JP2003315348A - Specimen processing system and specimen inspection automating system using it - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To solve the problem that advantages of automatization such as rapidity, labor saving or infection prevention are reduced due to man power requirement, because, in the case of a deficient serum quantity, narrowing of items and dispensation processing following a manual by an operator are required, though the determination of sufficiency of the serum quantity for the requested items is performed by a serum quantity measuring device. <P>SOLUTION: The order of priority to inspection items to each specimen is registered beforehand, and the serum quantity necessary for inspection is compared with the serum quantity measured by a liquid quantity measuring unit. When the serum quantity is deficient, dispensation is performed in the order of high priority of the inspection item, to thereby remove the intervention of the man power. An alarm is sounded relative to an item incapable of analysis (dispensation) to warn an operator. A stopping target of a rack is controlled based on a dispensation result. <P>COPYRIGHT: (C)2004,JPO

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a clinical test system for automatically analyzing biological samples such as blood and urine, and in particular, the so-called pretreatment for performing a treatment such as opening, centrifuging and closing the collected biological samples. The present invention relates to a sample processing system including a processing device.

[0002]

2. Description of the Related Art A sample test automation system is a system that sorts samples such as blood and urine collected from a patient according to test contents, and automates pretreatment, analysis, and report of test results. In analysis in the fields of biochemistry and immunology, since serum is mainly used for analysis, blood collected from the human body is subjected to pretreatment to separate it into serum and blood clots. afterwards,
There are cases where it is applied to the analyzer as it is, or only serum is dispensed into another container and the dispensed container is applied to the analyzer. The advantage of dispensing is that parallel processing can be executed by a plurality of analyzers even when there are many analysis items.

The amount of serum required for each analysis item is fixed. However, whether or not the actual amount of serum obtained after centrifugation is sufficient for the test items can be estimated to some extent from the amount of blood collected from the human body, but to be exact it can only be determined after centrifugation. Can not. In a facility that does not have an automated system installed, a centrifuge is used in a stand-alone centrifuge, so it was possible to visually confirm whether the amount of serum was sufficient before applying it to the analyzer. Since the processing system automates processes such as blood injection, centrifugation, opening, dispensing, and analysis without human intervention, it is virtually impossible to visually confirm after centrifugation. .

The adverse effect resulting from this is that the amount of serum is insufficient only after the sample is dispensed for analysis by the analyzer.

In order to solve such a problem, Japanese Patent Laid-Open No. 200-200
In Japanese Patent Laid-Open No. 1-165752, a device for measuring a serum amount, that is, a liquid amount measuring unit has been developed and incorporated into a sample pretreatment system. As a result, it became possible to determine whether the actual measured serum amount after centrifugation and whether the serum amount was sufficient for each test item.

[0006]

However, in the present system which uses the liquid volume measuring unit, it is merely to judge whether or not the serum amount is sufficient, and when it is insufficient, an alarm is generated and the sample is stored. It is transported to the department and the subsequent processing is entrusted to the operator. Specifically, the operator asks the doctor who requested the test for the priority of the test item, manually dispenses the necessary amount so that as many samples as possible can be used, and then performs the analysis. In addition, the analysis will not be performed for the shortage, or additional blood will be collected from the patient for analysis.

As described above, even when the serum amount is insufficient as compared with the necessary amount for the analysis item to be tested,
The sample is not discarded, and some analysis is always performed by narrowing down the test items, but in the conventional technology, the dispensing process has to be done by hand, and swiftness, labor saving, infection prevention, etc. Had reduced the benefits of automation.

The object of the present invention is to collect collected samples manually even if the amount of the sample (serum etc.) used for the analysis is insufficient as compared with the necessary amount for the analysis item to be tested. An object of the present invention is to provide a sample processing system capable of performing analysis quickly and automatically without intervention.

[0009]

The structure of the present invention for achieving the above object is as follows.

