JPH09325150A - Method and apparatus for automatic analysis - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an automatic analyzer which dispenses with a calibration operation anew and allows application of a highly reliable data during the analysis of a specimen. SOLUTION: In an automatic analyzer, a mechanism to recognize a plurality of reagent bottles 12 is arranged and multiple sets of reagents are set in the same item to execute a calibration per reagent bottle 12. A computer 10 stores the results of the calibration for every reagent bottle 12. Thereafter, every specimen is caused to react using the reagents subjected to the calibration. Absorbance is measured for the results of the reaction. The computer 10 stores a hourly changing parameter to correct the data at each item by inputting from an operator and the data is corrected and outputted with the passage of time up to the general analysis of the specimen from the execution of the calibration.

Description

Detailed Description of the Invention

[0001]

TECHNICAL FIELD The present invention relates to an automatic analysis method and device, a sample such as blood collected from a patient in a special hospital, etc., is reacted with a reagent, and the reaction result is measured to measure an analysis item in the sample. A suitable automatic analyzer and method.

[0002]

2. Description of the Related Art In an automatic analyzer, in the case of a disc method, a set of reagent bottles is set for each analysis item to be analyzed in a sample, and a standard solution is used for the set reagents before starting the analysis. Then, the calibration for density calculation is performed and the result is stored. A set of reagent bottles means one reagent bottle containing the reagent in the case of analysis items that require only one type of reagent, and those in the case of analysis items that require multiple types of reagents. It means a reagent bottle in which one reagent of each type is separately stored. In this case, since only one set of reagent bottles is set, there is a shortage of reagents when measuring a large amount of samples. In this case, the device is stopped during the analysis, the bottle is replaced, the calibration is performed again, and the analysis is restarted.

After that, a plurality of sets of reagent bottles can be set for the same item, and a barcode label is attached to the reagent bottle to distinguish the reagent bottles by the code number and the serial number. in this case,
When the reagent in one bottle runs out, the analysis is performed using another reagent bottle, but the stored calibration results show the reagent in the set of reagent bottles initially set for each item. Since it is only a thing, when moving to the next reagent bottle use, regarding the reagent in it,
A new calibration is performed using the standard solution set on the sample disk. When the calibration is not executed, the calibration result for the previous reagent bottle is used as it is.

In the case of a system in which a large-sized automatic analyzer has a plurality of analysis units and a rack on which a sample, a standard solution, and a control sample are placed is moved between the analysis units, the standard solution is used to perform calibration. The loaded rack is placed on the moving line, and the calibration execution information is input from the operation unit. If the rack containing the standard solution is not loaded, the calibration is not executed and the previous calibration result is used as it is.

[0005]

DISCLOSURE OF THE INVENTION In the case of the disk system,
As described above, it is possible to set a plurality of sets of reagent bottles, but it is necessary to calibrate the reagents used each time the bottles are replaced. However, it is difficult to keep the quality of the standard solution used for calibrating the reagent constant for 2 hours or more after opening. Therefore, since the standard solution set on the disk cannot be used for a long time, it is necessary for the operator to reset a new standard solution at regular intervals, which is an obstacle to complete automation. Moreover, the price of the standard solution itself is high, and the cost is high if the standard solution is prepared for each calibration.

In the case of the rack system, the rack on which the standard solution is placed is not automatically loaded, but the operator sets it in the apparatus as needed. However, when measuring a large amount of general sample with a large-sized automatic analyzer having multiple analysis units, it is necessary to accurately determine which analysis unit runs out of reagents and requires calibration, and request,
It is difficult to load the standard solution rack.

It is an object of the present invention to provide an automatic analysis method and apparatus which do not require a calibration operation during the analysis of a sample and therefore can perform the analysis efficiently.

Another object of the present invention is to provide an automatic analysis method and apparatus suitable for giving highly reliable measurement results.

[0009]

In the present invention, prior to the analysis of an analysis item in a sample, standard samples are prepared for reagents in a plurality of sets of reagent bottles necessary for the analysis of the same analysis item in the sample. The calibration is performed collectively by using the calibration results stored in each reagent bottle.

According to this, it is not necessary to carry out the calibration every time the reagent bottle is changed during the analysis, so that the analysis can be efficiently performed.

According to another aspect of the present invention, based on the elapsed time from the execution of the calibration on the reagent in the reagent bottle to the use of the reagent for the analysis of the analysis item in the sample. Therefore, the analysis result of the analysis item in the sample is corrected.

According to this, since the change with time of the measurement result due to the deterioration of the reagent is corrected, a highly reliable measurement result is provided.

[0013]

BEST MODE FOR CARRYING OUT THE INVENTION The outline of the operation of the embodiment according to the present invention is as follows.

