JP2007093382A - Hybrid substrate, analyzing substrate, recording substrate, and analyzer - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To realize a hybrid substrate which enables an analytic data keeping or utilizing person to keep analytic data safely without anxiety. <P>SOLUTION: The hybrid substrate includes an analytic substrate 2 capable of performing the analysis of a sample, a recording substrate 3 capable of recording the analytic data being the data which shows the analytic result of the sample in the analytic substrate 2, and a dividing region 4 for cutting off both substrates. The analytic substrate 2 includes an inherent code 92b and the recording substrate 3 can record the inherent code. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

  The present invention relates to a hybrid substrate for analyzing a sample, particularly a physical or chemical analysis, an analysis substrate constituting the hybrid substrate, a recording substrate, and an analysis apparatus.

  In recent years, for example, techniques for analyzing samples such as biological samples have been remarkably developed. For example, analyzers that analyze DNA, RNA, proteins, and the like have been developed one after another. Due to the development of analytical technology, there is a growing need for devices that perform assays (analyses) quickly, efficiently, accurately and at low cost.

  As one of such analyzers, by reading an assay element into a part of a compact disc (CD) or digital video disc (DVD), the software pre-recorded on the CD or DVD is read by a reader. An apparatus for controlling a process from before to after an assay using a protocol included in the software has been proposed.

  For example, Patent Document 1 discloses a disk called a biocompact disk as an example of an analysis instrument used in the analysis apparatus. A plan view of this biocompact disc is shown in FIG. As shown in FIG. 12, the biocompact disc 80 includes an assay sector 81 and a software sector 82 which are divided in the circumferential direction. The biocompact disc 80 has a diameter of 20 to 200 mm and a thickness of 0.5 to 3 mm. This biocompact disc 80 is loaded into a conventional CD-ROM or DVD reader and rotates. A central hole 83 is provided in the biocompact disc 80 for loading into such a reader. By controlling rotation with a reader, reagents and samples can be delivered to appropriate sites on the assay sector 81 for incubation, electrophoresis, isoelectric focusing, and the like. Protocols such as rotation speed and rotation timing control are recorded in the software sector 82 in advance.

As described above, there have been proposed devices and biocompact discs that can reduce costs and perform centrifugation by rotating by using a CD or DVD as described above. Therefore, it is possible to accurately perform digital analysis of a sample at a treatment base such as a hospital or at home.
Special Table 2000-515632 (announced on November 21, 2000) JP 2003-66003 A (published on March 5, 2003)

  However, the conventional biocompact disc 80 does not disclose a method for safely using or storing analysis data as a result of the assay. Therefore, for example, after analysis at a treatment base such as a hospital or at home, the analysis data (participant, measurement subject) as a part of the medical record, for example, can be safely held by a patient, or stored at another treatment base. You can't bring it for diagnosis or treatment.

  Here, in order to hold the analysis data, the read-only software sector 82 in the conventional biocompact disc is replaced with a recording medium in a CD-R or CD-RW to form an information sector which is a recordable area. A method is easily conceived.

  However, when analysis data is recorded in a recordable area (information sector), the analysis subject or the diagnostician must store or carry the assay element (assay sector 81) mounted on the biocompact disc together. Become. Then, contamination by reagents used in the assay or pathogenic bacteria may occur, which may cause secondary diseases. In addition, if the person to be analyzed or the diagnostician easily disposes of the biocompact disc, there is a risk of environmental pollution. In addition, even when storing at the treatment center rather than the subject of analysis, the analysis element should be stored so that only the analysis data can be taken out as necessary. If the assay element (assay sector 81) is not stored separately, Similar problems arise.

  The present invention has been made in view of the above problems, and analysis data storage users and analysis data users, such as a patient who is an analysis target and a diagnostician who diagnoses the patient, can safely analyze the analysis data. The object is to realize a hybrid substrate, an analysis substrate, a recording substrate, and an analysis apparatus that can be stored.

  In order to solve the above problems, the hybrid substrate of the present invention has an analysis substrate capable of analyzing a sample and a record capable of recording analysis data, which is data indicating a result of analyzing the sample on the analysis substrate. A substrate and a dividing portion for separating the two substrates, and at least one of the analysis substrate and the recording substrate includes association information that can be compared with the other substrate. It is said.

  According to the above configuration, since at least one of the analysis substrate and the recording substrate has the association information that can be compared with the other substrate, the analysis substrate and the recording substrate are separated from each other. It can be easily verified.

  Here, the association information may be any information as long as it can be collated with the other substrate in the analysis substrate and the recording substrate, and either the analysis substrate or the recording substrate. May be provided, or both substrates may be provided. Further, when both the analysis substrate and the recording substrate are provided, the correspondence information between the two substrates may be the same information or different information. In addition, the association information can be collated more easily if it is visible, for example. “Equipped” may be recorded on a substrate by printing or processing, or may be a sticker or the like attached to the substrate. Further, for example, it may be possible to collate by separating the dividing portion connecting the analysis substrate and the recording substrate into a unique shape for each hybrid substrate and fitting them together. Here, the separated shape is the “association information”. In addition, since each hybrid substrate is cut off in a unique shape, it means “having association information”.

  After recording the analysis data on the recording board, the recording board and the analysis board are separated, and the recording board is used as analysis data afterwards, and the analysis board prevents secondary diseases and environmental pollution, and is safe for storage. Stored in. When both substrates need to be verified, the correspondence information can be read out so that both substrates can be verified even after separation. Therefore, the data custodian such as the person to be analyzed separates the recording substrate from the analysis substrate. Therefore, only the recording substrate having the analysis data can be safely held. If necessary, it can be collated with an analysis board in a storage such as an inspection organization. Further, the analysis data recorded on the stored recording substrate can be collated with the sample after the analysis of the analysis substrate.

  In the hybrid board of the present invention, in addition to the above configuration, the association information may be identification information unique to each hybrid board.

  According to the above configuration, since it is possible to collate using information unique to each hybrid substrate, it is possible to collate the analysis substrate and the recording substrate accurately and individually for each hybrid substrate.

  In order to solve the above problems, the hybrid substrate of the present invention has an analysis substrate capable of analyzing a sample and a record capable of recording analysis data, which is data indicating a result of analyzing the sample on the analysis substrate. A substrate and a dividing portion for separating the two substrates, the analysis substrate is provided with identification information unique to each hybrid substrate, and the recording substrate can record the identification information. It is characterized by being.

  According to the above configuration, the identification information provided on the analysis substrate can be collated with the record information recorded on the recording substrate. Therefore, after the analysis substrate and the recording substrate are divided, both the analysis substrate and the recording substrate can be collated.

  After recording the analysis data on the recording board, the recording board and the analysis board are separated, and the recording board is used as analysis data afterwards, and the analysis board prevents secondary diseases and environmental pollution, and is safe for storage. Stored in. When verification of both substrates is necessary, for example, the identification information recorded on the recording substrate is first reproduced and displayed on a display or the like. Next, the analysis board stored in the storage is taken out, and the identification information provided in the analysis board is compared with the unique code displayed on the display. If the identification information provided on the analysis board is visible, verification is particularly easy. However, it may not be visible, and may be displayed on the display by being reproduced, for example.

  In this way, since both boards can be verified even after being separated, the data custodian such as the analysis target person can store the recording board and the analysis board separately, and only the recording board with the analysis data can be stored. Can be safely and securely held. If necessary, it can be collated with an analysis board in a storage such as an inspection organization. Further, the analysis data recorded on the stored recording substrate can be collated with the sample after the analysis of the analysis substrate.

  In order to solve the above-described problems, an analysis apparatus according to the present invention is an analysis apparatus that uses the hybrid substrate, and includes a recording unit that records the identification information on the recording substrate.

