> may be connected to a reception unit <NUM> that receives a change in the measurement order from a medical worker. As the reception unit <NUM>, an input device such as a keyboard and a touch panel can be used. Through the reception unit <NUM>, a medical worker may change the measurement items of the measurement order as shown in <FIG>.

The host computer <NUM> including the measurement order generating unit <NUM> is connected to an information processing unit <NUM> connected to the sample preparation device <NUM> shown in <FIG> via the communication network. The sample preparation device <NUM> pretreats a specimen to be measured by the flow cytometer included in the sample measuring device <NUM>. The reader included in the sample measuring device <NUM> reads the identifier of the specimen container and the identifier of the specimen rack. The reader sends the read identifier to the information processing unit <NUM>. The information processing unit <NUM> queries the host computer <NUM> via the communication network for the measurement order of the specimen provided with the identifier. The information processing unit <NUM> sends the measurement order received from the measurement order generating unit <NUM> to the sample preparation device <NUM>. For example, the sample preparation device <NUM> pierces a stopper of the specimen container containing the specimen transported by the specimen transport device <NUM> with a suction tube to aspirate a required amount of specimen from the specimen container. The sample preparation device <NUM> may stir the specimen in the specimen container before aspirating the specimen.

The sample preparation device <NUM> dispenses the specimen aspirated from the specimen container into the sample container. The sample preparation device <NUM> adds a labeling reagent containing an antibody to the specimen in the sample container, based on the measurement order. Thereby, the specimen and the labeling reagent react to form a sample. In the labeling reagent, for example, an antibody such as a monoclonal antibody is labeled with a fluorescent reagent. When the specimen and the labeling reagent react, the sample container may be warmed.

The sample preparation device <NUM> adds a hemolytic agent into the sample container based on the measurement order, and the sample and the hemolytic agent react. When the sample and the hemolytic agent react, the sample container may be warmed. The hemolytic agent hemolyzes erythrocytes, which are undesirable to be present when analyzing the sample with the flow cytometer included in the sample measuring device <NUM>.

The sample preparation device <NUM> centrifuges the sample in the sample container, based on the measurement order. After centrifugation, the sample preparation device <NUM> removes a supernatant from the sample in the sample container. As a result, sediment of the hemolyzed erythrocytes and the labeling reagent which has not bound to the blood cell antigen contained in the supernatant are removed.

The sample preparation device <NUM> dilutes the sample in the sample container with a buffer, based on the measurement order. The sample preparation device <NUM> may not seal the sample container containing the prepared sample.

An information processing unit <NUM> is connected to the sample measuring device <NUM>. The information processing unit <NUM> sends the measurement order received from the measurement order generating unit <NUM> included in the host computer <NUM> to the sample preparation device <NUM>. The flow cytometer included in the sample measuring device <NUM> may be integrated with the sample preparation device <NUM>. The flow cytometer included in the sample measuring device <NUM> includes a flow cell. The sample preparation device <NUM> aspirates the sample in the sample container via a nozzle and a sample flow path. The sample preparation device <NUM> sends the sample to the flow cell included in the sample measuring device <NUM>. The sample supplied to the flow cell is irradiated with light from a light source, and a light detection unit detects forward scattered light, side scattered light, and fluorescence emitted from the sample. An analysis unit included in the information processing unit <NUM> is connected to the light detection unit. The analysis unit analyzes the forward scattered light, the side scattered light, and the fluorescence detected by the light detection unit. The analysis unit analyzes the type and antigen characteristic of blood cells contained in the sample.

The sample preparation device <NUM> and the sample measuring device <NUM> may not be integrated. In this case, the sample preparation device <NUM> may hold the sample container containing the prepared sample on a sample container holder such as carousel and rack. The sample container or the sample container holder holding the sample container may be transported from the sample preparation device <NUM> to the sample measuring device <NUM> by a medical worker. Alternatively, the sample transport device may transport the sample container or the sample container holder holding the sample container from the sample preparation device <NUM> to the sample measuring device <NUM>. The sample transport device includes, for example, a conveyor or a robotic arm. Every time a sample is prepared by the sample preparation device <NUM>, a sample container containing the prepared sample may be transported to the sample measuring device <NUM>.

