JP2010107260A - Sample analyzer and sample analysis method - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a sample analyzer and a sample analysis method, capable of properly developing a sample and adding a sample, readily and properly. <P>SOLUTION: The sample analyzer analyzes the components in a sample, by detecting a reaction state of a reagent carried by a specimen and the sample, where the sample is developed, from a sample addition section to a development section provided in the specimen 1, when the sample is added to the sample addition section provided at the edge of the specimen 1, with the specimen 1 being fitted to a specimen holder 61. The sample analyzer has an attitude-switching means for moving the specimen holder 61 so that the specimen 1 is in a posture for addition that is suitable for adding the sample to the sample addition section. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

  The present invention relates to a sample analysis apparatus and a sample analysis method for analyzing a component in a sample by developing the sample on a development layer of a test piece.

  Sample analyzers and sample analysis methods based on immunochromatography are widely used as sample analyzers and sample analysis methods for measuring and analyzing components (also called measurement objects) contained in liquid samples such as blood, plasma, and urine. Used (Patent Document 1, etc.). 6A and 6B are diagrams showing an example of a test piece for analysis using an immunochromatography method, wherein FIG. 6A is a plan view and FIG. 6B is a cross-sectional view. The test piece 1 includes a sample addition unit 3 to which a liquid sample such as blood is spotted on a support 2 made of a thin plate-shaped liquid-impermeable sheet material, and an added sample. And a deployment layer 4 for spreading the membrane by capillary action. In addition, the antibody reagent part provided at the center in the longitudinal direction or the downstream side of the spreading layer 4 (hereinafter, the sample addition part 3 side at one end side in the longitudinal direction of the test piece 1 is referred to as the upstream side and the other end side is referred to as the downstream side). An antibody reagent is supported and immobilized on 5, and a dye labeling reagent portion 6 provided on the upstream side of the development layer 4 holds a dye labeling reagent that binds to a specific antigen to be measured in the sample. Yes. The sample addition section 3 is formed by a gap between the transparent space forming material 7 and the support 2, and a sample addition opening that is an opening of the sample addition section 3 at the upstream end of the test piece 1. 3a faces the outside. The spreading layer 4 is made of a nonwoven fabric or a porous material. In some cases, a protective member (not shown) such as a transparent sheet is attached to the surface of the development layer 4 in order to prevent the sample from drying when the sample is developed.

  At the time of analysis, when a sample is added from the sample addition port 3a of the test piece 1, the sample addition unit 3 is filled with the sample and reaches the upstream end of the development layer 4 provided on the downstream side. The sample that has reached the development layer 4 elutes the dye labeling reagent held in the dye labeling reagent section 6 on the upstream side of the development layer 4, and the specific antigen in the sample and the dye labeling reagent are combined. The sample that has reacted with the dye labeling reagent further flows downstream of the development layer 4 by capillary action and reaches the antibody reagent part 5. At this time, the antibody reagent in the antibody reagent unit 5 captures a specific antigen in the sample by an antigen-antibody reaction. Since the dye-labeled reagent is bound to the captured antigen, a color corresponding to the concentration of the specific antigen in the sample is generated in the antibody reagent portion 5 on which the antibody reagent is supported on the development layer 4.

  By optically detecting this colored state, the concentration of the specific antigen in the sample can be measured. As an optical detection method, the test piece 1 is irradiated with laser light, and the scattered light from the test piece 1 at that time is detected with a photodiode. The test piece 1 is imaged with an image sensor, and a captured image is obtained. There are methods for obtaining absorbance by image processing, and various sample analyzers using these methods have already been proposed.

  When blood is used as a sample without pretreatment such as blood cell separation, blood cell components such as red blood cells are present as solids in the blood. The above-mentioned blood cell component is clogged in the fiber part or the hole part of the porous material, causing a problem that the sample is not normally developed. As a method of minimizing the occurrence of such a problem, the blood cell component in the blood added by holding the blood cell contracting agent 8 in the sample adding unit 3 and spotting it is contracted in the sample adding unit 3. Then, a method of flowing through the spreading layer 4 is used (for example, Patent Document 2).

  By the way, as shown in FIG. 7 (a), when the sample is added to the sample addition unit 3 in a state where the test piece 1 is held in a horizontal posture, and then the test piece 1 is held and developed in a horizontal posture, Due to the difference in the viscosity of the sample such as blood, a difference occurs in the developing speed of the sample traveling in the developing layer 4. Therefore, in this case, a difference occurs in the amount of the sample flowing through the carrying part of the antibody reagent 5 of the development layer 4 within a predetermined time, and an error occurs in the analysis result. In particular, when the viscosity of the sample is extremely high, there is a possibility that the sample does not reach the supporting portion of the developing reagent 4 on the antibody reagent 5 within a predetermined time, resulting in a problem that the reliability of the analysis accuracy is greatly reduced.

