JPH05273216A - Automatic analyzer - Google Patents

Abstract

PURPOSE:To ensure that a reaction container at the dispensing position for a sample is the same as a reaction container at the measuring position for measuring the result after the reaction in a chemical analyzer or the like utilizing the immunological agglutination. CONSTITUTION:A plurality of reaction containers are arranged in matrix in a micro plate 6. A predetermined amount of each of a sample and a reagent is distributed to a plurality of the micro plates 6. The sample and the reagent are reacted in the reaction containers formed within the micro plate 6. This analyzer is provided with a measuring means for measuring the result of the reaction on a reaction line 8. An identifying member 1 is attached to every micro plate 6. Identifying data of the micro plate is described in the member 1 in a manner to be able to be read out mechanically or by eyes. A first reading means 11-1 and a second reading means 11-2 are set at the position where the sample and the reagent are dispensed and at the position where the reaction result is measured, respectively, to read out the identifying data described in the identifying member. The identifying data read by the first and second reading means are compared with each other, thereby to detect the coincidence.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an automatic analyzer, and more particularly to an automatic analyzer for analyzing a sample such as blood or body fluid using immunological agglutination reaction,
The present invention relates to an automatic analyzer that can reliably and efficiently perform an analysis operation by determining that the microplate before the reaction is the same as the microplate after the reaction.

[0002]

2. Description of the Related Art As a means for performing various immunological analyzes of blood, a microplate in which a plurality of reaction vessels are arranged in a matrix is used, and a part of an immunological agglutination analysis method such as a sample or a sample is used. A microtiter method is known which mechanizes the quantitative dispensing of reagents and the measurement of the presence or absence of aggregation.

On the other hand, a method of detecting an agglutination pattern using an agglutination reaction is a means for effectively analyzing blood type determination and detection of various antigenic antibodies such as HBs antigen and syphilis antibody with an extremely small amount of blood. Are known. An example of a method for detecting this aggregation pattern is disclosed in, for example, Japanese Patent Publication No. Sho 6
It is disclosed in Japanese Patent Publication No. 1-59454. In the method disclosed in this publication, a microplate in which a large number of reaction vessels in which at least a part of a bottom surface is provided with an inclined surface such as a conical shape is arranged is used. Blood cell particles for determining the type,
The standard antiserum reagent is dispensed, stirred, and allowed to stand for a relatively short period of time, and then the aggregation pattern formed on the bottom surface of the reaction container is detected.

Further, the applicant of the present application discloses, in Japanese Patent Publication No. 2-16875, a device in which the analysis efficiency and the analysis accuracy are improved by automatically performing such immunological analysis. In the automatic analyzer disclosed in this publication, various immunological analyzes relating to blood, that is, blood cell components such as red blood cell type, white blood cell type, platelets, lymphocyte type and type, various antibody antigens, specific proteins It is possible to selectively perform the components in serum such as virus, virus and the like and foreign substances in the same device by utilizing the agglutination reaction using blood cell particles, latex particles, carbon particles and the like. This automatic analyzer is compact and requires little space for installation.

FIG. 4 is a diagram showing an analysis step in the analyzer disclosed in Japanese Patent Publication No. 2-16875. Blood collected from the subject is contained in the test tube 46, and a subject ID label 47 having ID information of the subject is attached to the outer surface of the test tube 46. This ID information is described using a means such as a barcode. The test tube 46 containing the blood of the subject is contained in the rack 48 and is conveyed to the diluent dispensing position 52 by the conveying means 49 such as a belt conveyor. ID such as a bar code reader on the transport path of the rack 48
An information reading device 50 is arranged so that when the rack 48 accommodating a plurality of test tubes 46 passes in front of this device, the information written on the subject ID label 47 is read. The subject ID information 51 read by the device 50 is a CP that controls the entire device and determines the analysis result.
It is sent to U73.

The blood in the test tube 46 sent to the diluting liquid dispensing device 52 is diluted with the diluting liquid and dispensed into the sample container 53. Next, the sample container 53 is transported to the sample / sample dispensing position 54. On the other hand, the microplate housing 5
The plurality of microplates 56 accommodated in 7 are sequentially transported to the sample dispensing position 54 by the transport mechanism 58. A large number of reaction vessels 55 are arranged and formed in a matrix on each microplate 56, and an inclined surface is formed on at least a part of the bottom surface of each reaction vessel 55.

The sample container 53 and the microplate 56 stop at the sample dispensing position 54, where the sample container 53
The diluted sample contained in the sample is dispensed by the diluted sample nozzle 59 into the reaction container 55 formed on the microplate 56. Further, a required reagent is dispensed into the reaction container 55 by the reagent dispensing nozzle 60 according to various analysis items. Furthermore, a sensor 61 is arranged at the dispensing position 54 so as to detect the presence or absence of the microplate 56. A signal 62 indicating the presence or absence of the microplate 56 detected by the sensor 61 is sent to the CPU 73, and is counted by the CPU as the microplate number sequentially sent to the dispensing position 54.

