JP3271741B2 - Automatic analysis method and device - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an automatic analysis method and apparatus, which is used for reacting a sample such as blood collected from a patient at a special hospital with a reagent, measuring the reaction result, and measuring 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 disk system, 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 reagent before the start of analysis. Calibration for density calculation, and stores the result. A set of reagent bottles refers to a single reagent bottle containing reagents for analysis items that require only one type of reagent, and those for analysis items that require multiple types of reagents. Means a reagent bottle containing one reagent for each type. In this case, since only one set of reagent bottles is set, when a large amount of sample is measured, the reagent is insufficient. In this case, the apparatus 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 bar code label is attached to the reagent bottle, and the reagent bottle is distinguished by its code number and serial number. in this case,
If one bottle runs out of reagents, analysis will be performed using another reagent bottle, but the stored calibration results will be based on the reagents in the first set of reagent bottles set for each item. When using the next reagent bottle,
Calibration is newly performed using the standard solution set on the sample disk. When the calibration is not executed, the calibration result of the previous reagent bottle is used as it is.

[0004] In the case of a large-sized automatic analyzer having a plurality of analyzers and a rack in which a sample, a standard solution, and a control sample are moved between the analyzers, the standard solution is used to execute calibration. The loaded rack is placed on the moving line, and calibration execution information is input from the operation unit. If the rack on which the standard solution is loaded is not loaded, the calibration is not executed, and the previous calibration result is used as it is.

[0005]

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 used reagent every time a bottle is replaced. However, it is difficult to keep the quality of the standard solution used for calibrating the reagent constant for at least two hours after opening. Therefore, since the standard solution set on the disk cannot be used for a long time, the operator needs to reset a new standard solution at regular intervals, which is an obstacle to complete automation. Further, the price of the standard solution itself is high, and the cost increases if the standard solution is prepared for each calibration.

In the case of the rack system, the rack on which the standard solution is loaded is not automatically loaded, but is set in the apparatus by an operator as needed. However, when measuring a large number of general samples with a large automatic analyzer with multiple analyzers, it is necessary to accurately determine which analyzer will run out of reagents and need to be calibrated. request,
It is difficult to insert a standard solution rack.

[0007] It is an object of the present invention to provide an automatic analysis method and apparatus which does 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 a highly reliable measurement result.

[0009]

According to the present invention, prior to analysis of an analysis item in a sample, a standard sample is prepared for reagents in a plurality of sets of reagent bottles necessary for analysis of the same analysis item in the sample. The calibration results are collectively used to store the calibration results for each reagent bottle.

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

According to another aspect of the present invention, the calibration is performed on a reagent in a reagent bottle based on an elapsed time from when the reagent is used for analysis of an analysis item in a sample. Thus, the analysis result of the analysis item in the sample is corrected.

[0012] According to this, since the time-dependent change of the measurement result due to the deterioration of the reagent is corrected, a highly reliable measurement result is provided.

[0013]

DESCRIPTION OF THE PREFERRED EMBODIMENTS The outline of the operation of the embodiment according to the present invention is as follows.

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

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

3. When the rack on which the standard solution is loaded is input or the start is designated after the standard solution is set on the sample disk, the calibration is executed based on the combination information of the reagent bottles and the calibration request information.

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

5. In the measurement of a general sample, a parameter of a corresponding calibration curve is called from a code number and a serial number of a reagent bottle used for analysis, and a concentration calculation is performed. If a time-varying parameter that predicts the temporal change of the reagent bottle after calibration is input and stored, the parameters of the calibration curve are corrected based on the elapsed time from the execution of the calibration, and the concentration calculation is performed.

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 and reagent stirring mechanism 3, a reaction disk 5 on which a reaction vessel 4 for reacting a sample and a reagent is set, and a reaction disk 5 in the reaction vessel. A photometer 6 for measuring absorbance, a reaction vessel washing mechanism 7, a sample disk 8 for setting a sample, a reagent disk 9 for setting a reagent,
And 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 rotates and moves 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 vessel 4 is
And the 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 the analysis, the reaction container 4 is washed by the reaction container washing mechanism 7 and used for the next analysis.

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

Reagent registration (S1) A plurality of sets of reagent bottles 1 of the same item are placed on the reagent disk 9.
2 is set. A bar code 13 (see FIG. 2) is attached to a side surface of the reagent bottle 12. The information contained in this barcode includes the item name, reagent manufacturing lot number,
Expiration date of reagent, 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 used for calibration, and the reagent bottle. The designation information is stored in the computer 10.