  On the other hand, as shown in FIG. 7 (b), the test piece 1 is arranged in a vertical posture in which the upstream side of the development layer 4 is upward along the vertical direction, and the sample is added through the sample addition port 3a. When the sample is added to the sample 3 and analyzed, when the sample is added to the sample addition unit 3, the sample develops by gravity before the blood cell contraction agent 8 held in the sample addition unit 3 is sufficiently dissolved. Since the sample flows out into the layer 4, the sample may not be normally developed to the downstream of the development layer 4.

  Therefore, in order to deal with the above problem, the inventors of the present invention add a sample to the sample addition unit 3 and mix the blood cell contractor 8, and then change the posture of the test piece 1 with respect to the direction of gravity. The present inventors have devised a sample analysis method and a sample analysis device configured to stabilize both the sample development speed and the mixed state of the sample such as the blood cell contractor 8 and the sample.

FIG. 8 is a diagram showing an example of the configuration of the proposed sample analyzer, FIG. 8 (a) is a perspective view showing a state at the time of sample addition, and FIG. 8 (b) shows a state at the time of sample development. It is a perspective view.
In FIG. 8, 1 is a test piece, 11 is a test piece holder for holding the test piece 1, 12 is a motor for rotating the test piece holder 11, and 15 is an image of a colored portion (antibody reagent unit 5) of the test piece 1. In this optical system 15, 16 is a lens, 17 is an image sensor, and 18 is a light source that illuminates the surface of the test piece 1. The optical system 15 is configured to cause the lens 16 to form an image of the colored portion (antibody reagent portion 5) of the test piece 1 on the imaging surface of the image sensor 17.

  At the time of analysis, first, as shown in FIG. 8A, the test piece 1 is added in a horizontal state while a sample (blood) is spotted on the sample addition unit 3. A blood cell contraction agent 8 is held in the sample addition unit 3, and the blood cell contraction agent 8, which is a drug, elutes and mixes with the sample by the added sample, and the blood cell component in the sample (blood) contracts. When a predetermined time elapses until the blood cell contraction is completed, the holder 12 is rotated by the motor 12, and as shown in FIG. 8B, the upstream side of the test piece 1 (that is, the sample addition port 3a). So that it faces upward along the vertical direction. Then, a sample whose blood cells are sufficiently contracted by the blood cell contractor 8 flows toward the downstream side of the development layer 4. Here, not only the capillary action force due to the spreading layer 4 but also the gravity to the downstream side of the spreading layer 4 acts on the sample at the same time, so even when the spreading speed of the specimen is stable and the viscosity of the specimen is high, It is possible to develop the antibody reagent part 5 within a predetermined time. According to this sample analysis method and sample analyzer, when the sample and the blood cell contractor 8 are mixed, since the test piece 1 is in a horizontal posture, the sample and the blood cell contractor 8 are mixed well. Moreover, since the test piece 1 is in a vertical posture during deployment, the deployment speed of the sample is stabilized.

Although not shown, as a similar technique in that the drug is disposed in the sample addition section 3 of the test piece 1, a dye labeling reagent is disposed in the sample addition section 3 instead of being provided on the development layer 4. A method is proposed in which a dye labeling reagent is mixed with a sample and reacted in advance in the sample addition unit 3 and then developed in the development layer 4. Even in this case, when the dye labeling reagent disposed in the sample addition unit 3 is mixed with the sample, it is considered preferable to place the test piece 1 in a horizontal posture.
Republished patent WO01 / 090754 Japanese Patent No. 3655283

  However, in the above-described conventional sample analysis method and sample analyzer, when the sample is added (so-called spotting), the test piece 1 is held in a horizontal posture, so that the sample addition port 3a of the sample addition unit 3 is provided. There is a problem that the person to be added (person who is trying to spot) often has difficulty in seeing the sample addition port 3a. As a result, it becomes difficult to add a sample (for example, it becomes difficult to spot blood of a finger), which is inconvenient as a sample analyzer and has a problem of poor operability.

  An object of the present invention is to solve the above-mentioned problems and problems, and to provide a sample analyzer and a sample analysis method capable of developing a sample satisfactorily and easily and satisfactorily adding a sample. And

  In order to solve the above-described conventional problems, the sample analyzer of the present invention is configured such that a test piece can be freely attached to a test piece holder that holds a test piece, and the test piece is attached to the test piece holder. When a sample is added to the sample addition section provided at the end of the piece, the sample is developed from the sample addition section to the development section provided in the test piece, and the reagent carried on the test piece and the sample Is a sample analyzer that quantitatively or qualitatively analyzes the components in the sample by detecting the reaction state with the test piece so that the test piece has an addition posture suitable for adding the sample to the sample addition portion And a posture switching means for moving the specimen holder.

