JPH05256852A - Automatic analysis method - Google Patents

Abstract

PURPOSE:To perform analysis again by diluting an ultra-high unit specimen automatically without bothering a worker's hand by selecting reference items from other measurement items and then performing an analysis for items to be analyzed which indicated an abnormal analysis result. CONSTITUTION:A rack 20 where a specimen is mounted is transported to a sample dispensing part 6. A sample pipetter is inserted into a sample container 21, sucks a specified amount of sample, and then dispenses it to a reaction container 22. The container 22 is carried to a reagent dispensing part 8 and then a reagent is sucked from a reagent container 23 and then is dispensed. The container 22 is carried to an absorbance measuring part 10 for measurement. When there is a specimen with analysis items outside a reference range, one or more analysis items within the reference range are selected as the reference item. Then, a dilution liquid is poured and then a dilution specimen is adjusted. After that, the items to be analyzed outside the reference range and reference items are analyzed again. Then, by comparing previous measurement values of the reference items with reinspection values, the reinspection measurement value is converted for the items to be analyzed outside the reference range, thus calculating the measurement value before adjustment.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a clinical biochemical automatic analysis method, and in particular, to obtain a correct measurement value by performing an analysis again on a sample showing an abnormal measurement value for each analysis item as a result of the automatic analysis. Automatic analysis method of.

[0002]

2. Description of the Related Art Conventionally, when performing automatic analysis on a series of specimens, if the concentration of the measurement component in the sample is very widely distributed, it should be as high as possible within the measurement range where the measurement accuracy can be maintained. Set the liquid volume ratio of the sample and reagent to be dispensed into the reaction vessel so that even samples in the concentration range can be measured.

Generally, this is contrary to the improvement of measurement accuracy and the expansion of measurement range. For example, when analyzing a serum sample, CK, LDH, GOT (AST), GPT (AL
T) and other enzyme-based analysis items and immunoglobulin G, immunoglobulin A, immunoglobulin M, and other analysis items, when attempting to accurately measure the normal value range of healthy subjects, for example, several hundred to four patients will receive 1 An extremely high unit sample exceeding the measurement range may occasionally appear with a frequency of 1 to several people.

When such an unmeasurable sample occurs, a sample number indicating an abnormal value is searched from the output data group of a series of samples, the sample container to which this sample number is assigned is searched, and the analysis operator Manually operates the analyzer to obtain a certain dilution ratio (eg 1/5 or 1/10) for the sample.
The data was corrected by using the dilution rate from the measured value obtained by performing the work of diluting the sample into the sample and analyzing again.

[0005]

However, such reanalysis work is a complicated procedure and requires a long time even for a skilled worker to cause a decrease in processing speed of the automatic analyzer. there were.

In addition, when diluting a sample of ultra-high unit specimen,
The cleaning water remains in the sample dispensing nozzle, or the position control error of the sample dispensing nozzle varies.
It is difficult to dilute with an accurate dilution rate, and even if data is corrected using the specified dilution rate for the obtained measurement value, the actual sample dilution rate will differ, so the corrected measurement value will be There was a problem that an error occurred.

[0007] Further, when the reanalysis is not performed, the sample amount to be dispensed into the reaction vessel is reduced without diluting the sample, and the liquid volume ratio in the reaction liquid is reduced, so that the obtained measurement value can be obtained from the apparatus. It is expected that the analysis will be performed within the measurement range, but the mechanism for dispensing the sample, such as the structure of the sample dispensing nozzle and sample pump, limits the amount of sample to be dispensed. However, there was a problem that the measurement range for reanalysis was limited.

In order to solve such a problem, the present invention is an automatic analysis method capable of automatically diluting an ultra-high unit sample and re-analyzing it without bothering an analysis operator. The purpose is to provide.

[0009]

In order to achieve the above object, the automatic analysis method of the present invention is such that, as a result of automatic analysis of a series of samples, the measured values of each analysis item designated in advance for each sample meet a predetermined standard. If there is a sample having an analysis item outside the reference range by judging whether it is within the range, one or more of the analysis items within the reference range are selected as the reference item, and the sample in the sample container for the sample is selected. After adjusting a diluted sample by removing a part of the sample and injecting a predetermined amount of the diluent, the diluted sample is analyzed again for the analysis item outside the reference range and the reference item, and the previous measurement of the reference item is performed. It is characterized in that the measured value of the sample before adjustment is calculated by converting the measured value of the retest for the analysis item outside the reference range by comparing the value with the measured value of the retest.