Input of time-dependent change correction parameter (S3) The operator inputs a correction parameter a for K-factor and a correction parameter b for reagent blank absorbance, which will be described later, from the CRT screen 15, keyboard 16 or floppy disk 17 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 into the sample cup 11 and sets it on the sample disk 8. When the start of calibration 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 vessel, 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 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. A plurality of reagent bottles set for the same item are used first from the one set at the lower 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 the result to the CRT screen 15 or the printer 18. The measurement result is stored in the computer 10 together with information on the measurement time and the used reagent bottle.

When the first of a plurality of reagent bottles becomes empty or approaches empty during the measurement and the computer 10 recognizes it, the second reagent is set from the next analysis, that is, the next lower position number is set. The reagent is dispensed from the reagent bottle that has been used and the analysis is performed. That is, the computer
The data 10 determines whether the first reagent bottle is empty, that is, whether there is a bottle change replacement request (S6).
-1) If the answer is "requested", it is further determined whether or not 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 to the determination in step S6-1 is "no request", the flow returns to step 6, and the answer to the determination in step S6-2 is "not executed".
In this case, 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, this change is corrected as follows.

The computer 10 observes the elapsed time from the execution of the calibration to the measurement of the sample, and (1)
K used directly 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) where K1 is a K factor at the time of calibration K2 is a corrected K factor S1 is an absorbance of a reagent blank at the time of calibration S2 is a corrected reagent blank Absorbance of a: Correction parameter for K factor b: Correction parameter for reagent blank absorbance t: Time from calibration execution to general sample analysis Using 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) where C: the concentration of the sample to be output A: the absorbance of the sample K: the corrected K factor S: the corrected absorbance of the reagent blank FIG. 3 shows the measurement results of alkaline phosphatase in control serum as a sample. FIG. 4 is a graph plotting the measurement results at each time point starting from the end point of the calibration. Curve A shows the data obtained when the change in the measurement results due to the aging of the reagent is corrected using equation (3). Curve B is data without such correction. As is clear from FIG. 4, more stable and reliable results can be obtained by performing data correction.

[0033]

According to the present invention, there is provided an automatic analysis method and apparatus which does 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 highly reliable measurement result.

[Brief description of the drawings]

FIG. 1 is a schematic diagram showing the entire configuration of an automatic analyzer according to one 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 diagram relating to calibration and sample measurement as an example based on the present invention.

FIG. 4 is a diagram showing data when a correction result due to deterioration with time of a reagent is added to the measurement result of alkaline phosphatase in a control serum as a sample, and data when no correction is made; .

[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 vessel washing mechanism, 8 ... sample disk, 9 ... reagent disk, 10 ... computer, 11 ... sample cup, 12 ... reagent bottle, 13 ... barcode, 14 ... barcode reader, 15 ... CRT screen, 16 ... keyboard , 17 ... Floppy disk, 18 ... Printer

Continuation of front page (56) References JP-A-4-138365 (JP, A) JP-A-4-65676 (JP, A) JP-A-8-262028 (JP, A) JP-A-62-144071 (JP) JP-A-5-281242 (JP, A) Patent 2525063 (JP, B2) Patent 2524454 (JP, B2) Utility model registration 2503751 (JP, Y2) Japanese Patent Publication No. 1-25077 (JP, B2) ) Field surveyed (Int. Cl. ⁷ , DB name) G01N 35/00-35/10 JICST file (JOIS)

Claims (4)

(57) [Claims] 1. An automatic analysis method for reacting a sample with a reagent, measuring the result of the reaction, and analyzing an analysis item in the sample, wherein the same item in the sample is analyzed prior to the analysis of the analysis item in the sample. Automatic analysis characterized by carrying out calibration of reagents in a plurality of sets of reagent bottles necessary for analysis of an analysis item by using a standard sample and storing the calibration result for each reagent bottle Method. 2. The method according to claim 1, further comprising the step of: executing the calibration of the reagent in the reagent bottle until the reagent is used for analysis of the analysis item in the sample. 2. 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, measuring a result of the reaction, and analyzing an analysis item in the sample, wherein a plurality of sets necessary for analyzing the same analysis item in the sample are provided. Calibration is performed on the reagents in the reagent bottles in advance using a standard sample, and the calibration results for each of the reagent bottles are stored in a storage device, and based on the storage results stored in the storage device. An automatic analyzer characterized by analyzing an analysis item in the sample. 4. An analysis item in the sample based on an elapsed time from when the calibration is performed on the reagent in the reagent bottle to when the reagent is used for analysis of the analysis item in the sample. 4. The automatic analyzer according to claim 3, wherein the analysis result is corrected.