  In this configuration, the posture switching means moves to the addition posture by moving the test piece holder so that the test piece is in an addition posture suitable for adding the sample to the sample addition portion when the sample is added. Therefore, the sample can be easily and satisfactorily added to the sample adding portion, and the convenience as a sample analyzer can be improved.

  Further, the posture switching means of the sample analyzer of the present invention is characterized in that the test strip holder is moved so that the test strip can be switched between the adding posture and the developing posture suitable for developing the sample. To do.

  According to this configuration, when the sample is developed by the posture switching means, the sample holder can be moved so that the test piece is in the deployment posture. Can be improved.

  In addition, the posture switching means of the sample analyzer of the present invention is a test so that the test piece can be switched over the addition posture, the deployment posture, and the mixing posture suitable for mixing the drug and the sample. The single holder is moved.

  According to this configuration, when the medicine and the sample are mixed by the posture switching means, the medicine and the sample can be mixed well by moving the test piece holder so that the test piece is in the mixing posture. It is possible to improve the analysis accuracy.

  Further, in the sample analyzer of the present invention, the test piece holder is supported so as to be rotatable around a rotation axis that is orthogonal to the development direction in the development layer of the test piece and extends in the development layer width direction of the test piece. It is characterized by being.

According to this configuration, the test piece can be rotated in a stable state so that the entire surface of the development layer is in a posture along a horizontal plane, a vertical plane, or an inclined plane.
Further, in the sample analyzer of the present invention, the posture switching means includes a motor that rotates the test piece holder around the rotation axis, and a control unit that controls the posture of the test piece holder, The test piece holder is rotated so that the test piece is in the adding position when the sample is added, and the test piece holder is controlled to be rotated so that the test piece is in the deploying position after adding the sample. And

  According to this configuration, when the sample is added, the test piece has an addition posture suitable for adding the sample to the sample addition portion, and when the sample is added after the sample addition, the test piece is suitable for deployment of the sample. become. Therefore, the sample can be easily and satisfactorily added at the time of sample addition, and the sample can be favorably developed at the time of development.

  In the sample analyzer of the present invention, the posture switching means includes a motor that rotates the test piece holder around the rotation axis, and a control unit that controls the posture of the test piece holder, The specimen holder is rotated so that the specimen is in the adding position when the sample is added, and the specimen holder is rotated so that the specimen is in the mixing attitude after adding the specimen. The test piece holder is controlled to be rotated so that is in a deploying posture.

  According to this configuration, when mixing the sample, the test piece has a mixing posture suitable for mixing the drug and the sample. Therefore, it is possible to satisfactorily mix the drug and the sample when mixing the sample.

  Further, in the sample analyzer of the present invention, the posture switching means has a motor that rotates the test piece holder around the rotation axis, a control unit that controls the posture of the test piece holder, and the test piece has an addition posture. And an addition posture detection switch for detecting that the test piece holder has rotated to an inclination angle of, and the addition posture detection switch is rotatably supported coaxially with the rotation axis of the test piece holder. It is characterized by. According to this configuration, the sample addition posture can be changed by rotating the addition posture detection switch.

  Moreover, the sample analyzer of the present invention is characterized in that the addition posture is a posture in which the sample addition port of the sample addition portion of the test piece faces obliquely upward. According to this configuration, when the sample is added, the sample addition port can be set to the posture for addition in which the sample addition port faces obliquely upward. The sample can be easily and satisfactorily added, and convenience is improved.

  In the sample analyzer of the present invention, the deployment posture is a posture in which the deployment direction of the test piece is downward. According to this configuration, when the sample is blood, even when the samples have different viscosities, the development speed between the samples can be made to be uniform, and measurement accuracy can be improved.

  In the sample analyzer of the present invention, the mixing posture is a posture in which the test piece is horizontal. According to this configuration, when the drug is provided in the sample adding part, for example, if the sample is added to the sample adding part, the sample and the drug are not forcibly sent to the spreading layer due to gravity or the like. Can be mixed well, and as a result, the measurement accuracy can be improved.

  In the sample analysis method of the present invention, the test piece can be freely attached to the test piece holder that holds the test piece, and the test piece is provided at the end of the test piece with the test piece being attached to the test piece holder. When a sample is added to the sample addition section, the sample is developed from the sample addition section to the development section provided on the test piece, and the reaction state between the reagent carried on the test piece and the sample is detected. The sample analysis method for quantitatively or qualitatively analyzing the components in the sample, and when adding the sample to the sample addition portion of the test piece, the test piece is in an addition posture suitable for adding the sample. It is characterized by arranging.

