JP2000275255A - Automatic measuring device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To eliminate maloperation such as placing a specimen vessel or a reaction vessel on the erroneous position by providing a preparing means preparing a work list constituted of identification information of the specimen and specific component information to be measured. SOLUTION: Specimen identification information 4 is displayed, for example, on the outer surface such as the side of a specimen vessel. A memory means (register means) 2 stores inspection request information 1 including the specimen identification information 4 and specific component information to be measured for the each specimen. A work list preparing means 6 prepares a work list constituted of specimen identification information 4 and specific component information to be measured as to the specimen, based on the specimen identification information 4 readout by a first identification means 5. A second identification means 8 automatically read out specific component information displayed in a reaction vessel during carrying by a carrying meanes 10. A collation means compares the specific component information readout by the second identification means 8 with indicated order, in the case of conforming both to each other and/or in the case of not conforming, the fact is displayed.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an apparatus for automatically measuring trace components contained in a sample such as blood, serum, plasma, urine and the like. The present invention relates to an automatic measuring device for measuring chemically or immunologically.

[0002]

2. Description of the Related Art In the field of clinical diagnosis, diseases of a subject are measured based on the results of measurement on the presence and concentration of specific components contained in samples such as blood, serum, plasma, and urine collected from the subject. Diagnosis and determination of a subject's recovery from a disease are performed.

[0003] In the above-described measurement, a plurality of types of samples are used for each sample for the purpose of effectively utilizing a sample collected from a subject or performing a more reliable diagnosis based on the presence of a plurality of types of specific components. It is common to measure specific components.

[0004] When the types of specific components to be measured per specimen increase, it becomes necessary to repeatedly perform a large number of measurement operations. Therefore, conventionally, such repeated measurement operations have been performed quickly and simply using an automatic measurement device. Is common. For example, to measure various specific components for each sample,
Prepare a reaction container in which reagents corresponding to the measurement of specific components have been enclosed in advance, and add a predetermined amount of sample to it, and use an automatic measurement device that keeps the reaction container at a constant temperature or cleans it as necessary. Have been.

[0005] Further, for example, a mounting device (for example, Japanese Patent Publication No. 3-58668) for automatically selecting a reaction container in which a reagent corresponding to the measurement of a specific component has been sealed and mounting it on a tray or the like on a transport line. ) Or the operator performs the operation of placing the sample container and the reaction container on the transport line, and automatically performs the subsequent operations from transporting the sample container and the reaction container to outputting the measurement results. (See, for example, JP-A-3-51762).

[0006] An automatic measuring device provided with a single transport means,
It is widely used because of its small size, light weight, low cost, and easy maintenance because it has few moving parts. For example, after the operator arranges the sample container and the reaction container on a conveyor such as a conveyor, such an apparatus can automatically perform everything from the transport of the sample and the reaction container to the output of the measurement result. (For a conveyor-type automatic immunoassay apparatus, see, for example, JP-A-3-1762).

[0007]

As described above, an automatic measuring apparatus provided with a single conveying means such as a conveyor has advantages such as a reduction in size and weight and a reduction in cost. On the other hand, there is a possibility that the operator places the sample container or the reaction container in an incorrect position, or erroneously places a reaction container other than the reaction container for the specific component to be measured.

[0008] As described above, if the sample container or the reaction container is erroneously placed on the transporting means, the scheduled measurement cannot be performed without any problem during the subsequent automatic measurement operation. Since a reaction container prepared for one specific component is used for measuring a different specific component, an erroneous measurement result may be obtained.

Therefore, an object of the present invention is to provide a method for mounting a sample container and a reaction container in an incorrect position as described above even when the operator mounts the sample container and the reaction container on the transport means. Another object of the present invention is to provide an automatic measuring apparatus having a function of detecting such an erroneous operation and detecting such an erroneous operation even when it occurs.

