Calibration system and calibration rack

Abstract

To provide a calibration system and a calibration rack for an analyzer capable of efficiently calibrating the analyzer.SOLUTION: An analyzer 10 carries a feces sampling container 28 held in a sample rack 26 into a device main body and analyzes a sample in the feces sampling container 28. The analyzer includes: a calibration rack that holds a standard concentration liquid and in which standard concentration information of the standard concentration liquid is mounted; a reading device (a second barcode reader 22) that is disposed on a rack conveying path in the device main body and reads the standard concentration information mounted on the calibration rack; and a control device 40 that records a conversion formula for calculating concentration of a component to be analyzed in the sample from a measured value of the sample on the basis of the standard concentration information read by the reading device and the measured value using the standard concentration liquid. The calibration rack includes an information holding portion (card slot) that replaceably holds an information medium (standard concentration card) indicating the standard concentration information.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to a calibration system and a calibration rack. [Background technology]

[0002] Conventionally, the Fecal Immunochemical Test (FIT) has been known. This test uses an antigen-antibody reaction to detect human hemoglobin (Hb) in feces, making it possible to detect bleeding from the lower digestive tract. This test is used, for example, in screening for colon cancer, and can detect minute amounts of blood in stool that has bled from colon cancer or polyps. An example of an analytical device used in the above test is disclosed in Patent Document 1. In a fecal occult blood test, a subject collects his or her own stool sample and places it in a stool collection container (specimen container), and the stool sample is dissolved in a stool dissolving liquid in the stool collection container. The solution containing the stool sample is then carried into an analytical device together with the stool collection container, and the components in the sample are measured in the analytical device using a dedicated measurement reagent. The stool collection containers are carried into the main body of the analytical device while being inserted and held in a sample rack in multiple places. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] International Publication No. 2014 / 200031 Summary of the Invention [Problem to be solved by the invention]

[0004] Incidentally, the above-mentioned analytical device needs to be calibrated periodically. In the calibration process, first, a standard concentration solution is held in a calibration rack and transported to the device body. A standard concentration is set in the standard concentration solution, and this set standard concentration is written on a standard concentration card as a barcode and / or numerical information. In general, the standard concentration information is input to the device body by reading the barcode written on this standard concentration card with a handheld barcode reader, or by an operator manually inputting the numerical information written on the standard concentration card. However, there is a need to make calibration of analytical instruments easier and more efficient.

[0005] An object of the present disclosure is to provide a calibration system for an analytical device and a calibration rack that can easily and efficiently calibrate an analytical device. [Means for solving the problem]

[0006] As a means for solving the above problems, a first aspect of the present disclosure is a calibration system for an analytical device that transports sample containers held on a sample rack into the device body and analyzes the samples in the sample containers, and is characterized in that it includes a calibration rack that holds standard concentration liquids and is equipped with standard concentration information for the standard concentration liquid, a reading device that is arranged on a rack transport path in the device body and reads the standard concentration information equipped on the calibration rack, and a control device that records a conversion formula for calculating the concentration of the analyte component in the sample from the actual measurement value of the sample based on the standard concentration information read by the reading device and the actual measurement value using the standard concentration liquid. According to this configuration, the calibration system of the analyzer loads standard concentration information onto a sample rack holding a standard concentration solution, and automatically reads the standard concentration information with a reading device disposed on the rack transport path of the main body of the analyzer. Then, based on the read standard concentration information and an actual measurement value using the standard concentration solution, a conversion formula is recorded in the memory unit, etc. This makes it possible to easily and efficiently record the conversion formula for calculating the concentration of the analyte component in the sample from the actual measurement value of the sample in the analyzer, i.e., to calibrate the analyzer.

[0007] A second aspect of the present disclosure is characterized in that, in the first aspect described above, the specimen container is equipped with specimen information that enables the specimen in the specimen container to be identified, and the reading device also serves as a specimen reading device that reads the specimen information. According to this configuration, by using a combined reading device for standard concentration information and a sample reading device for sample information, it is possible to read the standard concentration information using the existing sample reading device in the analytical device, thereby preventing an increase in the number of parts, thereby preventing cost increases and facilitating part maintenance work.