  According to this method, when the sample is added, the test piece becomes an addition posture suitable for adding the sample to the sample adding portion, so that the sample can be easily and satisfactorily added to the sample adding portion. Can be improved.

  In addition, the sample analysis method of the present invention is characterized in that after the sample is added, the test piece is placed in a deployment posture suitable for developing the sample. According to this method, the sample can be developed well and the analysis accuracy can be improved.

  In the sample analysis method of the present invention, after the sample is added, the test piece is placed in a mixing posture suitable for mixing the drug and the sample, and after the sample is mixed, the test piece is developed. It arrange | positions in the attitude | position for deployment suitable for. According to this method, after mixing a chemical | medical agent and a sample favorably, a sample can be expand | deployed favorably and an analysis precision can be improved.

  The sample analysis method of the present invention is characterized in that the addition posture is a posture in which the sample addition port of the sample addition portion of the test piece faces obliquely upward. According to this method, when adding a sample, the sample addition port can be in an addition posture with the upper side obliquely upward, and the sample can be easily and satisfactorily added while looking at the sample addition port well. To improve convenience.

  The sample analysis method of the present invention is characterized in that the deployment posture is a posture in which the deployment direction of the test piece is downward. According to this method, when the sample is blood, even if the sample has different viscosities, fluctuations in the development speed can be suppressed, and thus the measurement accuracy can be improved.

  In the sample analysis method of the present invention, the mixing posture is a posture in which the test piece is horizontal. According to this method, when the sample is added to the sample addition unit, for example, when the sample is provided in the sample addition unit, the sample and the drug are not forcibly sent to the spreading layer due to gravity or the like. Can be mixed well, and as a result, measurement accuracy can be improved.

  According to the sample analyzer and the sample analysis method of the present invention, when a sample is added, the test piece is added to the sample addition portion suitable for adding the sample to the sample addition portion, for example, the sample addition port of the sample addition portion of the test piece. Therefore, the sample can be easily and satisfactorily added to the sample addition portion while looking at the sample addition port well, and convenience and operability can be improved.

  Further, when the specimen is developed, the specimen can be developed satisfactorily by setting the test piece to a deployment posture suitable for developing the specimen. Further, when the sample is blood, even when the samples have different viscosities, the developing speed between the samples can be made to be uniform, and the measurement accuracy can be improved.

  In addition, when the drug and sample are mixed, the test piece is placed in a mixing posture suitable for mixing the drug and sample, so that the drug and sample can be mixed well, and thus the measurement accuracy is improved. Can be improved.

  Further, as the sample analyzer, the posture switching means includes an addition posture detection switch for detecting that the test piece holder has been rotated to an inclination angle at which the test piece is in the addition posture. By supporting the test piece holder so as to be rotatable coaxially with the rotation axis of the specimen holder, the addition posture detection switch can be rotated to change the sample addition posture. According to this configuration, the sample addition posture can be changed according to the usage status of the user adding the sample, the addition state of the sample, and the like, and the convenience as the sample analyzer can be improved.

Embodiments according to a sample analyzer and a sample analysis method of the present invention will be described below with reference to the drawings.
1A and 1B are a plan view and a cross-sectional view of a sample analyzer according to an embodiment of the present invention. FIGS. 2A and 2B are overall perspective views of the sample analyzer, respectively. Both FIG. 1 and FIG. 2 show the state at the time of drug mixing. In the sample analyzer and the sample analysis method according to this embodiment, the test piece 1 having the same components and functions as those of the test piece 1 described with reference to FIGS. 6 and 7 is used. In addition, the same code | symbol is attached | subjected about the component of the same function in the test piece 1. FIG.

  As shown in FIGS. 1 and 2, the sample analyzer 50 includes a base (base) 51 placed on a horizontal and flat installation surface, and a pair of left and right support frames erected upward from the base 51. 52 and a support piece portion 52a provided on the support frame 52 are rotatably supported via a rotation shaft 53 (note that the axis of the rotation shaft 53 becomes the rotation axis). An analyzer main body 55 incorporating an optical system, a motor 56 and a speed reduction mechanism 57 as drive sources for moving the analyzer main body 55 to a predetermined posture, which will be described later, a battery 58 as a power source, and a display for displaying measurement results and the like. And a control unit for performing various controls of the sample analyzer 50. Note that the display unit and the control unit are not shown.

