WO2025192655A1 - Specimen measurement chip, method for manufacturing specimen measurement chip, specimen measurement device, specimen measurement method, and specimen measurement program - Google Patents

Abstract

A specimen measurement chip 2, which is used for measuring a specimen, has a space 22 in which a specimen or a reagent is accommodated so as to prevent erroneous detection of the accommodation state of the specimen or the reagent while obtaining a stable reflected light quantity. The specimen measurement chip 2 includes a detection unit 23 formed on an inner surface 2a forming the space 22 and detecting the accommodation state of the specimen or the reagent. The detection unit 23 includes: a linear groove 231 formed with a reflection surface 231x that reflects light on a bottom surface; and an air lead-out passage 232 communicating with one end 231a of the groove 231.

Description

Sample measurement chip, sample measurement chip manufacturing method, sample measurement device, sample measurement method, and sample measurement program

The present invention relates to a sample measurement chip, a method for manufacturing a sample measurement chip, a sample measurement device, a sample measurement method, and a sample measurement program.

Patent Document 1 shows a microchip that has been considered for use in biochemical testing, chemical synthesis, environmental analysis, and the like. This microchip uses centrifugal force applied by a centrifuge to move a sample within a fluid circuit formed inside the microchip, allowing the sample to be analyzed.

The above-mentioned microchip is equipped with a liquid detection unit for detecting whether a sample or reagent has been introduced into the desired area. This liquid detection unit is composed of a concentric pattern of multiple circular protrusions of different diameters, arranged so that their centers coincide. After the sample or reagent is introduced into this liquid detection unit, light is irradiated, and if the amount of reflected light is reduced compared to the blank measurement (before the sample or reagent was introduced into the liquid detection unit), it can be detected that the sample or reagent has been introduced.

JP 2013-221918 A

However, when using a concentric circle pattern as described above, it is difficult for air to be expelled from between the multiple circular protrusions when a sample or reagent is introduced into the sample detection unit, and air and the sample or reagent may become mixed in the sample detection unit. This causes detected values such as the amount of reflected light to change compared to when there is no air mixed in, and there is a possibility that the sample may be falsely detected as not being present even when it is.

The present invention was conceived in consideration of the problems described above, and its main objective is to prevent erroneous detection of the storage status of specimens or reagents.

In other words, the specimen measurement chip according to the present invention has a space for accommodating a specimen or a reagent, is a specimen measurement chip used for measuring the specimen, and is provided with a detection unit disposed on the inner surface forming the space for detecting the state of the specimen or the reagent, and is characterized in that the detection unit has a groove and an air outlet path communicating with one end of the groove.

Such a sample measurement chip has an air outlet path that connects to one end of the groove, allowing air within the groove to be discharged through the air outlet path, preventing erroneous detection of the sample or reagent storage status due to air being mixed in.

The specimen or reagent is contained in the detection section by centrifugal force applied by rotation around the rotation axis, and it is desirable that the groove extend in a radial direction centered on the rotation axis.
With this configuration, the groove extends in the direction of centrifugal force, so that the specimen or reagent easily flows into the groove when centrifugal force is applied.

It is desirable that the air guide passage communicate with a radially outer end of the groove.
With this configuration, air can be easily expelled from the groove by being pushed by the specimen or reagent flowing into the groove due to centrifugal force.

In order to make it easier to detect the state of the sample or reagent contained in the detection unit, it is desirable that multiple grooves be formed and that the air outlet path be connected to one end of each of the multiple grooves.

If light is irradiated onto the detection unit of the present invention, the unevenness in the amount of light reflected from each groove can be reduced, resulting in a stable amount of reflected light. This also makes it possible to prevent erroneous detection of the storage status of the specimen or reagent.

As a specific embodiment of the multiple grooves and air discharge passages, it is desirable that the multiple grooves are formed within an area that is circular in plan view, and that the air discharge passages are formed circumferentially around the multiple grooves.

In order to further reduce unevenness in the amount of reflected light due to the structure of multiple grooves, it is desirable that the multiple grooves be linear, have the same cross-section shape, and be formed at the same pitch.

In order to maximize the amount of reflected light, it is desirable that the cross-sectional shape of the groove be an isosceles triangle with a 90-degree apex angle.

Furthermore, the method for manufacturing a specimen measurement chip according to the present invention is the above-mentioned method for manufacturing a specimen measurement chip, characterized in that the specimen measurement chip is manufactured by molding a first component having the detection unit by injection molding, and then joining another component to the first component.