For example, the sample preparation device <NUM> prepares a plurality of samples and stores the samples in a plurality of sample containers. The plurality of sample containers are held, for example, by one sample container holder. It is preferable that the samples contained in each of the plurality of sample containers held by the sample container holder have a short time interval for preparation. For example, when the sample container is not stoppered, a solvent is more evaporated in the sample prepared earlier and the concentration of the sample is higher than in the sample prepared later, and it may affect the measurement of the sample measuring device <NUM>.

Therefore, the specimen measurement system according to the embodiment may further include a storage unit <NUM> that stores the specimen container. The storage unit <NUM> is disposed between the specimen measuring device <NUM> and the sample preparation device <NUM>, for example, between the smear preparing apparatus <NUM> and the sample preparation device <NUM>. The storage unit <NUM> stores the specimen container until the sample preparation device <NUM> can prepare a plurality of samples from the specimen.

In the sample preparation device <NUM>, when the sample container holder becomes empty, the sample preparation device <NUM> transmits a signal capable of receiving the specimen to the transport controller <NUM>. The transport controller <NUM> that has received the signal in which the sample preparation device <NUM> can receive the specimen controls the storage unit <NUM>, and the storage unit <NUM> sends out the specimen rack containing the specimen container to the specimen transport device <NUM>. The transport controller <NUM> controls the specimen transport device <NUM>, and the specimen transport device <NUM> transports the specimen container from the storage unit <NUM> to the sample preparation device <NUM>. This shortens the interval of preparation time of each of the plurality of samples held by the sample container holder.

However, when a certain time or more elapses after the blood specimen is collected, the blood specimen may be degraded to affect the measurement of the sample measuring device <NUM>. Therefore, when the storage time exceeds a certain time, the specimen transport device <NUM> may return the specimen container from the storage unit <NUM> to the placement unit <NUM>.

The specimen measurement system according to the embodiment may further include a specimen transfer device <NUM> that transfers the specimen container held in the specimen rack to another specimen rack, according to the destination of the specimen container. The specimen transfer device <NUM> is disposed, for example, between the smear preparing apparatus <NUM> and the storage unit <NUM>. For example, when the specimen transport device <NUM> transports a specimen container from the specimen measuring device <NUM> or the smear preparing apparatus <NUM> to the sample preparation device <NUM>, the specimen transfer device <NUM> does not transfer the specimen container held in the specimen rack to another specimen rack. For example, when the specimen transport device <NUM> returns the specimen container from the sample preparation device <NUM> or the storage unit <NUM> to the placement unit <NUM>, the specimen transfer device <NUM> transfer the specimen container held in the specimen rack to another specimen rack. However, disposition of the specimen transfer device <NUM> is optional.

Next, the specimen measurement method according to the embodiment will be described with reference to a flowchart shown in <FIG>. In the specimen measurement method according to the embodiment, step <NUM> of measuring the specimen by the specimen measuring device <NUM>, and step <NUM> of determining that whether or not the determination unit <NUM> measures the specimen by the flow cytometer based on the measurement result of the specimen measuring device <NUM>.

Steps included in step <NUM> of <FIG> will be described with reference to a flowchart shown in <FIG>. In step S101, the specimen rack holding a plurality of specimen containers is placed on the placement unit <NUM>. The reader included in the placement unit <NUM> reads the identifier of the specimen container and the identifier of the specimen rack. The reader sends the read identifier to a transport controller <NUM>. The transport controller <NUM> queries the host computer <NUM> via a communication network whether the received identifier corresponds to a specimen to be examined by any of the plurality of specimen measuring devices <NUM>. When the identifier corresponds to the specimen to be examined by any of the plurality of specimen measuring devices <NUM>, the transport controller <NUM> controls the placement unit <NUM>, and the placement unit <NUM> sends out the specimen rack containing the specimen container to the specimen transport device <NUM>.