  A worm gear 56 a is attached to the drive shaft of the motor 56, a plurality of reduction gears are attached to the speed reduction mechanism 57, and one rotation shaft in the rotation shaft 53 protruding from the analyzer main body 55 on both sides. A passive gear 53 a is attached to 53. Further, the rotational axis of the rotational shaft 53 is disposed so as to be orthogonal to the direction of deployment of the test layer 1 in the development layer 4 and to extend along the width direction of the development layer 4 of the test piece 1. Has been. The rotational driving force of the motor 56 is decelerated from the worm gear 56a attached to the drive shaft of the motor 56 to the passive gear 53a of the rotating shaft 53 via each reduction gear of the reduction mechanism 57 (drive). The analyzer main body 55 is configured to be rotated about the rotation axis of the rotation shaft 53 as the torque is increased).

  Next, the analyzer main body 55 will be described. In the following description, the vertical position in the main body case 60 is described with reference to the state shown in FIG. The right side in (b) is referred to as the front side or the near side. The analyzer main body 55 is mounted through a main body case 60 that forms an outer shell, and an insertion hole 60a (see FIG. 1B) that is disposed in the lower portion of the main body case 60 and formed in the lower front portion of the main body case 60. The test piece holder 61 that holds the test piece 1 and the test piece 1 that is mounted on the test piece holder 61 of the analyzer main body 55 indicate that the sample has been added to the sample addition section 3 of the test piece 1. An addition detection sensor 62 to detect, a measuring optical system comprising a lens 63 for measuring the coloration state of the antibody reagent part 5 of the test piece 1, an image sensor (CCD) 64, and the development completion position (for example, the test piece 1 A sensor for detecting that the sample has been developed to the downstream of the antibody reagent part 5 in FIG. 5 and an addition for instructing the person so that the analyzer main body 55 is in a post-addition (point wearing) posture, which will be described later. Instruction button Down switch 59, the test piece 1 is provided with such mounting detection switch 70 for detecting that mounted on the analyzer body 55.

  As will be described later, the analyzer main body 55 includes a deployment posture (see FIG. 4) suitable for the test piece 1 to deploy the reagent and an addition posture (see FIG. 4) suitable for adding the sample to the sample addition unit 3. 3 (see (a) and (b)) and a mixing posture (see FIGS. 1 (a), (b), 2 (a) and (b)) suitable for mixing the drug and the sample. Switching is controlled by the control unit so as to be moved over two postures.

  As shown in FIG. 2 (b), in this embodiment, one side surface of the main body case 60 of the analyzer main body 55 (in this embodiment, at a position on the left side of the front surface of the analyzer main body 55). A position detection projection 66 for detecting the posture of the analyzer main body 55 (that is, the position of the analyzer main body 55) is formed at a rear position substantially the same height as the rotation shaft 53. Correspondingly, the analyzer main body 55 (that is, the entire analyzer main body 55 including the test specimen holder 61) is placed on the left support frame 52 at a position where the test piece 1 is in the deployment posture. A deployment posture detection switch 67 for detecting that the position is moved, a loading posture detection switch 68 for detecting that the analyzer main body 55 has moved to a position where the test piece 1 is in the loading posture, and the test piece 1 And a mixing posture detection switch 69 for detecting that the analyzer main body 55 has moved to a position where the mixing posture is suitable for mixing. Note that the addition attitude detection switch 67, the addition attitude detection switch 68, and the mixing attitude detection switch 69 are constituted by, for example, contact switches that can be brought into contact with and separated from the position detection projection 66 and turned on and off. Or a light sensor capable of blocking the light path by the position detection projection 66.

  Further, the test piece 1 is placed between the mixing posture, the adding posture, and the deploying posture by the motor 56, the speed reduction mechanism 57, the battery 58, the control unit, the posture detection switches 67, 68, 69, and the like described above. Posture switching means for moving the test strip holder 61 (in this embodiment, the entire analyzer main body 55 including the test strip holder 61) is configured so that the posture can be switched.

  Here, in this embodiment, as shown in FIGS. 3A and 3B, the addition posture is such that the sample addition port 3a of the sample addition portion 3 of the test piece 1 faces obliquely upward. The addition posture detection switch 68 (see FIG. 2B) is arranged so that the test piece 1 is positioned in such an addition posture when the sample is added. Further, in the present embodiment, as shown in FIG. 4, the deployment posture is a posture in which the deployment direction of the test piece 1 is downward, that is, the sample addition port 3a of the sample addition unit 3 faces directly above. The deployment position detection switch 67 (FIG. 2 (b)) is configured such that the test piece 1 extends directly below the sample addition port, and the test piece 1 is positioned in such a deployment position when the sample is deployed. )) Is arranged. In the present embodiment, the mixing posture is such that the test piece 1 is horizontal as shown in FIGS. 1 (a), 1 (b), 2 (a), and 2 (b). The mixing posture detection switch 69 (see FIG. 2B) is arranged so that the test piece 1 is positioned in such a mixing posture at the time of mixing (when mixing the reagent or drug and the sample). Yes. In this embodiment, the mixing posture detection switch 69 is attached to the support frame 52 at a position behind the support portion of the rotating shaft 53, and the addition posture detection switch 68 is oblique to the mixing posture detection switch 69. The deployment posture detection switch 67 is mounted at the lower position, and is mounted at the lower position of the support portion of the rotation shaft 53. However, the present invention is not limited to this and is disposed at a position corresponding to the posture of the test piece 1 respectively. It only has to be.