Further, the automatic analysis method of the present invention judges whether or not the measured value of each analysis item designated in advance for each sample is within a predetermined reference range as a result of automatic analysis of a series of samples, If there is a sample with external analysis items,
One or more analysis items other than the analysis items designated in advance are selected as reference items, analysis of the sample is additionally performed for the reference items, and then one sample in the sample container for the sample is added. After adjusting the diluted sample by removing a part and injecting a predetermined amount of the diluent, the diluted sample is analyzed again for the analysis item outside the reference range and the reference item, and the previous measurement value of the reference item It is characterized in that the measured value of the sample before adjustment is calculated by converting the measured value of the retest for the analysis item outside the reference range based on the comparison of the measured value of the retest.

In each of the above-mentioned constitutions, when the diluted sample is analyzed again for the reference item, it is preferable to increase the amount of the sample to be dispensed into the reaction container as compared with the previous analysis.

[0012]

According to the first configuration described above, the data obtained by automatically analyzing a series of samples is set by presetting the reference range for judging whether the measured value for each analysis item is abnormal. The device control program can automatically determine whether or not it falls within this reference range.

Further, a sample container of a sample having an analysis item outside the reference range is conveyed to a predetermined position, a part of the sample in the sample container is sucked and removed by a sample dispensing nozzle, and a predetermined amount of diluent is injected. By doing so, the sample can be diluted easily.

Further, one or more of the analysis items for which measured values within the reference range are obtained are selected as reference items, and the diluted sample is analyzed again for the analysis items outside the reference range and the reference items. By comparing the previous measurement value with the re-inspection measurement value and considering the change in the measurement value of the reference item, it becomes possible to calculate the dilution rate at which the sample was actually diluted. It is possible to reduce the error due to the data correction of.

Next, according to the above-mentioned second structure, in addition to the above-mentioned action, an analysis item different from each analysis item designated in advance, for example, a sample always has a constant concentration and is measured. Select one or more analysis items such as albumin and total protein contained in samples such as serum and blood samples that do not show ultrahigh values exceeding the range, and select this reference item. By additionally performing the analysis of the sample with respect to, it is possible to obtain stable reference data with little variation, and it is possible to further reduce the error associated with the data correction for the analysis items outside the reference range.

Next, according to the above-mentioned third preferred configuration, when the diluted sample is analyzed again for the reference item, the amount of the sample dispensed to the reaction container is increased from that in the previous analysis to perform the analysis. By doing so, it becomes easy to introduce the measured value for the reference item into the range of the measurement range, and the reference data with higher accuracy can be obtained. Therefore, the types of analysis items that can be selected as reference items can be increased.

[0017]

EXAMPLES Examples of the present invention will be described below. FIG. 2 is a schematic perspective view of an automatic analysis device to which the automatic analysis method of the present invention can be applied. The automatic analyzer 1 carries out an automatic analysis by transporting a rack 20 in which a series of samples are stored, and is generally called a pickup system. The rack supply unit 2, the rack collection unit 3, and the rack transport unit are provided. 4, rack standby unit 5, sample dispensing unit 6, reaction container transporting unit 7, reagent dispensing unit 8, reagent container transporting unit 9, absorbance measuring unit 1
0 and a device control unit 30 that controls each unit. The rack transfer section 4 is composed of two transfer lines, a forward transfer line and a return transfer line. Particularly, the return transfer line is a transfer line for reanalysis, and the number of transfer lines can be increased or decreased as necessary. Although the sample dispensing unit 6 is also used as the sample suction / disposal unit, the sample suction / disposal unit can be separately installed.

In particular, the sample suction / disposal section is mainly composed of a sample pipettor and a suction / disposal pump. Since the conventional sample pipettor has only a function of sucking only the sample necessary for the analysis and dispensing it into the reaction container 22, the maximum suction amount is 10
Although it was about 0 μl, a sample pipettor and a suction discard pump that can suck at least 1 ml of sample to suck and discard (and then wash) an excess amount of sample in order to add the function of adjusting the diluted sample Is provided.

Since the sample is diluted in the sample container 21,
Except for the original sample that remains in the sample container 21 in an amount corresponding to a predetermined dilution rate, it is sucked and removed by the sample pipette.
When the inner shape of the sample container 21 is constant, the amount of the original sample to be left is determined by the nozzle tip position of the sample pipettor at the time of suction and the height of the inner bottom portion of the sample container 21, so that the height of the nozzle tip may be increased as necessary. Control Then, a predetermined amount of diluent (for example, physiological saline) is added to the sample container 21 and stirred to prepare a uniform diluted sample.