[0008] A third aspect of the present disclosure is a calibration rack for use in the calibration system of the first or second aspect, characterized in that it is provided with an information holding section that exchangeably holds an information medium on which standard concentration information is displayed. According to this configuration, the calibration rack is provided with an information holding section that holds the information medium in an exchangeable manner, making it possible to exchange the standard concentration information each time calibration is performed, and the calibration rack can be easily reused. Effect of the Invention

[0009] According to the calibration system and calibration rack of the present disclosure, the calibration of an analytical device can be performed efficiently. [Brief description of the drawings]

[0010] [Figure 1] FIG. 2 is a plan view of an analysis device according to an embodiment of the present disclosure. [Diagram 2] FIG. 2 is a front view (schematic diagram) of a calibration rack of the above-mentioned analysis device. [Diagram 3] FIG. 2 is a perspective view of a sample rack of the above-mentioned analyzer. [Figure 4] FIG. 2 is a front view of a rack body of the calibration rack. [Diagram 5] FIG. 2 is a top view of the rack body. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] Hereinafter, embodiments of the present disclosure will be described with reference to the drawings. [Analyzer 10] As shown in Fig. 1, the analysis device 10 includes a cell cassette transport unit 11, a cell supply / disposal unit 12, a reaction table 13, a reagent table 14, a reagent dispensing unit 15, a specimen transport unit 16, a sample dispensing unit 17, a photometry unit 18, and a disposal box 19. The analysis device 10 is placed on a horizontal surface. The lower side of the figure indicates the front of the analysis device 10, the upper side of the figure indicates the rear of the analysis device 10, the left side of the figure indicates the left side of the analysis device 10, and the right side of the figure indicates the right side of the analysis device 10. The front side of the paper in Fig. 1 indicates the top of the analysis device 10, and the back side of the paper indicates the bottom of the analysis device 10.

[0012] In the analysis device 10 , first, the reaction cell 11 a on the cell cassette transport unit 11 is set on the reaction table 13 by the cell supply / discard unit 12 . Next, the reagent on the reagent table 14 is added to the reaction cell 11a on the reaction table 13 by the reagent dispensing unit 15, and the sample is supplied to the same reaction cell 11a by the sample dispensing unit 17. This causes the reagent and the sample to react in the reaction cell 11a. The sample is extracted by the sample dispensing unit 17 from a stool collection container (specimen container) 28 housed in a specimen rack 26 described later.

[0013] In addition, the absorbance of the mixed solution in the reaction cell 11a is measured by the photometry unit 18. After the measurement, the reaction cell 11a is discarded into a waste box 19 by the cell supply / disposal unit 12. In the analysis device 10, the above-mentioned operations are repeatedly performed in parallel.

[0014] 1 and 3, a plurality of sample racks 26 are arranged in the sample transport unit 16. A plurality of stool collection containers 28 containing samples are held in each sample rack 26. The sample rack 26 moves in the directions of arrows A, B, and C in Fig. 1 in order. The position of the moving sample rack 26 is detected by a position detection sensor (not shown). The area in the sample transport unit 16 where the sample rack 26 is moved in the direction of arrow A (from the front to the rear) is called the input lane 16a, the area where the sample rack 26 is moved in the direction of arrow B (from the right to the left) is called the lateral movement lane 16b, and the area where the sample rack 26 is moved in the direction of arrow C (from the rear to the front) is called the output lane 16c.

[0015] In the carry-in lane 16a, a plurality of sample racks 26 are arranged in a line in the front-rear direction. The sample rack 26 has a generally rectangular parallelepiped appearance and is flattened such that one dimension (thickness) of the three directions is smaller than the other dimensions. The sample rack 26 is set in the input lane 16a in an upright position with its thickness oriented in the front-rear direction and its front and rear faces (only the front face is indicated by reference symbol 24b) aligned in the up-down direction. A plurality of sample racks 26 are set in the input lane 16a in the front-rear direction, and the sample racks 26 move to the lateral movement lane 16b in order from the rearmost position (most downstream position) of the input lane 16a.