1. When the reagent bottle is set in the device, the barcode label attached to the bottle will
Recognize the serial number that distinguishes the analysis item and reagent bottle. When several types of reagents such as the first reagent and the second reagent are required for one analysis item, and when a plurality of these types of reagents are set, which reagent bottle is to be combined into one set is registered and stored. . In this case, the reagent bottles of all kinds of reagents are usually different if the sets are different. However, the reagent bottles of either type of reagent may be common to a plurality of sets.

2. On the calibration screen, the presence or absence of the calibration result for each combination of reagent bottles is displayed as a list. The operator registers the combination of bottles that require calibration from the operation unit. Which standard solution is required for each analysis item is specified and stored in advance.

3. When the rack is loaded with the standard solution or the start is specified after setting the standard solution on the sample disk, the calibration is executed according to the reagent bottle combination information and the calibration request information.

4. As the calibration result, the item code, serial number, and calibration curve parameters are stored for each combination of reagent bottles.

5. In the measurement of a general sample, the parameter of the corresponding calibration curve is called from the code number and serial number of the reagent bottle used for the analysis, and the concentration is calculated. Further, when the time-dependent change parameter that predicts the time-dependent change of the reagent bottle after calibration is input and stored, the parameter of the calibration curve is corrected according to the elapsed time from the execution of calibration, and the concentration is calculated.

An embodiment of the present invention will be described below with reference to FIG.

This automatic analyzer comprises a sample dispensing mechanism 1, a reagent dispensing mechanism 2, a sample-reagent stirring mechanism 3, a reaction disk 5 in which a reaction container 4 for reacting the sample and the reagent is set, and a reaction container A photometer 6 for measuring absorbance, a reaction container cleaning mechanism 7, a sample disk 8 for setting a sample, a reagent disk 9 for setting a reagent,
It is composed of a computer 10 for controlling the whole. The sample is put in the sample cup 11 and set on the sample disk 8. The reagent is placed in a reagent bottle 12 and set on a reagent disk 9.

To explain an operation example of the automatic analyzer to which the present invention is applied, the sample disk 8 is rotationally moved to move the sample container containing the sample to be analyzed to the position of the sample dispensing mechanism 1. . After aspirating the sample, the sample dispensing mechanism 1 discharges a required amount into the reaction container 4. Thereafter, the reaction disk 8 rotates and stops at the position of the reagent dispensing mechanism 2, and a required amount of reagent is discharged into the reaction container 4 by the reagent dispensing mechanism 2. After that, the reaction container 4 is stirred by the stirring mechanism 3.
It moves to the position of and stirring is performed. The stirred reaction vessel 4 passes through the position of the photometer 6 and the absorbance is automatically measured, and the absorbance is converted into a concentration by the computer 10. After completion of the analysis, the reaction container 4 is washed by the reaction container washing mechanism 7 and used for the next analysis.

Next, the method of calibration and the method of measuring the sample will be specifically described with reference to FIG.

Reagent registration (S1) On the reagent disk 9, a plurality of sets of reagent bottles 1 of the same item
2 is set. A barcode 13 (see FIG. 2) is attached to the side surface of the reagent bottle 12. The information contained in this barcode is the item name, reagent manufacturing lot number,
The expiration date of the reagent and the reagent bottle size. The information on the reagent bottle read by the barcode reader 14 and the position of the reagent bottle on the reagent disk are stored in the computer 10.

Designation of Calibration (S2) The operator uses the CRT screen 15, the keyboard 16 or the floppy disk 17 to designate the items to be calibrated, the standard solution and the reagent bottle used for the calibration. The designation information is stored in the computer 10.

Input of time-dependent change correction parameters (S3) The operator uses the CRT screen 15, the keyboard 16 or the floppy disk 17 to input a correction parameter a for K factor and a correction parameter b for reagent blank absorbance described later for each analysis item. input. The input parameters are stored in the computer 10.

Execution of calibration (S4) and output of the result (S5) The operator puts the standard solution in the sample cup 11 and sets it on the sample disk 8. When the calibration start is designated, the computer controls the apparatus according to the stored information, dispenses the designated standard solution and the reagent in the reagent bottle into the reaction container, and performs photometry after the reaction is completed. The calibration result for each reagent bottle is stored in the computer 10 for each reagent bottle together with the code number, serial number, and calibration execution time of the reagent bottle, and is output to the CRT screen 15 or the printer 18.

Measurement of general sample (S6) and output of the result (S7) A large number of general samples are set on the sample disk, and the operator uses the CRT screen 15, keyboard 16 or floppy disk 17 to analyze the sample and analysis items. Is specified. The analysis is started, and the sample and the reagent are dispensed into the reaction container 6. The reagent bottles in which a plurality of sets are set for the same item are first used from the one set in the young position number on the reagent disk 9. The computer 10 calls the calibration result of the reagent bottle from the code number and serial number of the reagent bottle used for the analysis of the sample, calculates the measurement result of the sample, and outputs it to the CRT screen 15 or the printer 18. Further, the measurement result is stored in the computer 10 together with the measurement time and the information of the reagent bottle used.