  According to the above configuration, the identification information unique to each hybrid substrate can be recorded on the recording substrate for the analysis substrate having the identification information unique to each hybrid substrate and the hybrid substrate capable of recording the identification information. . First, before separating the recording substrate and the analysis substrate, identification information is recorded as information on the recording substrate. For example, if the identification information provided on the analysis board is visible, an analyzer or the like can visually read and input from an input device such as a keyboard so that the recording means records on the recording board. Good. With the above configuration, since the identification information is recorded on the recording substrate, it is possible to collate the analysis substrate and the recording substrate by collating the identification information provided on the analysis substrate with the identification information recorded on the recording substrate. .

  In the hybrid substrate of the present invention, in addition to the above configuration, the analysis substrate may include a drawing region on which a recording medium capable of optically recording the identification information is formed.

  According to the above configuration, the identification information can be described by optical recording in the drawing area of the analysis substrate. Further, since the recording substrate can record information, the identification information can be recorded on the recording substrate together with the analysis data. Therefore, even after the analysis substrate and the recording substrate are divided, the analysis substrate and the recording substrate can be verified by collating the identification information.

  Further, when the identification information is recorded in the drawing area of the analysis substrate, the unique code can be read visually by the difference in reflection or transmittance between the recorded portion and the unrecorded portion of the recording medium. Therefore, when the identification information on the recording substrate is reproduced and displayed on the display, the identification information recorded on the analysis substrate can be easily verified visually.

  In order to solve the above-described problems, the analyzer of the present invention is an analyzer that uses the hybrid substrate, and includes identification information output means for generating unique identification information for each hybrid substrate to be used, and the identification information. Recording means for recording on the recording substrate and drawing the identification information in the drawing area may be provided.

  According to the above configuration, with respect to an analysis disk having a drawing area capable of optical recording on the analysis board, unique identification information for each analysis disk is recorded on the drawing area of the analysis board and a recording board capable of recording information. be able to. Therefore, by collating the identification information, the analysis substrate and the recording substrate can be collated. Furthermore, since it is not necessary to record the unique code by embossing or the like when manufacturing the analysis disk, the manufacturing cost of the analysis disk can be reduced.

  In the hybrid substrate of the present invention, in addition to the above configuration, the recording medium may be a non-rewritable additional recording type medium.

  According to the above configuration, rewriting of the association information drawn in the drawing area can be prevented, and the analysis board can be prevented from being replaced. Even if new association information is additionally recorded, the original association information remains, and evidence that it has been forcibly rewritten remains. In addition, when the association information is deleted, the deleted trace can be clearly seen. Therefore, since the rewriting and erasure of the association information can be confirmed, it is possible to prevent the analysis substrate from being replaced and the recording substrate from being impersonated.

  In the hybrid substrate of the present invention, in addition to the above configuration, the identification information may be a unique identifier that is continuously described across the analysis substrate and the recording substrate.

  According to the above configuration, even after the analysis substrate and the recording substrate are separated from each other, if the analysis substrate and the recording substrate are aligned as in the original, it is possible to collate by visual inspection. Particularly easy to collate is an identifier such as a bar code. If the bar positions are at the same position, it is possible to collate whether the analysis substrate and the recording substrate are a pair. In addition, alphabets and numbers may be recorded. The unique identifier is not limited to the above, and a unique pattern may be used. In order to record in the straddled area, printing may be performed by, for example, ink jet. If printing is performed, the unique code can be drawn at low cost at high speed on each of the hybrid boards.

  In the hybrid substrate of the present invention, in addition to the above configuration, the hybrid substrate has a disk shape, and the analysis substrate is disposed at an outer side position in the disk radial direction, and the inner side in the disk radial direction with respect to the analysis substrate. The recording substrate may be disposed at a side position, and the dividing portion may be formed between the analysis substrate and the recording substrate.

  According to the above configuration, the recording substrate on which the analysis data is recorded can be a small disc and can be reproduced by the disc reproducing apparatus. In the analysis disk, the diameter of the small disk, which is the recording substrate separated by the dividing portion, may be set to the standard diameter of the optical disk. For example, the diameter of the entire hybrid substrate can be 12 cm in accordance with the standards of compact discs and digital video discs, and the diameter of the small disc that is the recording substrate after being divided by the dividing portion can be the same as the small diameter size (8 cm) of the same standard. For example, a small disk as a recording substrate can be reproduced by a commercially available CD-ROM device or the like, and convenience is further improved.

  As described above, the hybrid substrate of the present invention includes an analysis substrate capable of analyzing a sample, a recording substrate capable of recording analysis data, which is data indicating a result of analyzing the sample on the analysis substrate, A separation unit for separating the two substrates, and at least one of the analysis substrate and the recording substrate includes association information that can be compared with the other substrate.

  According to the above configuration, since at least one of the analysis substrate and the recording substrate is provided with association information that can be compared with the other substrate, the analysis substrate and the recording substrate are separated, You can easily match each other.

  Here, the association information may be any information as long as it can be collated with the other substrate in the analysis substrate and the recording substrate, and either the analysis substrate or the recording substrate. May be provided, or both substrates may be provided. Further, when both the analysis substrate and the recording substrate are provided, the correspondence information between the two substrates may be the same information or different information. In addition, the association information can be collated more easily if it is visible, for example. “Equipped” may be recorded on a substrate by printing or processing, or may be a sticker or the like attached to the substrate. Further, for example, it may be possible to collate by separating the dividing portion connecting the analysis substrate and the recording substrate into a unique shape for each hybrid substrate and fitting them together. Here, the separated shape is the “association information”. In addition, since each hybrid substrate is cut off in a unique shape, it means “having association information”.

  After recording the analysis data on the recording board, the recording board and the analysis board are separated, and the recording board is used as analysis data afterwards, and the analysis board prevents secondary diseases and environmental pollution, and is safe for storage. Stored in. When both substrates need to be verified, the correspondence information can be read out so that both substrates can be verified even after separation. Therefore, the data custodian such as the person to be analyzed separates the recording substrate from the analysis substrate. Therefore, only the recording substrate having the analysis data can be safely held. If necessary, it can be collated with an analysis board in a storage such as an inspection organization. Further, the analysis data recorded on the stored recording substrate can be collated with the sample after the analysis of the analysis substrate.

  In addition, the hybrid substrate of the present invention includes an analysis substrate capable of analyzing a sample as described above, and a recording substrate capable of recording analysis data that is a result of analyzing the sample on the analysis substrate. And a dividing portion for separating the two substrates, the analysis substrate is provided with identification information unique to each hybrid substrate, and the identification information can be recorded on the recording substrate. .

  According to the above configuration, the identification information provided on the analysis substrate can be collated with the record information recorded on the recording substrate. Therefore, after the analysis substrate and the recording substrate are divided, both the analysis substrate and the recording substrate can be collated.

  After recording the analysis data on the recording board, the recording board and the analysis board are separated, and the recording board is used as analysis data afterwards, and the analysis board prevents secondary diseases and environmental pollution, and is safe for storage. Stored in. When verification of both substrates is necessary, for example, the identification information recorded on the recording substrate is first reproduced and displayed on a display or the like. Next, the analysis board stored in the storage is taken out, and the identification information provided in the analysis board is compared with the unique code displayed on the display. If the identification information provided on the analysis board is visible, verification is particularly easy. However, it may not be visible, and may be displayed on the display by being reproduced, for example.

  In this way, since both boards can be verified even after being separated, the data custodian such as the analysis target person can store the recording board and the analysis board separately, and only the recording board with the analysis data can be stored. Can be safely and securely held. If necessary, it can be collated with an analysis board in a storage such as an inspection organization. Further, the analysis data recorded on the stored recording substrate can be collated with the sample after the analysis of the analysis substrate.