[0016] A first sticker 31a bearing a first barcode 31 is affixed to the left side surface 24a (the side surface facing the downstream side of the lateral movement lane 16b) of each sample rack 26. When the sample rack 26 reaches a downstream position of the input lane 16a, the first barcode 31 on the left side surface 24a of the sample rack 26 is read by a first barcode reader 21 installed in the device body. Based on the identification information obtained from the first barcode 31, the control device 40 of the analysis device 10 identifies information on the sample rack 26 that has moved to the lateral movement lane 16b (attributes common to the multiple samples held by the sample rack 26) and determines the processing of the next step.

[0017] In the lateral movement lane 16b, the sample rack 26 is sent downstream one stool collection container 28 at a time. In the lateral movement lane 16b, the stool collection container 28 that has reached the sample suction position P1 undergoes a sample suction process by the sample dispensing unit 17. A second sticker 32a bearing a second barcode 32 is affixed to each stool collection container 28. The second barcode 32 is read by a second barcode reader 22 installed in the device body shortly after the sample rack 26 moves to the lateral movement lane 16b. The control device 40 of the analysis device 10 obtains identification information of the sample in each stool collection container 28 (for example, information identifying the person who provided the sample) based on the identification information obtained from the second barcode 32. When the sample suction process has been performed on all of the stool collection containers 28 held by the sample rack 26, the rack body 24 moves to the discharge lane 16c and becomes removable.

[0018] Each stool collection container 28 has a generally rectangular cross-sectional shape and is rod-like extending in one direction. The stool collection container 28 is inserted and held in the insertion section 27 of the sample rack 26 in an upright position with its longitudinal direction aligned in the up-down direction. The insertion section 27 in FIG. 3 has a plurality of rectangular openings into which the stool collection containers 28 can be individually inserted. The multiple openings are provided so as to be aligned in a row in the width direction of the sample rack 26. The insertion section 27 inserts and holds the stool collection container 28 with the long side of the cross-sectional shape of the stool collection container 28 aligned along the long side of the opening.

[0019] Fecal collection container 28 is inserted into insertion portion 27 until it hits the bottom, with its upper portion protruding above insertion portion 27. A second barcode 32 is affixed to the upper portion of stool collection container 28. Second barcode 32 is affixed so as to cover the short side portion of the cross-sectional shape of stool collection container 28. With the sample rack 26 set in the carry-in lane 16a, the stool collection container 28 is arranged so that the second barcode 32 is located on the short side facing forward in the cross-sectional shape of the stool collection container 28. By reading this second barcode 32 with the second barcode reader 22, the sample in each stool collection container 28 can be identified. Each of the barcodes 31 and 32 is, for example, a one-dimensional barcode, but may be another identification means such as a two-dimensional barcode or an IC tag.

[0020] The sample dispensing unit 17 is equipped with a rotating arm 34 having a specimen dispensing pipette 36 attached to its tip. The rotating arm 34 can be rotated horizontally about a rotation axis 34a by a drive mechanism (not shown) and can be raised and lowered in the up-down direction (vertical direction). By rotating the rotating arm 34, the specimen dispensing pipette 36 reciprocates in an arc shape in a plan view between the stool collection container 28 arranged at the specimen suction position (extraction position, probe piercing position) P1 in the specimen transport unit 16 and the reaction cell 13b arranged at the specimen dispensing position P2 on the reaction table 13.

[0021] A suction and discharge device (not shown) for suctioning and discharging the sample is connected to the specimen dispensing pipette 36. In this manner, the specimen dispensing pipette 36 is capable of dispensing the sample aspirated from the stool collection container 28 into the reaction cell 13b.