  A sample analysis method of the present invention using this sample analyzer 50 will be described. First, the test piece 1 is mounted on the sample analysis apparatus 50, more specifically, the test piece holder 61 of the analysis apparatus main body 55 through the insertion hole 60 a of the main body case 60. As the posture of the analyzer main body 55 at this time, for example, as shown in FIGS. 2 (a) and 2 (b), the test piece 1 may be in the same posture as the deployment posture, which is horizontal. It is not limited.

  When the test strip 1 is mounted on the test strip holder 61 of the analyzer main body 55, this mounting operation is detected by the mounting detection switch 70, and the power source of the sample analyzer 50 is turned on and energized. When blood drawn from the fingertip is added (spotted) to the sample adding portion 3 of the test piece 1, the motor 56 is driven by, for example, pressing the addition instruction button switch 59, and the test is performed. The analyzer main body 55 is moved until the piece 1 is in the adding posture (that is, until the position detecting projection 66 of the analyzer main body 55 contacts the adding posture detecting switch 68). As a result, the test piece 1 attached to the analyzer main body 55 is used for addition in which the sample addition port 3a of the sample addition portion 3 of the test piece 1 faces obliquely upward as shown in FIGS. 3 (a) and 3 (b). It is assumed to be a posture. Therefore, a person who wants to add a sample can easily and satisfactorily place a sample on the sample addition portion 3 of the test piece 1 by bringing a sample such as blood into contact with the sample addition port 3a while looking at the sample addition port 3a. Can be added. Therefore, the convenience of the sample analyzer 50 is improved, and the sample analyzer 50 is easy to handle (easy to operate).

  When a sample is added to the sample addition unit 3 of the test piece 1, the addition state is detected by the addition detection sensor 62, and the analyzer main body 55 is set so that the test piece 1 assumes a horizontal posture. Moved. Then, in the state as it is, the mixing posture is maintained, for example, for a predetermined time or until the sample in the sample addition unit 3 is reduced to a predetermined ratio. Thereby, the blood cell contraction agent 8 as a medicine and the blood as a sample are well mixed in a state where the blood is collected in the sample addition unit 3.

  In such a state in which the mixing posture is maintained, the test piece 1 is reached after reaching a condition that is considered to be well mixed, for example, for a predetermined time or by decreasing the sample of the sample addition unit 3 by a predetermined ratio. The analyzer main body 55 is moved so as to be in a deployment posture in which is a vertical posture. As a result, not only the capillary action force caused by the spreading layer 4 but also the gravity on the downstream side of the spreading layer 4 acts simultaneously on the sample, the developing speed of the sample is stable, and even when the viscosity of the sample is high, the antibody It is possible to deploy the reagent 5 to the support portion within a predetermined time. As a result, even if there is a difference in the viscosity of the sample compared to the standard one, it is possible to bring the development speed close to a uniform value, and to minimize the decrease in measurement accuracy due to the difference in the viscosity of the sample. Measurement accuracy can be improved.

  Thereafter, when the development completion detection sensor 65 detects that the sample has been developed to the development completion position, the measurement optical system such as the lens 63 and the image sensor 64 is driven to detect the antibody of the test piece 1. The color state of the reagent unit 5 is measured. And the component in a sample is analyzed quantitatively.

  As described above, according to the present invention, when the sample is added, the test piece 1 is added to the sample adding unit 3 in an adding posture suitable for adding the sample, for example, the sample adding port of the sample adding unit 3 of the test piece 1 3a can be set to be inclined upward, so that a person adding a sample to the sample adding portion 3 of the test piece 1 can easily and satisfactorily add a sample to the sample adding portion 3 while looking at the sample adding port 3a. As a result, convenience can be improved. In addition, when the specimen is developed, the specimen can be developed satisfactorily by placing the test piece 1 in a deployment posture suitable for developing the specimen. Further, when the sample is blood, even when the samples have different viscosities, the developing speed between the samples can be made to be uniform, and the measurement accuracy can be improved. In addition, when the sample is mixed, the sample can be mixed well by placing the test piece 1 in a mixing posture suitable for mixing the blood cell contraction agent 8 as a drug and the sample, and thus the measurement accuracy. Can be improved.