A biological sample storage container for storing the collected biological sample, and a biological sample stored in the biological sample storage container are processed to generate a test sample that can be analyzed by an analyzer. At least centrifugation. Pretreatment means including separation processing, inspected sample amount measuring means for measuring the amount of the inspected sample generated by the pretreatment means, inspection items of the inspected sample, and inspection objects necessary for analysis of the inspection items Inspection item storage means for storing the amount of sample, priority storage means for storing the inspection priority of the inspection item, inspected sample amount measured by the inspected sample amount measuring means, and the inspection item storage means The inspection item stored in the table and the amount of the inspected sample necessary for the analysis of the inspected sample calculated from the amount of the inspected sample necessary for the analysis of the inspection item are compared. If the amount of the sample to be inspected is smaller than the required amount of the sample to be inspected as a result of the comparison by the comparing means and the comparing means, the inspected sample is stored according to the priority of the inspection item stored for the sample to be inspected. A test item selecting means for selecting a test item that can be measured by the sample amount, and an amount of the test sample required for analysis of the test item selected by the test item selecting means, A sample processing system, comprising: a dispensing means for dispensing into a storage container.

In the present invention, a biological sample collected from a human body is not directly subjected to analysis but is subjected to a treatment such as centrifugation to prepare a sample (inspection sample) to be subjected to analysis from the biological sample. Intended for processing systems. By such processing, the amount of the sample to be inspected obtained from the biological sample differs for each biological sample, and the amount of the sample to be inspected actually obtained cannot be known unless it is measured. On the other hand, when there are a plurality of test items to be analyzed for one biological sample, the amount of the sample to be inspected necessary for analyzing those test items is different for each biological sample. Therefore, register the analysis items for each biological sample with priority, and compare it with the amount of the actually inspected sample to determine which inspection item to analyze for each biological sample.
Amount required for the analysis (+ called dead volume,
It is a feature of the present invention that an extra amount attached to the inner wall of the container and lost is dispensed into the container for the sample to be inspected. The number of containers for inspected samples is not limited to one. That is, when it is necessary to perform, for example, an immunoassay or a biochemical analysis on one biological sample, the immunoassay analyzer and the biochemical analyzer are usually different devices, and thus one test sample is not used. It takes a long time to perform analysis by dispensing in a sample container and sequentially performing those devices.
Therefore, it is efficient to divide the sample to be inspected into two containers, an inspected sample container for the immunoanalyzer and an inspected sample container for the biochemical analyzer, and analyze them in parallel.
Even in such a case, it is possible to provide a function of determining how many containers the test sample is to be divided into and determining the dispensed amount for each container based on the priority of analysis.

Further, when there is an analysis item that cannot be dispensed because the amount of the sample to be inspected is insufficient, the operator is warned by an alarm.

The warning may simply warn that the dispensing could not be performed, or the analysis item and the insufficient amount of the sample to be inspected that could not be dispensed may be displayed.
Further, according to the present invention, by controlling the transfer line on the basis of the dispensing result preferentially dispensed, when a plurality of analyzers are connected, it is not necessary to stop by because the sample amount is insufficient. It is possible to carry out the inspection efficiently and quickly without carrying the rack to the new analyzer.

[0014]

BEST MODE FOR CARRYING OUT THE INVENTION An embodiment according to the present invention will be shown below.

FIG. 1 is a block diagram showing an example of a sample processing system to which the present invention is applied. In this embodiment,
An example is shown in which the sample pretreatment unit and the analyzer are independent of each other and are not connected by the transport line, and the sample dispensed by the dispensing unit is analyzed by the analyzer.

Reference numeral 1 denotes a host system that collectively manages information such as test request items and test results indicating what kind of test is to be performed on each sample. Input of test request items and output of test results are input. It is performed at the output terminal 0.