[0022] The reaction table 13 has a circular shape in a plan view, and a plurality of reaction cells 13b are arranged on the outer periphery of the reaction table 13. The reaction cells 13b are rectangular prism-shaped cells with an open top, and are made of heat-resistant glass or resin having optical transparency.

[0023] The reaction table 13 can be rotated about a rotation axis 13a by a driving mechanism (not shown). By rotating the reaction table 13, each reaction cell 13b moves in the circumferential direction of the reaction table 13.

[0024] The photometric unit 18 is provided with a light source (not shown) and a light receiving section (not shown) that detects light. The light source may be, for example, an LED light source or a halogen lamp, and the light receiving section may be a light receiving section corresponding to the light source. The light source irradiates light onto the reaction cell 13b of the reaction table 13. The light receiving section receives the light that has passed through the mixture of the reagent and the sample in the reaction cell 13b. Here, the concentration of the component in the specimen can be calculated by measuring the absorbance of the light that has passed through the mixture of the reagent and the sample at any one or multiple timings. For example, the concentration of the component in the specimen can be calculated by measuring the absorbance of the light that has passed through the mixture before the reaction of the reagent and the sample and the absorbance of the light that has passed through the mixture after the reaction of the reagent and the sample. The component in the specimen to be calculated may be, for example, human hemoglobin. In addition to measuring the absorbance by receiving the light that has passed through the mixture of the reagent and the sample with the light receiving section, the scattering intensity may be measured by receiving the light that has been scattered by the mixture of the reagent and the sample with the light receiving section. In addition, the absorbance and scattering intensity may be measured together using a plurality of light receiving parts.

[0025] [Calibration system] Next, a calibration system for the analysis device 10 will be described. As shown in FIGS. 1 and 2, the calibration system includes a calibration rack 23, a reading device (second barcode reader 22), and a control device 40.

[0026] The calibration rack 23 has standard concentration information 33 of the standard concentration liquid 29 mounted on a rack body 24' (see Figs. 4 and 5) that holds the standard concentration liquid 29. The reading device is, for example, the second barcode reader 22. The reading device is disposed on the rack transport path (sample transport unit 16) in the device body, and reads the standard concentration information 33 mounted on the calibration rack 23. That is, the standard concentration information 33 is written in a one-dimensional barcode similar to the second barcode 32. The control device 40 controls the overall operation of the analysis device 10. The control device 40 records the standard concentration information 33 in the memory unit 40a based on the information read by the reading device.

[0027] The calibration rack 23 holds the standard concentration liquid 29 in a container in any one of the multiple insertion parts 27. The standard concentration liquid 29 may be held in any one of the multiple insertion parts 27 in advance, for example, so that the standard concentration liquid 29 is always held in the same insertion part 27. Alternatively, for example, a standard concentration card 33a described later may include information indicating which insertion part 27 holds the standard concentration liquid 29, along with the concentration (standard concentration) of the standard concentration liquid 29. The standard concentration liquid 29 may be one or multiple liquids indicating different concentrations. A first sticker (not shown) with a first barcode (not shown) is attached to the left side surface 24a of the calibration rack 23. The first barcode in the calibration rack 23 includes identification information indicating that it is the calibration rack 23. The calibration rack 23 has a card slot 25 for inserting the standard concentration card 33a on the left side of the front surface 24b. The standard concentration card 33a indicates, by a barcode, information such as the concentration (standard concentration) of the standard concentration liquid 29 held in the insertion section 27. Here, when there are a plurality of standard concentration liquids 29, the barcode indicated on the standard concentration card 33a may be a single barcode including concentration information for the plurality of standard concentration liquids 29. The card slot 25 holds the standard concentration card 33a in a removable (replaceable) manner. After being used for one calibration, the calibration rack 23 can be repeatedly used for multiple calibrations by holding a new standard concentration liquid 29 and replacing the old card with the standard concentration card 33a containing the new standard concentration liquid 29 and holding it in the card slot 25.

