JPH07103972A - Automatic biochemical analyzing device - Google Patents

Abstract

PURPOSE:To store normal values for each sex and age and to optimize it for each hospital and examination organization. CONSTITUTION:In a data storage part 6, normal values for each item, and far each sex and age, are stored. A data process/control part 10 compares the analysis result with the normal value stored in the data storage part 6, so that whether it is within the range of normal value or it is abnormal is judged, and if it is normal, the analysis value is accumulated for each sex and age. When these accumulated data reach the specified numbers for each item, and for each sex and age, the normal value for each item, and for each sex and age, is calculated based on those accumulated data, and then the stored data in the data storage part 6 is automatically updated based on time calculated value.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a biochemical automatic analyzer for measuring the concentrations of various components of biochemical specimens such as blood and urine and providing them as auxiliary data for diagnosis.

[0002]

2. Description of the Related Art In an automatic biochemical analyzer, when outputting the analysis result of an analyzed sample, whether the analysis value is in a normal value range, an abnormal value lower than the normal value range, or a normal value range. It is determined whether the abnormal value is higher than that, and the determination result is output together with the analysis result. For example, FIG. 1 shows an example of such an analysis result report,
8-40 if GOT is a normal value range for each item
For IU / L and ALP, those set as 4.5-11.0K.A. Are shown, and if the measured value of the sample is abnormally high with respect to the normal value range, it is called H. A mark is added, and conversely, if a low value is abnormal, a mark L is added and output.

The normal value range for each item varies depending on the group of specimens considered to be normal. Also, depending on the item, the age and sex also differ (see, for example, "Clinical Pathology" Vol. 15, p. 105, 1967). Generally, the normal value for adults is used as the normal value, but if the normal value range for adults is used to distinguish between normal and abnormal serum ALP measurement results of pediatric and elderly samples, correct determination should be performed. I can't. Normally, when a doctor makes a judgment by looking at an analysis result report, the judgment is made by taking into consideration whether the subject is a child or an elderly person or gender, and making appropriate corrections. ing. However, there are individual differences in the judgment depending on the doctor, and it may be difficult to make an accurate judgment. Therefore, an automatic analyzer has been proposed in which the normal value range can be set for each sex and age, and whether the measured value is normal or abnormal can be finely determined (see Japanese Patent Laid-Open No. 5-80046).

[0004]

Even if the normal value range can be set according to gender and age like the automatic analyzer described in the cited example, at present, the analysis method is different for each hospital or laboratory. , A common normal value range has not been established, and data cannot be used for accurate judgment unless each hospital or laboratory independently measures and sets the normal value range. However, collecting data for obtaining the normal value range at each hospital is a difficult task. An object of the present invention is to maintain normal values for each sex and age, and to facilitate the normal values to be optimal values for each hospital or inspection institution.

[0005]

With reference to FIG. 2 showing an embodiment, an automatic biochemical analyzer according to the present invention comprises an analysis unit 2 for analyzing designated items of a sample,
An input unit 4 for inputting attribute data such as the subject's sex and age and instructing analysis items, a data storage unit 6 for storing normal values for each item of gender and age, and analysis results And an analysis result output unit 8 for outputting the analysis result, and instructs the analysis unit 2 to analyze the sample according to the items input from the input unit 4 and compares the analysis result with a normal value stored in the data storage unit 6. It is discriminated whether it is within the normal value range or a low value or a high value abnormality, and the discrimination result is added to the analysis result and output from the analysis result output unit 8, and for each item obtained by the analysis. Data within the normal value range (hereinafter referred to as normal data) is accumulated by sex and age, and a normal value for each sex and age for each item is calculated based on the accumulated normal data to calculate the normal value of the data storage unit 6. You can update the stored data with its calculated value And a data processing and control unit 10. How much normal data by sex and age for each item should be accumulated and how much data in the data storage unit 6 should be updated may be set appropriately. The term-specific terms are used not only to indicate a division in units of one year, but also to include a category that includes several years and a category that is above or below a certain age.

[0006]

In the initial state, the data storage unit 6 stores standard normal values for each item, such as sex and age. While performing analysis of samples using this biochemical automatic analyzer, data within the normal value range (normal data) is accumulated compared to standard normal values, and the When the normal data for each age is accumulated, a normal value is calculated based on the normal data collected by the hospital or inspection organization, and the storage data of the data storage unit 6 is updated. The stored data in the data storage unit 6 may be updated automatically or by an operator's operation. As a result, the normal value of the data storage unit 6 is replaced with a value specific to the hospital or laboratory in which the biochemical automatic analyzer is used.

[0007]

FIG. 2 shows an example in which the present invention is embodied as an independent apparatus having a data processing function in addition to an analysis unit in a biochemical automatic analysis apparatus. An analysis unit 2, an input unit 4, a data storage unit 6, an analysis result output unit 8 and a data processing / control unit 10 are provided in one biochemical automatic analyzer 12.

FIG. 3 shows another embodiment.
This is an example of a case where the automatic biochemical analysis device 20 that analyzes a sample and outputs the analysis result and the data processing device 22 are configured as different devices. The data processing device has a part of the functions of the input unit 4, the data storage unit 6, the analysis result output unit 8 and the data processing / control unit 10, and also has the function of updating the normal value for each item by gender and age. ing. The data processing device 22 sends a request for analysis items to the automatic biochemical analysis device 20, and also sends a request for re-examination. From the automatic biochemical analysis device 20, the analysis result of the sample is transmitted to the data processing device 22.