  An embodiment of the present invention will be described below with reference to FIGS. The shape of the hybrid substrate in the present embodiment may be any shape such as a plate shape, a disk shape, or a cylindrical shape, but in this embodiment, a disk-shaped hybrid substrate (hereinafter abbreviated as an analysis disk). ) As an example. The analysis disk is a substrate that is expected to be used in the future because it can be measured while rotating to search a plurality of measurement cells, measurement channels, and the like on the disk at high speed.

  FIG. 1 is a plan view showing an analysis disk 1 according to an embodiment of the present invention. As shown in FIG. 1, the analysis disk 1 includes an analysis substrate 2, a recording substrate 3, and a dividing area (dividing part) 4. The dividing region 4 is formed in an annular shape with a narrow width, the inner region in the radial direction with respect to the dividing region 4 is the recording substrate 3, and the outer region is the analysis substrate 2.

  The dividing region 4 includes a connecting portion 4a and a cutout portion 4b. The connecting portion 4 a connects the analysis substrate 2 and the recording substrate 3, and a plurality of connecting portions 4 a are formed in the circumferential direction of the dividing region 4. Of course, the number of connecting portions 4a is not limited. Between these connecting portions 4a and the adjacent connecting portion 4a is a notch 4b, that is, a space. Therefore, the analysis disk 1 is separated into a portion of the recording substrate 3 (recording substrate) and a portion of the analysis substrate 2 (measurement substrate) by the notch 4b, and the portion of the recording substrate 3 and the portion of the analysis substrate 2 are separated. It is connected by the connecting part 4a. The structure of the dividing region 4 is not limited to that described above. For example, the cutout portion 4b is not provided, the connecting portion 4a is continuously formed in the circumferential direction, and the thickness of the connecting portion 4a is determined by the analysis substrate 2 or the recording substrate. The analysis substrate 2 and the recording substrate 3 may be easily separated from each other by reducing the thickness of the substrate 3.

  The connecting portion 4a can be easily cut with a blade such as a cutter, and by this cutting, the analysis disk 1 can be separated into the analysis substrate 2 and the recording substrate 3 as shown in FIG. It should be noted that a dedicated cutting device can be used for separating the analysis substrate 2 and the recording substrate 3. In this case, the structure of the dividing region 4 is not limited to that described above, and may be formed as a region that can be cut by the cutting device.

  The recording substrate 3 is provided with a recording area 3a on which a recording medium is formed. After the analysis of the sample, analysis data, a unique code for each analysis disk 1 to be described later, and the like are registered as described below. Information can be recorded. On the recording substrate 3, as the recording medium, an optical recording medium similar to a normal optical disk (for example, a multilayer film structure) is formed, and in addition, tracking grooves, address information, and the like are recorded in an uneven shape, for example. ing. As a material of the recording medium, a dye material used for CD-R or DVD-R, a phase change material used for CD-RW, DVD-RW, or the like can be used. The tracking groove has an uneven groove shape, but a wobble pit shape may also be used.

  In order to prevent the analysis data recorded in the recording area 3a of the recording substrate 3 from being falsified, erasure and rewriting of the recording area 3a may be prohibited. This can be done by software or hardware techniques. In particular, if a write-once medium such as that used in a CD-R is used, a hardware prohibition function is added, so that the security function is further improved.

  The analysis substrate 2 includes an analysis region 2a including an analysis chip 5x, so that a sample can be analyzed. The analysis chip 5x and the analysis method will be described later. In the analysis region 2a, other than the analysis chip 5x may be provided as long as the sample can be analyzed.

  In addition to this, a unique code 92 b for each analysis disk is drawn on the analysis board 2 on the analysis disk 1. That is, the analysis board 2 includes a unique code 92b for each analysis disk. As long as the unique code can identify the analysis disk 1, any code may be drawn by any method. For example, a combination of alphabets and numbers may be drawn so as to be visible. In the present embodiment, as shown in FIG. 1, for example, “FC34P086” is printed with ink. Alternatively, it may be drawn by embossing when the analysis disk 1 is molded.

  When the analysis of the sample is completed in the analysis chip 5x of the analysis substrate 2 using the analysis device 13 described below, analysis data indicating the analysis result is recorded on the recording substrate 3. At this time, information of the unique code “FC34P086” is also recorded. Since the unique code 92b “FC34P086” is visually confirmed, for example, an analyst (operator) visually confirms this and inputs “FC34P086” from the input unit (eg, keyboard) of the analyzer 13. The generated unique code may be recorded together with the analysis data. The analysis data is recorded in a data area (not shown) of the recording substrate 3 and the unique code is recorded in a lead-in area (registration information area) (not shown) of the recording substrate 3 by optical recording. The unique code 92b is drawn on the analysis board 2. Thereafter, the recording board 3 and the analysis board 2 are separated, and the recording board 3 is held by, for example, a user or patient who is an analysis target, and the analysis board 2 is stored in, for example, a storage (preferably a freezer storage) of an inspection organization. Is done. Thereafter, analysis data holders and analysis data users such as users and patients who are analysis subjects can hold only the recording substrate 3 and use the analysis data.

  When searching for the analysis board 2 stored in the storage based on the recording board 3 held by the analysis data holder, the unique code 92b “FC34P086” recorded on the recording board 3 is first reproduced. The data is reproduced by a functional analyzer and displayed on a display, for example. Next, the analysis board 2 on which the same unique code 92b “FC34P086” is drawn is searched from the storage. As described above, if the recording substrate 3 and the analysis substrate 2 can be collated, even the analysis substrate 2 with a pathogen and dangerously infected can be stored in a storage box without being discarded. It is possible to find out.

  The above is an example in which the unique code 92b “FC34P086” is printed on the analysis board 2 with ink or recorded on the analysis board 2 so as to be visible by embossing. However, recording a different unique code for each analysis disk when manufacturing the analysis disk increases costs. Therefore, an example of an analysis disk provided with a drawing area 91 in which a unique code 91a can be recorded instead of the unique code 92b as follows.

  Instead of providing the unique code 92b, the analysis substrate 2 of the analysis disk 1 is provided with a drawing area 91 on which a recording medium capable of optical recording is formed. When the drawing area 91 is provided, the unique code 92b need not be drawn. As a recording medium material of the drawing area 91, as with the recording substrate 3, a dye material used for CD-R or DVD-R, or a phase change used for CD-RW or DVD-RW is used. Material is used. If the recording medium in the drawing area 91 is formed at the same time as the recording medium of the recording substrate 3 is formed, there is no need to print a different unique code for each analysis disk, and the manufacturing cost can be reduced.

  When the drawing area 91 is on the analysis disk 1, the unique code is first output from the unique code generating means of the analyzer 13 described later after the analysis is completed. Assume that this unique code is “FC34P086” as described above. Then, the unique code “FC34P086” is recorded on the recording substrate 3 together with the analysis data. Further, the unique code 92 a “FC34P086” is drawn in the drawing area 91 on the analysis board 2. It is necessary to make the reflectance or transmittance of the recording medium different between the drawn portion of the drawn unique code 92a “FC34P086” and the other non-drawn portions. In this case, the unique code 92a “FC34P086” can be visually confirmed by the difference in reflectance and transmittance. After the unique code 92a is drawn, the recording board 3 and the analysis board 2 are separated and stored as described above. Since the verification method of the recording substrate 3 and the analysis substrate 2 has been described above, the description thereof will be omitted.

  If the recording medium in the drawing area 91 is the same medium as the additional recording type CD-R or DVD-R that is not rewritable, the unique code 92a is prevented from being rewritten and the collation reliability is improved. For example, the unique code 92 a “FC34P086” is recorded in the drawing area 91. Deliberately rewriting to a new unique code (for example, “UI81R253”), the drawing area 91 is an additional recording medium that cannot be rewritten. Evidence of rewriting remains. Further, even when the unique code 92a “FC34P086” is erased, the erased trace can be clearly seen by the difference in transmittance and reflectance. Therefore, rewriting and erasing of the unique code can be confirmed. Therefore, alteration of the analysis board 2 can be prevented. Further, even if only the recording substrate 3 is forged, the forgery is clarified by collation with the analysis substrate 2, so that the recording substrate 3 can be prevented from being impersonated.