Furthermore, the specimen measurement device of the present invention is a specimen measurement device into which the above-mentioned specimen measurement chip is set and which measures the specimen in the specimen measurement chip, and is characterized by comprising a light irradiation unit that irradiates light toward the detection unit, a light detection unit that detects light reflected by the detection unit, and a signal processing unit that detects the storage state of the specimen or reagent based on the output signal of the light detection unit.

Furthermore, it is desirable that identification information is attached to the surface of the sample measurement chip, that the sample measurement device further includes a camera that captures the identification information, and that the light detection unit is configured using the camera.
With this configuration, the identification information of the sample measurement chip can be read and sample management can be performed. In addition, the camera for reading the identification information of the sample measurement chip can be used to detect the state of the sample or reagent contained therein, which simplifies the device configuration.

Furthermore, the specimen measurement method according to the present invention is a specimen measurement method for measuring a specimen in the specimen measurement chip described above, characterized in that a light irradiation unit irradiates light toward the detection unit, a light detection unit detects light reflected by the detection unit, and the storage state of the specimen or reagent is detected based on an output signal from the light detection unit.

In addition, the specimen measurement program of the present invention is a specimen measurement program used in the specimen measurement device described above, characterized in that before the specimen or reagent is contained in the detection unit, the light irradiating unit is controlled to irradiate the detection unit with light, and the signal processing unit detects a first containment state based on the output signal of the light detecting unit, and after the containment operation for containing the specimen or reagent in the detection unit, the light irradiating unit is controlled to irradiate the detection unit with light, and the signal processing unit detects a second containment state based on the output signal of the light detecting unit.

The sample measurement program may be distributed electronically or may be recorded on a program recording medium such as a CD, DVD, or flash memory.

The present invention described above can prevent erroneous detection of the sample or reagent storage status.

1 is a diagram illustrating the overall configuration of a specimen measurement device according to an embodiment of the present invention. FIG. 2 is a plan view showing the configuration of the specimen measurement chip of the same embodiment. 1A and 1B are a plan view and a front view, respectively, showing the configuration of the specimen measurement chip (with an identification information label) of the same embodiment. FIG. 2 is a partially enlarged perspective view of a detection section of the front surface member of the embodiment, as viewed from the back surface side. FIG. 2 is a partially enlarged plan view of the detection section of the front surface member of the embodiment, viewed from the back surface side. FIG. 2 is an enlarged cross-sectional view taken along line AA of the embodiment. 3A and 3B are schematic diagrams showing the flow of a sample and air to a detection unit in the embodiment. 4 is a flowchart showing a sample measurement method according to the embodiment.

<One embodiment of the present invention>
An embodiment of a specimen measurement device using a specimen measurement chip according to the present invention will be described below with reference to the drawings. Note that, for ease of understanding, all of the drawings shown below are drawn in a schematic manner, with appropriate omissions or exaggerations. Identical components are designated by the same reference numerals, and their descriptions will be omitted where appropriate.

<Configuration of specimen measurement device 100>
The specimen measurement device 100 of this embodiment is equipped with a specimen measurement chip 2 for measuring a specimen, and measures the specimen in the specimen measurement chip 2. The specimen in this embodiment is, for example, a biological sample such as blood, but may also be various other specimens.

Specifically, as shown in Figure 1, the specimen measurement device 100 includes a tip mounting section 3 on which a specimen measurement tip 2 is mounted, and a rotating device 4, such as a centrifuge, that rotates the tip mounting section 3 around a predetermined rotation axis C.

The rotation device 4 has a rotating body 41 on which the chip mounting section 3 is provided, and a rotation drive section 42 including a motor and the like that rotates the rotating body 41 around the rotation axis C.

Here, the tip mounting section 3 is configured to be rotatable relative to the rotor 41. By rotating the tip mounting section 3 relative to the rotor 41, the direction in which centrifugal force is applied to the specimen measurement tip 2 can be changed. The tip mounting section 3 is rotated relative to the rotor 41 by a mounting rotation section 5 including a motor or gears, etc., which is disposed between the tip mounting section 3 and the rotor 41.

The rotating body 41 is provided with a chip setting section 6 for setting the balance chip BC on the opposite side of the rotation axis C from the chip setting section 3 on which the specimen measurement chip 2 is set. The chip setting section 6 is also rotatable relative to the rotating body 41, and is rotated by the setting rotation section 5.