In step S102, the transport controller <NUM> controls the specimen transport device <NUM>, and the specimen transport device <NUM> transports the specimen rack holding the specimen container from the placement unit <NUM> to the specimen measuring device <NUM> designated by the host computer <NUM>. In step S103, the reader included in the specimen measuring device <NUM> to which the specimen rack has been transported reads the identifier of the specimen container and the identifier of the specimen rack, and the information processing unit <NUM> sends the identifier to the host computer <NUM>. The host computer <NUM> sends the measurement order prepared in advance for the identifier back to the information processing unit <NUM>. In step S104, the specimen measuring device <NUM> measures the specimen in accordance with the measurement order received by the information processing unit <NUM>. Thereafter, the process proceeds to step S2 of <FIG>.

Steps included in step <NUM> of <FIG> will be described with reference to flowcharts shown in <FIG> and <FIG>. In step S201, the determination unit <NUM> included in the host computer <NUM> receives the measurement result of the specimen by the specimen measuring device <NUM> from the information processing unit <NUM>. The determination unit <NUM> determines whether the specimen meets a predetermined condition, based on the measurement result of the specimen by the specimen measuring device <NUM>. The determination unit <NUM> determines whether or not the specimen is to be measured by the flow cytometer included in the sample measuring device <NUM>. When it is determined that the specimen meets the predetermined condition and the specimen is to be measured by the flow cytometer, in step S202, the determination unit <NUM> determines whether the image of the specimen is to be analyzed.

When the determination unit <NUM> determines that the image is to be analyzed, in step S203, the transport controller <NUM> controls the specimen transport device <NUM>, and the specimen transport device <NUM> transports the specimen rack holding the specimen container from the specimen measuring device <NUM> to the smear preparing apparatus <NUM>. A medical worker may carry the specimen to the smear preparing apparatus <NUM>.

In step S204, the smear preparing apparatus <NUM> smears the specimen on a transparent substrate. The smear preparing apparatus <NUM> stains the specimen with a staining solution to prepare a smear preparation. In step S205, the imaging device <NUM> captures an image of the smear preparation, and the image analysis apparatus <NUM> analyzes the image of the smear preparation.

In step S206, the determination unit <NUM> included in the host computer <NUM> receives the analysis result of the image of the smear preparation from the image analysis apparatus <NUM>. The determination unit <NUM> determines whether the specimen meets the predetermined condition, based on the measurement result of the specimen by the specimen measuring device <NUM> and the analysis result of the image of the smear preparation by the image analysis apparatus <NUM>. The determination unit <NUM> determines whether or not the specimen is to be measured by the flow cytometer included in the sample measuring device <NUM>. When it is determined that the specimen meets the predetermined condition and the specimen is to be measured by the flow cytometer, in step S207, the transport controller <NUM> queries whether the sample preparation device <NUM> can receive the specimen. When the sample preparation device <NUM> can receive the specimen, in step S208, the transport controller <NUM> controls the specimen transport device <NUM>, and the specimen transport device <NUM> transports the specimen rack holding the specimen container from the smear preparing apparatus <NUM> to the sample preparation device <NUM>. A medical worker may carry the specimen to the sample preparation device <NUM>. Thereafter, the process proceeds to step S301 in <FIG>.