  Next, the analysis apparatus 13 for recording the unique code 92a in the drawing area 91 will be described with reference to FIG. Here, generation (output) and recording operations of the unique code will be described, and other operations will be described later. In addition, since the analyzer 13 is an analyzer that uses a disk-shaped hybrid substrate, if the hybrid substrate is a plate shape or a cylindrical shape, the device configuration is suitable for it.

  FIG. 3 is a block diagram showing a main part of the analyzer 13. The analysis device 13 includes a unique code generation circuit 71 (identification information output means). The unique code generation circuit 71 includes a random number generation circuit therein, and generates a unique code n (here, “n” is shown because a signal representing the unique code is shown) based on the random number. Therefore, the unique code changes each time, and the analysis disk 1 is prevented from being falsified. A command signal m for generating a unique code is sent from the controller 56 to the unique code generating circuit 71 in accordance with a flowchart to be described later. In response to this, the unique code generation circuit 71 returns the unique code n to the controller 56. After the end of the analysis operation, the controller 56 outputs the unique code n to the data recording / reproducing circuit 54 and records it from the optical pickup 7 to the analysis disk 1 together with the analysis data. The analysis data is recorded in the data area of the recording area 3a of the recording substrate 3. The unique code “FC34P086” is recorded as registration information in a registration information recording area (for example, a lead-in area) of the recording area 3 a of the recording substrate 3. Furthermore, the unique code n is drawn on the drawing area 91 of the analysis board 2 so as to be visible. As described above, the unique code n generated on the basis of the random number in the unique code generation circuit 71 is recorded in the lead-in area of the recording board 3 and drawn in the drawing area 91 of the analysis board 2 so that it is divided. Can be matched with each other. The description of other parts in this apparatus will be described later, and the flow of the recording operation of the unique code will be described below.

  FIG. 4 is a flowchart showing an operation flow when the unique code 92a is recorded in the drawing area 91 by the analyzer 13 equipped with the unique code generation circuit 71 serving as a unique code output means. FIG. 4 is a diagram for explaining in detail a part of FIG. 8 showing the flow of the operation of the entire analyzer 13. Since the operation of the entire analyzer 13 will be described later with reference to FIG. 8, only the unique code recording operation (step 27, hereinafter referred to as S27) will be described here.

  In the analyzer 13, when all the analysis operations are completed and the analysis disk 1 is used, a used display is performed (S17 in FIG. 8). Thereafter, the unique code recording operation is started (S27 in FIGS. 8 and 4). In FIG. 4, when the recording operation of the unique code is started (S20), first, the unique code output means generates a unique code based on the random number (S21). Next, the pickup is moved to the analysis substrate 2 (s22). The generated unique code is drawn and recorded in the drawing area 91 in the analysis board (s23). The pickup is moved to the recording substrate 3 (S24). The unique code and unique code drawing end information are recorded in the lead-in area (registered information recording area) in the recording area of the recording substrate 3 (S25). The recording of the unique code is terminated (S26). Since the analysis substrate 2 and the recording substrate 3 can be separated, a separation display for instructing separation to the user of the analyzer 13 is performed on the display unit (not shown) (S18 in FIG. 8).

  As described above, one analysis substrate 2 of the analysis disk includes the drawing area 91, and a recording medium capable of optical recording is formed in the drawing area 91. If the unique code for each analysis disk 1 is recorded in the drawing area 91, the analysis substrate 2 and the recording substrate 3 can be collated. Furthermore, since it is not necessary to record a unique code by embossing or the like when manufacturing the analysis disk 1, the manufacturing cost of the analysis disk 1 can be reduced.

  The analysis device 13 includes a unique code generation circuit (identification information output means) 71 for generating a unique code, records the unique code on the recording substrate 3, and draws the unique code in the drawing area 91. be able to. Therefore, even after the analysis substrate 2 and the recording substrate 3 are separated, the analysis substrate 2 and the recording substrate 3 can be collated.

  In the analysis disk 1, identifiers as shown below may be used instead of the unique code 92a and the unique code 92b. As shown in FIG. 1, this identifier is printed in an area 93 extending between the analysis board 2 and the recording board 3 of the analysis disk 1 so that it can be visually verified. An enlarged view of the straddled region 93 is shown in FIG. As an example, in FIG. 5, a bar code 95 is used as an identifier instead of the unique code “FC34P086”. The reason for using the bar code is that the bar code is cut in the middle, and then the cut bars are put together so that the identifier can be easily confirmed visually. Of course, the identifier is not limited to a barcode.

  First, the barcode 95 is printed in a state where the analysis substrate 2 and the recording substrate 3 are connected by the connecting portion 4a. As shown in FIG. 5, each bar forming the barcode 95 is printed across the analysis substrate 2 and the recording substrate 3 in the longitudinal direction of the bar. After the analysis of the sample is completed and the analysis data is recorded on the recording substrate 3, when the analysis substrate 2 and the recording substrate 3 are separated, the bar code 95 is connected to the connecting portion 4a and the notch portion 4b in the dividing region 4. Is cut almost in the middle. When the analysis substrate 2 and the recording substrate 3 are separated after the analysis substrate 2 and the recording substrate 3 are separated from each other, the same barcode 95 can be visually observed if the analysis substrate 2 and the recording substrate 3 are aligned with each other. It can be verified by checking whether or not. In addition, alphabets and numbers may be recorded across the area 93. Further, the present invention is not limited to this, and a unique pattern may be used. In order to record across the border, for example, printing is performed by inkjet or the like. If printing is performed, the unique code can be drawn at low speed and high speed on each analysis disk.

  In the present embodiment, the analysis board 2 is provided with a unique code, and the unique code is recorded on the recording board 3. That is, in this embodiment, both the analysis board 2 and the recording board 3 are provided with association information (in this embodiment, a unique code) that can be collated with the other, but the analysis board 2 and the recording board 3 are recorded. It suffices that at least one of the substrates 3 has correspondence information that can be compared with the other substrate. If it does so, after the analysis board | substrate 2 and the recording board | substrate 3 are parted, it can collate each other easily.

  Here, the association information may be any information as long as it can be collated with the other substrate between the analysis substrate 2 and the recording substrate 3, and the analysis substrate 2 and the recording substrate 3 Either of these may be provided, or both substrates may be provided. Further, when both the analysis substrate and the recording substrate are provided, the correspondence information between the two substrates may be the same information or different information. In addition, the association information can be collated more easily if it is visible, for example. “Equipped” may be recorded on a substrate by printing or processing, or may be a sticker or the like attached to the substrate. Further, for example, even if the dividing portion connecting the analysis substrate 2 and the recording substrate 3 is separated into a shape unique to each analysis disk 1 and fitted, it can be collated. Good. Here, the separated shape is the “association information”. Further, since each analysis disk 1 is cut into a unique shape, it means that “the association information is provided”.

  The analysis substrate 2 of the analysis disk 1 and other configurations of the analysis device 13 will be described in detail below.

  In FIG. 1, the analysis substrate 2 of the analysis disk includes a plurality of analysis chips 5x, 5x,... Arranged radially from the center of the analysis disk 1. Note that the analysis substrate 2 may be provided with other ones as long as the analysis of the sample is possible, not the analysis chip 5x, for example, a flow path for performing electrophoresis or chromatography. However, the present invention is not limited to these.