[0028] 2 to 5, for example, the rack body 24' of the calibration rack 23 may have the same configuration as the rack body 24 of the sample rack 26, except for the rack type identification information included in the first barcode. In this case, the sample rack 26 may also be provided with a card slot 25. The opening of the insertion portion 27 shown in Fig. 5 has, for example, a circular shape. The barcode (standard concentration information 33) written on the standard concentration card 33a is read by the second barcode reader 22. That is, the second barcode reader 22 also serves as a specimen reading device that reads the second barcode 32 (specimen information) of each stool collection container 28. The first barcode on the calibration rack and the barcode (standard concentration information 33) printed on the standard concentration card 33a are, for example, one-dimensional barcodes, but may be other identification means such as two-dimensional barcodes or IC tags.

[0029] The control device 40 is a computer device equipped with a processor such as a CPU (Central Processing Unit), a memory, and a storage (storage unit 40a) such as an HDD (Hard Disk Drive) or an SSD (Solid State Drive). The control device 40 controls the steps of each part of the analysis device 10 by executing processing based on a preset program.

[0030] When the calibration rack 23 is set in the carry-in lane 16a of the sample transport unit 16, the first barcode reader 21 reads the first barcode on the side of the calibration rack 23. This allows the control device 40 to recognize that the calibration rack 23 has been carried into the analysis device 10, and a calibration process including calibration is set.

[0031] In the calibration process, first, the barcode (standard concentration information 33) of the standard concentration card 33a is read by the second barcode reader 22. Next, the control device 40 records the concentration of the standard concentration solution (standard concentration information 33) based on the information read by the second barcode reader 22. Next, an analysis is performed using the standard concentration solution 29 to obtain an analysis actual value such as absorbance. Next, the control device 40 compares the analysis actual value of the standard concentration solution 29 such as absorbance with the concentration of the standard concentration solution recorded in the memory unit 40a, calculates a conversion formula for calculating the concentration of the measurement target component from the analysis actual value such as absorbance, and records it in the memory unit 40a. Here, the conversion formula for calculating the concentration of the measurement target component from the analysis actual value such as absorbance is a formula that shows the relationship between the analysis actual value such as absorbance and the concentration of the measurement target component. Then, the concentration of the measurement target component in each sample is calculated from the recorded conversion formula and the analysis actual value such as absorbance in each sample. In addition, in order to calculate the conversion formula for calculating the concentration of the component to be measured based on the analytical measured value of the standard concentration solution 29 such as absorbance and the concentration of the standard concentration solution recorded in the memory unit 40a, in addition to the analytical measured value of the standard concentration solution 29 such as absorbance and the concentration of the standard concentration solution recorded in the memory unit 40a, correction information previously set for each analysis device, correction information previously set for each type of measurement reagent, correction information previously set for each manufacturing lot of the measurement reagent, etc. may be used. The correction information may be, for example, a formula showing the relationship between the analytical measured value such as absorbance and the concentration of the component to be measured, which is previously set for each analysis device; a formula showing the relationship between the analytical measured value such as absorbance and the concentration of the component to be measured, which is previously set for each type of measurement reagent; or a formula showing the relationship between the analytical measured value such as absorbance and the concentration of the component to be measured, which is previously set for each manufacturing lot of the measurement reagent.

[0032] It is also preferable to perform calibration at regular intervals. By performing calibration at regular intervals, even if the actual analytical values ​​such as absorbance vary due to deterioration of the reagent, a new conversion formula is recorded in the memory unit 40a every time calibration is performed, and the concentrations of the components to be analyzed in various samples can be calculated more accurately.