When one of the reagent bottles in the plurality of reagent bottles becomes empty or near empty during measurement and the computer 10 recognizes it, the second reagent from the next analysis, that is, the next lower position number is set. The reagent is dispensed from the reagent bottle and the analysis is performed. That is, the computer
The server 10 determines whether the first reagent bottle is empty, that is, whether there is a bottle change request (S6).
-1) If the answer is "requested", it is further determined whether the calibration has been executed (S6-2),
If the answer is "executed", the bottle is changed (S6-3) and the analysis of the general sample is continued (S6).
-4). If the answer in step S6-1 is "No request", the flow returns to step 6, and the answer in step S6-2 is "not executed".
If so, the flow returns to step S4.

Since the measurement result changes due to the deterioration of the reagent over time and the reliability is impaired, the change is corrected as follows.

The computer 10 observes the elapsed time from the execution of calibration to the measurement of the sample, and (1)
K directly used for the concentration calculation of the sample by the formula and the formula (2)
Determine the factor and reagent blank absorbance.

K2 = K1 + at (1) S2 = S1 + bt (2) Here, K1 ... K factor during calibration K2 ... Corrected K factor S1 ... Absorbance of reagent blank during calibration S2 ... Corrected reagent blank Absorbance of a ... Correction parameter for K factor b ... Correction parameter for reagent blank absorbance t ... Time from execution of calibration to analysis of general sample Calculated K factor and reagent blank absorbance using equation (3) The density is calculated and output to the CRT screen 15 or the printer 18.

C = K × (A−S) (3) Here, C ... Concentration of the sample to be output A ... Absorbance of the sample K ... Corrected K factor S ... Corrected reagent blank absorbance In FIG. The measurement result of alkaline phosphatase in control serum as a sample is shown. FIG. 4 is a plot of the measurement result at each time point starting from the end point of the calibration, and the curve A shows the data when the change in the measurement result due to the deterioration of the reagent with time is corrected using the equation (3). Curve B is the data without such correction. As is clear from FIG. 4, more stable and reliable results can be obtained by correcting the data.

[0033]

Industrial Applicability According to the present invention, there is provided an automatic analysis method and apparatus which do not require a calibration operation during the analysis of a sample and therefore can perform the analysis efficiently.

According to another aspect of the present invention, there is provided an automatic analysis method and apparatus suitable for giving a reliable measurement result.

[Brief description of drawings]

FIG. 1 is a schematic diagram showing the overall configuration of an automatic analyzer according to an embodiment of the present invention.

FIG. 2 is an external view of a reagent bottle used in the automatic analyzer of FIG.

FIG. 3 is a flow chart regarding calibration and sample measurement as an example according to the present invention.

FIG. 4 is a diagram showing data obtained by correcting the alkaline phosphatase measurement result in control serum as a sample with correction due to deterioration with time of the reagent, and data without the correction. .

[Explanation of symbols]

REFERENCE SIGNS LIST 1 sample dispensing mechanism 2 reagent dispensing mechanism 3 stirring mechanism 4 reaction vessel 5 reaction disk 6 photometer 7
... Reaction container cleaning mechanism, 8 ... Sample disk, 9 ... Reagent disk, 10 ... Computer, 11 ... Sample cup, 12 ... Reagent bottle, 13 ... Bar code, 14 ... Bar code reader, 15 ... CRT screen, 16 ... Keyboard , 17 ... Floppy disk, 18 ... Printer

Claims (4)

[Claims] 1. An automatic analysis method in which a sample is reacted with a reagent, and the reaction result is measured to analyze an analysis item in the sample, which is the same in the sample prior to the analysis of the analysis item in the sample. An automatic analysis characterized in that calibration is performed collectively using standard samples for reagents in multiple sets of reagent bottles necessary for analysis of analysis items, and the calibration results for each reagent bottle are stored. Method. 2. An analysis item in the sample based on the elapsed time from the execution of the calibration for the reagent in the reagent bottle to the use of the reagent for the analysis of the analysis item in the sample. The automatic analysis method according to claim 1, wherein the analysis result is corrected. 3. An automatic analyzer for reacting a sample with a reagent and measuring the reaction result to analyze the analysis item in the sample, comprising a plurality of sets required for analyzing the same analysis item in the sample. Carry out the calibration in advance using the standard sample for the reagents in the reagent bottles, store the calibration results for each reagent bottle in a storage device, and based on the storage results stored in the storage device. An automatic analyzer characterized in that it analyzes an analysis item in the sample. 4. The analysis item in the sample based on the elapsed time from the execution of the calibration for the reagent in the reagent bottle to the use of the reagent for the analysis of the analysis item in the sample. The automatic analyzer according to claim 3, wherein the analysis result of (1) is corrected.