[0010]

Means for Solving the Problems According to the present invention, which has been made to solve the above problems, there is provided a sample container for containing a sample and displaying sample identification information for identifying the contained sample.
And contains a reagent for measuring a specific component in the sample,
An automatic measuring device for measuring a specific component in a sample while transporting a reaction vessel on which specific component information indicating a specific component is displayed by a single transport unit in a state where both are mixed, and has the following features. It is a device having.

(1) storage means for storing test request information including the sample identification information and specific component information indicating one or more specific components to be measured for each sample;
(2) first identification means for reading the sample identification information displayed on the sample container; and (3) 1 to be measured for the sample based on the sample identification information read by the first identification means.
The specific component information representing the specific component is extracted from the test request information stored in the storage unit, and the specific component information is extracted from the sample identification information of the sample and the specific component information indicating one or more specific components to be measured for the sample. A work list creating means for creating a work list, (4) a placement order designating means for designating the order of sample containers and reaction vessels to be placed on the single transport means based on the work list; (5) A second identification means for automatically reading the specific component information displayed on the reaction vessel during the transportation by the transportation means; and (6) comparing the specific component information read by the second identification means with the specified order, and Collating means for displaying the fact that the IDs match and / or when they do not match.

The present invention relates to an apparatus for measuring a specific component or a series of specific components using different reagents, wherein the automatic measurement is carried out using a reaction container containing all or a part of the reagents in advance. Applicable to the device. As such an automatic measurement device, for example, an automatic immunoassay device for measuring a specific component in a sample using an immune reaction, for example, an automatic immunoassay device for measuring a specific component in a sample using a biochemical reaction Although a chemical measurement device or the like can be exemplified, a case where the present invention is configured as an automatic immunoassay device will be described in detail below with reference to the drawings.

[0013]

DESCRIPTION OF THE PREFERRED EMBODIMENTS FIG. 1 shows an outline of an embodiment of the automatic measuring apparatus according to the present invention, wherein 1 is test request information, 2 is storage means, 3 is a sample container, 4 is sample identification information,
5 is a first identification means, 6 is a work list creation means, 7 is a display device, 8 is a second identification means, 9 is a third identification means, 10 is a single transport means, 11 is a reaction / detection apparatus, and 12 is a reaction / detection apparatus. The collation means 13 is a measurement result output device. FIG. 2 shows an outline of the reaction vessel.

The sample container 3 is a container for storing samples such as blood, serum, plasma, urine, and the like. In order to identify each sample using the first identification means, the sample identification information is stored on an external surface such as a side surface. Will be displayed. The specimen identification information only needs to be capable of identifying each specimen, and for example, non-overlapping alphabets, numerals, or a combination thereof, or a pattern meaningless per se can be used. In the invention of the present application, a bar code or a pattern obtained by coding an alphabet or a number and the like are printed on a seal, and then a blood collection tube or a sample container having a magnetic recording medium on the surface is preferably used. Can be exemplified. In the present invention, it is preferable that the sample identification information be visually identified along with the code or the like so that the operator can visually identify the sample identification information in order to provide a guide when the operator places the sample container on the transporting means.

As shown in FIG. 2, a reagent corresponding to a specific component is stored in the reaction container in advance. In an automatic biochemical measurement device, a chemical reagent or the like that generates a color by generating a biochemical reaction with a specific component can be exemplified as the reagent. In an automatic immunoassay device, an antibody that generates an immune reaction with the specific component as the reagent (Antigen) and enzymes.

The reaction vessel illustrated in FIG. 2 contains ferritin (FER) which is a protein present in a sample such as blood or serum.
Is contained in a heterogeneous one-step sandwich EIA. Specifically, FE
Water-insoluble magnetic beads on which an antibody that specifically binds to R are immobilized, and an enzyme-labeled antibody that specifically binds to FER are contained in a lyophilized state. In addition, such a configuration of the reaction vessel can be applied to EIA by a competitive measurement method and measurement using a fluorescent substance or a chemiluminescent substance instead of an enzyme as a labeling substance, in addition to the sandwich EIA.