The sample processing system is composed of a loading section 4, a storage unit 5a and various processing units and a line. Each of them directly exchanges information or exchanges information in the sample pretreatment system and the sample rack via another unit. It is connected by a communication cable 6 to a central control unit 2 that controls both of the flows. Further, the central control unit 2 is connected to the host system by a communication cable 3, and various information such as inspection request items is exchanged. Further, in the central control unit 2, the amount of serum required for analysis and the dead volume in the analyzer are registered for each test item using an input terminal (not shown).

The analyzers 8a and 8b are connected to the host system 1 by a communication cable 9, and inquire with the host system 1 about the test request item of the sample and exchange the information of the analysis result.

The sample is placed on the sample rack and loaded into the sample processing system from the loading unit 4. The sample rack loaded from the loading unit 4 stops at each processing unit according to an instruction from the central control unit, and the processed rack is stored in the storage unit 5a.
Is stored in. Thereafter, the sample dispensed by the operator is manually carried to the analyzer and analyzed.

Next, the details of information exchange and the flow of the sample rack according to the present embodiment will be described with reference to FIGS. In this embodiment, as an example, the charging unit 4, the centrifugal separation unit 10,
A pretreatment system composed of a cap opening unit 11, a liquid amount measuring unit 12, a dispensing unit 13, and a storage unit 5a and two stand-alone analyzers 8a and 8b will be mentioned.

First, the examination request item for a certain patient and the priority of the examination item are input through the input / output terminal 0 by the doctor's examination, and this is registered in the host system 1. After that, the sample is loaded from the loading unit 4, and the sample ID is read by the sample identifier reading unit 15 such as a barcode. The central control unit 2 receives the sample ID information from the input unit 4 by communication and transfers it to the host system 1. Based on the transmitted sample ID, the host system transmits to the central control unit 2 what examination items are requested for the sample and their priorities.

On the other hand, the sample rack is processed by following the path registered in advance for each sample rack on which the sample is installed. As an example, the sample rack is subjected to centrifugal separation processing in the centrifugal separation unit 10, and the stopper of the sample container is opened in the opening unit 11. As another example, if the sample has been subjected to manual centrifugal separation processing externally, the centrifugal separation unit 10 is skipped and transported to the uncapping unit 11, and the like, the route is various.

Next, the liquid amount measuring unit 12 measures the amount of serum. As a method of measuring the liquid volume, for example, an image of each sample container is taken with a camera, and the boundary position of each is determined from the difference in the gradation of serum, separating agent, and blood clot by image processing. For example, there is a method of obtaining the serum amount by calculation from the diameter of the test tube.

The liquid amount measuring unit 12 reports the serum amount thus measured to the central control unit 2.

On the other hand, the central control unit 2 refers to the required serum amount for the test item registered in advance for the test request item transmitted from the host system 1 and refers to the sample. The total amount of serum necessary for performing all analyzes and the total dead volume generated in the analyzer are calculated, and the measured values transmitted from the liquid volume measurement unit 12 are compared.

For the sake of understanding, a detailed description will be given with reference to the flow chart of FIG. The amount of serum required for the analysis of item a is Va, and the amount of item b is V
If b, item c is Vc, item d is Vd, and dead volume is VD, these pieces of information are registered in the central control unit 2 in advance. Further, assuming that the items requested to the patient A are a, b, and d, and the priorities are in the order of a, b, d, this examination request information is registered in the host system 1 from the input / output terminal 0. It Then, it is assumed that the sample is put into the feeding unit 4, and after the treatment such as centrifugation and opening, the measured value of the serum amount of the patient A measured by the liquid volume measurement unit 12 is Vm. In this case, the central control unit 2 calculates the total sum Va + Vb + Vd + VD of the serum volume and dead volume necessary for the analysis and compares it with the measured value Vm. At this time, if Vm> Va + Vb + Vd + VD, all the analyzes can be performed without any problem, and therefore the sample rack is transported to the dispensing unit as it is, and the dispensing unit dispenses all the items. However, if Vm <Va + Vb + Vd + VD, the serum is insufficient to perform all analyses. In such a case, the previously registered priority is used, and Va excluding the lowest priority d among a, b, and d is used.
Recalculate + Vb + VD and compare again with Vm. Here, if Vm> Va + Vb + VD, the items a and b can be analyzed, and the item d cannot be analyzed. In this case, the central control unit 2 conveys the sample rack to the dispensing unit,
An alarm is generated to instruct the operator to perform only dispensing for items a and b, and to warn the operator that dispensing is not performed for item d due to insufficient serum amount. When Vm <Va + Vb + VD, since serum is still insufficient to perform both analyzes of items a and b, Va + VD excluding b having the next lowest priority is calculated again, and Vm is calculated again. Compare with.