<Configuration of specimen measurement chip 2>
2 and 3, the specimen measurement chip 2 of this embodiment is of a type in which a capillary CP that has aspirated a liquid specimen is loaded. The specimen measurement chip 2 has a space in which the specimen or reagent is accommodated. Here, the space in which the specimen or reagent is accommodated conceptually includes an internal flow path 22 through which the specimen or reagent moves.

Specifically, as shown in Figures 2 and 3, the specimen measurement chip 2 has a loading section 21 into which the capillary CP is loaded, and an internal flow path 22 that communicates with the loading section 21.

The internal flow path 22 is provided with, as needed, reagent holding sections 22a, 22b for containing liquid reagents that mix with or react with the specimen, a separation section 22c for extracting specific components from the specimen, a specimen measuring section 22d for measuring the specimen (including the case where the specimen is a specific component), a reagent measuring section 22e for measuring the reagent, mixing sections 22f, 22g for mixing the specimen and reagent, and an analysis section 22h for testing or analyzing the resulting mixture.

The internal flow path 22 of the specimen measurement chip 2 of this embodiment is provided with a detection unit 23 for detecting the state of the specimen or reagent contained therein, as shown in Figures 2 to 7.

In this embodiment, the detection unit 23 is illuminated with light and is provided on the inner surface 2a that forms the space (internal flow path 22), as shown in Figures 4 and 5. In this embodiment, the detection unit 23 is connected to the specimen measuring unit 22d in the internal flow path 22 and accommodates specimens that have overflowed from the specimen measuring unit 22d. In this embodiment, the detection unit 23 is provided in the overflow storage unit 22i that accommodates specimens that have overflowed from the specimen measuring unit 22d (see Figures 2 and 3).

As shown in Figure 3(b), the specimen measurement chip 2 has a light-blocking back surface member 2A and a light-transmitting front surface member 2B that covers the back surface member 2A and forms the internal flow path 22, etc., and the detection unit 23 is formed on the inner surface 2a of the front surface member 2B. Furthermore, light for detecting the storage state of the specimen or reagent is irradiated from above on the front surface member 2B side.

Specifically, the detection unit 23 can detect a specimen or reagent by irradiating light onto at least the groove, and as shown in Figures 4 to 6, has one or more linear grooves 231 with a reflective surface 231x that reflects light on the bottom surface, and an air outlet channel 232 that communicates with one end 231a of one or more grooves 231. Note that in this embodiment, a configuration with multiple grooves 231 will be described.

Furthermore, rotation around the rotation axis C applies centrifugal force, causing the sample or reagent to be contained in the detection unit 23, and the multiple grooves 231 extend in a radial direction (centrifugal force direction) centered on the rotation axis C. Here, "extending in a radial direction" means that the extension direction of the grooves 231 is not only parallel to the radial direction, but also includes being inclined (forming an acute angle) with respect to the radial direction, for example, within a range of up to ±45 degrees. Furthermore, the air discharge path 232 is connected to the ends 231a of the multiple grooves 231 that are radially outward from the rotation axis C.

As shown in Figure 5, the multiple grooves 231 are formed in a region (hereinafter referred to as groove formation region 23R) that is circular in plan view. In groove formation region 23R, the multiple grooves 231 are formed from one end to the other. In this groove formation region 23R, multiple linear protrusions are formed, and grooves 231 are formed between these multiple protrusions. In groove formation region 23R, the multiple protrusions are formed from one end to the other.

Furthermore, the multiple grooves 231 have cross sections with the same shape and are formed at the same pitch. Here, the cross section of the grooves 231 is an isosceles triangle with a 90-degree apex angle, as shown in Figure 6. Note that the cross section has the same shape when the groove width and groove depth are the same. In this embodiment, "same" does not only mean completely same, but also same in the sense that it includes tolerances that are allowable in design and manufacturing.

Furthermore, the air discharge path 232 is a flow path that is partially annular in plan view and formed circumferentially around the multiple grooves 231. In this embodiment, it is formed so as to surround at least the centrifugal force direction side (radially outward) of the circular groove formation region 23R in which the multiple grooves 231 are formed. Specifically, the air discharge path 232 is constituted by a partition portion 23T formed around the groove formation region 23R. This air discharge path 232 has the same depth as the multiple grooves 231, but it only needs to be connected to the ends of the grooves 231, and may be shallower or deeper than the depth of the grooves 231.