The operation of the embodiment shown in FIG. 2 will be described with reference to FIGS. 4 to 8. The operation of the embodiment shown in FIG. 3 is similar. FIG. 4 shows the analysis request operation. When accepting a sample, enter the attribute data such as the chart number, patient name, sex, date of birth, blood sampling date, etc. for the sample acceptance number (for example, the serial number of the day) from the keyboard of the input unit 4 and select the analysis item for that sample. input. Patient attributes are input as shown in FIG. 5, for example. The data processing / control unit 10 calculates the age of the patient based on the input information, stores the sample acceptance number, the age, and the sex, and instructs the analysis unit 2 on the analysis request item.

The analysis and the determination operation of the analysis result will be described with reference to FIGS. 6 and 7. As shown in FIG. 6, the data storage unit 6 stores, as standard data, a large approximate value as a normal value for each sex for each age group. In the analysis operation, as shown in FIG. 7, when the analysis of the designated item of the sample number is completed and the analysis value is obtained, the data processing / control unit 10 responds to the age and sex of the sample number. The normal value to be obtained is extracted from the normal value data stored in the data storage unit 6, and it is determined whether or not the analyzed value is within the normal value range. If the analysis value is within the normal value range, it is stored as normal data, and then an analysis result report is created and output. On the other hand, if the analyzed value is out of the normal range, comment out the abnormality by adding a symbol L for low value abnormality and H for high value abnormality for each item indicating abnormality. Create and output an analysis result report.

FIG. 8 shows the procedure for updating the data. Normal data within the normal value range of the sample analyzed at the hospital or testing institute has a certain number of normal data according to age and sex for each item, for example. When 100 or more data are accumulated, those normal data are statistically processed to calculate a normal value. In general, it is known that the distribution of measured values of serum components in a normal population is either a left-right contrasted normal distribution type centered on the mode or a lognormal distribution type depending on the measurement item (eg “Clinical Chemistry”). (See Kodansha Scientific, pp. 50-52). The lognormal distribution type is a normal distribution type when data is logarithmically transformed. Therefore, the item indicating the normal distribution type is the analysis data itself, and the item indicating the lognormal distribution type is the logarithmic conversion of the analysis data, and then the average value X and the standard deviation SD are calculated. The stored data in the data storage unit 6 is updated with the calculated X ± 2SD as a normal value for each sex and age at the hospital or inspection institution.

In FIG. 2, the data processing / control unit 10 is realized as a main computer unit, and the data storage unit 6 is realized by a nonvolatile storage device such as a floppy disk device or a hard disk device. The input unit 4 is realized by a keyboard and can input attribute data and request items interactively with a display such as a CRT. The analysis result output unit 8 is, for example, a printer. The analysis unit 2 is an automatic analysis device that can automatically perform an analysis process and output an analysis result if an analysis item is designated. In the configuration shown in FIG. 3, the automatic analysis device 20 and the data processing device 22 having a different configuration are realized by a computer having an input / output device.

[0013]

According to the present invention, the normal values of sex and age are stored for each item, and are stored by using the normal data obtained by the analysis while conducting the analysis at each hospital or laboratory. Since the normal values that are stored can be updated, for example, even if the normal value range varies depending on the region, the optimum normal value range is stored for each region by sex and age. It becomes easy to accurately determine whether or not is normal.

[Brief description of drawings]

FIG. 1 is a diagram showing an example of a conventional analysis result report.

FIG. 2 is a block diagram showing an embodiment.

FIG. 3 is a block diagram showing another embodiment.

FIG. 4 is a flow chart diagram showing an analysis request operation in one embodiment.

FIG. 5 is a diagram showing an example of registration of patient attribute data in one embodiment.

FIG. 6 is a diagram showing an example of normal values of item ALP by age and sex.

FIG. 7 is a flowchart showing an analysis operation in one embodiment.

FIG. 8 is a flowchart showing a data update operation of the data storage unit in the embodiment.

[Explanation of symbols] 2 analysis unit 4 input unit 6 data storage unit 8 analysis result output unit 10 data processing / control unit 12 biochemical automatic analyzer 20 automatic biochemical analyzer 22 data processing device

Claims (1)

[Claims] 1. An analysis unit for performing analysis of items designated for a sample, an input unit for inputting attribute data such as a subject's sex and age, and designating analysis items, and a gender and year for each item. A data storage unit that stores normal values for each instruction, an analysis result output unit that outputs analysis results, and an analysis unit is instructed to analyze the sample according to the items input from the input unit, and the analysis results are stored as data. Compared with the normal value stored in the storage unit, it is determined whether it is within the normal value range or abnormal value of low value or high value, and the determination result is added to the analysis result and output from the analysis result output unit. In addition, the data within the normal value range for each item obtained by analysis is accumulated by gender and age, and the normal value for each item is calculated based on the accumulated data. Calculate the storage data of the storage unit Biochemical automatic analyzer characterized by comprising a data processing and control unit that can be updated with the value, the.