In step S207, when the sample preparation device <NUM> cannot receive the specimen, in step S241, the transport controller <NUM> controls the specimen transport device <NUM> and the storage unit <NUM>, the specimen transport device <NUM> transports the specimen rack holding the specimen container from the smear preparing apparatus <NUM> to the storage unit <NUM>, and the storage unit <NUM> stores the specimen rack. In step S242, in the sample preparation device <NUM>, when the sample container holder becomes empty, the sample preparation device <NUM> transmits a signal capable of receiving the specimen to the transport controller <NUM>, and the transport controller <NUM> controls the storage unit <NUM> and the specimen transport device <NUM>, and the specimen transport device <NUM> transports the specimen rack holding the specimen container from the storage unit <NUM> to the sample preparation device <NUM>. Thereafter, the process proceeds to step S301 in <FIG>.

When it is determined in step S201 in <FIG> that the specimen does not meet the predetermined condition and the specimen is not to be measured by the flow cytometer, in step S211, the transport controller <NUM> controls the specimen transport device <NUM>, and the specimen transport device <NUM> returns the specimen rack holding the specimen container from the specimen measuring device <NUM> to the placement unit <NUM>. A medical worker may remove the specimen from the specimen measuring device <NUM>. When, in step S202, the determination unit <NUM> determines that the image is not to be analyzed, in step S221, the transport controller <NUM> controls the specimen transport device <NUM>, and the specimen transport device <NUM> transports the specimen rack holding the specimen container from the specimen measuring device <NUM> to the sample preparation device <NUM>. A medical worker may carry the specimen to the sample preparation device <NUM>. The specimen rack may be stored in the storage unit <NUM> as necessary. Thereafter, the process proceeds to step S301 in <FIG>. When it is determined in step S206 in <FIG> that the specimen does not meet the predetermined condition and the specimen is not to be measured by the flow cytometer, in step S231, the transport controller <NUM> controls the specimen transport device <NUM>, and the specimen transport device <NUM> returns the specimen rack holding the specimen container from the smear preparing apparatus <NUM> to the placement unit <NUM>. A medical worker may remove the specimen from the smear preparing apparatus <NUM>.

In step S301 in <FIG>, the measurement order generating unit <NUM> included in the host computer <NUM> generates a measurement order of the flow cytometer included in the sample measuring device <NUM>, based on at least one of the measurement result by the specimen measuring device <NUM> and the analysis result of the image of the smear preparation by the image analysis apparatus <NUM>. In step S302, the measurement order generating unit <NUM> arbitrarily receives a change in the measurement order.

In step S303, the measurement order generating unit <NUM> sends the measurement order to the information processing unit <NUM> connected to the sample preparation device <NUM>. The sample preparation device <NUM> prepares a sample by adding a labeling reagent containing an antibody to the specimen in the sample container, based on the measurement order received by the information processing unit <NUM>. The prepared sample is sent to a sample measuring device <NUM> including the flow cytometer. The measurement order generating unit <NUM> sends the measurement order to the information processing unit <NUM> connected to the sample measuring device <NUM>. The sample measuring device <NUM> measures the sample, based on the measurement order received by the information processing unit <NUM>.

The embodiment of the invention has been described above; however, it should not be understood that the description and drawings constituting part of this disclosure limit the scope of the claimed invention. With this disclosure, various alternative embodiments, examples and operating technologies should be apparent to those skilled in the art. For example, the specimen measurement system according to the embodiment may, in an embodiment not falling under the scope of the claimed invention, not include the smear preparing apparatus <NUM>, the imaging device <NUM>, and the image analysis apparatus <NUM>. In this case, the determination unit <NUM> may determine whether or not the specimen is to be measured by the flow cytometer, based on the measurement result of the specimen by the specimen measuring device <NUM>, without using the result of the image analysis. Alternatively, the determination unit <NUM> and the measurement order generating unit <NUM> may receive the analysis result of the image of the smear preparation from the image analysis apparatus outside the specimen measurement system according to the embodiment.

