JP2008096218A - Clinical examination system - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a clinical examination system that takes into consideration the "uncertainty", and the like, of examination data, in normal daily examinations. <P>SOLUTION: The clinical examination system that includes an in vitro diagnostic examination apparatus is equipped with an examination device for outputting measured data and a comparison system for comparing the measuring data, outputted from the examination device, with various determination levels. When the values of the measured data due to the comparison system are compared with the determination levels, the measured data is automatically discriminated as data having width, that takes into consideration measurement errors or the uncertainty in the examination data. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

  The present invention relates to a clinical test system that provides information for diagnosing a subject by comparing the results of measuring concentrations of various components in a body fluid such as blood and urine with various determination levels.

  A reference value (for example, a normal value) is the most common judgment level for test data in a sample such as a body fluid. In addition, there are those for which a judgment level is defined in a specific item in order to diagnose a specific disease. For example, the blood glucose level for diagnosing diabetes and the total cholesterol level as hyperlipidemia correspond to this.

  Conventionally, the test result in the sample testing device is compared with various judgment levels stored in advance in the device, and when the level exceeds or falls below that level, a symbol that can be used to determine that is the test value. It was attached to and output.

  For example, in ALT (GPT), which is one of the test items used for diagnosing liver dysfunction, the reference value range is defined as 6 to 30 U / l. When the specimen inspection data is 40 U / l, the specimen inspection apparatus gives an output to the inspector that the inspection data exceeds the upper limit of the reference range, and outputs it with a symbol such as H (High). . Usually, a report to a clinician is accompanied by a reference range, and a symbol indicating that the judgment level is exceeded is not given.

  How the clinician interprets the test data when obtaining and diagnosing the test result will be described by taking the total cholesterol value, which is a test item for diagnosing a specific disease, as an example.

  Even if the reference range of total cholesterol is 130 to 250 mg / dl, the ideal upper limit value is 200 mg / dl, the monitoring range is 201 to 220 mg / dl, and the range that requires treatment is 221 mg / dl, and the data is managed. Suppose you have a facility. In such a facility, a person with a test result of 199 mg / dl is judged to be within the ideal range, but the test result naturally includes an error, and the value of 199 mg / dl is inherently within a certain range. Needs to be interpreted. However, conventionally, information relating to the measurement error is not provided to the examination data and provided to the clinician, and the clinician reads the data assuming some error.

  On the other hand, in laboratories, efforts have been started to obtain more accurate examination data with the intention of eliminating data differences between hospitals. Part of that effort is to clarify the uncertainty of inspection data. However, in reality, the concept of “uncertainty” is still understood only by a limited number of people.

  In addition, a system is disclosed in which patient data measured by an automatic analyzer is taken online into a clinical examination system, and normality / abnormality is automatically determined (see, for example, Patent Document 1).

JP 11-296605 A

  In the conventional technology, there is a possibility that the inspection data near the determination level is not properly interpreted. First, when the test data is automatically compared with various judgment levels in the specimen testing device or test system, the data numerical values themselves are compared, taking into account the range of data reliability, that is, the uncertainty associated with measurement errors. May not have been. For this reason, inspection data near the determination level may not be properly determined.

  In addition, since the clinician who diagnoses the patient based on the test result is not provided with information on how much the data should be considered, the test data near the judgment level is appropriate even in this diagnosis. May not be judged.

  On the other hand, a laboratory accreditation system has been started with the aim of improving the quality of specimen testing. In this certification system, it is required to grasp the "uncertainty" of inspection data in daily inspections, and a protocol for determining this uncertainty is presented. However, there is no system that reflects the information in the test report to the clinician, and a test system that can make use of the uncertainties required is necessary.

  The present invention has been made in view of the above, and an object of the present invention is to construct a clinical test system in consideration of “uncertainty” of test data.

  In order to solve the above-described problems and achieve the object, the invention of claim 1 is a clinical examination system including an in-vitro diagnostic examination apparatus, an examination apparatus that outputs measurement data, and measurement data output by the examination apparatus. A comparison system that compares the measured value with various judgment levels.When comparing the measured data value with the judgment level by the above comparison system, the measurement data is a width that takes into account measurement errors and uncertainties. It is characterized in that it is automatically discriminated as having certain data.

  The invention according to claim 2 is the clinical examination system according to claim 1, wherein the measurement error and uncertainty of the measurement data are obtained in advance at one or more concentrations, and based on the results, the individual measurement data The automatic calculation is performed according to the density.

  According to a third aspect of the present invention, in the clinical test system according to the first aspect, the measurement error and uncertainty estimated for each measurement data as a test report are output as a test report.

  The invention of claim 4 is the clinical examination system according to claim 2, wherein only measurement data having a value close to the determination level is output in consideration of measurement error and uncertainty of the measurement data. The clinical test system according to claim 2.

  According to a fifth aspect of the present invention, in the clinical test system according to the first aspect, the measurement error and the uncertainty of the measurement data are obtained in advance at one or more concentrations, and based on the results, various determination levels are obtained. Corresponding errors and uncertainties are calculated, and based on the calculated errors and uncertainties, the errors and uncertainties are output for measurement data in the vicinity of various determination levels.

  According to a sixth aspect of the present invention, in the clinical examination system according to the fifth aspect, the comparison system is capable of setting a range in the vicinity of the various determination levels.

  According to the present invention, it is possible to construct a judgment / diagnosis system in consideration of “uncertainty” of test data, to appropriately interpret measurement data in the vicinity of various judgment levels, and to provide high diagnostic accuracy by a clinician. Become. In addition, it is possible to easily determine whether or not the change in measurement data during follow-up observation is within an error range.