  In the analysis disk 1 of the present embodiment, for example, eight analysis chips 5x are mounted. The number and size are not limited. Although not shown, a number is assigned to each analysis chip 5x, and the used and unused ones of the analysis chip 5x can be distinguished by referring to the numbers.

  In the present embodiment, a case where the analysis chip 5x is an electrophoresis chip will be described as an example of the analysis chip 5x. In the electrophoresis chip, for example, DNA or protein to which fluorescent molecules are bound can be electrophoresed, and the speed of electrophoresis can be detected by irradiating with excitation light, and the mass and charge can be analyzed. Analysis data indicating the result of analysis by the analysis substrate 2 is recorded on the recording substrate 3 as described later.

  The analysis chip 5x includes liquid reservoirs 5a to 5d and a migration path 5e. The structure of the electrophoresis chip is a commonly used structure, and is disclosed in Patent Document 2 together with an analysis example, for example.

  The migration path 5e is formed in a groove shape, and includes a first migration path that extends in the radial direction of the analysis disk 1 and a second migration path that extends in a direction orthogonal to the first migration path, and these form a cross shape. Is arranged. Each of the liquid reservoirs 5a to 5d is arranged at four ends of the migration path 5e so as to communicate with the migration path 5e. That is, a liquid reservoir 5a is disposed at one end of the second migration path, 5c is disposed at the other end, a liquid reservoir 5b is disposed at one end of the first migration path, and 5d is disposed at the other end.

  The width and depth of the migration path 5e are several μm to several hundred μm, and the diameters of the liquid reservoirs 5a to 5d are several hundred μm to several mm. Such a thin migration path 5e is generally called a microchannel or a microcapillary. The migration path 5e is sealed by a cover layer as will be described later, while the liquid reservoirs 5a to 5d are exposed on the surface of the analysis disk 1 because a buffer solution and a sample solution are injected.

  In the present embodiment, electrodes (power connection wirings) 6a to 6d connected to the liquid reservoirs 5a to 5d are formed by being drawn out to the outermost peripheral part of the recording substrate 3 (the outermost peripheral part of the analysis disk 1). Electrophoresis power is supplied from the analyzer 13 to the electrode end via a connector. Specifically, the electrode 6a is connected to the liquid reservoir 5a, the electrode 6b is connected to the liquid reservoir 5b, the electrode 6c is connected to the liquid reservoir 5c, and the electrode 6d is connected to the liquid reservoir 5d.

  In the present embodiment, an example of an electrophoresis chip is shown as the analysis chip 5x included in the analysis substrate 2 of the analysis disk 1. However, the present invention is not limited to this, and the analysis chip 5x may include incubation, column chromatography, and the like. It may be replaced with a chip.

  FIG. 6 is a perspective view showing a cross section of the migration path 5e and the liquid reservoir 5d (which may be any liquid reservoir, but will be described using the liquid reservoir 5d) in the analysis substrate 2. FIG. In the figure, for convenience of explanation, the entire analysis chip 5x is not shown, and as a part thereof, a cross section of the migration path 5e and the liquid reservoir 5d is shown. As shown in FIG. 6, the analysis disk 1 basically has a structure in which a plastic cover layer 42 is bonded to a plastic substrate 41 with an adhesive. The thickness of the substrate 41 is 1.2 mm or 0.6 mm, and the thickness of the cover layer 42 is 0.1 mm. On the substrate 41, the migration path 5e and the liquid reservoir 5d are molded. Further, guide grooves (grooves) 43, 43,... For attracting and scanning the light beam a are formed on the substrate 41 in order to detect the analyzed band in the migration path 5e with the light beam a. Yes. The depth and width of the guide groove 43 are, for example, when the wavelength of the light beam a is 400 nm and the numerical aperture of the objective lens in the optical pickup (recording means, reproducing means) 7 is 0.65, the width is 400 to 600 nm. Is 40-50 nm. In addition, a reflective film 44 for returning reflected light to the optical pickup 7 is formed on the substrate 41 in order to perform focus servo and tracking servo of the light beam a.

  Note that the metal reflection film 44 is not formed below the migration path 5e. Therefore, the electric field for electrophoresis is not easily generated by the metal reflection film 44. This is not the case when a reflective film other than metal is provided. Further, if the intensity of the reflected light is detected by the optical pickup 7, the presence or absence of the reflective film 44 can be determined. This is due to the following reason. The reflected light is strong if reflected by the reflective film 44, and weak if not reflected. Therefore, a relative difference in reflected light occurs between the region of the guide groove 43 where the reflective film 44 is present and the region of the migration path 5e where the reflective film 44 is absent. Therefore, if the reflected light is detected, the presence or absence of the analysis substrate 2 can be known. That is, in the analysis disc 1, when the analysis substrate 2 is present, a high level reflected light amount and a low level reflected light are detected depending on the presence or absence of the reflective film 44, and the analysis substrate 2 is separated and recorded without being present. When only the substrate 3 is provided, the presence or absence of the analysis substrate 2 can be determined by detecting only the low-level reflected light amount.

  For example, when the presence / absence information of the presence / absence of the analysis substrate 2 is recorded in the registration information in the recording region 3a of the recording substrate 3, the registration information is read from the recording substrate 3 to read the analysis substrate 3 Can know the presence or absence of 2. That is, it can be determined by the light beam a from the optical pickup 7 whether it is the analysis disk 1 with the analysis substrate 2 or the analysis disk 1 having only the recording substrate 3 after the analysis substrate 2 is separated. Therefore, it is determined whether the analysis disk 1 has been completely analyzed and no unused analysis chip 5x is present, or is the analysis disk 1 in which the analysis has not been completed and the unused analysis chip 5x remains. Can be determined. As a result, it is possible to prevent malfunction such as the analysis device 13 erroneously performing an analysis operation on the analysis disk 1 that has been analyzed, or erroneously refusing the analysis operation of the analysis disk 1 that has not been analyzed. it can. The registered information is information related to analysis, such as the analysis date and time, detailed information related to the analysis sample (sample), and the number of the analysis chip 5x used. Further, the registered information may include, for example, the name of the analysis subject, the analysis location, and the like.

  Next, the principal part of the analyzer 13 of this Embodiment is demonstrated using FIG. The analysis device 13 is a device that uses a disk-shaped substrate. For example, if the substrate is a plate shape or a cylindrical shape, the analysis device 13 has a device configuration suitable for it. The analyzer 13 includes an optical pickup 7, a connector 9, a data recording / reproducing circuit 54, a servo circuit 55, a controller 56, a light amount detection circuit 57, a memory 58, an electrophoresis power supply circuit 59, and a unique code generation circuit 71.

  As shown in FIG. 3, the optical pickup 7 includes an optical pickup main part 51, an objective lens 52, and an objective lens actuator 53. The optical pickup main part 51 irradiates the analysis disk 1 with a laser beam emitted from a semiconductor laser such as a semiconductor laser, a collimating lens, a beam splitter and a photodetector (not shown) via the objective lens 52 and also through the objective lens 52. A known configuration for obtaining a reproduction signal based on the reflected light from the incident analysis disk 1 is provided.

  The light beam a emitted from the semiconductor laser of the main part 51 of the optical pickup is condensed on the analysis disk 1 by the objective lens 52 in the optical pickup. Focusing servo is performed so that the focused spot is focused on the reflective film 44 in the analysis region 2 b of the analysis substrate 2. As a result, the light beam a is guided to the tracking guide groove 43 to access a desired detection position on the migration path 5e and is scanned. In addition, since the reflecting film 44 and the bottom surface of the migration path 5e are substantially in the same plane, the focusing path 5e can be focused, and highly sensitive analysis and detection are possible.

  In the recording area 3a of the recording substrate 3, a recording medium 60 is formed instead of the reflection film 44, and the light beam a is focused on the recording medium 60, and high-density data recording is possible. In the recording substrate 3, a guide groove (not shown) similar to the guide groove 43 is formed. The technique of recording / reproducing while tracking the guide groove is within the scope of the conventional optical disk technique and is well known, so the description thereof is omitted.