The reagent contained in the reaction vessel may be in a liquid state or in a lyophilized state as in the example of FIG. Also, the reaction vessel contains only the reagent corresponding to the specific substance to be measured using the reaction vessel,
For example, the reagent commonly used in the measurement of all the specific substances may be separately added during the transport of the container by the transport means.

The reaction container accommodates the reagent and provides a reaction space between the sample and the reagent. Specific component information is displayed on a side surface or a sealing foil covering the upper opening as shown in FIG. 2, for example. Is done. The specific component information only needs to be able to identify the specific component corresponding to the reagent contained in the reaction container. For example, alphabets, numerals, a combination thereof, or a pattern meaningless per se can be used. In the present invention, a preferred example is a plastic container in which a bar code or a pattern obtained by encoding an alphabet or a number or the like is printed on a sticker and affixed to a side surface, or a container having a magnetic recording medium on the surface. Can be exemplified. In the reaction vessel shown in FIG.
Since the reagent corresponding to the ER measurement is stored, the letters “FER” and the production lot number are displayed together with the dot code meaning “FER” on the sealing foil covering the upper opening, and visually observed by the operator. It is configured to allow confirmation and the like.

The specific component information displayed in the reaction container includes, in addition to the function indicating which specific component the reaction container is compatible with, the amount of the sample to be measured and the diluent to be added to the sample. Specify the measurement parameters required to measure the specific component, such as the amount of reagent, the content and amount of reagents to be added in addition to the reagents contained in the reaction vessel, and the type of calibration curve to be used in the final step. It also plays a role.

The above-mentioned sample container and reaction container are mounted on a single transfer means 10 and transferred. The conveying means can be constituted by, for example, an endless track such as a belt conveyor or a snake chain, a driving device such as a sprocket, and a support for supporting the endless track.

The transport means 10 transports the sample container and the reaction container in a mixed state. For this reason, the automatic measuring device of the present invention can be downsized when compared with a device in which different transport means are arranged for each type of container.
In the example of FIG. 1, the sample container A
Upstream of the reaction container B containing a reagent corresponding to the specific component to be measured for the sample contained in the sample container A
Followed by reaction containers D and E containing reagents corresponding to the specific components to be measured for the sample container C and the sample contained in the sample container C. Thus, the sample container is 2
They are not placed one after another, but are always placed with the reaction vessel in between.

The automatic measuring apparatus according to the present invention is used to generate a reaction for measuring a specific component such as a biochemical reaction or an immune reaction, or to measure a signal related to the specific component, which is generated as a result of the reaction. Are provided. Various devices may be appropriately arranged according to the measurement employed in the automatic measurement device of the present invention, for example, in an automatic immunoassay device employing a heterogeneous immunoassay using the enzyme shown as an embodiment as a label, An incubator device for keeping the reaction vessel at a constant temperature, a pipette device for aspirating a fixed amount of sample from the sample container and discharging it into the reaction container, and a container that moves water-insoluble magnetic beads previously contained in the reaction container. A magnet vibrating device for agitating the inside, a washing device (so-called B / B) for separating labeled antibodies and the like that did not bind to the insoluble magnetic beads after the immune reaction.
F separation device), a dispensing device for adding the substrate of the labeling enzyme to the reaction vessel, fluorescence for measuring the activity of the labeling enzyme,
It is a detection device for light absorption, light emission, and the like, and a control device for controlling the driving of the transport means, the driving of the pipette device, the discharge amount, and the like. Further, as shown in FIG. 2, when a reaction vessel whose upper opening is covered with a sealing foil is used, a sealing foil breaker device for breaking the sealing foil or the like is also provided.