The specimen measuring device <NUM> is not limited to inclusion of a flow cytometer. For example, when the present disclosure is applied to a test of adult T cell leukemia, it is determined whether the blood specimen is anti-HTLV-I antibody positive, using the specimen measuring device <NUM> including an immuno analysis device. When it is positive, the determination unit <NUM> determines that the specimen is to be measured by the flow cytometer, and the specimen transport device <NUM> transports the blood specimen to the sample preparation device <NUM>. The sample preparation device <NUM> prepares a sample from the blood specimen, using a labeling reagent containing, for example, antibodies against CD3, CD4, CD8, and CD45.

The flow cytometer included in the sample measuring device <NUM> determines whether each of CD3, CD4, CD8, and CD45 in the sample is positive or negative.

The present disclosure is also applicable to tests other than hematopoietic tumor test. For example, when the present disclosure is applied to the test of paroxysmal nocturnal hemoglobinuria (PNH), it is determined whether a urine specimen is positive for bilirubin, using a specimen measuring device <NUM> including a urine analyzer. When it is positive, the determination unit <NUM> determines that the specimen is to be measured by the flow cytometer, and the specimen transport device <NUM> transports the urine specimen to the sample preparation device <NUM>. The sample preparation device <NUM> prepares a sample from the urine specimen, using a labeling reagent containing, for example, antibodies against CD55 and CD59. The flow cytometer included in the sample measuring device <NUM> determines whether each of CD55 and CD59 in the sample is positive or negative.

Alternatively, when the present disclosure is applied to the test of ITP, it is determined whether prothrombin time (PT) and activated partial thromboplastin time (APTT) are normal in the blood specimen, using the specimen measuring device <NUM> further including a blood coagulation analyzer. When the platelet count is equal to or less than the reference value and PT and APTT are normal, the determination unit <NUM> determines that the specimen is to be measured by the flow cytometer, and the specimen transport device <NUM> transports the blood specimen to the sample preparation device <NUM>.

The sample preparation device <NUM> prepares a sample from the blood specimen, using a labeling reagent containing, for example, antibodies against CD36, CD41/<NUM>, CD42bc/a/d, CD49b/<NUM>, and CD110. The flow cytometer included in the sample measuring device <NUM> measures whether each of CD36, CD41/<NUM>, CD42bc/a/d, CD49b/<NUM> and CD1 <NUM> in the sample is positive or negative.

For example, when the present disclosure is applied to a test of stem cell transplantation, it is determined whether the leukocyte count in the blood specimen is equal to or more than a reference value, using the specimen measuring device <NUM> including a blood cell measuring apparatus. When the leukocyte count is equal to or more than the reference value, the determination unit <NUM> determines that the specimen is to be measured by the flow cytometer, and the specimen transport device <NUM> transports the blood specimen to the sample preparation device <NUM>. The sample preparation device <NUM> prepares a sample from the blood specimen, using, for example, a labeling reagent containing an antibody against CD34.

The flow cytometer included in the sample measuring device <NUM> measures CD34 positive cells in the sample to determine whether CD34 positive cells are present at a predetermined concentration or more.

Claim 1:
A specimen measurement system comprising:
a specimen measuring device (<NUM>) including a blood cell measuring apparatus configured to measure blood cells contained in a blood specimen;
a smear preparing apparatus (<NUM>) configured to prepare a smear of a blood specimen;
an image analysis apparatus (<NUM>) configured to analyze an image of the smear of the blood specimen;
a determination unit (<NUM>) configured to determine whether or not the blood specimen is to be measured by a flow cytometer, based on a measurement result of the blood cell measuring apparatus and/or based on an analysis result of the image analysis apparatus (<NUM>); and
a measurement order generating unit (<NUM>) configured to generate a measurement order for the flow cytometer, based on the measurement result of the specimen measuring device (<NUM>) and/or based on the analysis result of image analysis apparatus (<NUM>), wherein
the measurement order generating unit (<NUM>) is configured to designate a labelling reagent containing an antibody for preparing a sample from the specimen, to be measured by the flow cytometer, in the measurement order.