  The reflected light from the analysis disk 1 is converted into an electrical signal by the photodetector of the optical pickup main part 51. This photo detector includes a well-known servo division detector and an information reading detector. The output signal b of the servo division detector is sent to the servo circuit 55, and the error signal h is fed back to the objective lens actuator 53 in order to perform focus servo and tracking servo. The output signal j of the detector for reading information is an electric signal obtained by converting the amount of light detected in the electrophoresis band when the light beam a scans the analysis region 2 b of the analysis substrate 2, and is sent to the light amount detection circuit 57. The analysis data d is sent to the memory 58 and stored. Further, when the light beam a scans the recording area 3a of the recording substrate 3, the output signal j is a signal obtained by reading analysis data and other registered information recorded in the recording area 3a, and a data recording / reproducing circuit. 54, the reproduction data and registration information e are sent to the controller (output means) 56. When recording analysis data or registration information, a recording signal c is sent from the data recording / reproducing circuit 54 to the main part 51 of the optical pickup, and a recording laser pulse (light beam a) is sent from the built-in semiconductor laser to the analysis disk 1. The recording area 3a of the recording substrate 3 is irradiated and recording is performed.

  The controller 56 performs various controls as follows. First, analysis data is output as will be described later while exchanging command signals and stored data k with the memory 58. Further, the controller 56 outputs a command signal f to the electrophoretic power supply circuit 59, whereby the electrophoretic power supply circuit 59 sends the power supply voltage i to the connector 9, and the power supply voltage is supplied to the liquid reservoir as shown in FIG. i is supplied to control the electrophoresis process. Further, the command signal e is sent to the data recording / reproducing circuit 54 to reproduce the analysis data and registration information stored in the recording substrate 3 and record the analysis data stored in the memory 58 onto the recording substrate 3. Further, it also serves as an output means for outputting the number of the unused analysis chip 5x according to the reproduced registration information. Further, the unused analysis chip 5x is validated according to the registration information, and also serves as a control means for starting the analysis. Further, a command signal g is sent to the servo circuit, and the light beam a is accessed to an appropriate track on the recording substrate 3.

  Further, at the time of analysis, the controller 56 accesses the light beam a to a desired detection position of the migration path 5e on the analysis substrate 2 to detect analysis data. At this time, it also serves as means for determining in advance whether the analysis substrate 2 remains connected to the analysis disk 1 or only the recording substrate 3 is disconnected based on the reflected light amount signal to the optical pickup 7. The description of this operation is omitted because it has been described above using detection of reflected light from the reflective film 44 in FIG.

  An analysis process for analyzing a sample using the analyzer 13 having the above configuration will be described. First, the buffer solution is injected into the liquid reservoirs 5a to 5d shown in FIG. 1 so that bubbles do not enter, and then the sample solution (solution in which the sample to be analyzed is dissolved) is injected into the liquid reservoir 5a. The injection of the buffer solution sample solution may be performed by an analyst (measuring person) or may be automated and performed under the control of the controller 56. Then, a + voltage power supply (several tens to several hundreds volts) is connected to the electrode 6a from the power cord 10 and the connector 9 shown in FIG. 7, and the electrode 6c is connected to the ground. At this time, the electrode 6b and the electrode 6d are kept open. As a result, a positive voltage (several tens to several hundred volts) is applied to the liquid reservoir 5a, zero volts is applied to the liquid reservoir 5c, and the injected sample (specimen, for example, DNA) passes through the migration path 5e (microcapillary). The inside migrates from the liquid reservoir 5a toward the liquid reservoir 5c.

  Next, when the sample (for example, DNA) contained in the sample solution reaches the crossing point of the cross in the migration path 5e, the electrode 6b is connected to a + voltage power source (several tens to several kilovolts), and the electrode 6d is connected to the ground. The electrodes 6a and 6c are opened. Therefore, the electrode for electrophoresis is switched from the electrode 6a and the electrode 6c to the electrode 6b and the electrode 6d. As a result, a positive voltage (several tens to several kilovolts) is applied to the liquid reservoir 5b, zero volts is applied to the liquid reservoir 5d, and the injected sample moves through the migration path 5e from the liquid reservoir 5b toward the liquid reservoir 5d. Run. Since the principle of electrophoretic measurement using such a microcapillary is well known, detailed description is omitted. Note that the application of voltage is performed under the control of the controller 56.

  When the electrophoresis is completed on the analysis substrate 2, the optical pickup 7 provided in the analysis device 13 in FIG. 3 moves to the analysis substrate 2 of the analysis disk 1, and the migrated band is detected by the light beam (laser beam) a. Do. The sample is usually bound with fluorescent molecules, emitted by a light source such as a laser beam, and separated and detected by a wavelength selection filter in the main part 51 of the optical pickup. The detected data is stored in the memory 58 as will be described later, and the analysis process ends.

  In the analyzer 13, when the analysis process is completed, the recording process is started. In this case, the optical pickup 7 moves to the recording substrate 3 and records the analysis data on the recording substrate 3 by the light beam a. At this time, registration information such as the analysis date and time, detailed information about the sample, and the number of the analysis chip 5x used is added and recorded together. For example, when periodic analysis (periodic inspection) is performed on the blood of a single analysis subject (subject), the results of periodic diagnosis for eight times are sequentially recorded on the recording substrate 3. When eight periodic inspections are completed, there is no unused analysis chip 5x. Therefore, the analysis substrate 2 is not required in the analysis disk 1, and only the recording substrate 3 needs to be stored.

  As shown in FIG. 2, the analysis substrate 2 that has become unnecessary is separated from the recording substrate 3 by cutting the connecting portion 4 a in the dividing region 4. Note that the drawing area 91 is omitted. This separation operation may be performed manually or using a dedicated separation device.

  The overall diameter of the analysis disk 1 (the diameter including the analysis board 2) is 12 cm, which is a size that complies with the standards of a compact disk or a digital video disk, and the diameter of the recording board 3 (after being separated from the analysis board 2). If the diameter is set to 8 cm, which is a small diameter size of the same standard, a small-sized storage disk (recording substrate 3) on which analysis data is recorded can be reproduced on a commercially available CD-ROM device or DVD-ROM device. The property is further improved. Further, since the storage disk (recording substrate 3) is small in size, it is suitable for carrying and storage.

  When the above analysis disk 1 is used, if the above diagnostic analysis spreads widely to general households as well as specialized inspection institutions, the patient who is the subject of the analysis and the caregiver himself / herself periodically analyze it at home. It is possible to bring only a small-diameter disk, which is the result of eight regular examinations, to the hospital and receive a diagnosis, and the physical and psychological burdens of the patient and caregiver who are the analysis target can be greatly reduced.

  In analyzing the sample and recording data, the analysis disk 1 is placed on a turntable and rotated. The turntable 11 will be described. FIG. 7 is a perspective view showing the main part of the turntable 11 with the analysis disk 1 mounted in the analyzer 13. The analysis disk 1 is placed on the turntable 11 and fixed to the turntable 11 by connectors 9, 9,. Although only three connectors 9 are shown for convenience, the number of connectors 9 is actually mounted in the same number as the analysis chips 5x. The connector 9 is connected to the electrodes 6a to 6d drawn out and wired to the outermost peripheral portion of the analysis disk 1, and the power supply voltage i is supplied through the power cords 10, 10,. The turntable 11 is rotated by the spindle motor 12 at a predetermined rotation speed.

  Next, the analysis and recording operations performed by the analyzer 13 will be described using the flowchart of FIG. The following operation is performed under the control of the controller 56.