  In the above embodiment, the case where the addition posture detection switch 68 for positioning the addition posture is fixed at a predetermined position is described, but the present invention is not limited to this. For example, as shown in FIG. 5, the addition posture detection switch 68 is supported so as to be rotatable coaxially with the rotation axis of the test piece holder 61 (analyzer main body 55). You may comprise so that the attitude | position for addition can be changed by adjusting a position. In the case shown in FIG. 5, a position adjustment mounting portion 52 b extending in an arc shape around the rotation axis is formed on the support frame 52 to which the addition posture detection switch 68 is mounted, and this position adjustment mounting portion. The position of the addition posture detection switch 68 can be adjusted along the position 52b (for example, a plurality of mounting screw holes 52c are formed along the position adjustment mounting portion 52b, and the addition posture detection switch 68 is fixed. The position of the screw hole 52c to which the screw 68a is attached is selected.

  According to this configuration, it is possible to change the sample addition posture according to the use situation at the time of addition (spotting) of the user who adds the sample, and the operability and convenience as the sample analyzer 50 can be improved. Can be improved. That is, for example, the position where the sample is easily added (inclination angle of the test piece 1) varies depending on the height of the user adding the sample, but by adjusting the position of the addition posture detection switch 68 as described above, The inclination angle of the test piece 1 can be changed, and the operability and convenience as the sample analyzer 50 can be improved. Moreover, when adding using various addition tools, such as a microsyringe, the position (height) and attitude | position (an inclination attitude | position, a vertical attitude | position, etc.) suitable for the test piece 1 to add using the said instrument. The position of the addition posture detection switch 68 may be adjusted so that

  In the above-described embodiment, the case where the blood cell contraction agent 8 is disposed as a drug in the sample addition unit 3 of the test piece 1 is described. However, the present invention is not limited to this, and the sample addition unit 3 of the test piece 1 The same can be applied to a case where a dye labeling reagent is provided as a drug and the sample adding unit 3 is configured to mix the dye labeling reagent and the sample. In this case, there is an advantage that almost the entire amount of the dye-labeling reagent provided in the sample addition part 3 of the test piece 1 can be dissolved well in the sample. That is, when the dye labeling reagent portion 6 is provided on the development layer 4, the dye labeling reagent is used when the development layer 4 has a certain thickness and the sample is developed around the surface portion of the development layer 4. Although a part of the part 6 may not be mixed with the sample, there is an advantage that such a problem can be prevented.

  On the other hand, when plasma is added instead of blood as a sample, the blood cell contractor 8 is not necessary. In this case, when the dye labeling reagent part 6 is provided on the development layer 4, the sample addition part 3 does not need to mix the drug (blood cell contractor 8 or dye labeling reagent) and the sample. Therefore, in such a case, the analyzer main body 55 (the test piece holder 61) is moved without moving the test piece 1 to the mixing posture after the test piece 1 is set to the addition posture at the time of sample addition. What is necessary is just to move to the deployment posture.

  In the above embodiment, when the test piece 1 is mounted on the analyzer main body 55 (test piece holder 61), the analyzer main body 55 (test) is set so that the test piece 1 is in a mixing posture (horizontal posture). Although the case where the piece holder 61) is positioned has been described, the present invention is not limited to this, and the posture of the test piece 1 at the time of mounting is the same as the posture for addition, or a separate posture suitable for mounting (for example, for addition) Or a posture inclined more upward than the posture).

  In the above embodiment, the horizontal posture is described as the mixing posture. However, a posture suitable for mixing that is not horizontal may be used as the mixing posture, and further, the test piece 1 is placed in the horizontal posture. It may be configured such that the mixture is rotated while being tilted around a predetermined tilt angle range. Further, the deployment posture is not limited to the vertical posture, and may be set to a predetermined inclination angle range.

  In the above embodiment, the sample analysis apparatus and the sample analysis method for quantitatively analyzing the components in the sample have been described. However, the present invention is not limited to this, and the components in the sample are analyzed qualitatively. The present invention can also be applied to a sample analyzer and a sample analysis method.

  The sample analyzer and the sample analysis method according to the present invention can be applied to various sample analyzers and sample analysis methods for adding a sample to a test piece attached to the sample analyzer.