The microplate 56 for which dispensing has been completed is
It is carried into the reaction line 63 through the carry-in port 63-1 by the carrying mechanism 58. The reaction line 63 is a lifting mechanism 63
-2, and a plurality of microplates 56 into which a diluted sample and a reagent are dispensed are stored in the reaction line until the reaction time required for various analysis items elapses, and the sample is analyzed by the antigen-antibody reaction. Blood cell particles, latex particles, etc. inside are aggregated. Microplate 56 in which agglutination reaction is completed
Is transported by the transport mechanism 64 to the photometric position 65 via the reaction line outlet 63-3.

The microplate 56 stops at the photometric position 65, and a photoelectrical aggregation pattern detector 66 such as a CCD camera is used.
Thus, the difference in the aggregation pattern formed on the bottom surface of each reaction container 55 is detected. The information 67 on the agglomeration pattern thus detected is sent to the CPU 73. Furthermore,
A sensor 68 for detecting the presence / absence of the microplate 56 is arranged at the photometric position 65, and a signal 69 regarding the presence / absence of the microplate detected by the sensor 68 is also sent to the CPU 73, and then to the photometric position 65. It is counted as the microplate number during photometry that is sequentially sent. Photometrically completed microplate 56
Are sequentially discharged from the photometric position 65 by the transport mechanism 64.

In the conventional analyzer, the necessary analysis is performed through the above steps, and the analysis result of each blood sample for this analysis item is output via an output device such as a printer.

[0011]

FIG. 5 is a flow chart of the apparatus shown in FIG. 4 in which the blood collected from the subject is put in the apparatus as a sample and before the required analysis result is obtained as an output. It is a figure which shows the path | route of transmission / reception of the information. In order to correctly perform data processing on the photometric data 67 of the analytical test performed on the test blood 71 and obtain the output from the output device 72, the ID information 51 of the subject who collected the test blood 71 and It is essential that the photometric data 67 of the aggregation pattern formed on the bottom surface of the reaction container 55 of the microplate 56 as a result of the antigen-antibody reaction performed in the reaction line 63 be matched.

In the analysis process performed in the conventional apparatus shown in FIGS. 4 and 5, in order to make the ID information 51 of the subject and the photometric data 67 of the agglutination pattern coincide with each other, the reaction line 63 is used. It is indispensable to ensure that the microplate 56 before reacting the diluted blood with the reagent and the microplate 56 after the reaction is completed and comes out from the reaction line 63 are in agreement. That is,
It is necessary to guarantee that the microplate 56 in which the diluted blood and the reagent are dispensed at the dispensing position 54 is the same as the microplate 56 that is measured at the photometric position 65 after the reaction of the diluted blood and the reagent. Is.

However, in the conventional apparatus, the sensors 61 and 68 are arranged at the dispensing position 54 and the photometric position 65 to detect the presence or absence of the microplate 56, but these sensors 61 and 68 simply Only the signals 62 and 69 that detect the presence of the microplate 56 at each position are emitted, and the microplate itself is not identified to determine whether or not they match.

Therefore, for example, when a mechanical or electrical failure occurs while the analyzer is in operation and the analysis work in progress is interrupted, the microplate 56 is measured at the photometry position 65 when the operation is restarted, Microplate 56 dispensed at the dispensing position before interruption of analysis work
It was not possible to determine whether or not and match with the sensors 61 and 68 that only detect the presence or absence of the microplate.

In addition, since a plurality of microplates are always used in the apparatus, and these microplates do not have a display means for identifying each, the operator can visually identify the microplate when a failure occurs. It was also impossible to do. Therefore, in such a case, there is a problem that the reliability of the analysis result output after the failure recovery cannot be guaranteed.

According to the present invention, it is possible to discriminate that the microplate before the reaction process between the diluted blood and the reagent is in agreement with the microplate after the reaction process, and the operator can visually observe the microplate. To provide an automatic analyzer capable of obtaining an analysis result with high reliability even when analysis work is interrupted due to a device failure or the like by providing a display means for identifying a plate on a microplate. The purpose is.

[0017]

In order to solve the above-mentioned problems, the automatic analyzer of the present invention quantifies a sample and a reagent to be analyzed on a plurality of microplates in which a plurality of reaction vessels are arranged in a matrix. Dispensing means for dispensing, a reaction line for reacting the sample and the reagent in a reaction container formed in the microplate, a means for measuring the reaction result in this reaction line, and the identification information of the microplate itself is visually And a microplate identification member that is described in a mechanically readable form and is attached to each of the microplates, and microplate identification information that is described on the identification member at a position where the sample and the reagent are dispensed. First identification information reading means for reading the identification information, and the identification part at a position where the processing in the reaction line is completed and the reaction result is detected. A discriminating means for comparing the microplate identifying information read by the first and second identifying information reading means with the second identifying information reading means for reading the microplate identifying information described in 1. It is characterized by having.