The storage means 2 is for storing test request information including the sample identification information and specific component information indicating one or more specific components to be measured for each sample. For example, in the example shown in the figure, the test request information 1 is the sample identification information which is a combination of alphabets and numbers given to eight samples (S.ID01,..., S.ID08), and is measured for each sample. Specific component information which is an alphabet (FER, AFP, etc.) meaning a specific component to be included. The test request information may include personal information (name, date of birth, gender, etc.) of the subject and the name of a medical institution other than at least sample identification information and specific component information.

The storage means 2 includes an input device as an interface for inputting specimen identification information and specific component information.
When the storage unit is configured using a computer, the computer can be used as an input device using a keyboard, a touch panel, or the like. When the storage means is configured using a computer, for example, the computer can be installed separately from the main body of the automatic measurement device of the present invention. As such an external computer, for example, a host computer that collectively manages examination information of medical institutions can be used.

The first identification means 5 reads the specimen identification information displayed on the specimen container and outputs the result to the work list creation means. The first identification means is not particularly limited as long as it can read the sample identification information. For example, when the sample identification information is displayed in a barcode, the barcode reader is used. When the sample identification information is displayed in characters or symbols, the first identification means is used. Can be exemplified by using an optical reading device such as a small scanner or a video camera, and using a magnetic reading device when the specimen identification information is displayed on a magnetic recording medium. The first
The identification means may be of a handy type connected to the automatic measurement device of the present invention, or may be used to identify a holder for holding a sample container provided at a specific location on the measurement device and a sample container held by the holder. It may be constituted by means for performing

The work list creating means 6 having received the sample identification information read by the first identifying means 5
Extracting specific component information representing one or more specific components to be measured for the sample from the test request information stored in the sample, and identifying the sample identification information of the sample and one or more specific components to be measured for the sample. Create a worklist consisting of specific component information to be represented. The work list creation means 6 may include a display or output device for displaying and outputting the created work list.

Based on the work list created in this way, the placing order designation means designates the order of the sample containers and the reaction containers to be placed on the transport means for the operator.
The designation by the placement order designation means is achieved by, for example, displaying the placement order on a display device, outputting the placement order from an output device, or the like. The placement order designation means is
It is also possible to omit it by using the work list creation means 6 together. In FIG. 1, the work list creating means also functions as the placing order specifying means, and displays the placing order of the sample containers and the reaction containers on the display device 7 simultaneously with the creation of the work list.

The placement order designation means may simply designate the order of the sample containers and the reaction containers to be placed on the transport means in accordance with the order of the sample identification information read by the first identification means. From the information and the specific component information extracted from the storage means based on these, after calculating the sample order that can perform the most efficient measurement, the order of the sample containers and the reaction containers to be placed on the transport means is specified. It is preferable to configure. For example, a reaction vessel for a specific component for which dilution of a sample is required in a container group comprising a sample container and a reaction container corresponding to a specific component to be measured for the sample, which constitutes a mounting order designating means by a computer For example, it is possible to specify a program that specifies the order of the container groups that do not include the measurement of the specific component that requires dilution of the sample between different container groups.

The order of the reaction vessels, that is, the order of the specific components to be measured, among the order of the containers designated by the placing order designation means is output to the above-mentioned control device. It is particularly preferable to configure it to control. With such a configuration, the operator simply mounts the sample container and the reaction container on the transporting unit in accordance with the instruction of the mounting order specifying unit, and the apparatus automatically performs the measurement and outputs the result thereafter. Can be. Needless to say, instead of the output from the placing order specifying means, a device for identifying the specific component information displayed on the reaction vessel is separately provided, or the output from the third identifying means described later is utilized by using the output from the third identifying means. The control device may be configured to drive the pipette device or the like based on the output.