  The best mode for carrying out the present invention (hereinafter referred to as an embodiment) will be described below with reference to the accompanying drawings.

  FIG. 1 is a diagram showing a schematic configuration of a system according to an embodiment of the present invention. The measurement data obtained by the sample testing apparatus 1 is transmitted to the test system 2, and the test result is output by the test system 2. The test result to be output is printed by the printer 3 as a test report for each test item and provided to the clinician, for example.

  The inspection system 2 has a function as a comparison system for comparing the measurement data with the judgment level, and various types of measurement data that take measurement data into consideration based on the measurement error and “uncertainty” obtained in advance during the comparison. Estimate the judgment level range and add it to the inspection report.

  Next, from the measurement error obtained by measuring a sample having a plurality of concentrations in advance by the inspection system 2 in FIG. An example of a method for estimating “sa” is shown. For methods for obtaining measurement errors and “uncertainty” in advance, refer to “Internal accuracy control and clinical chemistry in clinical tests: 2004. Vol. 33 Supp. 2”.

  First, an estimation method from the correlation regression equation will be described.

For example, a correlation regression equation is obtained from the data of concentration (X) and expanded uncertainty (Y) shown in Table 1. In the case of the data in Table 1, Y = 1.37 + 0.016X.

  In the inspection item in which the upper limit of the determination level in the measurement data is set to 110 and the lower limit is set to 30, if the measurement data is 107, the expanded uncertainty obtained from the regression equation described above is 3.08. When expansion uncertainty is considered in this measurement data, it becomes “107 ± 3.08”, and it is necessary to perform diagnosis in consideration of the width of 104 to 110. In this case, the value 107 of the measurement data is lower than the upper limit value 110 when only the data measurement data is viewed, but this upper limit value is exceeded when considering the expansion uncertainty, so care must be taken during diagnosis. Become.

  For example, when the measurement data is greater than or equal to the upper limit of the judgment level, and “L” is given if the measurement data is less than or equal to the lower limit, the measurement data is In the case of 107, no symbol is particularly given, but in the determination method as in the present embodiment, the inspection report to which the symbol “H” is given by the inspection system 2 is output.

  Next, an example in which the ratio of the expanded uncertainty to the concentration is assumed to be constant will be described. When the concentration of the sample to be measured in advance is one type, it is desirable to measure a sample having a concentration near the determination level in order to obtain “uncertainty”. If this is not possible, the reliability is slightly lowered, but the “uncertainty” is calculated assuming that the ratio of “extended uncertainty / concentration” is the same.

  When only the data when the concentration (X) is 150 shown in Table 1 exists, 4/15 × 100 = 2.7 (%), and the expanded uncertainty for the measurement data 107 is 2.89. It becomes. Considering the expanded uncertainty in this measurement data, it becomes “107 ± 2.89”, and “H” is given to the inspection report as in the case described above.

  In any of the methods described above, the inspection report is output after adding a range in consideration of “uncertainty” to the measurement data. In the above-described example, “107 ± 3” or “107 (104 to 110)” may be used.

A range in which “uncertainty” is taken into consideration may be given to all measurement data and output. However, there is a case where it is not necessary to consider “uncertainty” for measurement data that differs greatly from the judgment level. In such a case, there is no need to indicate the range. Table 2 shows an example in which a range is given to all measurement data and an example in which a range is given only to measurement data near the determination level.

  Whether or not it is in the vicinity of the determination level can be set in consideration of “uncertainty”. In the example described above, the determination level is 110, and the “uncertainty” is 3.13. For example, the measurement data in the range of 105 to 115 may be targeted by widening a little.

  When comparing measured data and judgment level, it is not necessary to indicate the range that can be taken for all measured data, but in the case of data that is being followed, for example, to detect the presence or absence of changes Useful. For example, when the measurement data changes from 113 to 108, taking “uncertainty” into consideration, they become 110 to 116 and 105 to 111, and it cannot be determined that there is always a change. For the above reasons, it is only necessary to allow the inspection system 2 shown in FIG. 1 to set whether the range is described in all measurement data or only the measurement data near the determination level.

  As is clear from the above description, the present invention can include various embodiments and the like not described herein, and within a scope that does not depart from the technical idea specified by the claims. Various design changes can be made.

It is a figure showing a schematic structure of a system concerning an embodiment of the invention.

Explanation of symbols

1 Sample testing equipment (testing equipment)
2 Inspection system (comparison system)
3 Printer

Claims (6)

In clinical laboratory systems including in-vitro diagnostic inspection devices,
An inspection device that outputs measurement data;
A comparison system for comparing the value of the measurement data output by the inspection apparatus with various determination levels;
A clinical test characterized by automatically determining measurement data as a wide range of data that takes into account measurement errors and uncertainties when comparing the measurement data values and determination levels with the comparison system. system. The measurement error or uncertainty of the measurement data is obtained in advance at one or more concentrations, and automatic calculation is performed according to the concentration of each measurement data based on the result. Clinical laboratory system. The clinical test system according to claim 1, wherein a measurement error or uncertainty estimated for each measurement data as a test report is output as a test report. The clinical examination system according to claim 2, wherein only the measurement data having a value near the determination level is output in consideration of measurement error and uncertainty of the measurement data. Measurement errors and uncertainties in the above measurement data are obtained in advance at one or more concentrations. Based on the results, errors and uncertainties corresponding to the concentrations at various determination levels are calculated. The clinical examination system according to claim 1, wherein the error and uncertainty of the measurement data are output. 6. The clinical examination system according to claim 5, wherein the comparison system is capable of setting a range in the vicinity of the various determination levels.

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