Further, the automatic analyzer according to the present invention is characterized in that
In the automatic analysis device described in the paragraph [1], the discriminating means may be the first identification information reading means for each microplate based on the microplate identification information read by the first and second identification information reading means. Whether the read identification information of the microplate and the identification information of the microplate read by the second identification information reading means after the elapse of a predetermined reaction time match, and whether the reaction time in the reaction line was appropriate It is characterized by comprising means for determining whether or not, and outputting the determination result together with the analysis result of the reaction performed on the reaction line.

[0019]

1 is a diagram showing the concept of the present invention. In the present invention, each of the plurality of microplates 6 used in the apparatus is provided with the identification member 1 for identifying the microplate. The identification member 1 is provided with a mechanically readable identification code 1-1 and an identification code 1-2 visually readable by humans. In addition, the diluted blood and the reagent are mixed with the microplate 6
The identification information reading means 11- for reading the identification code 1-1 at the dispensing position 7 for dispensing the liquid and the photometric position 10 for photometrically measuring the reaction result after the reaction is completed in the reaction line 8.
It is equipped with 1 and 11-2.

The microplate 6 read by the identification information reading means 11-1 arranged at the dispensing position 7
12-1 and the identification information 12-2 of the microplate 6 read by the identification information reading means 11-2 arranged at the photometric position 10 are compared by the CPU 16 to obtain diluted blood of the subject. It is possible to guarantee that the microplate 6 into which the reagent has been dispensed and the microplate 6 from which the reaction has been completed and the reaction result has been measured match in the analysis process performed in the analyzer. Becomes

[0021]

FIG. 2 is a diagram showing the configuration of an embodiment of the analyzer of the present invention. The apparatus of this example is an apparatus for analyzing an antigen-antibody reaction of a test blood by using an immunological agglutination reaction. The analysis procedure is the same as that of the conventional apparatus shown in FIGS. 4 and 5, and therefore the description thereof will be appropriately omitted.

In the device of the present invention, the microplate 6 having the reaction vessel 6-1 for dispensing the diluted blood sample and the reagent necessary for the analysis is provided with a bar as an identification member for identifying each microplate. Code label 1 is attached. The bar code label 1 is attached in advance to the surface of each microplate 6 when the microplate 6 is set in the microplate accommodating portion 22 at the start of analysis.

Dispensing position 10 for dispensing a blood sample diluted at the dilution position 3 and reagents necessary for analysis into a reaction container 6-1 formed on the microplate 6, and a reaction line 8 after completion of the dispensing. Bar code readers 11-1 and 11-2 for reading the bar code displayed on the bar code label 1 are provided at the photometric position 10 for photometrically detecting the agglomeration pattern formed on the bottom surface of the reaction container 6-1. Are installed respectively.

ID information 13 of the subject who collected the blood sample
Is the barcode label 2 attached to the side surface of the test tube 2-4.
-2 is read by the bar code reader 17 and sent to the CPU 16 which determines the analysis result. Also, dilution of the sample blood,
After the dispensing of the diluted blood and the reagent to the microplate 6 is completed, the diluted blood and the reagent are sent to the reaction line 8 and, after the reaction is completed, the reaction container 6-1 of the microplate 6 that came out from the outlet 8-1 of the reaction line The agglomeration pattern formed on the bottom surface of the photometrically detected by the camera 31 at the photometric position 10,
The photometric data 14 is sent to the CPU 16.

The microplate 6 before the reaction treatment and the microplate after the reaction treatment, which are necessary for ensuring that the ID information 13 of the subject and the photometric data 14 detected by photometry are in agreement. It is determined whether or not 6 and 6 match with each other by the barcode reader 11 placed at the dispensing position.
Data read by -1 1 regarding microplate 6
2-1 and the bar code reader 11 arranged at the photometric position
-Data 1 for microplate 6 read at -2
It is performed by comparing 2-2 in the CPU 16.

From the output device 15, the ID information of the subject,
The comparison result and the analysis result based on the photometric data 14 are described together and output. In addition to this, the reaction time in the reaction line 8 may be measured, the CPU 16 may judge whether this reaction time is appropriate for the analysis item, and the result may also be described.