When the containers are placed on the transporting means in the order designated by the placing order designating means and the measurement is started, the placed containers are transported by the transporting means to the respective devices constituting the automatic measuring apparatus as described above. It is. In the automatic measuring device of the present invention,
The second identification means 8 is provided in the vicinity of the transport path by the transport means, and automatically reads at least the specific component information displayed on the reaction container during the transport by the transport means, and outputs the information to the collation means 12. The collating means 12 compares the specific component information sequentially read by the second identifying means 8 with the placing order of the reaction vessels designated by the placing order designating means, and when both match and / or when they do not match. If so, preferably in both cases, this is indicated or output by a display or output device.

The second identification means is not particularly limited as long as it can read the specific component information. For example, when the specific component information is displayed in a bar code, a bar code reader is used.
When the specific component information is displayed by characters or symbols, an optical reading device such as a scanner or a video camera may be used, and when the specific component information is displayed on a magnetic recording medium, a magnetic reading device may be used. Since the second identification means reads the specific component information displayed on the reaction container conveyed by the conveyance means, the specific component information is displayed on the reaction container at a position where the second identification means can read the information. And As such a position, FIG.
As shown in the above, an example is on a sealing foil covering the upper opening of the reaction vessel. When a reaction vessel whose upper opening is covered with a sealing foil is used, it is necessary to rupture the sealing foil prior to the measurement. Therefore, the second identification means is disposed in front of the sealing foil breaking device.

In the present invention, in addition to the second identification means, the third identification means 9 is provided near the transport path by the transport means,
It is preferable that the sample identification information displayed on the sample container is automatically read sequentially during transportation by the transportation means. By outputting the sequentially read sample identification information to the collating means 12, it is compared with the placing order of the sample container and the reaction container designated by the placing order designating means, and when they match and / or both match. If not, preferably in both cases this may be indicated or output by a display or output device.

When the order of the reaction vessels designated by the placing order designation means does not match the output from the second identification means, the collation means 12 displays or outputs the fact by a display device or an output device. For example, it may be configured to instruct the control device of the automatic measuring device to stop the measuring operation.

For example, by including information for distinguishing between the specimen identification information and / or the specific component information, one identification means can be used as both the second identification means and the third identification means. In this case, it is necessary to consider the display position on the sample container or the reaction container so that both the sample identification information and the specific component information are located at substantially the same position. Here, since the sample container and the reaction container usually have different sizes and shapes, it is often difficult to read both the sample identification information and the specific component information by one identification means. In such a case, it is preferable to dispose the third identification means in addition to the second identification means. However, in order to avoid confusion between the reading results obtained by the two, for example, the specimen identification information is displayed on the side of the specimen container. It is preferable that the specific component information be displayed in an upper opening of the reaction vessel so that the identification by the identification means is performed from different directions.

The automatic measuring apparatus of the present invention employing the above-described configuration can detect an erroneous human operation which may occur when the sample container and / or the reaction container are placed on the transport means. In particular, the place where the container is placed
It is preferable that the container cannot be placed or taken out downstream of the reading position by the identification means or the third identification means.

Next, the automatic measuring device illustrated in FIG. 1 will be described from the viewpoint of a person who operates the measuring device. For example, the operator has stored a sample to be measured. A sample container 3 on which a barcode indicating sample identification information with ID01 is attached.
Is provided to the first identification means 5 composed of a barcode reader. The first identification unit 5 reads the sample identification information and outputs the information to the work list creation unit 6.

The work list creation means 6 is provided with ID01
From the test request information registered in the storage unit 2 based on the sample identification information S. Specific component information (FER) indicating a specific component to be measured for ID01 is extracted, and a work list including sample identification information (S.ID01) and specific component information (FER) is created. If the storage device is an external computer system, the automatic measurement device and the external computer system are communicated with each other by external communication means, and inquiry and acquisition of specific component information with respect to sample identification information are performed to create a work list.

In this example, the work list creating means also functions as the placing order instructing means, and the operator designates the order of the containers placed on the transport means 10 from the display device 7 to the operator. In this case, the sample identification information S. The sample container of ID01 is placed, and then the specific component information instructs to place the reaction container of FER. The operator follows the instruction and places S.D. The sample container of ID01 is placed, and then a reaction container for FER measurement is placed at a position B behind the sample container.