When the specimen measurement chip 2 configured in this manner is rotated by the rotation device 4, the specimen is introduced into the detection unit 23 from the radially inner side of the multiple grooves 231, as shown in Figure 7. Furthermore, as the specimen is introduced into the multiple grooves 231, the air within the multiple grooves 231 is drawn out from the radially outer side of the multiple grooves 231 to the air lead-out path 232. As a result, it is possible to prevent air from mixing within the multiple grooves 231.

<Method of manufacturing the specimen measurement chip 2>
Next, a method for manufacturing the specimen measurement chip 2 will be briefly described.
As described above, the specimen measurement chip 2 of this embodiment has a light-blocking back surface member 2A and a light-transmitting front surface member 2B that is placed over the back surface member 2A to form an internal flow path 22, etc.

The first component, which is the front surface member 2B having the detection unit 23, is molded by injection molding. The second component, which is the back surface member 2A, is also molded by injection molding. If any other components are required, they are molded by injection molding or the like. Then, the specimen measurement chip 2 is manufactured by joining other components, such as the second component, to the first component by, for example, heat welding.

<Detection function of specimen storage state of specimen measurement device 100>
1, the specimen measurement device 100 comprises a light irradiating unit 10 that irradiates light toward the detecting unit 23 of the specimen measurement chip 2, a light detecting unit 11 that detects the light reflected by the detecting unit 23, and a signal processing unit 12 that detects the state of the specimen or reagent storage based on the output signal of the light detecting unit 11. In addition, the specimen measurement device 100 comprises a receiving unit 14 that receives input commands from an operator (e.g., power on/off, start of measurement, etc.), and a display unit 15 that has a display or the like that displays measurement results, etc.

The light irradiation unit 10 irradiates light from above the surface member 2B of the analyte measurement chip 2, and in this embodiment has one or more LEDs. The light detection unit 11 is configured using a camera that captures the identification information ID (for example, a two-dimensional barcode such as a QR code; see Figure 3) attached to the surface of the analyte measurement chip 2. The identification information ID is printed on the identification information sticker 2S.

The signal processing unit 12 is composed of a computer having a CPU, memory, input/output interface, AD converter, or display device such as a display. Based on a sample measurement program stored in memory, the signal processing unit 12 not only controls the overall operation of the sample measurement device 100 through cooperation between the CPU and peripheral devices, but also performs the determination function described below. The signal processing unit 12 may be composed of a physically integrated computer, or may be composed of physically separate computers.

<Method for determining the storage state of the specimen (determination function of the signal processing unit 12)>
Next, a method for determining the storage state of the specimen using the detection unit 23 will be described.

<Judgment method 1>
After the sample is introduced into the detection unit 23, the amount of reflected light S is measured once or multiple times.
If the reflected light amount S is less than a predetermined reference light amount value (S<reference light amount value), it is determined that a "specimen is present."
On the other hand, if the reflected light amount S is equal to or greater than a predetermined light amount reference value (S≧light amount reference value), it is determined that “no specimen is present.”

<Judgment method 2>
The amount of reflected light (Ref) before the sample is introduced into the detection unit 23 (when the detection unit 23 is empty) and the amount of reflected light (Sam) after the sample is introduced into the detection unit (when the detection unit 23 is filled with the sample) are obtained, and the following judgment formula is used.
Judgment value D=1−Sam/Ref
If the judgment value D is less than a predetermined judgment reference value (D<judgment reference value), it is judged as "no specimen present."
On the other hand, if the judgment value D is equal to or greater than a predetermined judgment reference value (D≧judgment reference value), it is judged that “a sample is present.”

<Judgment method 3>
The average brightness value (Ref) of the detection unit image before the sample is introduced into the detection unit 23 (when the detection unit 23 is empty) and the average brightness value (Sam) of the detection unit image after the sample is introduced into the detection unit (when the detection unit 23 is filled with the sample) are obtained, and the following judgment formula is used.
Rate of change r = 1 - Ref/Sam
If the rate of change r is less than a predetermined reference value (r<reference value), it is determined that "no specimen is present."
On the other hand, if the rate of change r is equal to or greater than a predetermined reference value (r≧reference value), it is determined that a sample is present.

<Sample measurement method (operation of sample measurement device 100)>
Next, the operation of the specimen measurement device 100 of this embodiment and the specimen measurement method will be described with reference to Fig. 8. The operation of the specimen measurement device 100 is controlled by the signal processing unit 12.