FIG. 3 is a view showing an example of the identification label 1 attached to the microplate 6 used in the apparatus of the present invention. The microplate 6 has a plurality of reaction vessels 6 each having a conical inclined surface formed on at least a part of its bottom surface.
-1 are arranged in a matrix. A part of the surface of the microplate 6 where the reaction container 6-1 is not formed is provided, and the identification label 1 for identifying each microplate is attached to this part. As the identification label 1, a resin film or paper label coated with an adhesive on one side is used so that it can be easily peeled off after being used in the apparatus. Further, on the surface of the identification label 1, a barcode 1-2 is displayed as identification information that can be read by the barcode readers 11-1 and 11-2 which are photoelectric information detecting devices, and The identification information 1-2 by letters and / or numbers is displayed so that the operator can visually confirm it.

The material of the identification label 1 is a ceramic substrate,
By using a corrosion resistant alloy plate with excellent chemical resistance, and by using an adhesive used for attaching this label with excellent chemical resistance, it is possible to use the micro plate as a specification that does not need to be detached. You can leave the label on the plate until it becomes unusable.

As a means for displaying the identification information, in addition to the photoelectric method using a bar code or the like, a display which can be read using magnetism, radio waves or the like is attached to the microplate to detect the magnetic or radio waves. The reading device may be arranged in place of the bar code reader to read the identification information.

[0030]

As described above, in the analyzer including the microplate identifying means of the present invention, the diluted blood sample and the reagent are dispensed into the reaction container formed in the microplate, The identity with the microplate that has come to the photometric position for photometric detection of the aggregation pattern formed in the reaction container of the microplate can be guaranteed in the analysis process of the analyzer itself.
Therefore, the ID information of the subject who collected the blood sample,
The result of the analytical test can be correctly matched.

Further, since each of the plurality of microplates used in the analyzer has identification information of the microplate itself, the analysis work is interrupted due to mechanical or electrical failure during operation of the device. Even if such a situation occurs, the identification information of the microplate detected and identified at the photometric position after resuming the work and the identification information of the microplate detected and identified at the dispensing position before the work interruption can be compared, so The match between the ID information of the person and the analysis result is surely guaranteed.

Even if the identification information of the microplates at the dispensing position and the identification information of the microplates at the photometric position do not match as a result of performing the confirmation operation, the identification labels attached to the respective microplates. By displaying identification information such as numbers and characters that can be visually confirmed by humans, the operator can collate the analysis result output from the output device with the microplate used for the analysis. It is possible. Therefore, it is possible to easily guarantee whether or not the subject ID information and the analysis result match by visual inspection by the operator without relying only on the mechanical judgment of the device, and the analysis result is discarded. You can eliminate the waste of doing and re-analyzing. In particular, it contributes to improvement in reliability and efficiency of analysis work in a laboratory or the like that performs a large amount of blood analysis within one day.

[Brief description of drawings]

FIG. 1 is a diagram for explaining the concept of the present invention.

FIG. 2 is a diagram showing a configuration of an analyzer of the present invention and explaining an analysis step in the analyzer.

FIG. 3 is a diagram showing a configuration of a microplate used in the analyzer of the present invention.

FIG. 4 is a diagram showing a configuration of a conventional analyzer.

FIG. 5 is a diagram showing a route of information exchange in the conventional analyzer shown in FIG.

[Explanation of symbols]

 1 Microplate identification label 2-1 Blood to be tested 2-2 Subject ID information label 3 Diluting device 4 Reagent dispensing device 5 Diluting blood dispensing device 6 Microplate 7 Dispensing position 8 Reaction line 9 Photometric device 10 Photometric position 11-1, 11-2 Bar code reader 15 Output device 16 Data processing device 17 Bar code reader

Claims (2)

[Claims] 1. A dispensing means for quantitatively dispensing a sample and a reagent to be analyzed into a plurality of microplates in which a plurality of reaction vessels are arranged in a matrix, and the sample in the reaction vessel formed in the microplate. A reaction line for reacting a reagent, a means for measuring the result of reaction in the reaction line, identification information of the microplate itself are described in a visually and mechanically readable form, and attached to each of the microplates. A microplate identification member, a first identification information reading means for reading the microplate identification information described in the identification member at a position where the sample and the reagent are dispensed, the processing in the reaction line is completed, Second identification information for reading the microplate identification information written on the identification member at the position for detecting the reaction result Automatic analyzer which means collected, characterized in that it comprises a determining means for determining the identity by comparing the microplate identification information read by said first and second identification information reading means. 2. The automatic analyzer according to claim 1, wherein the discriminating means determines, for each microplate, based on the microplate identification information read by the first and second identification information reading means. The identification information of the microplate read by the first identification information reading means and the identification information of the microplate read by the second identification information reading means after a lapse of a predetermined reaction time match, and the reaction line An automatic analyzer comprising means for determining whether or not the reaction time in step 1 was appropriate, and outputting the determination result together with the analysis result of the reaction performed on the reaction line.