After that, the above is repeated, and items having lower priority are deleted, and only the items that can be analyzed are dispensed, and the items that cannot be dispensed are alarmed. Occurs and alerts the operator.

As described above, which item can be analyzed for a certain sample is determined, and a dispensing instruction is transmitted from the central control unit 2 to the dispensing unit 13, whereby the sample is dispensed. It is dispensed by the unit 13 and finally stored in the storage unit 5a. The operator can take out the dispensed sample from the storage unit 5a, carry it by hand to the analyzers 8a, 8b, etc. for analysis based on the dispensing result.

Further, as a result of the comparison described above, when the amount of the sample is insufficient to inspect even one item, the sample rack is transported to the storage unit 5a without stopping at the dispensing unit. Raise a warning alarm.

FIGS. 4 and 5 show a sample inspection automation system in which the sample pretreatment system and the analyzers 8a and 8b exemplified in FIGS. 1 and 2 are connected via a transport line and analyzer connecting units 14a and 14b. This is also an example, and in this case as well, after the similar processing is performed in the pretreatment unit, the sample dispensed via the transfer line is automatically transferred to the analyzer connection units 14a and 14b, and after the analysis is completed. A sample (rack) is stored in the storage unit 5b.

At this time, the control of the rack transport destination can be changed by the central control unit 2 based on the dispensing result performed by the dispensing unit 13. Here, for the sake of explanation, it is assumed that the analyzer connection units 14a and 14b are units having a route that stops at the analyzer and a route that does not stop at the analyzer as shown in FIG.

For example, items a and b are analyzer 8a and item d.
Is analyzed by the analyzer 8b. In this case, when the amount of the sample is sufficient, the central control unit checks that the dispensed sample passes through the route of the analyzer connection unit 14a to the analyzer, and the analyzer 8a analyzes the items a and b. After dispensing the sample amount necessary for the analysis, the analysis device connection unit 14b passes through the route to the analysis device, and the analysis device 8b dispenses the sample amount necessary for analyzing the item d, and then stores it in the storage unit 5b. Control the transfer line so that it will be stored.

However, as a result of the measurement by the liquid amount measuring unit 12, it is assumed that there is a required sample amount for the items a and b and that there is a shortage for the item d. In this case, the dispensing unit 13 dispenses the items a and b and does not dispense the item d and issues an alarm. The central control unit 2 changes the transfer destination based on the above dispensing result. That is, since the dispensed items a and b are analyzed by the analyzer 8a, they are transported to the route stopping by the analyzer connecting unit 14a, but the item d should be analyzed by the analyzer 8b. However, since the dispensing was not performed, the analysis unit connection line 14b is carried to a route that does not stop at the analysis unit 8b, and finally stored in the storage unit 5b.

According to the above example, it is possible to completely eliminate the manual processing even when the amount of the sample is insufficient.

[0035]

[Effect of the Invention] Even if the amount of the sample (serum etc.) used for analysis according to the present invention is insufficient as compared with the required amount for the analysis item to be tested, it is necessary to manually collect the collected sample. It is possible to provide a sample processing system capable of performing analysis quickly and automatically without intervention.

[Brief description of drawings]

FIG. 1 is a block diagram of a pretreatment system according to an embodiment of the present invention.

FIG. 2 is a pre-processing system configuration for FIG.