[0033] As described above, the calibration system in the above embodiment is applied to an analysis device 10 which transports a stool collection container 28 held in a sample rack 26 into the device body and analyzes the sample in the stool collection container 28, and is equipped with a calibration rack 23 which holds a standard concentration liquid 29 and is equipped with standard concentration information 33 for the standard concentration liquid 29, a reading device (second barcode reader 22) which is arranged on the rack transport path in the device body and reads the standard concentration information 33 equipped on the calibration rack 23, and a control device 40 which records a conversion formula for calculating the concentration of the target component in the sample from the actual measurement value of the sample, based on the standard concentration information 33 read by the reading device and the actual measurement value using the standard concentration liquid 29. According to this configuration, the calibration system of the analyzer 10 loads standard concentration information 33 on the sample rack 26 holding the standard concentration solution 29, and automatically reads the standard concentration information 33 with a reading device arranged on the rack transport path of the device body. Then, based on the read standard concentration information 33 and the actual measurement value using the standard concentration solution 29, a conversion formula is recorded in the memory unit 40a. This makes it possible to easily and efficiently record the conversion formula for calculating the concentration of the analyte component in the sample from the actual measurement value in the analyzer 10, i.e., to easily and efficiently calibrate the analyzer 10.

[0034] In the above calibration system, the stool collection container 28 is equipped with specimen information (second barcode 32) that enables the specimen in the stool collection container 28 to be identified, and the reader also serves as a specimen reader that reads the specimen information. According to this configuration, by using a combined reading device for the standard concentration information 33 and a sample reading device for the sample information, it is possible to read the standard concentration information 33 using the existing sample reading device in the analysis device 10, thereby preventing an increase in the number of parts, thereby preventing costs from increasing, and facilitating part maintenance work.

[0035] The calibration rack 23 in the above embodiment is a calibration rack 23 used in the calibration system of the analytical device 10, and is equipped with an information holding section (card slot 25) that exchangeably holds an information medium (standard concentration card 33a) showing standard concentration information 33. According to this configuration, the calibration rack 23 is equipped with an information holding section that holds the information medium in an exchangeable manner, making it possible to replace the standard concentration information 33 each time calibration is performed, and the calibration rack 23 can be easily reused.

[0036] The present invention is not limited to the above-mentioned embodiment. For example, the stool collection container in the embodiment is arranged upright along the vertical direction, but may be arranged at an angle to the vertical direction. In this case, the first barcode reader and the second barcode reader also have a similar angle. The information storage unit of the calibration rack is not limited to a card slot, and may be, for example, a sticker attachment unit for attaching an information medium such as a sticker. In the embodiment, the present invention is applied to an analyzer that uses a stool collection container that contains a stool sample, but may also be applied to an analyzer that uses a sample container that contains a sample other than a stool sample, such as serum or plasma. The configurations in the above-described embodiments are merely examples of the present invention, and various modifications are possible without departing from the gist of the present invention, such as replacing the components of the embodiments with well-known components. [Explanation of symbols]

[0037] 10 Analyzer 22 Second barcode reader (reading device) 23 Calibration Rack 25 Card slot (information storage unit) 26 Sample Rack 27 Insertion part 28 Stool collection container (specimen container) 29 Standard concentration solution 31 First barcode (specimen information) 33 Standard concentration information 33a Standard concentration card (information medium) 40 Control device 40a Memory section

Claims

1. 1. A calibration system for an analyzer that carries a sample container held in a sample rack into an analyzer body and analyzes a sample in the sample container, comprising: a calibration rack for holding standard concentration solutions and storing standard concentration information of the standard concentration solutions; a reading device disposed on a rack transport path in the apparatus body and configured to read the standard concentration information mounted on the calibration rack; and a control device that records a conversion formula for calculating the concentration of the target component in the sample from the actual measurement value of the sample based on the standard concentration information read by the reading device and the actual measurement value using the standard concentration solution.

2. The specimen container is provided with specimen information that enables identification of the specimen in the specimen container; 2. The calibration system according to claim 1, wherein the reading device also serves as a sample reading device that reads the sample information.

3. A calibration rack for use in the calibration system according to claim 1 or 2, A calibration rack comprising an information holding section for holding, in an exchangeable manner, an information medium on which the standard density information is displayed.

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