(A) And (b) is the top view and sectional drawing in the attitude | position for mixing of the sample analyzer which concerns on embodiment of this invention (A) and (b) are perspective views of the sample analyzer in the mixing posture. (A) And (b) is a sectional view and a perspective view in the posture for addition of the sample analyzer The perspective view in the deployment posture of the sample analyzer The perspective view of the sample analyzer which concerns on other embodiment of this invention. (A) and (b) are a plan view and a sectional view of a test piece. (A) And (b) is a perspective view of the test piece in a conventional mixing / addition posture and a perspective view in a deployment posture. (A) And (b) is the perspective view in the attitude | position for mixing and addition of the conventional sample analyzer, and the perspective view in the attitude | position for expansion | deployment

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Test piece 2 Support body 3 Sample addition part 3a Sample addition port 4 Expanding layer 5 Antibody reagent part 6 Dye labeling reagent part 7 Space formation material 8 Blood cell contractor 50 Sample analyzer 51 Base 52 Support frame 53 Rotating shaft 55 Analysis Device body 56 Motor 57 Deceleration mechanism 58 Battery 59 Addition instruction button switch 60 Body case 61 Specimen holder 62 Addition detection sensor 63 Lens 64 Image sensor 65 Deployment completion detection sensor 66 Position detection protrusion 67 Deployment posture detection switch 68 Addition Posture detection switch 69 Posture detection switch for mixing 70 Wear detection switch

Claims (16)

When a sample is added to a sample addition section provided at an end of the test piece in a state where the test piece can be attached to the test piece holder holding the test piece and the test piece is attached to the test piece holder. The sample is developed from the sample addition part to the development part provided in the test piece, and the components in the sample are quantified or qualitatively detected by detecting the reaction state between the reagent carried on the test piece and the sample. A sample analysis device for analyzing automatically,
A sample analyzer comprising a posture switching means for moving the test piece holder so that the test piece has an addition posture suitable for adding a sample to the sample addition section.   2. The sample analysis according to claim 1, wherein the attitude switching means moves the test specimen holder so that the test specimen can be switched between the adding attitude and the developing attitude suitable for developing the specimen. apparatus.   The posture switching means is characterized in that the test piece holder is moved so that the test piece can be switched over the addition posture, the deployment posture, and the mixing posture suitable for mixing the drug and the sample. The sample analyzer according to claim 2.   The test piece holder is supported so as to be rotatable about a rotation axis that is perpendicular to the developing direction of the developing layer of the test piece and extends in the developing layer width direction of the test piece. 4. The sample analyzer according to any one of 3 above. The posture switching means includes a motor that rotates the test piece holder around the rotation axis, and a control unit that controls the posture of the test piece holder.
The control unit controls the test piece holder to rotate so that the test piece is in the adding position when the sample is added, and rotates the test piece holder so that the test piece is set in the deploying position after adding the sample. The sample analyzer according to claim 2, wherein: The posture switching means includes a motor that rotates the test piece holder around the rotation axis, and a control unit that controls the posture of the test piece holder.
The control unit rotates the test specimen holder so that the test specimen is in the adding position when the sample is added, and rotates the test specimen holder so that the test specimen is in the mixing attitude after adding the sample. 4. The sample analyzer according to claim 3, wherein the specimen analyzer is controlled so that the specimen holder is rotated so that the specimen is in a deployment posture later. The attitude switching means includes a motor that rotates the specimen holder around the pivot axis, a control unit that controls the attitude of the specimen holder, and the specimen holder that rotates to an inclination angle at which the specimen becomes an addition attitude. It is equipped with a posture detection switch for addition that detects that it has moved,
The sample analyzer according to any one of claims 1 to 3, wherein the addition posture detection switch is rotatably supported coaxially with a rotation axis of the test piece holder.   The sample analyzer according to any one of claims 1 to 7, wherein the addition posture is a posture in which the sample addition port of the sample addition portion of the test piece faces obliquely upward.   3. The sample analyzer according to claim 2, wherein the developing posture is a posture in which the developing direction of the test piece is downward.   4. The sample analyzer according to claim 3, wherein the mixing posture is a posture in which the test piece is horizontal. When a sample is added to a sample addition section provided at an end of the test piece in a state where the test piece can be attached to the test piece holder holding the test piece and the test piece is attached to the test piece holder. The sample is developed from the sample addition part to the development part provided in the test piece, and the components in the sample are quantified or qualitatively detected by detecting the reaction state between the reagent carried on the test piece and the sample. A sample analysis method for analyzing automatically,
A sample analysis method, wherein when a sample is added to a sample addition portion of the test piece, the test piece is disposed in an addition posture suitable for adding the sample.   The sample analysis method according to claim 11, wherein after the sample is added, the test piece is arranged in a developing posture suitable for developing the sample.   After adding the sample, place the test piece in a mixing posture suitable for mixing the drug and the sample, and after mixing the sample, place the test piece in a developing posture suitable for developing the sample. The sample analysis method according to claim 11.   The sample analysis method according to any one of claims 11 to 13, wherein the addition posture is a posture in which the sample addition port of the sample addition portion of the test piece faces obliquely upward.   The sample analysis method according to claim 12, wherein the deployment posture is a posture in which the deployment direction of the test piece is downward.   The sample analysis method according to claim 13, wherein the mixing posture is a posture in which the test piece is horizontal.

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