FIG. 3 is a processing flow for FIG.

FIG. 4 is a block diagram of a sample test automation system according to an embodiment of the present invention.

5 is a configuration of an automated sample test system for FIG.

FIG. 6 is an explanatory diagram of a rack transport path of the analyzer connection unit.

[Explanation of symbols]

0 ... Input / output terminal, 1 ... Host system, 2 ... Central control unit, 3, 6, 9 ... Communication cable, 4 ... Input unit, 5a, 5
b ... storage unit, 8a, 8b, 8c ... analysis device, 10
... Centrifugal separation unit, 11 ... Opening unit, 12 ... Liquid amount measuring unit, 13 ... Dispensing unit, 14a, 14b ...
Analyzer connection unit.

─────────────────────────────────────────────────── ─── Continuation of the front page (51) Int.Cl. ⁷ Identification code FI theme code (reference) G01N 35/10 G01N 35/06 A (72) Inventor Nobuo Suzuki 882 Ichige, Ichige, Hitachinaka City, Ibaraki Prefecture Company Hitachi High-Technologies Corporation Design / Manufacturing Headquarters Naka Plant (72) Inventor Ryuyu Imaoka 882 Ichige, Ichige, Hitachinaka City, Ibaraki Prefecture Hitachi High-Technologies Design & Manufacturing Headquarters Naka Plant F-term (reference) 2G045 AA01 BA08 BB03 BB10 CA26 HA01 2G052 AA30 AD26 CA03 CA08 CA18 ED17 HA08 HB04 HC04 HC16 HC26 JA06 JA07 2G058 AA05 BA06 CA02 CB09 CB15 EA02 EA14 EB01 GB03 GC02 GC05 GE01 GE03 GE05 GE06 GE10 HA04

Claims (5)

[Claims] 1. A biological sample storage container for storing a collected biological sample, and a biological sample stored in the biological sample storage container is processed to generate a test sample that can be analyzed by an analyzer. Pretreatment means including at least a centrifugal separation treatment, inspected sample amount measuring means for measuring the amount of the inspected sample generated by the pretreatment means, inspection items of the inspected sample and necessary for analysis of the inspection items Test item storage means for storing the amount of the test sample, priority storage means for storing the test priority of the test item, test sample amount measured by the test sample amount measuring means, and the test item An inspection item stored in the storage means and an amount of the inspected sample necessary for the analysis of the inspected sample calculated from the amount of the inspected sample necessary for the analysis of the inspection item; As a result of the comparison by the comparing means and the comparing means, if the amount of the sample to be inspected is smaller than the required amount of the sample to be inspected, the amount of the sample to be inspected is determined according to the priority of the inspection item stored for the sample to be inspected. A test item selecting means for selecting a test item that can be measured by a test sample amount, and an amount of the test sample necessary for analyzing the test item selected by the test item selecting means, A sample processing system, comprising: a dispensing means for dispensing into a sample storage container. 2. The sample processing system according to claim 1, further comprising a function of dispensing a sample from a biological sample stored in the same biological sample storage container into a plurality of test sample storage containers. A sample processing system characterized by: 3. The sample processing system according to claim 2, wherein when there are a plurality of analyzers for analyzing the sample to be inspected, a function of dispensing to each different sample container to be inspected is provided for each of the plurality of analyzers. A sample processing system comprising: 4. An automatic analyzer is connected to the sample processing system according to claim 1 through a transfer line, and the dispensed sample to be inspected is analyzed through the transfer line. A sample test automation system, which is equipped with a mechanism for carrying to a device and performing analysis. 5. The sample test automation system according to claim 4, wherein the transport line is controlled by a central control unit of the sample processing system, and the measurement result by the test sample amount measuring means is measured. An automatic sample inspection system comprising a mechanism for controlling a destination of a rack on which the sample to be inspected is installed, based on a dispensing result of the sample to be inspected which is preferentially dispensed based on the above.