Next, an embodiment of the automatic analysis method of the present invention will be described. FIG. 1 is a control flow chart showing an embodiment of the automatic analysis method of the present invention. In “input of analysis instruction information for each item”, each analysis item for a series of samples is instructed to the device control unit 30, and a reference range for determining whether or not the measurement value of each analysis item is abnormal is set. In order to store information necessary for operating other devices in the device control unit 30, information is input by an input device such as a keyboard.

In the "start of initial analysis of each item", the rack loaded with the series of samples is transported to the sample dispensing unit 6.
Next, the sample pipettor is inserted into the sample container 21 in the rack, and a predetermined amount of sample is sucked and dispensed into the reaction container 22 corresponding to each sample. The reaction container 22 containing the sample is conveyed to the reagent dispensing unit 8, and the reagent corresponding to each analysis item previously instructed by the reagent dispensing nozzle is sucked from the reagent container 23, and a predetermined amount of the reagent is reacted. Dispense into container 22. The reaction container into which the sample and the reagent have been injected is conveyed to the absorbance measuring unit 10, and the absorbance measurement at a predetermined wavelength and the absorbance time change measurement are performed. After the measurement, the reaction vessel is washed and used again for the next measurement. In this way, a series of samples is automatically analyzed for each analysis item, and the obtained measurement values are stored in the data storage unit of the device control unit 30.

In the case of "occurrence of abnormality analysis result?", As a result of analyzing a series of samples, it is judged whether the measured value of each analysis item is within a predetermined reference range. If there is no abnormal analysis result, the analysis of a series of samples ends. If there is an abnormality analysis result, move to the next step.

The "interruption analysis of the non-diluted sample retest item" is a re-analysis under the same conditions as the initial analysis conditions during the return route from the rack standby section 5 to the rack collection section 3 in a normal automatic analysis routine. Is a step for obtaining a more reliable measurement value from the results of two analyzes. The “interruption analysis” means that the undiluted sample is preferentially analyzed over the sample showing the abnormal analysis result.

In "whether there is a matter corresponding to sample dilution?", It is judged whether or not there is a possibility that an appropriate measurement value can be obtained by diluting the sample and re-analyzing the sample for which an abnormal analysis result has appeared. To do. If an appropriate measurement value cannot be obtained even by sample dilution, for example, if the absorbance is too low and the sample dilution is even lower, it is stored in the device control unit 30 as a sample that cannot be retested and Stops the reanalysis.

In “Selection of provisional reference item”, (1) one or more of the analysis items for which the measured value within the reference range was obtained are selected as the reference item, or (2) the instruction is given in advance. One or more analysis items different from each analysis item are selected as reference items.

In the "analysis of reference item", if an appropriate measured value is obtained for the reference item selected in the previous step with respect to the sample before dilution, the next analysis is performed without analyzing the reference item. Go to step. However, if an appropriate measurement value is not obtained for the reference item or if an analysis item other than the analytical items specified in advance is selected as the reference item (corresponding to (2) in the previous step), dilution is performed. An appropriate measurement value is obtained by performing an analysis of the reference items concerning the previous sample.

In the "adjustment of diluted sample", the device control unit 30
Finds the sample showing the abnormal analysis result, and adjusts the sample by performing sample dilution for reanalysis in the middle of the return path where the rack containing the sample is transported from the rack standby section 5 to the rack collection section 3. To do. The dilution rate may be uniformly set to, for example, 1/10, but it is also possible to set a suitable dilution rate for each diluted sample retest item. In particular, regarding the immunity item, it is possible to determine the optimum dilution rate at the time of retesting from the results of the initial analysis. Further, when re-analyzing a reference item, by increasing the amount of sample to be dispensed into the reaction container from the time of the first analysis and performing the analysis, it is possible to obtain more accurate reference data for the reference item. .. In addition, when the dilution ratio is uniformly set, this step can be set between the step of “whether there is a sample dilution corresponding item?” To the step of “interruption analysis of diluted sample retest item and reference item”.

In the "diluted sample retest item and reference item interrupt analysis", the adjusted diluted sample is analyzed for the analytical item and the reference item to be re-analyzed, and each measured value is stored in the data of the device control unit 30. Store in the storage unit. The "interruption analysis" means that the diluted sample is preferentially analyzed over the undiluted sample.

In the "calculation of concentration of diluted sample retest item", the device control unit 30 retests the retest item showing an abnormal analysis result by comparing the previous measurement value C ₁ and the retest measurement value C ₂ for the reference item. The value D ₂ is converted to calculate the measured value D ₁ for the sample before adjustment. For example, if the change in concentration diluted change and the measurement value of the sample is proportional, can be obtained D ₁ are substituted into equation _{D 1 = D 2 × (C} 1 / C 2).