  When analysis of the analysis disk 1 is started by the analyzer 13 (step 1, hereinafter referred to as S1), it is first detected whether or not the analysis disk 1 includes the analysis substrate 2 (S2). This can be determined based on whether or not the predetermined amount of reflected light when the light beam a is applied to the reflective film 44 on the recording substrate 3 can be detected as described above. That is, in the analysis disk 1, when the analysis substrate 2 is present, a high level of reflected light and a low level of reflected light are detected depending on the presence or absence of the reflective film 44, and the analysis substrate 2 is separated and does not exist. When only the recording substrate 3 is provided, the presence or absence of the analysis substrate 2 can be determined by detecting only the low-level reflected light amount.

  When it is detected that there is no analysis substrate in the analysis disk 1 and only the recording substrate 3, that is, that the analysis substrate 2 is separated (NO in S2), the operation ends (S19).

  When the analysis substrate 2 is present on the analysis disk 1 (YES in S2), the optical pickup 7 is moved to the recording substrate 3 (S3), and the registered information is read (S4). It is determined from the registered information whether there is an unused migration path 5e (analysis chip 5x) (S5). When it is determined that there is no unused migration path 5e (analysis chip 5x) (NO in S5), a used display indicating that all analysis chips 5x are used is displayed on a display unit (not shown). (S17). Then, an instruction to detach the analysis board 2 is displayed to the analyst (S18), and the process ends (S19). Thereby, although there is no unused migration path 5e, it is possible to prevent a situation in which erroneous analysis data is detected by a residual sample by erroneously injecting a sample into the used migration path 5e.

  If it is determined in S5 that there is an unused migration path 5e (analysis chip 5x) (YES in S5), the number of the unused migration path 5e (analysis chip 5x) is displayed on the display unit (FIG. (S6), and a sample injection instruction is displayed (S7). The injection instruction is given to the analyst. For example, when the injection is automated, it may not be displayed. When the inspector manually injects the sample according to the sample injection instruction, electrophoresis is performed on the sample (analysis sample) (S8). At this time, a desired power supply voltage i is supplied from the electrophoresis power supply circuit 59 to the analysis chip 5x via the connector 9, and electrophoresis is performed.

  When the electrophoresis is completed, the optical pickup 7 is moved to the analysis substrate 2 (S9), and the fluorescent migration pattern band is detected as analysis data. In this case, for example, DNA analysis data that can be analyzed by electrophoresis is detected (S10). The analysis data is temporarily stored in the memory (S11).

  Next, the optical pickup 7 is moved to the recording substrate 3 (S12), and the analysis data temporarily stored in the memory 58 and registration information such as the number of the used migration path 5e (analysis chip 5x) and the analysis date and time are stored. Recording is performed on the recording substrate 3 (S13). When the recording is completed, the display of the end of analysis is performed on the display unit (S14).

  Thereafter, it is determined whether or not the unused analysis chip 5x still remains (S15). If it does not remain (NO in S15), a display indicating that all the analysis chips 5x have been used is performed. (S17) After the unique code is recorded (S27), the recording substrate 3 is separated and displayed (S18). On the other hand, if unused analysis chips 5x remain (YES in S15), the remaining number of analysis chips 5x is displayed on the display unit (S16), and the process ends (S19). The unique code recording operation (S27) is as shown in FIG.

  As described above, if the number of the unused analysis chip 5x or the used analysis chip 5x is registered in the recording substrate 3 as registration information together with the analysis data, the registration information regenerated in advance at the next analysis. Based on the above, it is possible to validate the unused analysis chip 5x and perform the analysis process.

  For example, when the same analysis subject performs periodic inspection analysis using the analysis disk 1, based on the registered information, the analysis is performed on the unused analysis chip 5 x and the analysis data is recorded on the recording substrate 3. To do. In the next analysis, analysis is performed using the remaining unused analysis chip 5 x on the same analysis disk 1, and analysis data is recorded on an empty recording substrate 3 in the recording substrate 3. If this is sequentially repeated for each periodic inspection, after all the analysis chips 5x of the analysis disk 1 are used, the recording substrate 3 and the analysis substrate 2 are separated, and the analysis subject stores the results of the periodic inspection in the recording substrate 3. be able to. Furthermore, if the erasure and rewriting of the recording substrate 3 are prohibited, the result of the periodic inspection will not be erased or rewritten by mistake. This erasure or rewrite prohibition operation can be performed by software or hardware. In particular, if the recording substrate 3 is composed of a recordable medium such as a CD-R or a DVD-R, it is hardware-like. Since the prohibition function is added, the safety of the analysis data is further improved.

  FIG. 9A is a diagram for explaining the flow necessary for the periodic inspection by replacing S6 described with reference to FIG. 8 with another step (S6 ′). FIG. 9B is a diagram for explaining the flow necessary for the periodic inspection by replacing S14 described with reference to FIG. 8 with another step (S14 ′).

  In S6 ', in addition to the display operation (S6) of the unused analysis chip 5x in FIG. 8, the patient name, examination history, and past analysis data are displayed. In S14 ', in addition to the analysis end display operation (S14) in FIG. 8, the patient name, examination history, past analysis data, and the next scheduled examination date are displayed. It should be noted that the past analysis data includes the analysis data analyzed this time. Through the processes of S6 ′ and S14 ′, the same analysis disk 1 is used in periodic inspections, the remaining unused analysis chip 5x is analyzed, and the analysis data is an empty area in the recording area of the recording substrate 3. You can check the progress of the diagnosis every time. In addition, after all the analysis chips 5x are used, the recording substrate 3 and the analysis substrate 2 can be separated, and the results of the periodic inspection of only the person to be analyzed can be stored in the recording substrate 3. The stored small-diameter disk (recording substrate 3) can be safely stored by the person to be analyzed and the diagnostician.

  In the present embodiment, as shown in FIG. 1, an example in which there are eight analysis chips 5x on the analysis disk 1 is shown, but the periodic inspection is not necessarily completed within eight times. That is, it does not necessarily end with one analysis disk 1. If the diagnosis exceeds eight times, the analysis data and registration information for eight times are first copied to the recording substrate 3 in the second unused analysis disk 1 and then 9 The second analysis is performed and additional recording is performed on the recording substrate 3. At this time, in order to record that it is the ninth periodic inspection, it is necessary to record by adding 8 to the number of times. If such a number of times of recording is continued on the third and subsequent analysis disks 1 as well, periodic inspection is possible until the capacity of the recording substrate 3 is full.

  In the periodic inspection, it is preferable to analyze one specimen and record analysis data on one analysis disk 1. This is because if analysis data of a plurality of analysis subjects is recorded on one analysis disk 1, the analysis subject himself / herself cannot store the analysis data as personal data. In the future, assuming that the patient who is the subject of analysis moves to a system that stores and manages the chart, it is necessary to analyze one sample and record analysis data on one analysis disk 1.

  When the analysis is performed using the analysis disk 1, it is confirmed whether or not the user is the person including the personal authentication data (including the name) based on the registration information. As a result, sample analysis and analysis data of an analysis subject other than the subject person are not performed.

  As described above, in the present embodiment, the analysis disk 1 including the dividing area 4 has been described. However, additional update of registered information over a plurality of analysis disks 1... And only unused analysis chips 5x based on the registered information. Control of the analysis operation and the like is effective even if the dividing area 4 is not provided.

  Further, the hybrid substrate according to the present invention can be used not only in electrophoresis but also in other assays such as hybridization, incubation, and column chromatography.

  In this embodiment, the light beam a is applied to the migration path 5 (first migration path) as a cell. However, the light beam a may be irradiated not on the migration path 5 but on a cell having another shape. This example will be described with reference to FIG.