First, before starting measurement, the operator aspirates a blood sample into the capillary CP. Then, the capillary CP with the aspirated blood sample is loaded into the sample measurement tip 2 (step S1). After that, the sample measurement tip 2 is placed in the tip placement section 3, and the measurement button on the sample measurement device 100 is pressed (step S2). This starts the measurement sequence under the control of the signal processing section 12.

The identification information ID attached to the surface of the specimen measurement chip 2 is captured by a camera (step S3). An individual measurement sequence is then selected based on the results of reading the identification information. For example, if the result of reading the identification information indicates that the measurement item is high-sensitivity CRP (hsCRP), the light irradiator 10 is controlled to irradiate light onto the detector 23, and the signal processor 12 detects the first storage state based on the output signal of the light detector 11 (camera) (step S4). In other words, a Ref measurement is performed when the detector 23 is empty.

Then, rotation by the rotating device 4 and rotation by the installation rotating unit 5 moves the blood sample in the capillary CP to the blood cell separating unit 22c of the sample measurement chip 2. Then, centrifugation is performed by the rotating device 4 to separate the blood sample into blood cell components and plasma components (step S5).

The separated plasma components are moved to the specimen measuring unit 22d by rotation by the rotating device 4 and the installation rotating unit 5. The volume to be used for the item measurement is then measured (step S6). Plasma components that overflow from the specimen measuring unit 22d are introduced into the detection unit 23.

Then, after the sample has been placed in the detection unit 23, the light irradiation unit 10 is controlled to irradiate the detection unit 23 with light, and the signal processing unit 12 detects the second placement state based on the output signal of the light detection unit 11 (step S7). In other words, the Sam measurement is performed in the state after the sample has been introduced into the detection unit 23. The placement state of the sample in the detection unit 23 is then determined using the above-described <Method for determining the placement state of the sample (determination function of the signal processing unit 12)> (step S8).

If the result of the judgment is "sample present," the measurement sequence continues (steps S9 to S11); if the result is "sample absent," the measurement sequence ends (step S12). If the measurement sequence continues, the sample that has reacted with each reagent is moved to the analysis unit 22h, and the analysis light irradiation unit (not shown) irradiates the analysis unit 22h with light. The resulting transmitted light or scattered light is detected by the analysis light detection unit 13 (step S9). The signal processing unit 12 calculates the measurement items, such as hsCRP, of the sample based on the light intensity signal obtained by the analysis light detection unit 13 (step S10). The calculated measurement items can be displayed on the display unit 15 (step S11).

<Effects of this embodiment>
In the specimen measurement device 100 of this embodiment configured as described above, the detection unit 23 is configured using a plurality of linear grooves 231 in the specimen measurement tip 2, thereby reducing unevenness in the amount of reflected light from each groove 231 and obtaining a stable amount of reflected light. Furthermore, the air outlet path 232 communicating with one end 231a of the plurality of grooves 231 is provided, and air within the grooves 231 can be discharged from the air outlet path 232, thereby preventing erroneous detection of the storage state of the specimen or reagent due to the presence of air.

<Other embodiments>
For example, the plurality of grooves 231 are formed in a region 23R that is circular in plan view, but they are not limited to circular regions 23R, and may be formed in regions 23R of various shapes, such as rectangular regions 23R.

Furthermore, in the specimen measurement chip 2 of the above embodiment, the specimen moves through the internal flow path 22 when centrifugal force is applied, but the specimen may also move through the internal flow path 22 when sucked or pressure-fed by a pump or the like.

Furthermore, the sample measurement chip 2 in the above embodiment is loaded with a capillary CP that has aspirated the sample, but it may also be configured with an inlet for introducing the sample, into which the sample is injected from the outside.

Furthermore, although the cross-sectional shape of the groove 231 in the above embodiment is V-shaped, it may also be other cross-sectional shapes such as rectangular, trapezoidal, or partially circular.

In the above embodiment, the groove is linear, but it does not have to be linear. It may have any shape, as long as one end and the other end are spaced apart and centrifugal force allows the sample or reagent to flow into the groove. For example, the groove may have a curved or bent shape in a plan view.

A single specimen measurement chip 2 may be provided with multiple detection units 23. Furthermore, the detection unit 23 is not limited to being connected to the specimen measurement unit 22d and configured to accommodate specimens that have overflowed from the specimen measurement unit 22d, but may also be connected to the reagent measurement unit 22e and configured to accommodate reagents that have overflowed from the reagent measurement unit 22e. Furthermore, the detection unit 23 is not limited to being configured to accommodate specimens or reagents that have overflowed from the measurement units 22d and 22e, but may also be provided in other locations.