In "Are there remaining samples?", It is judged whether or not a series of samples has been analyzed or re-analyzed. If there is any unanalyzed sample, proceed to the step of “Start first analysis of each item”, but if there is no unanalyzed sample, proceed to the next step “End of analysis” to complete the analysis work of a series of samples. To do.

In the above embodiments, an example of a pickup-type automatic analyzer was explained, but the automatic analysis method of the present invention is: (1) A special container dedicated to sample dilution is installed to measure each sample. An automatic analyzer that dilutes in the container,
(2) It is applied to an automatic analyzer which is provided with a diluted sample transfer line consisting of a plurality of dedicated containers for sample dilution, and (3) an automatic analyzer which dilutes a sample in another reaction container.

Further, in the above embodiment, it is possible to reanalyze a general sample showing normal analysis results and causing no measurement range over, by re-analyzing the sample, and by increasing the number of analyzes, The reliability of the measured value can be improved.

[0033]

As described above in detail, the automatic analysis method of the present invention is a reinspection of a sample showing an abnormal analysis result in the initial analysis, particularly an ultra-high unit sample over the measurement range of the automatic analyzer. Since it can be performed automatically, it is possible to efficiently perform automatic analysis without bothering the analysis operator.

For the analysis item showing the abnormal analysis result in the initial analysis, the reference item is selected from the other measurement items and analyzed together. Therefore, the previous measurement value and the re-examination measurement value of the reference item should be compared. Thus, the measured value of the analysis item indicating the abnormality analysis result can be data-corrected, and the measured value under the initial analysis condition can be accurately obtained.

Further, since the ultrahigh value sample showing the abnormal analysis result is reanalyzed by diluting the sample, it is possible to avoid the difficult work of reducing the amount of the sample of the sample, and the sample sampling accuracy by the sample dilution. Can be improved.

Further, when re-analyzing the diluted sample for the reference item, the amount of the sample to be dispensed into the reaction container is increased from that in the previous analysis to perform the analysis, thereby improving the measurement accuracy for the reference item. Therefore, the conversion error for the retest item can be reduced.

[Brief description of drawings]

FIG. 1 is a control flowchart showing an embodiment of an automatic analysis method of the present invention.

FIG. 2 is a schematic perspective view of an automatic analyzer to which the automatic analysis method of the present invention can be applied.

[Explanation of symbols]

 1 Automatic Analyzer 2 Rack Supply Section 3 Rack Collection Section 4 Rack Transfer Section 5 Rack Standby Section 6 Sample Dispensing Section 7 Reaction Container Transfer Section 8 Reagent Dispensing Section 9 Reagent Container Transfer Section 10 Absorbance Measurement Section 20 Rack 21 Sample Container 22 Reaction container 23 Reagent container 30 Device control unit

Claims (3)

[Claims] 1. As a result of automatic analysis of a series of samples, it is judged whether or not the measured value of each analysis item designated in advance for each sample is within a predetermined reference range, and a sample having an analysis item outside the reference range is detected. If present, 1 of the analysis items within the reference range
Select one or more as reference items, adjust a diluted sample by removing a part of the sample in the sample container for the sample, and injecting a predetermined amount of diluent, Analyzing the diluted sample again for the item, and by comparing the previous measurement value of the reference item with the re-examination measurement value, the re-examination measurement value of the analysis item outside the reference range is converted to calculate the measurement value of the sample before adjustment. Automatic analysis method. 2. As a result of automatic analysis of a series of samples, it is judged whether or not the measurement value of each analysis item designated in advance for each sample is within a predetermined reference range, and a sample having an analysis item outside the reference range is detected. If present, select one or more analysis items other than the previously designated analysis items as reference items, additionally analyze the sample for the reference items, and then perform the analysis of the sample in the sample container. After adjusting a diluted sample by removing a part of the sample and injecting a predetermined amount of diluent,
The diluted sample is analyzed again for the analysis item outside the reference range and the reference item, and the re-examination measurement value is adjusted for the analysis item outside the reference range by the comparison between the previous measurement value and the re-examination measurement value of the reference item. An automatic analysis method that calculates the measured value of the previous sample. 3. The automatic analysis method according to claim 1, wherein when the diluted sample is analyzed again for the reference items, the amount of the sample dispensed to the reaction container is increased from that in the previous analysis to perform the analysis. ..