  FIG. 10 is a diagram showing the structure of an analysis disk (hybrid substrate) 100 in which minute cells 81 for assay (for example, cells for DNA hybridization) are formed. The analysis disk 100 shown in FIG. 10 has a disk shape, like the analysis disk 1, and includes an analysis substrate 20, a recording substrate 30, and a dividing area (dividing part) 4. In this analysis disk 100, a number of assay cells 81 are formed instead of the migration path 5 described above. The size of each cell 81 is, for example, 10 μm to 1 mm. The size and number of cells are not particularly limited. A guide groove 82 is provided between the cells 81. Here, the hybrid substrate 1a is also provided with address information (not shown).

  Thus, in addition to the cell 81, the analysis disk 100 is provided with the guide groove 82 and the address information. Therefore, the analysis disk 100 can also access the cell 81 at a desired address and irradiate the light beam a.

  In the above description, the disk-shaped analysis disk is taken as an example of the hybrid substrate. However, the hybrid board according to the present invention is not limited to the disk shape, and may be a card-shaped analysis card 101 as shown in FIG. The analysis card 101 includes an analysis board 102, a recording board 103, a cutting area (cutting part) 104, a drawing area 105, and an analysis cell 106. The dividing region 104 includes a connecting portion 104a and a cutout portion 104b.

  The analysis substrate 102 can analyze the sample. A large number of assay cells 106 are formed on the analysis substrate 102 instead of the migration path 5e described above. The size and number of each cell 106 are not limited. The recording substrate 103 can record data. The dividing area 104 connects the analysis substrate 102 and the recording substrate 103 in the same manner as the dividing area 4 and includes a connecting portion 104a and a notch portion 104b. The connecting portion 104 a connects the analysis substrate 102 and the recording substrate 103, and a plurality of the connection portions 104 a are formed between the analysis substrate 102 and the recording substrate 103. Of course, the number of connecting portions 104a is not limited. A notch 104b, that is, a space is formed between the connecting portion 104a and the adjacent connecting portion 104a. Therefore, the analysis card 101 is separated into the analysis substrate 102 and the recording substrate 103 by the cutout portion 104b, and is connected by the connection portion 104a. The drawing area 105 can record information (analysis card identification information) that can be collated with data recorded on the recording substrate 103.

  The present invention is not limited to the above-described embodiments, and various modifications can be made within the scope of the claims. That is, embodiments obtained by combining technical means appropriately changed within the scope of the claims are also included in the technical scope of the present invention.

  The hybrid substrate of the present invention may be expressed as the following analysis substrate. That is, the analysis substrate according to the present invention includes an analysis region in which a sample solution can be analyzed, a recording region in which information can be recorded, and a separation region for separating the two regions between the analysis region and the recording region. The area and the analysis area may include a unique code for each analysis board.

  In addition to the above configuration, the analysis substrate of the present invention may include a drawing area in which a recording medium capable of optical recording is formed in the analysis area, and a unique code for each analysis board may be recorded in the drawing area. .

  In addition to the above configuration, the analysis substrate of the present invention may be an additional recording medium that is not rewritable.

  In addition to the above configuration, the analysis board of the present invention may include a unique identifier that can be collated across the analysis area and the recording area.

  In addition to the above-described structure, the analysis substrate of the present invention has a disk shape, and the analysis region is disposed at an outer side position in the disk radial direction, and the inner side in the disk radial direction relative to the analysis region The recording area may be disposed at the side position, and a dividing area for separating the two areas may be formed between the analysis area and the recording area.

  Moreover, you may express the analyzer of this invention as follows. That is, the analysis apparatus according to the present invention may be configured to include any of the above-described analysis substrates and a recording unit that records the unique code in the recording area.

  In addition to the above configuration, the analysis apparatus of the present invention further includes a unique code output unit that generates a unique code, records the unique code in the recording area by the recording unit, and draws the unique code in the drawing area. It may be a configuration.

  The hybrid substrate and the analysis apparatus of the present invention are combined with the optical disc technology and the bioanalytical chip technology in order to perform high-accuracy diagnosis easily and inexpensively. It can greatly contribute to the spread of familiar digital medical analysis equipment in the treatment base or the home where the subject of analysis resides. Therefore, the present invention can be used, for example, in the medical device field, the analysis device field, the optical disk field, and the like.

It is a top view which shows the structure of the analysis disk in embodiment of this invention. In the analysis disk shown in FIG. 1, it is explanatory drawing that a used analysis board | substrate can be cut off and only a recording board | substrate can be stored. It is a block diagram which shows the structure of the analyzer which uses the analysis disk of FIG. It is a flowchart which shows the operation | movement which records the specific code | cord | chord of the analyzer shown in FIG. It is a figure which shows the intrinsic | native code ranging over the area | region for a division | segmentation in the analysis disc of FIG. It is a perspective view which shows the cross section of the migration path and liquid reservoir in the analysis board | substrate shown in FIG. It is a perspective view which shows the principal part of the turntable in the state which mounted | wore the analysis disk in the analyzer which uses the analysis disk shown in FIG. It is a flowchart explaining the analysis and the data recording operation in the analyzer shown in FIG. (a) is a figure which shows other operation | movement of S6 shown in FIG. 8, (b) is a figure which shows other operation | movement of S14 shown in FIG. It is a top view which shows another structure of the analysis disk in embodiment of this invention. It is a top view which shows the hybrid board | substrate of other embodiment of this invention. It is a top view which shows the structure of the conventional biocompact disk.

Explanation of symbols

1,100 Analysis disk (hybrid substrate)
2,102 Analysis board 2a Analysis area 3,103 Recording board 3a Recording area 4 Dividing area (dividing part)
4a Connecting part 4b Notch part 5a-5d Liquid reservoir 5e Electrophoretic path 5x Analysis chip 6a-6d Electrode 7 Optical pickup (recording means, reproducing means)
13 analyzer 44 reflective film 56 controller 71 unique code generation circuit (identification information output means)
91 Drawing area 92a, 92b Unique code 93 Area straddling analysis board and recording board 100 Hybrid board 101 Analysis card (hybrid board)

Claims (11)

An analysis board capable of analyzing a sample, a recording board capable of recording analysis data, which is data indicating a result of analyzing the sample on the analysis board, and a dividing unit for separating both the boards ,
A hybrid substrate, wherein at least one of the analysis substrate and the recording substrate includes association information that can be collated with the other substrate.   The hybrid board according to claim 1, wherein the association information is identification information unique to each hybrid board. An analysis board capable of analyzing a sample, a recording board capable of recording analysis data, which is data indicating a result of analyzing the sample on the analysis board, and a dividing unit for separating both the boards ,
The analysis board is provided with unique identification information for each hybrid board,
The hybrid substrate characterized in that the identification information can be recorded on the recording substrate.   The hybrid substrate according to claim 3, wherein the analysis substrate includes a drawing region on which a recording medium capable of optically recording the identification information is formed.   The hybrid substrate according to claim 4, wherein the recording medium is a non-rewritable additional recording medium.   4. The hybrid substrate according to claim 3, wherein the identification information is a unique identifier that is continuously described across the analysis substrate and the recording substrate. The hybrid substrate has a disk shape,
The analysis substrate is disposed at an outer position in the disk radial direction, the recording substrate is disposed at an inner position in the disk radial direction with respect to the analysis substrate, and the separation is performed between the analysis substrate and the recording substrate. The hybrid substrate according to any one of claims 1 to 6, wherein a portion is formed.   The analysis board which comprises the hybrid board of any one of Claims 1-7.   A recording substrate constituting the hybrid substrate according to claim 1. An analyzer using the hybrid substrate according to claim 3,
An analyzer comprising recording means for recording the identification information on the recording substrate. An analyzer using the hybrid substrate according to claim 4,
Identification information output means for generating unique identification information for each hybrid substrate to be used;
An analyzer comprising: recording means for recording the identification information on the recording substrate, and further drawing the identification information in the drawing area.

Images