A sample to be subsequently measured, for example, S. Sample container 3 on which a barcode indicating sample identification information with ID05 is attached.
Is supplied to the first identification means 5 in the same manner as described above to read the specimen identification information. As shown in the example of the display device 7 in FIG. In the specific component information FER corresponding to ID01, sample identification information S.D. Specific component information TSH and FT4 corresponding to ID05 are added. The operator places S.D. at the position of C of the transport means 10 according to the display on the display device 7. The sample container of ID05 is placed, and then T
The reaction container for SH measurement is placed at the position of the reaction container for SH measurement, E.

[0040]

According to the automatic measuring device of the present invention, (1)-
By adopting each means of (6), even when the operator places the sample container and the reaction container in the wrong order on the transport means of the apparatus, the operation is performed using the reaction container which is not compatible. It is possible to eliminate the possibility that a measurement result of a specific component is issued and an erroneous diagnosis is performed based on the measurement result.

With the provision of the storage means, the automatic measuring apparatus of the present invention can also check the reading error of the sample identification information read by the first identification means. By providing the first identification means, the automatic measurement device of the present invention does not require the operator himself to visually check the sample identification information displayed on the sample container and input the information from an input device such as a keyboard, thereby making a visual error. And input mistakes can be eliminated, and the burden on the operator can be reduced. With the provision of the work list creation unit and the placement order designation unit, the automatic measurement apparatus of the present invention may cause the operator to place the sample container and the reaction container in the wrong order when placing the sample container and the reaction container on the transport unit. Can be reduced.

In the automatic measuring apparatus according to the present invention, since the second identifying means and preferably the third identifying means are provided, the operator places the sample container or the reaction container on the transport means in an incorrect order. In such a case, it is also possible to promptly display the error and stop the measurement.

[Brief description of the drawings]

FIG. 1 is a diagram schematically showing a case where the present invention is applied to an automatic immunoassay apparatus of the present invention.

FIG. 2 is a diagram schematically showing a reaction vessel.

[Explanation of symbols]

1; test request information, 2; storage means, 3; sample container, 4;
Sample identification information, 5; first identification means, 6; work list creation means, 7; display device, 8; second identification means, 9; third identification means, 10; transport means, 11; ;
Collation means, 13; measurement result output unit

Claims (2)

[Claims] 1. A sample container for accommodating a sample and displaying sample identification information for identifying the accommodated sample, and a reagent for accommodating a reagent for measuring a specific component in the sample and representing a specific component. An automatic measuring device for measuring a specific component in a sample while transporting a reaction vessel on which component information is displayed by a single transport unit in a state where both are mixed, and having the following characteristics; (1) A) storage means for storing test request information including the sample identification information and specific component information indicating one or more specific components to be measured for each sample; (2) the sample identification displayed on a sample container First identification means for reading information;
(3) extracting, from the test request information stored in the storage unit, specific component information representing one or more specific components to be measured for the sample based on the sample identification information read by the first identification unit; A work list creating unit for creating a work list including sample identification information of a sample and specific component information indicating one or more specific components to be measured for the sample; (4) the single transport unit based on the work list (5) second identification means for automatically reading specific component information displayed on the reaction container during transportation by the transportation means, And (6) matching means for comparing the specified component information read by the second identification means with the specified order, and displaying when both match and / or when they do not match. 2. The apparatus according to claim 1, wherein said second identification means automatically reads the sample identification information displayed on the sample container during the transportation by said transportation means, or displays the information on the sample container during transportation by said transportation means. The automatic measurement apparatus according to claim 1, further comprising a third identification unit that automatically reads the sample identification information, wherein the comparison unit compares the specific component information and the sample identification information with the work list. .