In the above embodiment, the light detection unit 11 is configured using a camera that captures the identification information ID attached to the specimen measurement chip 2, but a light detection unit that detects reflected light from the detection unit 23 may be provided separately from the camera.

In the above embodiment, the detection unit is configured to irradiate light and detect the reflected light, but it may also be configured to irradiate light and detect the transmitted light. The detection unit may also be configured to measure physical quantities that change depending on the presence or absence of liquid, such as electrical conductivity, resistance, capacitance, temperature, or weight. Sensors that measure these physical quantities may be provided outside the chip if they can measure them from outside the chip, or may be provided inside the chip if they can measure them inside the chip. Furthermore, the containment state of the specimen may be determined using the physical quantities described above (electrical conductivity, resistance, capacitance, temperature, weight, etc.) and the determination value or rate of change determined therefrom, instead of the reflected light amount S and the determination value D or rate of change r determined therefrom in the above embodiment.

In addition, various modifications and combinations of the embodiments may be made as long as they do not contradict the spirit of the present invention.

The present invention makes it possible to prevent erroneous detection of the specimen or reagent storage status.

100... specimen measurement device 10... light irradiation unit 11... light detection unit (camera)
12: Signal processing unit 2: Sample measurement chip C: Rotating shaft 22: Internal flow path (space)
23: Detection portion 231: Multiple grooves 231a: Radial outer end portion 23R: Groove formation region 232: Air discharge path

Claims (13)

A specimen measurement chip having a space for accommodating a specimen or a reagent, the chip being used for measuring the specimen,
a detection unit provided on an inner surface forming the space for detecting a storage state of the specimen or the reagent;
The detection unit
Groove and
an air outlet channel communicating with one end of the groove. the specimen or the reagent is accommodated in the detection unit by applying centrifugal force due to rotation around a rotation axis,
The analyte measurement chip according to claim 1 , wherein the groove extends in a radial direction around the rotation axis. The specimen measurement chip according to claim 2, wherein the air outlet path is connected to the radially outer end of the groove. A plurality of the grooves are formed,
The specimen measurement chip according to claim 1 , wherein the air outlet path is connected to one end of the plurality of grooves. the plurality of grooves are formed in a region that is circular in plan view,
The specimen measurement chip according to claim 4 , wherein the air outlet channel is formed around the plurality of grooves in a circumferential direction. The analyte measurement chip according to claim 4 or 5, wherein the plurality of grooves are linear, have the same cross-sectional shape, and are formed at the same pitch. The analyte measurement chip according to claim 6, wherein the cross-sectional shape of the groove is an isosceles triangle with a 90-degree apex angle. The specimen measurement chip according to any one of claims 1 to 7, wherein the detection unit is illuminated with light. A method for manufacturing the specimen measurement chip according to any one of claims 1 to 8,
A method for manufacturing a specimen measurement chip, comprising molding a first component having the detection unit by injection molding, and joining another component to the first component to manufacture the specimen measurement chip. A specimen measurement device in which the specimen measurement chip according to any one of claims 1 to 8 is set and a specimen in the specimen measurement chip is measured,
a light irradiating unit that irradiates light toward the detection unit;
a light detection unit that detects light reflected by the detection unit;
a signal processing unit that detects the state of the specimen or reagent contained therein based on the output signal of the light detection unit. Identification information is provided on the surface of the specimen measurement chip,
The specimen measurement device further includes a camera that captures the identification information,
The specimen measurement device according to claim 10 , wherein the light detection unit is configured using the camera. A sample measurement method for measuring a sample in the sample measurement chip according to any one of claims 1 to 8, comprising:
A light irradiation unit irradiates light toward the detection unit,
A light detection unit detects the light reflected by the detection unit,
A sample measurement method, comprising detecting a state of the sample or the reagent based on an output signal from the light detection unit. A specimen measurement program used in the specimen measurement device according to claim 10 or 11,
Before the specimen or the reagent is accommodated in the detection unit, the light irradiating unit is controlled to irradiate the detection unit with light, and the signal processing unit is caused to detect a first accommodation state based on an output signal from the light detection unit;
A sample measurement program that, after a storage operation for storing the sample or the reagent in the detection unit, controls the light irradiation unit to irradiate the detection unit with light, and causes the signal processing unit to detect a second storage state based on the output signal of the light detection unit.